Operative versus non-operative treatment for clavicle fracture
医学论文英文摘要的写作
英文标题的写作-注意事项 英文标题的写作 注意事项
2.尽量选用特指词和关键词 尽量选用特指词和关键词 一个含意常有多种表达方式 肝癌：hepatocarcinoma, liver cancer/ carcinoma, 肝癌： hepatic cancer/ carcinoma, liver/ hepatic neoplasm 望文生义 ：congenital skin webbed fingers syndactyly of fingers
A postmortem study of 64 vagus nerves from 32 children up to 1 year of age was done to determine the incidence of ectopic parathyroid tissue. The segments of nerve (average length, 2.6 cm), including the entire ganglion nodosum, were examined using a combination of step and serial sectioning. Discrete solitary collections of ectopic parathyroid chief cells were seen in 6% of vagus nerves and ranged in diameter from 162 to 360 micron. Confirmation of the nature of the cells was based on the presence of abundant glycogen and positive immunoreactivity for chromogranin and parathormone. The possible significance of intravagal parathyroid tissue is briefly discussed.
考研英语急救50词
hesitate
v.实现，取得
achieve
n.结论
conclusion
v.逆转，彻底改变
reverse
n.情形，状况
situation
n.消费者，顾客
consumer
v.-ing写
writing
n.目的
purpose
n.建议
suggestion
n.道歉
apology
adv.真诚地；诚实地
sincerely
n.环境；外界；围绕
environment
n.政府；治理
government
n.协调；和谐
harmony
n.想象力
imagination
adj.必不可少的；必须的
indispensable
n.必要性；必然性
necessity
n.哲学；哲理；人生观
philosophy
adj.心理的；心理学的
psychological
n.现象
phenomenon
v.描绘
depict/portray
adv.首先
initially
adj.有利的，有好处的
advantageous/beneficial/favorable
n.态度
attitude
n.挫折
setback
n.自制力；纪律
discipline
n.进步，提升
advancement
vt.加快；促进
accelerate
adj.明智的；可取的aFra bibliotekvisable
v.影响
influence/impact2/effect
n.竞争
2016年04月急性冠脉综合征治疗新药临床研究指导原则.(英文版)
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom1 April 2016 1 EMA/CHMP/207892/20152 Committee for medicinal products for human use (CHMP)3 Guideline on clinical investigation of new medicinal 4products for the treatment of acute coronary syndrome 5(CPMP/EWP/570/98) 6Draft7 Draft agreed by Cardiovascular Working PartyFebruary 2016 Adopted by CHMP for release for consultation1 April 2016 Start of public consultation 27 April 2016 End of consultation (deadline for comments)31 October 2016 8 This guideline replaces 'Points to consider on the clinical investigation of new medicinal products for the 9 treatment of acute coronary syndrome (ACS) without persistent ST segment elevation' 10 (CPMP/EWP/570/98). 1112 Comments should be provided using this template . The completed comments form should be sent to CVSWPSecretariat@ema.europa.eu .13Keywords Acute coronary syndrome, STE-ACS, NSTE-ACS, guideline, CHMP1415Table of contents16Executive summary (4)171. Introduction (background) (4)182. Scope (5)193. Legal basis and relevant guidelines (5)204. Choice of efficacy criteria (endpoints) (6)214.1. All-cause mortality and CV mortality (6)224.2. New myocardial infarction (6)234.3. Revascularisation (6)244.4. Unstable angina pectoris necessitating hospitalisation (6)254.5. Stent thrombosis (6)264.6. Stroke (7)274.7. Left ventricular function and heart failure (7)284.8. Composite endpoints (7)294.9. Endpoints in fibrinolysis studies (7)305. Methods to assess efficacy (how to measure the endpoints) (8)315.1. Mortality (8)325.2. New myocardial infarction (8)335.3. Revascularisation (8)345.4. Unstable angina pectoris necessitating hospitalisation (8)355.5. Stent thrombosis (8)365.6. Ventricular function and heart failure (9)375.7. Angiographic endpoints (9)386. Selection of patients (9)396.1. Study population (9)406.1.1. STE-ACS (ST elevation acute coronary syndrome) (9)416.1.2. NSTE-ACS (Non-ST elevation acute coronary syndrome) (9)426.1.3. Unstable angina (9)436.2. Inclusion criteria for the therapeutic studies (10)446.3. Exclusion criteria for the therapeutic studies (10)456.4. Risk Stratification (10)466.5. Special populations (11)476.5.1. Older patients (11)487. Strategy and design of clinical trials (11)497.1. Clinical pharmacology (11)507.2. Therapeutic exploratory studies (12)517.2.1. Objectives (12)527.2.2. Design (12)537.3. Confirmatory Therapeutic Studies (12)547.3.1. Objectives (12)557.3.2. Background therapy (12)567.3.3. Choice of comparator (13)577.3.4. Duration of clinical studies (13)587.3.5. Analyses and subgroup analysis (13)598. Safety aspects (14)608.1. Bleedings (14)618.2. All-cause mortality (15)628.3. Thrombocytopenia (15)638.4. Rebound effect (15)648.5. Effects on laboratory variables (15)658.6. Effects on concomitant diseases (15)66References (16)6768Executive summary6970Two CHMP Guidelines have been previously developed to address clinical investigations of new71medicinal products for the treatment of acute coronary syndrome (ACS): (I) the CHMP points toconsider (PtC) on the clinical investigation of new medicinal products for the treatment of acute7273coronary syndrome without persistent ST-segment elevation (CPMP/EWP/570/98), published in 2000 74[1], and (II) the CHMP PtC on the clinical development of fibrinolytic products in the treatment of75patients with ST segment elevation myocardial infarction (CPMP/EWP/967/01), published in 2003 [2].76Since their finalisation, major developments have taken place in the definitions, diagnosis,77interventions and management of ACS, as reflected in the relevant European Society of Cardiology78(ESC) clinical practice guidelines (3, 4). Currently, an update of the above mentioned CHMP Guidelines 79is considered necessary to take these new developments into consideration based on literature review 80and experience gained with medicinal products intended for treatment during the acute phase and81beyond. The present update includes the following changes: 1) guidance addressing both ST-segment 82elevation myocardial infarction (STEMI) and non-ST-segment elevation myocardial infarction83(NSTEMI), as well as unstable angina (UA), 2) update in their definitions, 3) risk stratification using84different scoring systems, 4) investigated endpoints, and 5) clinical developments of new medicinal85products beyond the acute stage, including agents other than antiplatelets and anticoagulants.1. Introduction (background)8687Cardiovascular diseases are currently the leading cause of death in industrialized countries and also 88expected to become so in emerging countries by 2020 [3, 4]. Among these, coronary artery disease 89(CAD) is the most prevalent manifestation and is associated with high mortality and morbidity. ACS 90has evolved as a useful operational term to refer to any constellation of clinical symptoms that are91compatible with acute myocardial ischemia. It encompasses (STEMI), NSTEMI, and UA.92ACS represents a life-threatening manifestation of atherosclerosis. It is usually precipitated by acute 93thrombosis induced by a ruptured or eroded atherosclerotic coronary plaque, with or without94concomitant vasoconstriction, causing a sudden and critical reduction in blood flow. In the complex95process of plaque disruption, inflammation was revealed as a key pathophysiological element. Non-96atherosclerotic aetiologies are rare e.g. such as arteritis and dissection.97The leading symptom of ACS is typically chest pain. Patients with acute chest pain and persistent (>20 min) ST-segment elevation have ST-elevation ACS (STE-ACS) that generally reflect an acute total9899coronary occlusion. Patients with acute chest pain but without persistent ST-segment elevation have 100rather persistent or transient ST-segment depression or T-wave inversion, flat T waves, pseudo-101normalization of T waves, or no ECG changes. At presentation, based on the measurement of102troponins, it is possible to further discriminate between the working diagnosis of non-ST-elevation ACS 103(NSTE-ACS) and unstable angina.104NSTE-ACS is more frequent than STE-ACS [5] with an annual incidence around 3 per 1000 inhabitants, 105but varying between countries [6]. Hospital mortality is higher in patients with STEMI than among 106those with NSTEMI (7% vs. 3–5%, respectively), but at 6 months the mortality rates are very similar 107in both conditions (12% and 13%, respectively) [5,7,8]. Long term follow-up shows that death rates 108were higher among patients with NSTE-ACS than with STE-ACS, with a two-fold difference at 4 years[8]. This difference in mid- and long-term evolution may be due to different patient profiles, since 109110NSTE-ACS patients tend to be older with more co-morbidities, especially diabetes and renal failure.2. Scope111112The aim of this guideline is to provide guidance when performing trials to develop medicinal products 113in the management of ACS. The primary goals of therapy for patients with ACS are to:1. Treat acute, life-threatening complications of ACS, such as serious arrhythmias, pulmonary 114115oedema, cardiogenic shock and mechanical complications of acute myocardial infarction (AMI). [9] 1162. Reduce the amount of myocardial necrosis that occurs in patients with AMI, thus preserving 117left ventricular (LV) function, preventing heart failure (HF), and limiting other cardiovascular118complications.1193. Prevent major adverse cardiac events like death, non-fatal myocardial infarction (MI), andneed for urgent revascularization.120121The focus in this Guideline concerns mainly the medical treatment of ACS (treatment goals 2 and 3). 122The choice of interventional procedures [percutaneous coronary intervention (PCI) or coronary artery 123bypass graft CABG)] falls outside the scope of this guideline.3. Legal basis and relevant guidelines124125This guideline has to be read in conjunction with the introduction and general principles and parts I 126and II of the Annex I to Directive 2001/83 as amended.127Pertinent elements outlined in current and future EU and ICH guidelines, should also be taken into 128account, especially those listed below:129•Dose-Response Information to Support Drug Registration (ICH E4; CPMP/ICH/378/95).130•Statistical Principles for Clinical Trials (ICH E9; CPMP/ICH/363/96).131•Choice of Control Group and Related Issues in Clinical Trials (ICH E10; CPMP/ICH/364/96).132•Points to consider on an Application with 1) Meta-analyses 2) One pivotal study133(CPMP/EWP/2330/99).134•Points to consider on multiplicity issues in clinical trials (CPMP/EWP/908/99).135•Investigation of subgroups in confirmatory clinical trials (EMA/CHMP/539146/2013).136•The Extent of Population Exposure to Assess Clinical Safety for Drugs (ICH E1A;137CPMP/ICH/375/95).138•Pharmacokinetic Studies in Man (3CC3A).139•Studies in Support of Special Populations: Geriatrics (ICH E7 CHMP/ICH/379/95) and related Q&A 140document (EMA/CHMP/ICH/604661/2009).141•Note for Guidance on the Investigation of Drug Interactions (CPMP/EWP/560/95).142•Reporting the Results of Population Pharmacokinetic Analyses (CHMP/EWP/185990/06).143•Reflection paper on the extrapolation of results from clinical studies conducted outside the EU to 144the EU-population (EMEA/CHMP/EWP/692702/2008).145•Draft Guideline on clinical investigation of medicinal products for the treatment of chronic heart 146failure (EMA/392958/2015 )•Guideline on clinical investigation of medicinal products for the treatment of acute heart failure147148(CPMP/EWP/2986/03 Rev. 1)4. Choice of efficacy criteria (endpoints)149150Definitions of clinical endpoints in confirmatory trials should be in line with the relevant clinical151guidelines to facilitate interpretation of the results, to allow comparisons across clinical studies and to 152extrapolate to clinical practice. Endpoints should be centrally adjudicated by a blinded committee. The 153following endpoints are relevant to the investigation of efficacy in patients with ACS.4.1. All-cause mortality and CV mortality154155As one of the goals of treatment of ACS is reduction of mortality, this is an important endpoint to156measure. There is an ongoing debate around the use of all-cause versus cardiovascular mortality in 157cardiovascular (CV) trials. All cause mortality is the most important endpoint in clinical trials for the 158estimation of the benefit-risk balance of a drug, in particular when investigating newer medicinal159products with possible safety issues. On the other hand, CV mortality is more specifically linked to the 160mode of action of CV medicinal products/intervention and is especially relevant when the earliest part 161of the follow up is assessed. The choice is also dependent on the objective of the study i.e. in non-162inferiority trials, CVmortality may be preferred while in superiority trials all cause mortality is usually 163used. In fibrinolysis studies, all cause mortality is preferred (see section 4.9).164As such, one of the two mortality endpoints should be included as a component of the primary165endpoint, with the other investigated as a key secondary endpoint.4.2. New myocardial infarction166167New onset MIis a relevant endpoint in studies of ACS and should always be investigated. The definition 168of MI has evolved through the years; at the time of drafting of this Guideline, the third universal169definition of MI is applicable [10]. Criteria of MI are the same as those used to define the index event 170(see below).4.3. Revascularisation171172Some clinical trials have included revascularization endpoints (PCI or CABG) as part of the primary 173composite with conflicting results [11, 12]. Such endpoints are considered more relevant tointerventional studies, and in the scope of this Guideline, their inclusion as a primary endpoint should 174175be clearly justified and their assessment pre-defined and systematically assessed.4.4. Unstable angina pectoris necessitating hospitalisation176177Unstable angina has been investigated in ACS clinical trials. Due to the varying definitions used, the 178associated subjectivity and the influence of local clinical practice, this endpoint is not encouraged to be 179included in the composite primary endpoint.4.5. Stent thrombosis180181Stent thrombosis (ST) is a rare event that can have fatal consequences. ST has been captured in some 182registration studies, but not consistently in the primary endpoint (PEP). The investigation of ST as part 183of the primary endpoint is not encouraged due to the uncertainty of the clinical relevance of all184captured events, except for the "definite" subcategory. Another category identified by the timing isintra-procedural stent thrombosis (IPST), which is a rare event indicating the development of occlusive 185186or non-occlusive new thrombus in or adjacent to a recently implanted stent before the PCI procedure is187completed. Some recent studies [13,14] show that these events may be of prognostic value. As such they should also be collected and presented as secondary endpoint but not included in the analysis of 188189ST.4.6. Stroke190191Stroke should be defined by a generally accepted definition [15]. Clinical studies in ACS have used192non-fatal stroke in the primary endpoint , including any types of strokes. However it is preferred to193include only ischemic strokes in the primary endpoint, as this is the true measure of efficacy;194haemorrhagic stroke should be included as a safety endpoint. An ischaemic stroke with haemorrhagic195conversion should be considered as “primary ischaemic”. The subgroup of “undefined strokes” should196be as small as possible in order to be able to properly assess the effect of the study treatment. In case 197all types of strokes are included in the primary endpoint, a sensitivity analysis including only ischemic198stroke should be submitted.4.7. Left ventricular function and heart failure199Some medicinal products such as modulators of reperfusion injury or inflammation, or gene/cell200201therapy are developed to improve myocardial function and reduce the occurrence of HF. In these202cases, measurement of myocardial function could be a relevant endpoint to investigate the mechanismof action. In phase III studies, these endpoints can be investigated as secondary endpoints to support 203204the clinical endpoints. Occurrence of HF should be considered as a clinical endpoint in phase III studies205aimed at showing benefit in long-term cardiovascular outcome. All-cause mortality and long term206follow-up are mandatory in studies with novel interventions.4.8. Composite endpoints207Due to the rather low incidence of cardiovascular events during the follow-up period after the acute 208209phase of the ACS, composite endpoints consisting of relevant components are acceptable, both as210primary and secondary endpoints. The composite of CV death, non-fatal MI and non-fatal stroke (Major211Adverse Cardiovascular Events, [MACE]) has commonly been used in registration studies, with non-212fatal strokes showing limited contribution to the results. As such, it is preferred to investigate the213composite of death and non-fatal MI in confirmatory studies; non-fatal ischaemic stroke could beincluded in the composite if justified. Sometimes different definitions of MACE are being used with214215novel therapies [16], that should be justified when used in place of MACE. The inclusion of less216objective and clinically derived outcomes in the same composite is generally not encouraged, as they217may either drive the efficacy or dilute the results. In case these endpoints are included they have to be218stringently defined, and adjudicated. Each component of the primary composite endpoint should be219analysed as secondary endpoint.220The net clinical benefit that includes both benefit and safety issues of the studied drug may be used as221a secondary endpoint to be evaluated if it contributes to the discussion on the benefit-risk balance of222the studied drug.4.9. Endpoints in fibrinolysis studies223224In fibrinolysis studies, angiographic studies using the TIMI (Thrombolysisi in Myocardial Infarction)perfusion grades as evaluation criteria are often used. However, complete recanalization cannot be 225226considered as a surrogate for survival when assessing fibrinolytic drugs, as some medicinal productsproviding higher complete recanalization rates than alteplase, failed to demonstrate additional survival 227228benefit. For this reason, all cause mortality is the most relevant endpoint or a combined endpoint as 229previously discussed (see 4.1). Secondary endpoints such as heart failure hospitalisations, left230ventricular function, ventricular arrhythmias, the need for rescue recanalization (emergent and/or231planned) should also be considered and justified.5. Methods to assess efficacy (how to measure the232endpoints)2335.1. Mortality234235Definition of CV death should be clearly defined, in line with acceptable standards [17]. It is mandatory 236to report and centrally adjudicate all mortality data where survival is an endpoint of the study.237Assessment of cardiovascular mortality will require censoring of other “types” of mortality, which may 238complicate its interpretation, in particular when non-CV deaths are in high proportion.5.2. New myocardial infarction239240The diagnostic of MI is based on the detection of a rise and/or fall of cardiac biomarker values241[preferably cardiac troponin (cTn)] with at least one value above the 99th percentile upper reference 242limit (URL). All MIs should be collected and also classified by their different sub types (i.e,243spontaneous, secondary to an ischemic imbalance, related to PCI, related to ST or CABG) [10]. This is 244particularly important considering the different prognostic values of each type of MI. For the same 245reason and to support the clinical relevance of post procedural MIs, these events should be presented 246with higher cut-off values (≥ 5 and ≥10x upper level of normal ULN, in case of CK-MB or ≥70x ULN of 247cTn) [18]. These higher cut-off values can also help in diagnosing MIs in the setting of elevated248baseline biomarkers, which is a problematic situation. In such cases, serial measurements of the249biomarkers are necessary, in addition to new ECG changes or signs of worsening of cardiac function, 250e.g. HFor hypotension [18].5.3. Revascularisation251252The underlying cause of revascularization should be identified: restenosis, ST or disease progression. 253In the latter case target vessel revascularization (TVR) could be included. Early target lesion eventsafter revascularization (before 30 days) are more likely to be caused by an angiographic complication 254255and should preferably be included as safety endpoint (see ST).5.4. Unstable angina pectoris necessitating hospitalisation256257When investigated, robust definitions should be employed. In order to support the seriousness of the 258event it should also be shown that it has led to a revascularisation procedure. Since a medicinalproduct that prevents death and/or new MI might result in more patients suffering from UA, the259260analysis of this endpoint should take into account censoring issues as well.5.5. Stent thrombosis261262ST should be collected and classified as definite, probable and possible in line with acceptable263definitions [19]. In addition, the timing of ST should be documented (acute, sub-acute, late and very 264late), as risk factors and clinical sequels differ with timing.5.6. Ventricular function and heart failure265266Investigation of cardiac function should follow state of the art methods. This can include among others 267measurement of ventricular function by isotopic method and/or by cardiac magnetic resonance imaging 268and/or echocardiography. Investigation of HFshould follow the relevant CHMP guidelines.5.7. Angiographic endpoints269270Angiograms should undergo central blinded reading. In principle, the rate of TIMI 3 flow (complete 271revascularization) of the infarct related artery at 90 minutes is considered the most relevant272angiographic endpoint, as it has been shown to correlate with an improved outcome in terms of273mortality and left ventricular function. An earlier evaluation of the patency pattern (i.e. 30 and 60274minutes) may provide important information on the speed of recanalization. Whatever is the time-point 275selected as primary outcome, it must be properly justified and pre-specified in the clinical trial.6. Selection of patients2766.1. Study population277The definition of the different ACS subtypes should be based on current guidelines/universal definition 278279of MI including STEMI and NSTEMI as well as UA [3, 4, 10].6.1.1. STE-ACS (ST elevation acute coronary syndrome)280281In patients with acute chest pain and persistent (>20 min) ST-segment elevation on ECG the282diagnostic of STE-ACS is made [3]. This condition generally reflects an acute total coronary occlusion.Most patients will ultimately develop an ST-elevation myocardial infarction (STEMI) with the criteria of 283284acute myocardial infarction described before [see 5.2].6.1.2. NSTE-ACS (Non-ST elevation acute coronary syndrome)285286In patients with acute chest pain but no persistent ST-segment elevation the diagnostic of NSTE-ACS is 287made [4]. ECG changes may include transient ST-segment elevation, persistent or transient ST-288segment depression, T-wave inversion, flat T waves or pseudo-normalization of T waves or the ECG 289may be normal. The clinical spectrum of non-ST-elevation ACS (NSTE-ACS) may range from patients 290free of symptoms at presentation to individuals with ongoing ischaemia, electrical or haemodynamic 291instability or cardiac arrest. The pathological correlate at the myocardial level is cardiomyocyte292necrosis (NSTEMI) or, less frequently, myocardial ischaemia without cell loss (UA). Currently, cardiac 293troponins play a central role in establishing a diagnosis and stratifying risk, and make it possible to 294distinguish between NSTEMI and UA[4].6.1.3. Unstable angina295296Unstable angina (UA) is defined as myocardial ischemia at rest or minimal exertion in the absence of 297cardiomyocytes necrosis, i.e. without troponin elevation. Among NSTE-ACS population, the higher298sensitivity of troponin has resulted in an increase in the detection of MI [4]; the diagnosis of UAis less 299frequently made.6.2. Inclusion criteria for the therapeutic studies300301Inclusion of both STEMI and NSTEMI and/or NSTE-ACS patients in the same clinical trial (or not)302should be justified based on the mechanism of action of the investigated product and the proposed 303time of intervention. If both subgroups are investigated in the same trial, both subgroups should be 304well represented. For interventions aimed at post-acute and longer term phases (secondary305prevention or plaque stabilisation) it may be justified to address both conditions in the same clinical 306trial. Time of inclusion of the patients in relation to the index event should be set and adequately307discussed a priori.308Patients with unstable angina represent a different risk category and prognosis that necessitates309different interventions than NSTEMI patients. However, during the acute presentation of NSTE-ACS it may be difficult to discriminate NSTEMI from UA so both groups have been included in some clinical 310311studies. In general, the investigation of interventions in these patients is encouraged, but preferably in 312separate clinical trials.If fibrinolysis is considered, inclusion criteria should be in line with the current treatment guidelines 313314concerning the inclusion for fibrinolysis [3].6.3. Exclusion criteria for the therapeutic studies315316If the patients do not fulfil the above criteria for ACS they should be excluded from the ACS studies. 317Other life-threatening conditions presenting with chest pain, such as dissecting aneurysm,318myopericarditis or pulmonary embolism may also result in elevated troponins and should always be 319considered as differential diagnoses [4].320If drugs interfering with the haemostatic system are tested, patients with a significant risk of bleeding 321(e.g. recent stroke, recent bleeding, major trauma or surgical intervention) and/or a propensity to 322bleed (e.g. thrombocytopenia, clotting disturbances, intracranial vascular diseases, peptic ulcers,323haemophilia) should be excluded from participation in the clinical studies.324Attention should be paid to the time elapsed between a previous application of antiplatelet or325anticoagulant acting agent beforehand and the administration of study drug (e.g. the pharmacokinetic 326[PK] and even more importantly, the pharmacodynamic [PD] half-life of these previously administered 327drugs).328For reasons of generalisability of the study results to the future target population it is strongly advised 329not to define the exclusion criteria too narrow, i.e. polymorbid patients (e.g. renal and/or hepatic330impairment, heart failure), should not automatically be excluded from the main therapeutic clinical 331trials.332When fibrinolysis is considered, exclusion criteria for fibrinolysis should be strictly respected [3].6.4. Risk Stratification333334In clinical trials, the ability of the therapy to demonstrate a treatment effect may depend on the335underlying risk and expected event rates. Enrichment strategies are sometimes used in trials to obtain 336the required number of events with a reasonable time in specific subgroups who are likely to exhibit a 337higher event rate than the overall target population and potentially larger treatment effect. In thatcase, it has to be shown that the results of this enriched study population can be extrapolated to the 338339general population.。
中译勿删
Article QQ.E.15:{管理审查的例外}在不妨碍QQ.E.4的范围和对其遵守的情况下，各成员方应该适用或维持对医药品管理审查的例外。
Article QQ.E.16:{药品数据保护/未披露的测试或其它数据的保护}(a)如果一个成员方要求，有关产品安全和效用的未披露的测试或其它数据的提交为获得新医药品上市审批的一个条件，该成员方不应该允许第三方，在没有之前提交这些信息的人同意的情况下，以如下依据营销相同或类似产品：(i)这些信息；或者(ii)授予提交这些信息的人的上市核准从新医药品在成员方地域内上市审批之日起至少5年内。
(b) 如果一个成员方允许提交产品之前在其它地域内上市审批所用的证据作为授予新医药品上市核准的一个条件，则该成员方不应该允许第三方，在没有之前提交的关于产品安全与效用信息的人同意的情况下，从新医药品于该成员方地域内上市审批之日起至少5年内，以有关此前在其它地域内上市审批所用的证据为基础营销相同或类似的产品。
2．各成员方应该：(a) 对于被要求提交的支持先前被核准的医药品的上市审批的关于新指标、新配方或者新管理方法的新临床资料，规定至少三年的比照适用Article QQ.E.16.1的期限；或者，(b)对于包含一种该成员方先前未被批准的化学物质新医药品，规定至少五年的比照适用Article QQ.E.16.1的期限。
3．尽管上述段一、段二和Article QQ.E.20的规定，一个成员方可以依据如下采取措施保护公共健康：(a) 《关于TRIPS协议和公共健康的宣言》（WT/MIN(01)/DEC/2）（简称《宣言》）;(b) 经WTO成员依据WTO协议同意的，放弃任何执行《宣言》的TRIPS协议条款并在成员双方间有效的声明；和(c)任何在成员方间生效的对TRIPS协议的执行《宣言》修正。
Article QQ.E.17如果一成员方允许除最初安全与有效性信息提交者之外的人，以此前被审批的有关某产品安全与有效性的证据或信息，例如此前由某成员方或在其它地域批准上市时的证据，为批准医药品上市的条件，该成员方应该提供：（a）一个向专利持有者发出通知或允许一位专利持有者在这一医药品上市前得到通知的机制，通知他其他这类人正在为被批准的产品或其被批准的使用方法提供保护的专利适用期内寻求该产品的上市。
OSHA现场作业手册说明书
DIRECTIVE NUMBER: CPL 02-00-150 EFFECTIVE DATE: April 22, 2011 SUBJECT: Field Operations Manual (FOM)ABSTRACTPurpose: This instruction cancels and replaces OSHA Instruction CPL 02-00-148,Field Operations Manual (FOM), issued November 9, 2009, whichreplaced the September 26, 1994 Instruction that implemented the FieldInspection Reference Manual (FIRM). The FOM is a revision of OSHA’senforcement policies and procedures manual that provides the field officesa reference document for identifying the responsibilities associated withthe majority of their inspection duties. This Instruction also cancels OSHAInstruction FAP 01-00-003 Federal Agency Safety and Health Programs,May 17, 1996 and Chapter 13 of OSHA Instruction CPL 02-00-045,Revised Field Operations Manual, June 15, 1989.Scope: OSHA-wide.References: Title 29 Code of Federal Regulations §1903.6, Advance Notice ofInspections; 29 Code of Federal Regulations §1903.14, Policy RegardingEmployee Rescue Activities; 29 Code of Federal Regulations §1903.19,Abatement Verification; 29 Code of Federal Regulations §1904.39,Reporting Fatalities and Multiple Hospitalizations to OSHA; and Housingfor Agricultural Workers: Final Rule, Federal Register, March 4, 1980 (45FR 14180).Cancellations: OSHA Instruction CPL 02-00-148, Field Operations Manual, November9, 2009.OSHA Instruction FAP 01-00-003, Federal Agency Safety and HealthPrograms, May 17, 1996.Chapter 13 of OSHA Instruction CPL 02-00-045, Revised FieldOperations Manual, June 15, 1989.State Impact: Notice of Intent and Adoption required. See paragraph VI.Action Offices: National, Regional, and Area OfficesOriginating Office: Directorate of Enforcement Programs Contact: Directorate of Enforcement ProgramsOffice of General Industry Enforcement200 Constitution Avenue, NW, N3 119Washington, DC 20210202-693-1850By and Under the Authority ofDavid Michaels, PhD, MPHAssistant SecretaryExecutive SummaryThis instruction cancels and replaces OSHA Instruction CPL 02-00-148, Field Operations Manual (FOM), issued November 9, 2009. The one remaining part of the prior Field Operations Manual, the chapter on Disclosure, will be added at a later date. This Instruction also cancels OSHA Instruction FAP 01-00-003 Federal Agency Safety and Health Programs, May 17, 1996 and Chapter 13 of OSHA Instruction CPL 02-00-045, Revised Field Operations Manual, June 15, 1989. This Instruction constitutes OSHA’s general enforcement policies and procedures manual for use by the field offices in conducting inspections, issuing citations and proposing penalties.Significant Changes∙A new Table of Contents for the entire FOM is added.∙ A new References section for the entire FOM is added∙ A new Cancellations section for the entire FOM is added.∙Adds a Maritime Industry Sector to Section III of Chapter 10, Industry Sectors.∙Revises sections referring to the Enhanced Enforcement Program (EEP) replacing the information with the Severe Violator Enforcement Program (SVEP).∙Adds Chapter 13, Federal Agency Field Activities.∙Cancels OSHA Instruction FAP 01-00-003, Federal Agency Safety and Health Programs, May 17, 1996.DisclaimerThis manual is intended to provide instruction regarding some of the internal operations of the Occupational Safety and Health Administration (OSHA), and is solely for the benefit of the Government. No duties, rights, or benefits, substantive or procedural, are created or implied by this manual. The contents of this manual are not enforceable by any person or entity against the Department of Labor or the United States. Statements which reflect current Occupational Safety and Health Review Commission or court precedents do not necessarily indicate acquiescence with those precedents.Table of ContentsCHAPTER 1INTRODUCTIONI.PURPOSE. ........................................................................................................... 1-1 II.SCOPE. ................................................................................................................ 1-1 III.REFERENCES .................................................................................................... 1-1 IV.CANCELLATIONS............................................................................................. 1-8 V. ACTION INFORMATION ................................................................................. 1-8A.R ESPONSIBLE O FFICE.......................................................................................................................................... 1-8B.A CTION O FFICES. .................................................................................................................... 1-8C. I NFORMATION O FFICES............................................................................................................ 1-8 VI. STATE IMPACT. ................................................................................................ 1-8 VII.SIGNIFICANT CHANGES. ............................................................................... 1-9 VIII.BACKGROUND. ................................................................................................. 1-9 IX. DEFINITIONS AND TERMINOLOGY. ........................................................ 1-10A.T HE A CT................................................................................................................................................................. 1-10B. C OMPLIANCE S AFETY AND H EALTH O FFICER (CSHO). ...........................................................1-10B.H E/S HE AND H IS/H ERS ..................................................................................................................................... 1-10C.P ROFESSIONAL J UDGMENT............................................................................................................................... 1-10E. W ORKPLACE AND W ORKSITE ......................................................................................................................... 1-10CHAPTER 2PROGRAM PLANNINGI.INTRODUCTION ............................................................................................... 2-1 II.AREA OFFICE RESPONSIBILITIES. .............................................................. 2-1A.P ROVIDING A SSISTANCE TO S MALL E MPLOYERS. ...................................................................................... 2-1B.A REA O FFICE O UTREACH P ROGRAM. ............................................................................................................. 2-1C. R ESPONDING TO R EQUESTS FOR A SSISTANCE. ............................................................................................ 2-2 III. OSHA COOPERATIVE PROGRAMS OVERVIEW. ...................................... 2-2A.V OLUNTARY P ROTECTION P ROGRAM (VPP). ........................................................................... 2-2B.O NSITE C ONSULTATION P ROGRAM. ................................................................................................................ 2-2C.S TRATEGIC P ARTNERSHIPS................................................................................................................................. 2-3D.A LLIANCE P ROGRAM ........................................................................................................................................... 2-3 IV. ENFORCEMENT PROGRAM SCHEDULING. ................................................ 2-4A.G ENERAL ................................................................................................................................................................. 2-4B.I NSPECTION P RIORITY C RITERIA. ..................................................................................................................... 2-4C.E FFECT OF C ONTEST ............................................................................................................................................ 2-5D.E NFORCEMENT E XEMPTIONS AND L IMITATIONS. ....................................................................................... 2-6E.P REEMPTION BY A NOTHER F EDERAL A GENCY ........................................................................................... 2-6F.U NITED S TATES P OSTAL S ERVICE. .................................................................................................................. 2-7G.H OME-B ASED W ORKSITES. ................................................................................................................................ 2-8H.I NSPECTION/I NVESTIGATION T YPES. ............................................................................................................... 2-8 V.UNPROGRAMMED ACTIVITY – HAZARD EVALUATION AND INSPECTION SCHEDULING ............................................................................ 2-9 VI.PROGRAMMED INSPECTIONS. ................................................................... 2-10A.S ITE-S PECIFIC T ARGETING (SST) P ROGRAM. ............................................................................................. 2-10B.S CHEDULING FOR C ONSTRUCTION I NSPECTIONS. ..................................................................................... 2-10C.S CHEDULING FOR M ARITIME I NSPECTIONS. ............................................................................. 2-11D.S PECIAL E MPHASIS P ROGRAMS (SEP S). ................................................................................... 2-12E.N ATIONAL E MPHASIS P ROGRAMS (NEP S) ............................................................................... 2-13F.L OCAL E MPHASIS P ROGRAMS (LEP S) AND R EGIONAL E MPHASIS P ROGRAMS (REP S) ............ 2-13G.O THER S PECIAL P ROGRAMS. ............................................................................................................................ 2-13H.I NSPECTION S CHEDULING AND I NTERFACE WITH C OOPERATIVE P ROGRAM P ARTICIPANTS ....... 2-13CHAPTER 3INSPECTION PROCEDURESI.INSPECTION PREPARATION. .......................................................................... 3-1 II.INSPECTION PLANNING. .................................................................................. 3-1A.R EVIEW OF I NSPECTION H ISTORY .................................................................................................................... 3-1B.R EVIEW OF C OOPERATIVE P ROGRAM P ARTICIPATION .............................................................................. 3-1C.OSHA D ATA I NITIATIVE (ODI) D ATA R EVIEW .......................................................................................... 3-2D.S AFETY AND H EALTH I SSUES R ELATING TO CSHO S.................................................................. 3-2E.A DVANCE N OTICE. ................................................................................................................................................ 3-3F.P RE-I NSPECTION C OMPULSORY P ROCESS ...................................................................................................... 3-5G.P ERSONAL S ECURITY C LEARANCE. ................................................................................................................. 3-5H.E XPERT A SSISTANCE. ........................................................................................................................................... 3-5 III. INSPECTION SCOPE. ......................................................................................... 3-6A.C OMPREHENSIVE ................................................................................................................................................... 3-6B.P ARTIAL. ................................................................................................................................................................... 3-6 IV. CONDUCT OF INSPECTION .............................................................................. 3-6A.T IME OF I NSPECTION............................................................................................................................................. 3-6B.P RESENTING C REDENTIALS. ............................................................................................................................... 3-6C.R EFUSAL TO P ERMIT I NSPECTION AND I NTERFERENCE ............................................................................. 3-7D.E MPLOYEE P ARTICIPATION. ............................................................................................................................... 3-9E.R ELEASE FOR E NTRY ............................................................................................................................................ 3-9F.B ANKRUPT OR O UT OF B USINESS. .................................................................................................................... 3-9G.E MPLOYEE R ESPONSIBILITIES. ................................................................................................. 3-10H.S TRIKE OR L ABOR D ISPUTE ............................................................................................................................. 3-10I. V ARIANCES. .......................................................................................................................................................... 3-11 V. OPENING CONFERENCE. ................................................................................ 3-11A.G ENERAL ................................................................................................................................................................ 3-11B.R EVIEW OF A PPROPRIATION A CT E XEMPTIONS AND L IMITATION. ..................................................... 3-13C.R EVIEW S CREENING FOR P ROCESS S AFETY M ANAGEMENT (PSM) C OVERAGE............................. 3-13D.R EVIEW OF V OLUNTARY C OMPLIANCE P ROGRAMS. ................................................................................ 3-14E.D ISRUPTIVE C ONDUCT. ...................................................................................................................................... 3-15F.C LASSIFIED A REAS ............................................................................................................................................. 3-16VI. REVIEW OF RECORDS. ................................................................................... 3-16A.I NJURY AND I LLNESS R ECORDS...................................................................................................................... 3-16B.R ECORDING C RITERIA. ...................................................................................................................................... 3-18C. R ECORDKEEPING D EFICIENCIES. .................................................................................................................. 3-18 VII. WALKAROUND INSPECTION. ....................................................................... 3-19A.W ALKAROUND R EPRESENTATIVES ............................................................................................................... 3-19B.E VALUATION OF S AFETY AND H EALTH M ANAGEMENT S YSTEM. ....................................................... 3-20C.R ECORD A LL F ACTS P ERTINENT TO A V IOLATION. ................................................................................. 3-20D.T ESTIFYING IN H EARINGS ................................................................................................................................ 3-21E.T RADE S ECRETS. ................................................................................................................................................. 3-21F.C OLLECTING S AMPLES. ..................................................................................................................................... 3-22G.P HOTOGRAPHS AND V IDEOTAPES.................................................................................................................. 3-22H.V IOLATIONS OF O THER L AWS. ....................................................................................................................... 3-23I.I NTERVIEWS OF N ON-M ANAGERIAL E MPLOYEES .................................................................................... 3-23J.M ULTI-E MPLOYER W ORKSITES ..................................................................................................................... 3-27 K.A DMINISTRATIVE S UBPOENA.......................................................................................................................... 3-27 L.E MPLOYER A BATEMENT A SSISTANCE. ........................................................................................................ 3-27 VIII. CLOSING CONFERENCE. .............................................................................. 3-28A.P ARTICIPANTS. ..................................................................................................................................................... 3-28B.D ISCUSSION I TEMS. ............................................................................................................................................ 3-28C.A DVICE TO A TTENDEES .................................................................................................................................... 3-29D.P ENALTIES............................................................................................................................................................. 3-30E.F EASIBLE A DMINISTRATIVE, W ORK P RACTICE AND E NGINEERING C ONTROLS. ............................ 3-30F.R EDUCING E MPLOYEE E XPOSURE. ................................................................................................................ 3-32G.A BATEMENT V ERIFICATION. ........................................................................................................................... 3-32H.E MPLOYEE D ISCRIMINATION .......................................................................................................................... 3-33 IX. SPECIAL INSPECTION PROCEDURES. ...................................................... 3-33A.F OLLOW-UP AND M ONITORING I NSPECTIONS............................................................................................ 3-33B.C ONSTRUCTION I NSPECTIONS ......................................................................................................................... 3-34C. F EDERAL A GENCY I NSPECTIONS. ................................................................................................................. 3-35CHAPTER 4VIOLATIONSI. BASIS OF VIOLATIONS ..................................................................................... 4-1A.S TANDARDS AND R EGULATIONS. .................................................................................................................... 4-1B.E MPLOYEE E XPOSURE. ........................................................................................................................................ 4-3C.R EGULATORY R EQUIREMENTS. ........................................................................................................................ 4-6D.H AZARD C OMMUNICATION. .............................................................................................................................. 4-6E. E MPLOYER/E MPLOYEE R ESPONSIBILITIES ................................................................................................... 4-6 II. SERIOUS VIOLATIONS. .................................................................................... 4-8A.S ECTION 17(K). ......................................................................................................................... 4-8B.E STABLISHING S ERIOUS V IOLATIONS ............................................................................................................ 4-8C. F OUR S TEPS TO BE D OCUMENTED. ................................................................................................................... 4-8 III. GENERAL DUTY REQUIREMENTS ............................................................. 4-14A.E VALUATION OF G ENERAL D UTY R EQUIREMENTS ................................................................................. 4-14B.E LEMENTS OF A G ENERAL D UTY R EQUIREMENT V IOLATION.............................................................. 4-14C. U SE OF THE G ENERAL D UTY C LAUSE ........................................................................................................ 4-23D.L IMITATIONS OF U SE OF THE G ENERAL D UTY C LAUSE. ..............................................................E.C LASSIFICATION OF V IOLATIONS C ITED U NDER THE G ENERAL D UTY C LAUSE. ..................F. P ROCEDURES FOR I MPLEMENTATION OF S ECTION 5(A)(1) E NFORCEMENT ............................ 4-25 4-27 4-27IV.OTHER-THAN-SERIOUS VIOLATIONS ............................................... 4-28 V.WILLFUL VIOLATIONS. ......................................................................... 4-28A.I NTENTIONAL D ISREGARD V IOLATIONS. ..........................................................................................4-28B.P LAIN I NDIFFERENCE V IOLATIONS. ...................................................................................................4-29 VI. CRIMINAL/WILLFUL VIOLATIONS. ................................................... 4-30A.A REA D IRECTOR C OORDINATION ....................................................................................................... 4-31B.C RITERIA FOR I NVESTIGATING P OSSIBLE C RIMINAL/W ILLFUL V IOLATIONS ........................ 4-31C. W ILLFUL V IOLATIONS R ELATED TO A F ATALITY .......................................................................... 4-32 VII. REPEATED VIOLATIONS. ...................................................................... 4-32A.F EDERAL AND S TATE P LAN V IOLATIONS. ........................................................................................4-32B.I DENTICAL S TANDARDS. .......................................................................................................................4-32C.D IFFERENT S TANDARDS. .......................................................................................................................4-33D.O BTAINING I NSPECTION H ISTORY. .....................................................................................................4-33E.T IME L IMITATIONS..................................................................................................................................4-34F.R EPEATED V. F AILURE TO A BATE....................................................................................................... 4-34G. A REA D IRECTOR R ESPONSIBILITIES. .............................................................................. 4-35 VIII. DE MINIMIS CONDITIONS. ................................................................... 4-36A.C RITERIA ................................................................................................................................................... 4-36B.P ROFESSIONAL J UDGMENT. ..................................................................................................................4-37C. A REA D IRECTOR R ESPONSIBILITIES. .............................................................................. 4-37 IX. CITING IN THE ALTERNATIVE ............................................................ 4-37 X. COMBINING AND GROUPING VIOLATIONS. ................................... 4-37A.C OMBINING. ..............................................................................................................................................4-37B.G ROUPING. ................................................................................................................................................4-38C. W HEN N OT TO G ROUP OR C OMBINE. ................................................................................................4-38 XI. HEALTH STANDARD VIOLATIONS ....................................................... 4-39A.C ITATION OF V ENTILATION S TANDARDS ......................................................................................... 4-39B.V IOLATIONS OF THE N OISE S TANDARD. ...........................................................................................4-40 XII. VIOLATIONS OF THE RESPIRATORY PROTECTION STANDARD(§1910.134). ....................................................................................................... XIII. VIOLATIONS OF AIR CONTAMINANT STANDARDS (§1910.1000) ... 4-43 4-43A.R EQUIREMENTS UNDER THE STANDARD: .................................................................................................. 4-43B.C LASSIFICATION OF V IOLATIONS OF A IR C ONTAMINANT S TANDARDS. ......................................... 4-43 XIV. CITING IMPROPER PERSONAL HYGIENE PRACTICES. ................... 4-45A.I NGESTION H AZARDS. .................................................................................................................................... 4-45B.A BSORPTION H AZARDS. ................................................................................................................................ 4-46C.W IPE S AMPLING. ............................................................................................................................................. 4-46D.C ITATION P OLICY ............................................................................................................................................ 4-46 XV. BIOLOGICAL MONITORING. ...................................................................... 4-47CHAPTER 5CASE FILE PREPARATION AND DOCUMENTATIONI.INTRODUCTION ............................................................................................... 5-1 II.INSPECTION CONDUCTED, CITATIONS BEING ISSUED. .................... 5-1A.OSHA-1 ................................................................................................................................... 5-1B.OSHA-1A. ............................................................................................................................... 5-1C. OSHA-1B. ................................................................................................................................ 5-2 III.INSPECTION CONDUCTED BUT NO CITATIONS ISSUED .................... 5-5 IV.NO INSPECTION ............................................................................................... 5-5 V. HEALTH INSPECTIONS. ................................................................................. 5-6A.D OCUMENT P OTENTIAL E XPOSURE. ............................................................................................................... 5-6B.E MPLOYER’S O CCUPATIONAL S AFETY AND H EALTH S YSTEM. ............................................................. 5-6 VI. AFFIRMATIVE DEFENSES............................................................................. 5-8A.B URDEN OF P ROOF. .............................................................................................................................................. 5-8B.E XPLANATIONS. ..................................................................................................................................................... 5-8 VII. INTERVIEW STATEMENTS. ........................................................................ 5-10A.G ENERALLY. ......................................................................................................................................................... 5-10B.CSHO S SHALL OBTAIN WRITTEN STATEMENTS WHEN: .......................................................................... 5-10C.L ANGUAGE AND W ORDING OF S TATEMENT. ............................................................................................. 5-11D.R EFUSAL TO S IGN S TATEMENT ...................................................................................................................... 5-11E.V IDEO AND A UDIOTAPED S TATEMENTS. ..................................................................................................... 5-11F.A DMINISTRATIVE D EPOSITIONS. .............................................................................................5-11 VIII. PAPERWORK AND WRITTEN PROGRAM REQUIREMENTS. .......... 5-12 IX.GUIDELINES FOR CASE FILE DOCUMENTATION FOR USE WITH VIDEOTAPES AND AUDIOTAPES .............................................................. 5-12 X.CASE FILE ACTIVITY DIARY SHEET. ..................................................... 5-12 XI. CITATIONS. ..................................................................................................... 5-12A.S TATUTE OF L IMITATIONS. .............................................................................................................................. 5-13B.I SSUING C ITATIONS. ........................................................................................................................................... 5-13C.A MENDING/W ITHDRAWING C ITATIONS AND N OTIFICATION OF P ENALTIES. .................................. 5-13D.P ROCEDURES FOR A MENDING OR W ITHDRAWING C ITATIONS ............................................................ 5-14 XII. INSPECTION RECORDS. ............................................................................... 5-15A.G ENERALLY. ......................................................................................................................................................... 5-15B.R ELEASE OF I NSPECTION I NFORMATION ..................................................................................................... 5-15C. C LASSIFIED AND T RADE S ECRET I NFORMATION ...................................................................................... 5-16。
当代研究生英语 第七单元 B课文翻译
价格的利润生物公司正在吞噬可改变动物DNA序列的所有专利。
这是对阻碍医学研究发展的一种冲击。
木匠认为他们的贸易工具是理所当然的。
他们买木材和锤子后，他们可以使用木材和锤子去制作任何他们所选择的东西。
多年之后来自木材厂和工具储藏室的人并没有任何进展，也没有索要利润份额。
对于那些打造明日药物的科学家们来说，这种独立性是一种罕见的奢侈品。
发展或是发现这些生物技术贸易中的工具和稀有材料的公司，对那些其他也用这些工具和材料的人进行了严格的监控。
这些工具包括关键基因的DNA序列，人类、动物植物和一些病毒的基因的部分片段，例如，HIV,克隆细胞，酶，删除基因和用于快速扫描DNA样品的DNA 芯片。
为了将他们这些关键的资源得到手，医学研究人员进场不得不签署协议，这些协议可以制约他们如何使用这些资源或是保证发现这些的公司可以得到最终结果中的部分利益。
许多学者称这抑制了了解和治愈疾病的进程。
这些建议使Harold得到了警示，Harold是华盛顿附近的美国国家卫生研究院的院长，在同年早期，他建立了一个工作小组去调查此事。
由于他的提早的调查，下个月出就能发布初步的报告。
来自安阿伯密歇根大学的法律教授，该工作组的主席Rebecea Eisenberg说，她们的工作组已经听到了好多研究者的抱怨，在它们中有一份由美国联合大学技术管理组提交的重量级的卷宗。
为了帮助收集证据，NIH建立了一个网站，在这个网站上研究者们可以匿名举报一些案件，这些案件他们相信他们的工作已经被这些限制性许可证严重阻碍了。
迫使研究人员在出版之前需要将他们的手稿展示给公司的这一保密条款和协议是投诉中最常见的原因之一。
另一个问题是一些公司坚持保有自动许可证的权利，该许可证是有关利用他们物质所生产的任何未来将被发现的产品，并且这些赋予他们对任何利用他们的工具所赚取的利润的支配权利的条款也有保有的权利。
Eisenberg说：“如果你不得不签署了许多这样的条款的话，那真的是一个大麻烦”。
药物替代疗法英语作文高中
药物替代疗法英语作文高中Title: Alternative Medicine: A Controversial Approach。
Introduction:Alternative medicine, also known as complementary or integrative medicine, has gained significant attention in recent years as a substitute for conventional medical treatments. While some advocate for its effectiveness and holistic approach, others remain skeptical due to the lack of scientific evidence and potential risks associated with certain practices. This essay delves into the controversial topic of alternative medicine, examining its principles, benefits, drawbacks, and the need for a balanced perspective.Body:I. Understanding Alternative Medicine。
A. Definition and Scope。
1. Definition of alternative medicine。
2. Various forms and practices: acupuncture, herbal medicine, chiropractic care, etc.B. Principles and Philosophy。
病历文书中常用基本用语的英文翻译
病历文书中常用基本用语的英文翻译导语：来源：梅斯医学1、抗生素医嘱[Antibiotic order]·Prophylaxis [预防性用药]Duration of order[用药时间] 24hrProcedure[操作，手术]·Empiric therapy [经验性治疗]Suspected site and organism[怀疑感染的部位和致病菌] 72hr Cultures ordered[是否做培养]·Documented infection[明确感染]Site and organism[部位和致病菌] 5days·Other[其它]Explanation required [解释理由] 24hr·Antibiotic allergies[何种抗生素过敏]No known allergy [无已知的过敏]·Drug dose Route frequency[药名剂量途径次数]2、医嘱首页[Admission / transfer]·Admit / transfer to [收入或转入]·Resident [住院医师] Attending[主治医师]·Condition [病情]·Diagnosis[诊断]·Diet [饮食]·Activity [活动]·Vital signs[测生命体征]·I / O [记进出量]·Allergies[过敏]3、住院病历[case history]·Identification [病人一般情况]Name[性名]Sex[性别]Age [年龄]Marriage[婚姻]Person to notify and phone No.[联系人及电话] Race[民族]I.D. No.[身份证]Admission date[入院日期]Source of history[病史提供者]Reliability of history[可靠程度]Medical record No[病历号]Business phone No.[工作单位电话]Home address and phone No.[家庭住地及电话] ·Chief complaint[主诉]·History of present illness[现病史]·Past History[过去史]Surgical[外科]Medical[内科]Medications[用药]Allergies[过敏史]Social History[社会史]Habits[个人习惯]Smoking[吸烟]Family History[家族史]Ob/Gyn History[ 婚姻/生育史]Alcohol use[喝酒]·Review of Aystems[系统回顾]General[概况]Eyes, Ears, Nose and throat[五官] Pulmonary[呼吸]Cardiovascular[心血管]GI[消化]GU[生殖、泌尿系统]Musculoskeletal[肌肉骨骼]Neurology[神经系统]Endocrinology[内分泌系统]Lymphatic/Hematologic[淋巴系统/血液系统] ·Phys ical Exam[体检]Vital Signs[生命体征]λP[脉博]Bp[血压]R[呼吸]T[温度]Height[身高]Weight[体重]General[概况]λHEENT[五官]Neck[颈部]Back/Chest[背部/胸部]Breast[乳房]Heart[心脏]λHeart rate[心率]Heart rhythm[心律]Heart Border[心界]Murmur[杂音]Abdomen[腹部]λLiver[肝]Spleen[脾]Rectal[直肠]Genitalia[生殖系统]λExtremities[四肢]λNeurology[神经系统]cranial nerves[颅神经]sensation[感觉]Motor[运动]*Special P.E. on diseased organ system[专科情况]*Radiographic Findings[放射]*Laboratory Findings[化验]*Assessment[初步诊断与诊断依据]*Summary[病史小结]*Treatment Plan[治疗计划]4、输血申请单[Blood bank requisition form](1)reason for infusion[输血原因]▲红细胞[packed red cells, wshed RBCs]:*Hb<8.5 [血色素<8.5]*>20% blood volume lost [>20%血容量丢失]*cardio-pulmonary bypass with anticipated Hb <8[心肺分流术伴预计血色素<8]*chemotherapy or surgery with Hb <10[血色素<10的化疗或手术者]▲全血[whole blood]:massive on-going blood loss[大量出血]▲血小板[platelets]:*massive blood transfusion >10 units[输血10单位以上者]*platelet count <50×103/μl with active bleeding or surgery[血小板<5万伴活动性出血或手术者]*Cardio-pulmonary bypass uith pl<100×103/μl with octivebleeding[心肺分流术伴血小板<10万，活动性出血者]*Platelet count <20×103/μl[血板<2万]▲新鲜冰冻血浆[fresh frozen plasma]:*documented abnormal PT or PTT with bleeding orSurgery[PT、PTT异常的出血或手术病人]*specific clotting factor deficiencies with bleeding/surgerg[特殊凝血因子缺乏的出血/手术者]*blood transfusion >15units[输血>15个单位]*warfarin or antifibrinolytic therapy with bleeding[华法令或溶栓治疗后出血]*DIC[血管内弥漫性凝血]*Antithrombin III dficiency[凝血酶III 缺乏](2)输血要求[request for blood components]*patient blood group[血型]*Has the patient had transfusion or pregnancy in the past 3 months? [近3个月，病人是否输过血或怀孕过？]*Type and crossmatch [血型和血交叉]*Units or ml[单位或毫升]5、出院小结[discharge summary]Patient Name[病人姓名]λMedical Record No.[病历号]λAttending Physician[主治医生]λDate of Admission[入院日期]λDate of Discharge[出院日期]λPrincipal Diagnosis[主要诊断]λSecondary Diagnosis[次要诊断]λComplications[并发症]λOperation[手术名称]λReason for Admission[入院理由]λPhysical Findings[阳性体征]λLab/X-ray Findings[化验及放射报告]λHospital Course[住院诊治经过]λCondition[出院状况]λDisposition[出院去向]λMedications[出院用药]λPrognosis[预后]λSpecial Instruction to the Patient(diet, physicalλ activity)[出院指导（饮食，活动量）]λFollow-up Care[随随访]λ6、住院/出院病历首页[Admission/discharge record] ·Patient name[病人姓名]·race[种族]·address[地址]·religion[宗教]·medical service[科别]·admit (discharge) date[入院（出院）日期]·Length of stay [住院天数]·guarantor name [担保人姓名]·next of kin or person to notify[需通知的亲属姓名] ·relation to patient[与病人关系]·previous admit date[上次住院日期]·admitting physician [入院医生]·attending physician [主治医生]·admitting diagnosis[入院诊断]·final (principal) diagnosis[最终（主要）诊断]·secondary diagnosis[次要诊断]·adverse reactions (complications)[副作用（合并症）]·incision type[切口类型]·healing course[愈合等级]·operative (non-operative) procedures[手术（非手术）操作] ·nosocomial infection[院内感染]·consultants [会诊]·Critical-No. of times[抢救次数]·recovered-No. of times[成功次数]·Diagnosis qualitative analysis[诊断质量]OP.adm.and discharge Dx concur [门诊入院与出院诊断符合率] Clinical and pathological Dx concur[临床与病理诊断符合率] Pre- and post-operative Dx concur [术前术后诊断符合率]·Dx determined with in 24 hours (3 days) after admission[入院后24小时（3 天）内确诊]·Discharge status[出院状况]recovered[治愈]improved[好转]not improved[未愈]died [死亡]·Dispositon[去向]home[家]against medical ad[自动出院]autosy[尸检]transferred to[转院到]。
肌间隙入路经伤椎椎弓根内固定治疗胸腰椎骨折
肌间隙入路经伤椎椎弓根内固定治疗胸腰椎骨折刘敏波;王俊【期刊名称】《浙江医学》【年(卷),期】2014(036)011【总页数】3页(P970-972)【作者】刘敏波;王俊【作者单位】311200 杭州市萧山区第一人民医院骨一科;311200 杭州市萧山区第一人民医院骨一科【正文语种】中文胸腰椎骨折是最常见的脊柱损伤，对于需要手术治疗的病例，后路切开复位椎弓根螺钉内固定术是最常用的手术方式之一。
传统后路手术中大范围椎旁肌的剥离和牵拉，致使椎旁肌缺血坏死及失神经支配，造成术后的平背畸形和顽固性腰背疼痛。
跨伤椎内固定手术治疗远期易出现矫正高度及角度丢失等问题。
为此，我院近年来开展了肌间隙入路经伤椎椎弓根内固定治疗无神经损伤表现的单节段胸腰椎骨折，取得了满意的临床及远期疗效，现报道如下。
1.1 一般资料 2009-09—2012-03我院收治采用肌间隙入路经伤椎椎弓根内固定复位治疗的胸腰椎骨折患者55例。
入选条件：（1）单节段胸腰椎压缩性骨折或无后柱损伤的爆裂性骨折；（2）Frankel分级为E级，不需要椎管减压；（3）手术时间在伤后2周内。
手术节段均为T12～L2，其中男30例，女25例，年龄18～58岁，平均45.6岁；除外明显骨质疏松者。
1.2 手术方法患者俯卧于骨科床上，架空腹部，经C臂X线机定位骨折节段。
取后正中切口，自腰背筋膜表面潜行分离皮下组织，寻找多裂肌及最长肌间隙。
切开胸腰筋膜，用食指钝性分离肌间隙直达关节突和横突，用电凝剥离小关节突的外侧部分，采用人字嵴或横突定位方法进行经伤椎的6枚椎弓根螺钉置入，并按相关操作行撑开复位。
1.3 术后处理术后常规使用抗生素1次，术后3～5d行X线片检查，卧床两周即佩戴支具下床活动，出院后定期门诊复查。
本组55例患者手术时间平均75min，出血量平均80ml，术后未发生切口感染等并发症，术后X线片示骨折复位及内固定良好。
全部病例均获得14～32个月，平均22个月的随访，其中40例患者已行内固定拆除术，钉棒系统无松动、断裂，患者术后未发现顽固性腰背痛，复查X线片1～2年后椎体高度和椎间隙高度丢失＜10%。
美国联邦法规CFR第篇食品与药品总目录
美国联邦法规C F R第篇食品与药品总目录 SANY标准化小组 #QS8QHH-HHGX8Q8-GNHHJ8-HHMHGN#美国联邦法规（CFR）第21篇“食品与药品”总目录概述：《美国联邦法规》（Code of Federal Regulations，CFR）第21篇“食品与药品”（Title 21―Food and Drugs）共有9卷（Volume）、3章（Chapter）、1499部（Parts）。
其中：第1―8卷第1章第1―1299部，为健康与人类服务部食品与药品管理局（Food and DrugAdministration，Department of Health and Human Services）的规章；第9卷第2章第1300―1399部，为司法部毒品强制执行局（Drug Enforcement Administration，Department of Justice）的规章；第9卷第3章第1400―1499部，为毒品控制政策办公室（Office of National Drug Control Policy）的规章。
第21篇“食品与药品”（Title 21―Food and Drugs）的概况卷（Volume）章（Chapter）部（Parts）规制机关（Regulatory Entity）？1 Ⅰ 1-99 健康与人类服务部食品与药品管理局（FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES）？2 100-169？3 170-199？4 200-299？5 300-499？6 500-599？7 600-799？8 800-1299？9 Ⅱ 1300-1399 司法部毒品强制执行局（Drug Enforcement Administration，Department of Justice）？Ⅲ 1400-1499 毒品控制政策办公室（Office of National Drug Control Policy）第21篇“食品与药品”（Title 21―Food and Drugs）的章、部目录部(Part) 中译文原英文第Ⅰ章―健康与人类服务部食品与药品管理局（CHAPTER Ⅰ―FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES）第A分章―总则（SUBCHAPTER A―GENERAL）？1 一般强制执行规章 GENERAL ENFORCEMENT REGULATIONS ？2 一般行政规则与决定 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS ？3 产品管辖权 PRODUCT JURISDICTION？5 组织 ORGANIZATION？7 强制执行政策 ENFORCEMENT POLICY？10 行政规范与程序 ADMINISTRATIVE PRACTICES AND PROCEDURES？11电子化记录；电子化签名 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES？12 正式证据的公众听证 FORMAL EVIDENTIARY PUBLIC HEARING？13 在公众质询委员会前的公众听证 PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY？14 在公众咨询委员会前的公众听证 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE？15 在FDA局长前的公众听证 PUBLIC HEARING BEFORE THE COMMISSIONER？16 在FDA前的规制性听证 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION？17 行政罚款听证 CIVIL MONEY PENALTIES HEARINGS？19 行为标准与利益冲突 STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST？20 公共信息 PUBLIC INFORMATION？21 隐私保护 PROTECTION OF PRIVACY？25 环境影响考虑 ENVIRONMENTAL IMPACT CONSIDERATIONS？26药品良好制造规范报告、医疗器械质量体系核查报告以及某些医疗器械产品评价报告的互认：美国与欧共体 MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY？50 人类受试者的保护 PROTECTION OF HUMAN SUBJECTS？54 临床试验者的财务公开 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS？56 机构审查委员会 INSTITUTIONAL REVIEW BOARDS？58对非临床实验室研究的良好实验室规范 GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES？60 专利期恢复 PATENT TERM RESTORATION？70 色素添加剂 COLOR ADDITIVES？71 色素添加剂申请 COLOR ADDITIVE PETITIONS？73 免除认证的色素添加剂的列表 LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION？74 适用认证的色素添加剂的列表 LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION？80 色素添加剂认证 COLOR ADDITIVE CERTIFICATION？81 用于食品、药品和化妆品的临时性色素添加剂的一般规范和一般限制 GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS？82 经认证的临时性列表的色素和规范的列表 LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS？83-98 [预留的] [Reserved]？99 已上市的药品、生物制品和器械的未经批准的/新的用途的信息的发布 DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES第B分章―用于人类消费的食品（SUBCHAPTER B―FOOD FOR HUMAN CONSUMPTION）？100 总则 GENERAL ？101 食品标识 FOOD LABELING ？102 非标准化食品的普通的或者通常的名称 COMMON OR USUAL NAME FOR NONSTANDARDIZEDFOODS ？104 食品的营养质量指南 NUTRITIONAL QUALITY GUIDELINES FOR FOODS？105 特殊膳食用途的食品 FOODS FOR SPECIAL DIETARY USE ？106 婴儿配方母乳替代食品质量控制程序 INFANT FORMULA QUALITY CONTROL PROCEDURES？107 婴儿配方母乳替代食品 INFANT FORMULA ？108 紧急许可控制 EMERGENCY PERMIT CONTROL ？109 在人类食品与食品-包装材料中的不可避免的污染物 UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL？110 在制造、包装或者保存人类食品中的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD111保健品（膳食补充剂）ＧＭＰ要求CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS113 装在密封容器中的热加工低酸食品 THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS？114 酸化食品 ACIDIFIED FOODS ？115 带壳蛋 SHELL EGGS ？119 存在显着或者不合理风险的膳食补充剂 DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK ？120 危害分析与关键控制点（HACCP）体系 HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS ？123 鱼与渔业产品 FISH AND FISHERY PRODUCTS ？129 饮用水加工与装瓶 PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER ？130 食品标准：总则 FOOD STANDARDS: GENERAL ？131 乳与奶油 MILK AND CREAM ？133 乳酪与相关乳酪产品 CHEESES AND RELATED CHEESE PRODUCTS ？135 冷冻点心 FROZEN DESSERTS ？136 烘焙产品 BAKERY PRODUCTS ？137 谷物粉与相关产品 CEREAL FLOURS AND RELATED PRODUCTS ？139 通心粉与面条产品 MACARONI AND NOODLE PRODUCTS ？145 罐装水果 CANNED FRUITS ？146 罐装水果汁 CANNED FRUIT JUICES ？150 水果黄油、果冻、防腐剂以及相关产品 FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS ？152 水果馅饼 FRUIT PIES ？155 罐装蔬菜 CANNED VEGETABLES ？156 蔬菜汁 VEGETABLE JUICES ？158 冷冻蔬菜 FROZEN VEGETABLES ？160 蛋与蛋制品 EGGS AND EGG PRODUCTS ？161 鱼与有壳的水生动物 FISH AND SHELLFISH ？163 可可制品 CACAO PRODUCTS ？164 树坚果与花生制品 TREE NUT AND PEANUT PRODUCTS ？165 饮料 BEVERAGES ？166 人造黄油 MARGARINE ？168 增甜剂与餐桌糖浆 SWEETENERS AND TABLE SIRUPS ？169 食品敷料与调味料 FOOD DRESSINGS AND FLAVORINGS ？170 食品添加剂 FOOD ADDITIVES ？171 食品添加剂申请 FOOD ADDITIVE PETITIONS ？172 允许直接加入用于人类消费食品的食品添加剂 FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION？173 在用于人类消费的食品中允许的次直接的食品添加剂 SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION ？174 间接食品添加剂：总则 INDIRECT FOOD ADDITIVES: GENERAL ？175 间接食品添加剂：胶粘剂与涂层的组分 INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS ？176 间接食品添加剂：纸与纸板组分 INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS ？177 间接食品添加剂：聚合体 INDIRECT FOOD ADDITIVES: POLYMERS ？178 间接食品添加剂：辅剂、生产助剂和消毒剂 INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS ？179 在食品生产、加工和处理中的辐照 IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD ？180 在额外试验期间临时在食品或者在与食品接触中被允许的食品添加剂 FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY ？181 先前核准的食品配料 PRIOR-SANCTIONED FOOD INGREDIENTS ？182 一般认为安全的物质 SUBSTANCES GENERALLY RECOGNIZED AS SAFE？184 被确认为一般认为安全的直接食品物质 DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE ？186 被确认为一般认为安全的间接食品物质 INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE ？189禁止用于人类食品的物质 SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD ？190 膳食补充剂 DIETARY SUPPLEMENTS ？191-199 [预留的] [Reserved]第C分章―药品：总则（SUBCHAPTER C―DRUGS: GENERAL）？200 总则 GENERAL ？201 标识 LABELING ？202 处方药广告 PRESCRIPTION DRUG ADVERTISING ？203 处方药销售 PRESCRIPTION DRUG MARKETING ？205 对批发处方药销售商颁发州执照的指南 GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS ？206 人用固体口服剂型药品的印码 IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE ？207 药品生产者的登记与商业销售的药品的列表 REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION？208 处方药的药物治疗指导 MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS ？210制造、加工、包装或者保存药品的现行良好制造规范；总则 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL ？211药品现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS ？216 药房配药 PHARMACY COMPOUNDING ？225含药饲料的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS ？226含A类药品的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES ？250特殊人用药品的特殊要求 SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS ？290管制药品 CONTROLLED DRUGS ？299 药品；正式名称与已确定的名称 DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES第D分章―人用药品（SUBCHAPTER D―DRUGS FOR HUMAN USE）？300 总则 GENERAL ？310新药 NEW DRUGS ？312 试验用新药申请 INVESTIGATIONAL NEW DRUG APPLICATION？314 FDA批准上市新药的申请 APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG ？315诊断用放射性药品 DIAGNOSTIC RADIOPHARMACEUTICALS ？316罕见病药 ORPHAN DRUGS ？320生物利用度与生物等效性要求 BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS ？328 含有酒精的预期用于口部摄入的非处方药品OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL？330一般认为安全有效以及不错贴标签的非处方人用药品 OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED ？331 非处方人用抗酸产品 ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE ？332 非处方人用抗胃肠气胀产品 ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？333非处方人用局部抗菌药品 TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？335非处方人用止泻药品 ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？336非处方人用止吐药品 ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？338 非处方人用助睡眠药品 NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？340 非处方人用兴奋药品 STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？341非处方人用的感冒、咳嗽、过敏症药、支气管扩张以及平喘药品 COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？343非处方人用内服止痛、退热以及抗风湿药品 INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？344 非处方人用局部耳部药品 TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？346 非处方人用肛肠药品 ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？347 非处方人用皮肤保护药品 SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？348 非处方人用外用止痛药品 EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？349非处方人用眼科药品 OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？350非处方人用止汗药品 ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？352非处方人用防晒药品 SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY] ？355 非处方人用防龋药品 ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？357 非处方人用其他内服药品 MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？358非处人用的其他外用药品 MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ？361 一般认为安全与有效以及不错贴标签的处方人用药品：用于研究的药品 PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH ？369 在非处方销售药品与器械上关于警告解释性声明 INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE？370-499 [预留的] [Reserved]第E分章―动物药品、饮料和相关产品（SUBCHAPTER E―ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS）？500 总则 GENERAL ？501 动物食品标识 ANIMAL FOOD LABELING ？502 非标准化动物食品的普通或通常名称 COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS ？509 在动物食品与食品-包装材料中的不可避免的污染物 UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL ？510新动物药 NEW ANIMAL DRUGS ？511 作为试验用途的新动物药 NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE？514 新动物药申请 NEW ANIMAL DRUG APPLICATIONS？515 含药饲料厂执照 MEDICATED FEED MILL LICENSE ？520 口服剂型的新动物药 ORAL DOSAGE FORM NEW ANIMAL DRUGS ？522 植入或者注射剂型的新动物药 IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS ？524 眼科和局部剂型的新动物药 OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS ？526 乳房内的剂型 INTRAMAMMARY DOSAGE FORMS ？529 某些其他剂型的新动物药 CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS？530 在动物中的特别标签药品使用 EXTRALABEL DRUG USE IN ANIMALS ？556 在食品中新动物药残留的容许量 TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD ？558 用于动物饲料的新动物药 NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS？564 [预留的] [Reserved]？570 食品添加剂 FOOD ADDITIVES ？571 食品添加剂申请 FOOD ADDITIVE PETITIONS ？573 在动物饲料与饮用水中允许的食品添加剂 FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS ？579 在动物饲料和宠物食品的生产、加工和处理中的辐照 IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD？582 一般认为安全的物质 SUBSTANCES GENERALLY RECOGNIZED AS SAFE？584 在动物饲料与饮用水中被确认为一般认为安全的食品物质 FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS ？589 禁止用于动物食品或者饲料的物质 SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED ？590-599 [预留的] [Reserved]？第F分章―生物制品（SUBCHAPTER F―BIOLOGICS）？600 生物制品：总则 BIOLOGICAL PRODUCTS: GENERAL ？601 颁发执照 LICENSING ？606对血液与血液组分的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS ？607 对人类血液与血液制品的制造者的机构登记与产品列表ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS ？610普通生物制品标准 GENERAL BIOLOGICAL PRODUCTS STANDARDS ？630 对血液、血液组分和血液衍生物的一般要求GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES ？640 对人类血液和血液制品的附加标准 ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS ？660 对用于实验室检测的诊断物质的附加标准 ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS ？680 对其他产品的附加标准 ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS第G分章―化妆品（SUBCHAPTER G―COSMETICS）？700 总则 GENERAL ？701 化妆品标识 COSMETIC LABELING ？710 化妆品机构的自愿登记 VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS ？720 化妆品配料构成声明的自愿存档 VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS ？740 化妆品警告声明 COSMETIC PRODUCT WARNING STATEMENTS ？741-799 [预留的] [Reserved]第H分章―医疗器械（SUBCHAPTER H―MEDICAL DEVICES）？800 总则 GENERAL ？801 标识 LABELING ？803 医疗器械报告 MEDICAL DEVICE REPORTING ？806 医疗器械；改正与移动的报告 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS ？807 对器械的制造者与首次进口者的机构登记与器械列表 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES ？808 对州和地方医疗器械要求的联邦优先权的豁免 EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS ？809 人用体外诊断产品 IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE？810 医疗器械召回权 MEDICAL DEVICE RECALL AUTHORITY ？812 试验用器械豁免 INVESTIGATIONAL DEVICE EXEMPTIONS ？813 [预留的] [Reserved]？814 医疗器械的上市前批准 PREMARKET APPROVAL OF MEDICAL DEVICES ？820 质量体系规章 QUALITY SYSTEM REGULATION ？821 医疗器械跟踪要求 MEDICAL DEVICE TRACKING REQUIREMENTS ？822 上市后监视 POSTMARKET SURVEILLANCE ？860 医疗器械分类程序 MEDICAL DEVICE CLASSIFICATION PROCEDURES？861 性能标准制定程序 PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT ？862 临床化学与临床毒理学器械 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES ？864 血液学与病理学器械 HEMATOLOGY AND PATHOLOGY DEVICES ？866 免疫学与微生物学器械 IMMUNOLOGY AND MICROBIOLOGY DEVICES ？868 麻醉学器械 ANESTHESIOLOGY DEVICES ？870 心血管器械 CARDIOVASCULAR DEVICES ？872 牙科器械 DENTAL DEVICES ？874 耳、鼻和咽器械 EAR, NOSE, AND THROAT DEVICES ？876 胃肠病学-泌尿学器械 GASTROENTEROLOGY-UROLOGY DEVICES ？878 普通与整形外科器械 GENERAL AND PLASTIC SURGERY DEVICES ？880 普通医院与个人使用器械 GENERAL HOSPITAL AND PERSONAL USE DEVICES？882 神经学器械 NEUROLOGICAL DEVICES ？884 产科与妇科学器械 OBSTETRICAL AND GYNECOLOGICAL DEVICES ？886 眼科器械 OPHTHALMIC DEVICES ？888 矫形外科器械 ORTHOPEDIC DEVICES ？890 内科学器械 PHYSICAL MEDICINE DEVICES ？892 放射学器械 RADIOLOGY DEVICES ？895 禁止的器械 BANNED DEVICES ？898 电极铅线与患者电缆的性能标准 PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES第I分章―乳房造影质量标准法（SUBCHAPTER I―MAMMOGRAPHY QUALITY STANDARDS ACT）？900 乳房造影法 MAMMOGRAPHY第J分章―放射学的健康（SUBCHAPTER J―RADIOLOGICAL HEALTH）？1000 总则 GENERAL ？1002 记录与报告 RECORDS AND REPORTS ？1003 缺陷与未能守法的通报 NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY ？1004 电子产品的回购、修理或者置换 REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS ？1005 电子产品的进口 IMPORTATION OF ELECTRONIC PRODUCTS ？1010 电子产品的性能标准：总则 PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL ？1020 电离辐射发生产品的性能标准 PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS ？1030 微波与射电频率发生产品的性能标准 PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS ？1040 发光产品的性能标准 PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS ？1050 声波、次声波和超声波发生产品的性能标准 PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS ？第K分章―[预留的]（SUBCHAPTER K―[RESERVED]）第L分章―根据由食品与药品管理局行政执行的某些其他法的规章（SUBCHAPTER L―REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION）？1210 根据《联邦进口乳法》的规章 REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT ？1230 根据《联邦腐蚀性毒物法》的规章 REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT ？1240 传染病的控制 CONTROL OF COMMUNICABLE DISEASES ？1250 州际运输卫生 INTERSTATE CONVEYANCE SANITATION ？1251-1269 [预留的] [Reserved]？1270 预期用于移植的人体组织 HUMAN TISSUE INTENDED FOR TRANSPLANTATION？1271 人体细胞、组织以及细胞的和基于组织的产品 HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS ？1272-1299 [预留的] [Reserved]第Ⅱ章―司法部毒品强制执行局（CHAPTER Ⅱ―DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE）？1300 定义 DEFINITIONS ？1301 管制物质的制造者、分销者和调剂者的登记 REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES ？1302 对管制物质的标识与包装要求 LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES ？1303 定额 QUOTAS ？1304 登记者的记录与报告 RECORDS AND REPORTS OF REGISTRANTS ？1305 令的格式 ORDER FORMS ？1306 处方 PRESCRIPTIONS ？1307 杂项 MISCELLANEOUS ？1308 管制物质的表 SCHEDULES OF CONTROLLED SUBSTANCES ？1309 表I化学品的制造者、分销者、进口者和出口者的登记REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS ？1310 列入表的化学品和某些机器的记录与报告 RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES ？1311 [预留的] [Reserved]？1312 管制物质的进口与出口 IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES ？1313 前体与必要化学品的进口与出口 IMPORTATION AND EXPORTATION OF PRECURSORS AND ESSENTIAL CHEMICALS ？1314-1315 [预留的] [Reserved]？1316 行政职能、规范和程序 ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES第Ⅲ章―毒品控制政策办公室（CHAPTER Ⅲ―Office of National Drug Control Policy）？1400 [预留的] [Reserved]？1401 信息的公众可及性 PUBLIC AVAILABILITY OF INFORMATION ？1402 强制性解密审查 MANDATORY DECLASSIFICATION REVIEW ？1403 对给予州和地方政府资金和合作协议的统一行政要求 UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE AGREEMENTS TO STATE AND LOCAL GOVERNMENTS ？1404 政府范围的排除与暂停（非获得） GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT) ？1405 对无毒品工作场所的政府范围的要求（财政援助） GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE) ？1406-1499 [预留的] [Reserved]。
学术英语 医学 Unit 6 Text A 翻译
Unit 6 Text A寻求临终护理数十年前，大多数人在自己家中去世，但是医疗方面的进步已经改变了这一情况。
如今，大多数美国人在医院或是疗养院中度过生命的最终时光。
他们中有些人是为了治疗疾病进了医院，有些可能是选择长期住在疗养院。
越来越多的人在生命的尽头开始选择临终关怀。
死亡没有一个称得上“合适”的地点。
何况，我们死亡的地方，大多数情况下也并非我们可以决定的。
但如果有选择的机会，每个人及其家属，都应该考虑究竟怎样的临终护理最为适合，在哪里可以享受到这样的关怀，家人和朋友能否提供帮助，以及他们应该如何支付相应的费用。
医院及疗养院64岁的George有充血性心力衰竭病史。
一天晚上，他因为胸痛被送入医院。
他与他最亲近的人事先便已决定，在任何情况下都要让医生使用最大努力来延续他的生命。
所以当他需要相应的治疗时，他选择了医院，因为那里有全天候工作的医生和护士。
医院提供一整套的治疗、检查及其他医疗照护。
一旦George的心脏出现持续衰竭，医院的重症监护病房（ICU）或冠心病重症监护病房（CCU）就可以提供及时的救护。
尽管医院有相关的规定，在有些情况下执行具有一定的弹性。
如果George的医生认为他的病情并没有因为治疗有所好转，并濒临死亡，他的家属可以要求更加宽松的探视时间。
如果他的家属想从家中给他带一些私人物品，可以向工作人员询问物品的尺寸限制或是是否需要消毒。
不论George住在ICU、CCU还是两病床的病房，其家属都可以要求更多的私人空间。
在医院环境中，对临终病人来说，身边永远会有知道该如何照料他的医务人员。
这一点令病人及其家属得以安心。
已有越来越多的人在生命尽头的时候选择疗养院，因为在这里，护理人员是随叫随到的。
疗养院有时也被称为专业护理所，在临终护理方面有利有弊。
与医院不同，疗养院里并不是全天候都有医生在场。
然而，由于临终护理可以事先安排，在病人濒临死亡时，不需要事先咨询医生而开展照护。
如果濒死病人已经在疗养院住了一段时间，家属很可能已经和护理人员建立了一定的关系，因而与医院相比，这里的护理工作更具个性化。
赵丽词汇详细版
naive 天真的，幼稚的nai+ve，奶+喂。
喂奶，给小孩native 土著人native去掉t，比土著人还要少一点，就是天真的，幼稚的；也可以理解成naive加上t，天真+很土(t)=土著人***tantalize 逗引或招惹。
逗弄，使干着急。
tantalus 致命的诱惑tantalizing 诱人的tantalizing smell 诱人的气味希腊神话，tantalus，因其将其子剁碎给众神吃而受到惩罚，被打入阴间并被罚站立在水中，当他想去饮水时水即流走，其头上挂有水果，但当他想拿水果时却退开。
***rim 边缘brim 边缘b+rim，不+rim。
b加在rim前意思不变。
grim 恐怖的g+rim，鬼+rim。
鬼站在边缘上，很恐怖。
trim 修剪整齐t+rim，剃+rim。
剃掉多余的部份，修剪整齐。
zjprim 呆板的prose 单调，散文p+rose，铺+rim。
铺天盖地的玫瑰，很单调。
另，散文经常写的是爱情，玫瑰是爱情的象征，铺天盖地的玫瑰，铺天盖地的爱情，就是散文。
plight 困境p+light，扑+light。
把光给扑灭了，就陷入困境。
pray 祈祷p+ray，扑+ray。
舞台上，一个人扑倒在一束光线的下面，在祈祷。
口决：只有rim是边缘；前面加b，含义不变；前面加鬼，真恐怖；前面加t才修剪整齐；p在rim前真呆板；铺到玫瑰上更单调；扑灭了光，就陷入困境；扑在光线下才是祈祷。
***chaos 混乱，紊乱chao+s。
吵的复数，混乱，紊乱。
***flirt 调情抚摸着她，逗她笑。
调情。
***quaint 古怪的guai怪，古怪。
acquaint 熟悉，见怪不怪ac+quaint，ac-词根，表示“一再的”。
一再的怪，到最后就熟悉，见怪不怪了。
***charisma 领袖气质cha+ris+ma，china+rise+mao。
中国升起了毛泽东，毛泽东具有领袖气质。
chari+s+ma，chair+s+man。
体外膜肺氧合应用下救治创伤致三尖瓣脱垂并房间隔穿孔
体外生命支持是呼吸功能衰竭和/或心力衰竭时提供的临时治疗处理。
体外膜肺氧合（extra⁃corporeal membrane oxygenation ，ECMO ）是目前应用的主要体外生命支持设备之一。
静脉⁃静脉ECMO （VV⁃ECMO ）是心功能保留的基础上对呼吸衰竭患者的选择。
有关ECMO 在难治性急性呼吸窘迫综合征（ARDS ）、心脏骤停患者和难治性心源性休克患者中的应用已多有报道［1-5］。
ECMO 的临床结果可能直接关系到实际应用的经验，重症监护病房的医生、护士和其他多学科团队成员需要掌握或熟悉这个技术。
本文的目的是提供作者ECMO支持危重病人的经验和过程。
1资料与方法1.1一般资料患者，男，24岁，既往体健，因乘坐小轿车与来车碰撞，致头、胸、腹及左上肢严重外伤，被送到当地医院抢救，期间出现顽固性低氧血症，呼吸机无法维持，2018⁃12⁃28遂请我科ECMO 小组参与救治。
查体：T ：38.4℃，P ：121次/分，BP ：103/65mmHg （多巴胺6μg/kg·min ），R ：28次/分，SpO 2：70%（呼吸机支持下，PC ：18cmH 2O ，PEEP ：8cmH 2O （1cmH 2O=0.098kPa ），FiO 2：100%），氧合指数62；神志昏迷，双侧瞳孔直径4mm ，对光反射减弱，GCS 评分6分；经口气管插管接呼吸机辅助呼吸，停留双侧胸腔闭式引流管，双肺呼吸粗，可闻及少许湿啰音；心律齐，心脏未闻及明显病理性杂音；腹平软，腹腔引流管有淡红色腹水引出；左前臂夹板固定。
结基金项目：东莞市社会科技发展（重点）项目（2018507150011645）作者单位：1.广东医科大学，广东湛江524000；东莞市人民医院2.重症医学科，3.心胸外科；4.心内科，广东东莞，523059*通讯作者：沈利汉，Email ：*********************体外膜肺氧合应用下救治创伤致三尖瓣脱垂并房间隔穿孔郑倩伟1，2，陈洁2，甘宇2，曹卫东3，郭素峡4，蔡立华2，沈利汉2*［摘要］体外膜肺氧合（ECMO ）在救治严重心肺功能衰竭患者中已显示出独特优势，应用日益广泛，但在急诊创伤患者中，因出血风险大，限制其应用。
医患矛盾 英语
医患矛盾英语
“医患矛盾”可以用"doctor-patient conflict"或"doctor-patient contradiction"来表达。
这个术语指的是医生和患者之间存在的紧张、不信任、冲突或矛盾关系。
医患矛盾可能源于多种因素，如沟通不畅、医疗失误、期望不一致、信息不透明、医疗资源紧张等。
这些问题可能导致患者对医生的不满、抱怨，甚至引发医患纠纷。
解决医患矛盾需要多方努力，包括加强医患沟通、提高医疗质量、加强医疗监管、改善医疗服务等。
同时，也需要提高患者对医疗过程的理解和认知，增强医患之间的信任。
另外，还可以使用一些相关的短语来描述医患矛盾，例如"resolve doctor-patient conflicts"（解决医患矛盾）、"mitigate doctor-patient tensions"（缓解医患紧张关系）、"improve doctor-patient relationships"（改善医患关系）等。
在英语中，准确描述医患矛盾需要根据具体语境和表达需要选择合适的词汇和短语。
如果你想进一步探讨医患矛盾的相关问题或需要更多例句，欢迎随时提问。
外敷中药结合VSD负压引流治疗跟腱断裂吻合术后感染1例
术后深部感染是外科较为棘手的问题。笔者分期运用院内制剂金黄膏、冲和膏、生肌膏结合VSD负压引流治疗跟腱断裂吻合术后深部感染1例，现报告如下：
1.病例报道
患者，男，26岁。主因扭伤致左踝部伴肿痛、活动受限1月入院，MR示：左跟腱陈旧性断裂。完善术前检查，未发现明显手术禁忌症，于入院后第3日在神经阻滞麻醉下行左跟腱陈旧性断裂切开修补术。仰卧位，取左跟腱内侧纵切口，逐层切开，见左跟腱于跟骨结节上方3cm处完全断裂，跟腱断端近侧约8CM范围内肌腱及肌肉纤维排列紊乱，有纤维瘢痕组织长入，肌腱增粗水肿，弹性减低，断端分离纤维化。用惰性线以Krackow法断端吻合，将近端腱膜切下6×1cm长翻下加强跟腱断端。术后左踝跖屈位固定。术后予消肿、止痛治疗。术后3天，一般情况正常出院。患者在术后21日因发热、左内踝后侧红肿来门诊，查体左内踝后上方距切口3cm红肿明显，波动感（-），血常规检查示WBC：14.85×109/L；C-反应蛋白：71mg/L。予抗生素静脉滴注两周，体温控制平稳。红肿处予中药金黄膏换药，红肿明显减轻，5日后改行冲和膏换药，3日后红肿开始局限，表皮软化，波动感（+），破溃。给予生肌膏引流换药。1周后创口愈合。其后间断出现破溃，术后3月时经探查窦道较深（图1），MR示：左跟腱周围局部炎性反应（图2）。经门诊收入院行切开病灶清创VSD负压引流术（图3），术中病灶美蓝染色，充分清除染色组织。术后1周拆除VSD，局麻下关闭创口。患者好转出院，定期门诊复查，现伤后1年半，左踝处未再次出现红肿、破溃（图4），患者已回到正常工作生活。
【参考文献】
[1] Wilkins R,Bisson L J.Operative versus nonoperative management of acute Achilles tendon ruptures: a quantitative systematic review of randomized controlled trials. The American journal of sports medicine, 2012, 40(9): 2154-2160.
锁骨上神经
锁骨上神经解剖分布及其临床评价邢宗英刘朝晖程立明郭万首王冉东邹海波摘要目的显示锁骨上神经解剖分布，避免在手术中损伤。
资料和方法从2004年7月-2009年8月，我科完成锁骨干粉碎性骨折及肩锁关节脱位复位固定手术75例，年龄24-46岁,;男性56例;女性19例。
75例锁骨粉碎性骨折做横切口复位固定。
18例患者术后出现了切口下永久性麻木。
在7具正常人尸体（男性4具，女性3具）解剖出锁骨上神经及其分支,了解其走行及与临床的关系。
结果锁骨上神经自颈丛，从胸锁乳突肌后缘中下1/2处发出，即分出内中外三支，位于深浅筋膜之间,向远端越过锁骨，支配锁骨周围的感觉。
锁骨上神经三支的体表投影大致为胸锁乳突肌后缘中点分别至胸骨柄外侧、锁骨中点及肩峰的三条引线。
结论在锁骨损伤的手术中应避免损伤锁骨上神经。
关键词锁骨上神经解剖损伤Distribution of the Supraclavicular Nerve and its Clinical EvaluationAbstractive Objective show the anatomy of the supraclavicular nerve and avoid injuring it in the operations.Materials and methods the supraclavicular nerve was found in 7 normal cadavers（4 males,3 females）,and 75 operations were performed cases with clavicular communited frature using transverse incisions.Results Supraclavicular nerve has three main branches and there are few anomal changes on it.The nerve originates from cervical complex and exits from the middle point of the posterior side of the sternocleidomastoid muscle ,and is immediately divided into main three branches:medial,middle,and lateral branch.All the three branches pass the clavicle between the deep and superficial fasciae and run into the skin round the clavicle.In the operations of fixation of clavicular shaft fractures,eighteen cases have the permanent numbness below the incisions due to injury of supraclavicular nerve.Conclusions the supraclavicular nerve should be identified and protected during procedure on the clavicle.Key words Supraclavicular nerve anatomy injury锁骨骨折手术日益增多，在我们临床工作中发现有部分患者出现锁骨切口下永久性麻木，考虑到锁骨上神经的损伤，为此，我们进行了锁骨部位的尸体解剖，并结合我们的临床工作进行总结，报告如下。
小儿肠套叠的治疗进展
小儿肠套叠的治疗进展发布时间：2023-03-16T08:51:21.630Z 来源：《医师在线》2022年35期作者：嘎丽巴敖道呼[导读] 肠套叠多见于1岁以内婴儿，是小儿急腹症，对患儿生命安全构成一定威胁。
随着医疗技术水平的发展，小儿肠套叠的治疗手段不断完善。
目前，临床上对小儿肠套叠开展了多种治疗方法。
嘎丽巴敖道呼内蒙古民族大学附属医院内蒙古通辽 028000摘要：肠套叠多见于1岁以内婴儿，是小儿急腹症，对患儿生命安全构成一定威胁。
随着医疗技术水平的发展，小儿肠套叠的治疗手段不断完善。
目前，临床上对小儿肠套叠开展了多种治疗方法。
本文对小儿肠套叠的治疗进展进行探讨，阐述了非手术治疗和手术治疗小儿肠套叠的方法的治疗效果。
小儿肠套叠大多数可以通过非手术治疗取得较好的治疗效果，值得临床上推广应用。
在不适用于非手术治疗小儿肠套叠的情况下，应及时进行手术治疗，避免因延误治疗导致肠坏死。
一旦出现疑似小儿肠套叠的症状，应立即干预，根据病情采取相应的治疗方法。
关键词：小儿肠套叠；治疗；进展Progress in Treatment of Intussusception in ChildrenGaliba AdaohuAbstract: Intussusception is usually seen in infants under 1 year old, which is an acute abdomen in children and poses a threat to the life safety of children. With the development of medical technology, the treatment of intussusception in children has been improved. At present, a variety of treatment methods have been developed for children's intussusception clinically. This article discusses the progress in the treatment of intussusception in children, and expounds the therapeutic effect of non operative treatment and surgical treatment of intussusception in children.The majority of intussusception in children can be treated by non-surgical treatment, which is worthy of clinical application. If it is not suitable for non-surgical treatment of intussusception in children, surgical treatment should be carried out in time to avoid intestinal necrosis due to delayed treatment. In case of suspected intussusception in children, it is necessary to intervene immediately and take corresponding treatment according to the condition.Key words: intussusception in children; treatment; progress肠套叠是小儿急腹症，常见于1岁以内婴儿，多为原发性肠套叠，男童患病率高于女童。
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ORIGINAL PAPEROperative versus non-operative treatment for clavicle fracture:a meta-analysisGuo-dong Liu &Song-lin Tong &Shan Ou &Le-shun Zhou &Jun Fei &Guo-xin Nan &Jian-wen GuReceived:2February 2013/Accepted:11March 2013/Published online:5May 2013#Springer-Verlag Berlin Heidelberg 2013AbstractPurpose The purpose of this study was to assess the effects of operative and non-operative treatment on clavicle fractures.Method Relevant clinical trials on the operative and non-operative treatment for clavicle fractures were retrieved through searching the databases MEDLINE,Embase,OVID and the Cochrane Central Register of Controlled Trials up to December 2011.The quality of the included studies was assessed by two authors.A meta-analysis was carried out onhomogeneous studies.Five studies involving 633clavicle fractures were included.Results The differences in nonunion [risk ratio (RR)0.12,95%confidence interval (CI)0.05–0.29],malunion (RR 0.11,95%CI 0.04–0.29)and neurological complications (RR 0.45,95%CI 0.25–0.81)were statistically significant between operative and non-operative treatment.There was no statistically significant difference in delayed union (RR 0.78,95%CI 0.31–1.95).Conclusion Operative treatment is better than non-operative treatment,but decisions should be made in accordance with specific conditions for clinical application.IntroductionClavicle fractures are frequent injuries,representing 2.6–10%of fractures in adults [1,2],of which midshaft fractures are the most common,accounting for approximately 81%of all clavicle fractures [2].Traditionally,clavicular fracture is treat-ed non-operatively with a figure-of-eight bandage or broad arm sling [3].Non-operative treatment is easily accepted by undemanding patients and patients who do not tolerate sur-gery well as it offers the advantages of minimal trauma,easy procedure and low cost.However,outcomes of non-operative treatment are not always excellent [4,5].Some specific sub-sets of patients are reported to be at a high risk for nonunion,shoulder dysfunction or residual pain after non-surgical man-agement [6].Therefore,operative treatment is playing an increasingly important role in the clinical setting,mainly using compression plating or intramedullary nail fixation [7–10].A number of studies have assessed the effectiveness of operative versus non-operative treatment for clavicle fractures in different populations;however,the results are inconsistent and inconclusive because of the small sample size in most of the studies [11–13].Meta-Guo-dong Liu and Song-lin Tong contributed equally to the study.G.-d.LiuDepartment 8,Research Institute of Surgery,Daping Hospital,Third Military Medical University,Chongqing 400042,People ’s Republic of ChinaS.-l.TongDepartment of Orthopedics,Cixi People ’s Hospital of Zhejiang Province,Cixi 315300,People ’s Republic of ChinaS.Ou (*):L.-s.ZhouDepartment of Anesthesiology,General Hospital of Chengdu Military Command,Chengdu,Sichuan 610083,People ’s Republic of Chinae-mail:euromountainou@J.FeiTraumatic Center,Research Institute of Surgery,Daping Hospital,Third Military Medical University,Chongqing 400042,People ’s Republic of ChinaG.-x.NanDepartment II of Orthopedics,Children ’s Hospital of Chongqing Medical University,Chongqing 400014,People ’s Republic of China J.-w.Gu (*)Department of Neurosurgery,General Hospital of Chengdu Military Command,Chengdu,Sichuan 610083,People ’s Republic of China e-mail:769419161@International Orthopaedics (SICOT)(2013)37:1495–1500DOI 10.1007/s00264-013-1871-zanalysis was first proposed by Beecher in1955and named by Glass in1976.It is defined as a statistical method for systematically combining the results of mul-tiple independent studies(controversial or even conflicting studies)and analysing a large data set to allow definite conclusions,offering great help for scien-tific research and practice decisions[14].Therefore,this report retrieved randomised controlled trials or clinical controlled trials of operative and non-operative treatment for clavicle fracture over nearly20years and meta-analysis was performed to provide a basis for the pre-ferred therapies for clavicle fracture in clinical practice.Materials and methodsLiterature searchThe databases PubMed,MEDLINE,EMBASE and the Cochrane Central Register of Controlled Trials(CCTR) were searched for all articles on operative and non-operative treatment for clavicle fracture with the following search terms:(clavicle)AND(fractures)AND(‘randomised controlled trial’OR‘controlled clinical trial’)where the search date was December2011.We also retrieved the relevant articles with Google Scholar.Inclusion and exclusion criteriaAbstracts of all citations and retrieved studies were reviewed.Studies meeting the following criteria were in-cluded:(1)original literature published at home and abroad;(2)randomised clinical trial(RCT)or controlled clinical trial(CCT)design;(3)having definite study time;(4)hav-ing definite sample size;(5)providing definite pathological diagnostic criteria;(6)the therapeutic methods are operative treatment(plating or intramedullary nailing)and non-operative treatment(arm sling or bandage);(7)the method of data collection is scientific and correct;and(8)compar-ison of Constant score(CS)scores,disabilities of the arm, shoulder and hand(DASH)scores,nonunion,delayed union or neurological complications.Studies were excluded if one of the following existed:(1) providing undefined sample and control source,non-therapeutic clinical studies,animal experiments,non-original studies and undefined grouping;(2)providing undefined path-ological diagnostic criteria;(3)patients without clavicle frac-ture due to trauma;(4)no control design;(5)the method ofTable1Basic situation and quality assessment of the studiesLiterature Journal Type Patients(n)Follow-up(n)Follow-uptimeOperative group Non-operativegroupBöhme(2011)[15]Z Orthop Unfall CCT120968months Plating/elasticintramedullary nailBandage fixation COTS(2007)[16]J Bone JointSurgRCT1321111year Plating Arm sling Jubel(2005)[17]Unfallchirurg CCT53536months Elastic intramedullary nail Bandage fixation Judd(2009)[18]Am J Orthop RCT57501year Elastic intramedullary nail Arm slingKulshrestha(2011) [19]J OrthopTraumaCCT736818months Plating Arm slingSmekal(2009)[20]J OrthopTraumaRCT68602years Elastic intramedullary nail Arm slingSmith(2001)[21]68th AM ofAAOSRCT1006518.5months Plating Arm slingVirtanen(2010) [22]75th AM ofAAOSRCT60511year Plating Arm slingCOTS Canadian Orthopaedic Trauma Society,AM of AAOS Annual Meeting of the American Academy of Orthopaedic SurgeonsTable2CS and DASH scoresLiterature CS scores DASH scoresOperative group Non-operativegroupOperativegroupNon-operativegroupBöhme(2011)[15]9490NA NACOTS(2007)[16]96.190.8 5.213Jubel(2005)[17]9890210 Judd(2009)[18]NA NA NA NAKulshrestha(2011)[19]NA NA NA NA Smekal(2009)[20]97.993.70.53 Smith(2001)[21]NA NA NA NA Virtanen(2010)[22]86.586.1 4.37.1 COTS Canadian Orthopaedic Trauma Societydata collection is not scientific and the method of data analysis is incorrect or not provided;(6)no therapeutic outcome;and (7)review literature,repeated reports and retrospective studies.Data extractionAll data were extracted independently by two authors according to the inclusion criteria listed above.Disagreements were resolved by discussion between the two reviewers.The following characteristics were collected from each study:the first author,year of publication,source,experiment design, sample size,sample characteristics,treatment outcome and others.Statistical analysisThe statistical analysis was conducted using Review Man-ager5.0software.Continuous data were expressed as standardised mean differences(SMD)and95%confidence intervals(CI).Dichotomous data were presented as risk ratios(RR)with95%CI.P≤0.05was considered statisti-cally significant.Heterogeneity was assessed with theχ2-based Q testing.If there was significant heterogeneity(P< 0.1),we selected a random effects model to pool the data.If not,a fixed effects model was used.ResultsLiterature characteristicsA total of37studies related to the effects of operative and non-operative treatment of clavicle fracture and the compli-cations were retrieved after the preliminary screening;eight of the37studies were incorporated into the study[15–22]. The basic characteristics of these studies such as the authors, publication year,journal,study type,the number of patients, therapeutic method and follow-up time are summarised in Table1.There were five RCT[16,18,20–22]and three CCT[15,17,19].The number of patients ranged from53to 132(Table1).Comparison of the CS and DASH scores between operative and non-operative treatment for clavicle fractureFive studies[15–17,20,22]reported the CS scores after the treatment of clavicle fracture and the results showed that the CS scores of the operative group were higher than those of the non-operative group.Four studies[16,17,20,22] reported the DASH scores and the DASH scores of the operative group were shown to be lower than those of the non-operative group.We did not compare thestatistical Fig.1Comparison of the nonunion rate after operative and non-operative treatment for claviclefractureFig.2Comparison of the malunion rate after operative and non-operative treatment for clavicle fracturedifference due to a lack of information on standard devia-tion..The definite scores are shown in Table2. Comparison of the nonunion rate between operativeand non-operative treatment for clavicle fractureEight RCT or CCT[15–22]reported the nonunion rate after operative and non-operative treatment of clavicle fracture in which306patients were included in the operative treatment group and260patients were included in the non-operative treatment group.No heterogeneity was observed between the studies(P=0.74,I2=0%);therefore,a fixed effect model was used.The result of meta-analysis showed that there was a statistical difference in the nonunion rate be-tween operative and non-operative treatment for clavicle fracture(RR0.12,95%CI0.05–0.29).Operative treatment could significantly reduce the nonunion rate(Fig.1). Comparison of the malunion rate between operativeand non-operative treatment for clavicle fractureSix RCT or CCT[15,16,19–22]reported the malunion rate after operative and non-operative treatment for clavicle frac-ture in which251patients were included in the operative treatment group and202patients were included in the non-operative treatment group.Heterogeneity was also not ob-served between the studies(P=0.97,I2=0%).The result of meta-analysis showed there was a significant difference in malunion rate between operative and non-operative treatment for clavicle fracture(RR0.11,95%CI0.04–0.29),indicating operative treatment reduces the malunion rate(Fig.2).Comparison of the delayed union rate between operative and non-operative treatment for clavicle fractureThere were five RCT or CCT[15,18–20,22]which had been performed to study the delayed union rate after operative and non-operative treatment of clavicle fracture.A total of337 patients were studied,including188patients receiving opera-tive treatment and149patients receiving non-operative treat-ment.No heterogeneity was present between the studies(P= 0.23,I2=29%).The result of meta-analysis showed that there was no statistical difference in the delayed union rate between operative and non-operative treatment for clavicle fracture (RR0.78,95%CI0.31–1.95),indicating operative treatment did not reduce the delayed union rate(Fig.3). Comparison of the neurological complication rateThere were seven RCT or CCT[15–18,20–22]which had been performed to study the neurological complication rate after operative and non-operative treatment for clavicle frac-ture.A total of468patients were studied,including261 patients receiving operative treatment and207patients re-ceiving non-operative treatment.No heterogeneity was pres-ent between the studies(P=0.23,I2=28%).The result of meta-analysis showed there was also no statistical difference in the neurological complication rate between operativeand Fig.3Comparison of the delayed union rate after operative and non-operative treatment for claviclefractureFig.4Comparison of the neurological complication rate after operative and non-operative treatment for clavicle fracturenon-operative treatment of clavicle fracture(RR0.45,95% CI0.25–0.80)(Fig.4).DiscussionSome systematic reviews on clavicle fracture treatment have been reported in previous studies.For example, Zlowodzki et al.[23]showed that the nonunion rate can reach4%by operative treatment and6%by non-operative treatment.However,this study only in-cluded three RCT containing a cohort study due to the limitation of methodology.Only one of the three RCT studied the effect of different operations on clavicle fracture.Lenza et al.[24]investigated three reports of non-operative treatment of middle third clavicle frac-tures,but the three reports could not analyse the effect of different operations on clavicle fracture.This meta-analysis included five RCT and three CCT published between2000and2011.This meta-analysis analysed the nonunion,malunion,delayed union and neurological complication rate after operative and non-operative treat-ment for clavicle fracture.The results showed that there were statistical differences in the nonunion,malunion and neurological complication rates between operative and non-operative treatment,suggesting operative treat-ment could decrease the incidence rate of these adverse events.Operative treatment did not reduce the delayed union rate in our study.These meta-analysis results should be cautiously interpreted because there are still some limitations to this study.(1)Although this meta-analysis was performed based on unbiased data,the bias must exist because of the differences in the concerned populations and regions in the studies.By collecting all papers about clavicle fracture using multiple languages,we believe that the results of the study are suitable for almost all populations.(2)Since the deficiency of the original data such as CS scores and the standard devi-ation of DASH scores,the CS scores and DASH scores only could be described.A statistical analysis could not be performed.(3)We did not analyse the effect of treatments on clavicle fracture according to different ages and sexes on account of the limitation of the studies included,which may affect the result of this meta-analysis.(4)Our study may also be influenced by the lack of final effect of the treatments on patients because of the delayed follow-up,the loss to follow-up and the increasing number of patients who dropped out of the studies.(5)Meta-analysis is a retrospective research tool that is subject to methodological deficiencies.Therefore, larger and well-designed studies are needed to confirm our results.ConclusionsOperative treatment reduces the nonunion,malunion and neurological complication rates of clavicle fractures,but does not affect the delayed union rate.For clinical applica-tion,we should make decisions in accordance with specific conditions.In order to avoid the risk of adverse events, operative treatment is a better therapeutic method if it is matched to the individual patient.Acknowledgments This study was supported by National Natural Science Foundation of China(No.81200964and No.31171069); 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