CAP 137A ANTIBIOTICS REGULATIONS一
CAP 137 ANTIBIOTICS ORDINANCE一
CAP 137 ANTIBIOTICS ORDINANCE一摘要：To control the sale and supply of certain antibiotic substances.(Amended 40 of 1969 s. 2)[4 June 1948](Originally 21 of 1948 (Cap 137 1950))Cap 137 s 1 Short titleThis Ordinance may be cited as the Antibiotics Ordinance.(Amended 40 of 1969 s. 3)Cap 137 s 2 InterpretationIn this Ordinance, unless the context otherwise requires-"authorized seller of poisons" (获授权毒药销售商) has the meaning assigned to it by the Pharmacy and Poisons Ordinance (Cap 138);"Director of Agriculture, Fisheries and Conservation" (渔农自然护理署署长) includes the senior veterinary officer and any veterinary officer; (Added 23 of 1962 s. 3. Amended L.N. 331 of 1999)"penicillin" (青霉素) has the meaning assigned to it by the regulations made under this Ordinance;"registered dentist" (注册牙医) means a person registered in the dentists register and a person deemed to be a registered dentist under the Dentists Registration Ordinance (Cap 156); (Amended 62 of 1987 s. 10) "registered medical practitioner" (注册医生) means a person registered or deemed to be registered under the Medical Registration Ordinance (Cap 161);"registered pharmacist" (注册药剂师) means a person registered in the register of pharmaceutical chemists or the register of chemists and druggists under the Pharmacy and Poisons Ordinance (Cap 138);"registered veterinary surgeon" (注册兽医) means a veterinary surgeon registered under the Veterinary Surgeons Registration Ordinance (Cap 529). (Replaced 96 of 1997 s. 36)Cap 137 s 3 Substances to which this Ordinance appliesThe substances to which this Ordinance applies are penicillin and such other anti-microbial organic substances produced by living organisms as may be prescribed by regulations made by the Director of Health under section 12 and, where such regulations prescribe a substance produced byliving organisms, the regulations may include any substance the chemical properties of which are identical with or similar to those of the substances so prescribed but which is not produced by living organisms: (Amended 50 of 1955 s. 2; 84 of 1992 s. 12)Provided that this Ordinance shall not apply to antibiotic substances contained in foods for livestock or to such substances which have been specially manufactured for the purpose of supplementing foods for livestock. (Added 50 of 1955 s. 2)Cap 137 s 4 Control of sale and supply of substances to which this Ordinance applies(1) Subject to the provisions of this section, no person shall sell or otherwise supply any substance to which this Ordinance applies or any preparation of which any such substance is an ingredient or part unless he is-(a) a registered medical practitioner, a registered dentist or a registered veterinary surgeon or a person acting in accordance with the directions of any such medical practitioner, dentist or veterinary surgeon, and the substance or preparation is sold or supplied for the purpose of treatment by or in accordance with the directions of thatmedical practitioner, dentist or veterinary surgeon; or (Amended 96 of 1997 s. 37)(b) a person who, although not a registered medical practitioner, practises medicine in a clinic in such circumstances that, by virtue of section 8(8) of the Medical Clinics Ordinance (Cap 343), he is not by reason solely of such practice guilty of an offence under section 28 of the Medical Registration Ordinance (Cap 161) and the substance or preparation is sold or supplied by him solely in the course of his practice in that clinic for the purpose of treatment by him or treatment in accordance with his directions; or (Added 14 of 1964 s. 2)(c) a registered pharmacist or an authorized seller of poisons, and the substance or preparation is sold or supplied under the authority of a prescription signed and dated by such medical practitioner, dentist or veterinary surgeon as aforesaid.(2) No person shall administer by way of treatment any such substance or preparation unless he is such a medical practitioner, dentist or veterinary surgeon or a person acting in accordance with the written directions of any such medical practitioner, dentist or veterinary surgeon, or a holder of a valid permit issued by the Director of Agriculture, Fisheries and Conservation under section 6(2), or a person acting under the direction of a holder of such permit, or a person referred to subsection (1)(b) and such substance orpreparation is administered in the course of his practice in the clinic concerned. (Amended 50 of 1955 s. 3; 23 of 1962 s. 3; 14 of 1964 s. 2; L.N. 331 of 1999)(3) Subsection (1) shall not apply to the sale or supply of any such substance or preparation-(a) to any person who is a holder of a valid permit issued under this Ordinance to deal in such substance or preparation; (Replaced 50 of 1955 s. 3)(b) to any person who is a holder of a valid permit issued by the Director of Agriculture, Fisheries and Conservation under section 6(2), if any substance or preparation so sold or supplied is clearly labelled "for veterinary purposes only" and "只限医治禽畜用"; (Added 23 of 1962 s. 3. Amended 80 of 1997 s. 115; L.N. 331 of 1999)(c) to any such medical practitioner, dentist or veterinary surgeon as aforesaid;(d) to any authority or person carrying on a hospital, clinic, nursing home or other institution providing medical, surgical or veterinary treatment:Provided that this paragraph shall not apply to any hospital, clinic, nursing home or other institution which is required to be registered under the Medical Clinics Ordinance (Cap 343) unless it is so registered; (Replaced 14 of 1964 s. 2)(e) to any person carrying on an institution or business which has among its recognized activities the conduct of scientific education or research, for use by persons engaged in that education or research; or(f) to any public department.(4) The person dispensing a prescription shall comply with the following requirements-(a) if the prescription contains a direction that it may be dispensed a stated number of times or, at stated intervals, it must not be dispensed otherwise than in accordance with the direction;(b) at the time of dispensing there must be noted on the prescription the signature of the prescriber, the name and address of the seller and the date on which the prescription was dispensed;(c) except in the case of a prescription which may be dispensed on more than one occasion, the prescription must for a period of 2 years be retained and kept on the premises on which it was dispensed, in such manner as to be readily available for reference.Cap 137 s 5 Prohibition of possession of substances to which this Ordinance applies(1) Subject to the provisions of subsection (2), no person shall have in his possession or under his control any substance to which this Ordinance applies or any preparation of which any such substance is an ingredient or part.(2) Subsection (1) of this section shall not apply to the following-(a) a registered medical practitioner;(b) a person referred to in section 4(1)(b); (Added 14 of 1964 s. 3)(c) a registered dentist;(d) a registered veterinary surgeon; (Amended 96 of 1997 s. 38)(e) a registered pharmacist;(f) an authorized seller of poisons;(g) a department of Government;(h) any person acting under the direction of a registered medical practitioner, registered dentist or registered veterinary surgeon; (Amended 45 of 1984 s. 2; 96 of 1997 s. 38)(i) a person who is the holder of a valid permit issued under this Ordinance to deal in such substance or preparation; (Amended 23 of 1962 s. 4; 45 of 1984 s. 2)(j) a person who is the holder of a valid permit issued by the Director of Agriculture, Fisheries and Conservation under subsection (2) of section 6; or (Added 23 of 1962 s. 4; 45 of 1984 s. 2. Amended L.N. 331 of 1999)(k) a person in bona fide possession of a substance supplied to him in conformity with section 4. (Added 45 of 1984 s. 2)(Added 50 of 1955 s. 4)。
注射用头孢洛林酯说明书(美国,英文)
1 23 4 5 678 91011 12 1314151617 18192021 22 23242554HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use TEFLARO safely and effectively. See full prescribing information for TEFLARO®.TEFLARO® (ceftaroline fosamil) injection for intravenous (IV) use Initial U.S. Approval: 2010To reduce the development of drug-resistant bacteria and maintain theeffectiveness of Teflaro and other antibacterial drugs, Teflaro should be used onlyto treat infections that are proven or strongly suspected to be caused by bacteria.-----------------------RECENT MAJOR CHANGES------------------------------------ Dosage and Administration (2.3) XX/2012 --------------------------INDICATIONS AND USAGE--------------------------------Teflaro ® is a cephalosporin antibacterial indicated for the treatment of the following infections caused by designated susceptible bacteria:• Acute bacterial skin and skin structure infections (ABSSSI)(1.1) • Community-acquired bacterial pneumonia (CABP) (1.2) ------------------------DOSAGE AND ADMINISTRATION-------------------------• 600 mg every 12 hours by IV infusion administered over 1 hour in adults ≥ 18 years of age (2.1) • Dosage adjustment in patients with renal impairment (2.2)Estimated CreatinineClearance # (mL/min) Teflaro Dosage Regimen > 50 No dosage adjustment necessary > 30 to ≤ 50 400 mg IV (over 1 hour) every 12 hours ≥ 15 to ≤ 30 300 mg IV (over 1 hour) every 12 hours End-stage renal disease (ESRD), including hemodialysis200 mg IV (over 1 hour) every 12 hours#As calculated using the Cockcroft-Gault formula -----------------------DOSAGE FORMS AND STRENGTHS -----------------------600 mg or 400 mg of sterile Teflaro powder in single-use 20 mL vials. (3) 26--------------------------CONTRAINDICATIONS---------------------------- 27 ∙Known serious hypersensitivity to ceftaroline or other members of28 the cephalosporin class. (4)29 -----------------------WARNINGS AND PRECAUTIONS----------------- 30 ∙Serious hypersensitivity (anaphylactic) reactions have been31 reported with beta-lactam antibiotics, including ceftaroline. 32 Exercise caution in patients with known hypersensitivity to beta33 lactam antibiotics. (5.1) 34 ∙Clostridium difficile -associated diarrhea (CDAD) has been35 reported with nearly all systemic antibacterial agents, including36 Teflaro. Evaluate if diarrhea occurs. (5.2)37 ∙Direct Coombs’ test seroconversion has been reported with38 Teflaro. If anemia develops during or after therapy, a diagnostic 39 workup for drug-induced hemolytic anemia should be performed 40 and consideration given to discontinuation of Teflaro. (5.3) 41 -----------------------------ADVERSE REACTIONS------------------------42 The most common adverse reactions occurring in >2 % of patients are 43 diarrhea, nausea, and rash. (6.3) 44 45 To report SUSPECTED ADVERSE REACTIONS, contact Forest46 Pharmaceuticals, Inc., at 1-800-678-1605 or FDA at 1-800-FDA47 1088 or /medwatch. 48 ---------------------------USE IN SPECIFIC POPULATIONS-------------49 ∙Dosage adjustment is required in patients with moderate or severe50 renal impairment and in ESRD patients, including patients on51 hemodialysis.(2.2, 12.3) 52 53See 17 for PATIENT COUNSELING INFORMATIONRevised:XX/2012 5556 FULL PRESCRIBING INFORMATION: CONTENTS* 84 8.4 Pediatric Use85 8.5 Geriatric Use 57 1 INDICATIONS AND USAGE86 8.6 Patients with Renal Impairment58 1.1 Acute Bacterial Skin and Skin Structure 87 10 OVERDOSAGE59 Infections 88 11 DESCRIPTION 60 1.2 Community-Acquired Bacterial Pneumonia 89 12 CLINICAL PHARMACOLOGY61 1.3 Usage90 12.1 Mechanism of Action62 2 DOSAGE ANDADMINISTRATION 91 12.2 Pharmacodynamics 63 2.1 Recommended Dosage 92 12.3 Pharmacokinetics64 2.2 Patients with Renal Impairment 93 12.4 Microbiology65 2.3 Preparation of Solutions 94 13 NONCLINICAL TOXICOLOGY66 3 DOSAGE FORMS AND STRENGTHS 95 13.1 Carcinogenesis,Mutagenesis, Impairment of 67 4 CONTRAINDICATIONS 96 Fertility 68 5 WARNINGS AND PRECAUTIONS 97 14 CLINICAL TRIALS69 5.1 Hypersensitivity Reactions 98 14.1 Acute Bacterial Skin and Skin Structure70 5.2 Clostridium difficile -associated Diarrhea 99 Infections71 5.3 Direct Coombs’ Test Seroconversion 100 14.2 Community-Acquired Bacterial Pneumonia72 5.4 Development of Drug-Resistant Bacteria 101 15 REFERENCES 73 6 ADVERSE REACTIONS 102 16 HOW SUPPLIED/STORAGE AND HANDLING 74 6.1 Adverse Reactions from Clinical Trials 103 17 PATIENT COUNSELING INFORMATION 75 6.2 Serious Adverse Events and Adverse 10476 Events Leading to Discontinuation 77 6.3 Most Common Adverse Reactions 10578 6.4 Other Adverse Reactions Observed During 106 *Sections or subsections omitted from the full prescribing information79 Clinical Trials of Teflaro107 are not listed.80 7 DRUGINTERACTIONS 81 8 USE IN SPECIFIC POPULATIONS82 8.1 Pregnancy83 8.3 Nursing MothersPage 1 of 13108 FULL PRESCRIBING INFORMATION 109 1. INDICATIONS AND USAGE110 Teflaro® (ceftaroline fosamil) is indicated for the treatment of patients with the following infections caused by susceptible isolates of the designated 111 microorganisms. 112 1.1Acute Bacterial Skin and Skin Structure Infections113 Teflaro is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram114 positive and Gram-negative microorganisms:Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes ,115 Streptococcus agalactiae , Escherichia coli , Klebsiella pneumoniae, and Klebsiella oxytoca. 116 1.2Community-Acquired Bacterial Pneumonia117 Teflaro is indicated for the treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following Gram-positive118 and Gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia),Staphylococcus aureus (methicillin119 susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli. 120 1.3 Usage121 To reduce the development of drug-resistant bacteria and maintain the effectiveness of Teflaro and other antibacterial drugs, Teflaro should be used to 122 treat only ABSSSI or CABP that are proven or strongly suspected to be caused by susceptible bacteria. Appropriate specimens for microbiological123 examination should be obtained in order to isolate and identify the causative pathogens and to determine their susceptibility to ceftaroline. When culture124 and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local125 epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. 126 2. DOSAGE AND ADMINISTRATION 127 2.1Recommended Dosage128 The recommended dosage of Teflaro is 600 mg administered every 12 hours by intravenous (IV) infusion over 1 hour in patients ≥ 18 years of age. The129 duration of therapy should be guided by the severity and site of infection and the patient’s clinical and bacteriological progress. 130 The recommended dosage and administration by infection is described in Table 1.131Table 1: Dosage of Teflaro by InfectionInfection Dosage FrequencyInfusion Time(hours)RecommendedDuration ofTotal Antimicrobial TreatmentAcute Bacterial Skin and Skin Structure Infection(ABSSSI) 600 mg Every 12 hours 1 5-14 days Community-Acquired Bacterial Pneumonia (CABP)600 mg Every 12 hours 1 5-7 days 132133 2.2 Patients with Renal Impairment 134Table 2: Dosage of Teflaro in Patients with Renal Impairment 135 136 137 138 139 140 141Estimated CrCl a (mL/min) Recommended Dosage Regimen for Teflaro> 50No dosage adjustment necessary > 30 to ≤ 50 400 mg IV (over 1 hour) every 12 hours ≥ 15 to ≤ 30 300 mg IV (over 1 hour) every 12 hours End-stage renal disease,including hemodialysis b 200 mg IV (over 1 hour) every 12 hours c ab End-stage renal disease is defined as CrCl < 15 mL/min.cTeflaro is hemodialyzable; thus Teflaro should be administered after hemodialysis on hemodialysis days.2.3 Preparation of SolutionsAseptic technique must be followed in preparing the infusion solution. The contents of Teflaro vial should be constituted with 20 mL Sterile Water forInjection, USP; or 0.9% of sodium chloride injection (normal saline); or 5% of dextrose injection; or lactated ringer’s injection . The preparation of Teflaro solutions is summarized in Table 3.143 Table 3: Preparation of Teflaro for Intravenous UseDosage Strength(mg) Volume of Diluent To BeAdded(mL)Approximate Ceftarolinefosamil Concentration(mg/mL)Amount to Be Withdrawn400 20 20 Total Volume600 20 30 Total Volume144145 The constituted solution must be further diluted in 250 mL before infusion. Use the same diluent for this further dilution, unless sterile water for 146 injection was used earlier. If sterile water for injection was used earlier, then appropriate infusion solutions include: 0.9% Sodium Chloride 147 Injection, USP (normal saline); 5% Dextrose Injection, USP; 2.5% Dextrose Injection, USP, and 0.45% Sodium Chloride Injection, USP; or Lactated 148 Ringer’s Injection, USP. The resulting solution should be administered over approximately 1 hour.149 Constitution time is less than 2 minutes. Mix gently to constitute and check to see that the contents have dissolved completely. Parenteral drug products 150 should be inspected visually for particulate matter prior to administration.151 The color of Teflaro infusion solutions ranges from clear, light to dark yellow depending on the concentration and storage conditions. When stored as 152 recommended, the product potency is not affected.153 Studies have shown that the constituted solution in the infusion bag should be used within 6 hours when stored at room temperature or within 24 hours 154 when stored under refrigeration at 2 to 8º C (36 to 46º F).155 The compatibility of Teflaro with other drugs has not been established. Teflaro should not be mixed with or physically added to solutions containing other 156 drugs.157 3. DOSAGE FORMS AND STRENGTHS158 Teflaro is supplied in single-use, clear glass vials containing either 600 mg or 400 mg of sterile ceftaroline fosamil powder.159 4. CONTRAINDICATIONS160 Teflaro is contraindicated in patients with known serious hypersensitivity to ceftaroline or other members of the cephalosporin class. Anaphylaxis and 161 anaphylactoid reactions have been reported with ceftaroline.162 5. WARNINGS AND PRECAUTIONS163 5.1 Hypersensitivity Reactions164 Serious and occasionally fatal hypersensitivity (anaphylactic) reactions and serious skin reactions have been reported in patients receiving beta-lactam 165 antibacterials. Before therapy with Teflaro is instituted, careful inquiry about previous hypersensitivity reactions to other cephalosporins, penicillins, or 166 carbapenems should be made. If this product is to be given to a penicillin- or other beta-lactam-allergic patient, caution should be exercised because cross 167 sensitivity among beta-lactam antibacterial agents has been clearly established.168 If an allergic reaction to Teflaro occurs, the drug should be discontinued. Serious acute hypersensitivity (anaphylactic) reactions require emergency 169 treatment with epinephrine and other emergency measures, that may include airway management, oxygen, intravenous fluids, antihistamines, 170 corticosteroids, and vasopressors as clinically indicated.171 5.2 Clostridium difficile-associated Diarrhea172 Clostridium difficile-associated diarrhea (CDAD) has been reported for nearly all systemic antibacterial agents, including Teflaro, and may range in 173 severity from mild diarrhea to fatal colitis.174 Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of C. difficile.175 C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased 176 morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all 177 patients who present with diarrhea following antibiotic use. Careful medical history is necessary because CDAD has been reported to occur more than 2 178 months after the administration of antibacterial agents.179 If CDAD is suspected or confirmed, antibacterials not directed against C. difficile should be discontinued, if possible. Appropriate fluid and electrolyte 180 management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated [see Adverse 181 Reactions (6.3)].182 5.3 Direct Coombs’ Test Seroconversion183 Seroconversion from a negative to a positive direct Coombs’ test result occurred in 120/1114 (10.8%) of patients receiving Teflaro and 49/1116 (4.4%) of 184 patients receiving comparator drugs in the four pooled Phase 3 trials.185 In the pooled Phase 3 CABP trials, 51/520 (9.8%) of Teflaro-treated patients compared to 24/534 (4.5%) of ceftriaxone-treated patients seroconverted 186 from a negative to a positive direct Coombs’ test result. No adverse reactions representing hemolytic anemia were reported in any treatment group.187 If anemia develops during or after treatment with Teflaro, drug-induced hemolytic anemia should be considered. Diagnostic studies including a direct 188 Coombs’ test, should be performed. If drug-induced hemolytic anemia is suspected, discontinuation of Teflaro should be considered and supportive care 189 should be administered to the patient (i.e. transfusion) if clinically indicated.191192 5.4 Development of Drug-Resistant Bacteria193 Prescribing Teflaro in the absence of a proven or strongly suspected bacterial infection is unlikely to provide benefit to the patient and increases the risk 194 of the development of drug-resistant bacteria.195 6. ADVERSEREACTIONS196 The following serious events are described in greater detail in the Warnings and Precautions section197 ∙Hypersensitivity reactions [see Warnings and Precautions (5.1)]198 ∙Clostridium difficile-associated diarrhea [see Warnings and Precautions (5.2)]199 ∙Direct Coombs’ test seroconversion [see Warnings and Precautions (5.3)]200 6.1 Adverse Reactions from Clinical Trials201 Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be compared 202 directly to rates from clinical trials of another drug and may not reflect rates observed in practice.203 Teflaro was evaluated in four controlled comparative Phase 3 clinical trials (two in ABSSSI and two in CABP) which included 1300 adult patients treated 204 with Teflaro (600 mg administered by IV over 1 hour every 12h) and 1297 patients treated with comparator (vancomycin plus aztreonam or ceftriaxone) 205 for a treatment period up to 21 days. The median age of patients treated with Teflaro was 54 years, ranging between 18 and 99 years old. Patients treated 206 with Teflaro were predominantly male (63%) and Caucasian (82%).207 6.2 Serious Adverse Events and Adverse Events Leading to Discontinuation208 In the four pooled Phase 3 clinical trials, serious adverse events occurred in 98/1300 (7.5%) of patients receiving Teflaro and 100/1297 (7.7%) of patients 209 receiving comparator drugs. The most common SAEs in both the Teflaro and comparator treatment groups were in the respiratory and infection system 210 organ classes (SOC). Treatment discontinuation due to adverse events occurred in 35/1300 (2.7%) of patients receiving Teflaro and 48/1297 (3.7%) of 211 patients receiving comparator drugs with the most common adverse events leading to discontinuation being hypersensitivity for both treatment groups at a 212 rate of 0.3% in the Teflaro group and 0.5% in comparator group.213 6.3 Most Common Adverse Reactions214 No adverse reactions occurred in greater than 5% of patients receiving Teflaro. The most common adverse reactions occurring in > 2% of patients 215 receiving Teflaro in the pooled phase 3 clinical trials were diarrhea, nausea, and rash.216 Table 4 lists adverse reactions occurring in ≥ 2% of patients receiving Teflaro in the pooled Phase 3 clinical trials.217 Table 4: Adverse Reactions Occurring in ≥ 2% of Patients Receiving Teflaro in the Pooled Phase 3 Clinical TrialsSystem Organ Class/ Preferred TermPooled Phase 3 Clinical Trials(four trials, two in ABSSSI and two in CABP)Teflaro(N=1300)Pooled Comparators a(N=1297) Gastrointestinal disordersDiarrhea 5 % 3 %Nausea 4 % 4 %Constipation 2 % 2 %Vomiting 2 % 2 %InvestigationsIncreased transaminases 2% 3 %Metabolism and nutrition disordersHypokalemia 2 % 3 %Skin and subcutaneous tissue disordersRash 3%2%Vascular disordersPhlebitis 2%1% 218 a219 IV every 24h in the Phase 3 CABP trials.220221222 6.4 Other Adverse Reactions Observed During Clinical Trials of Teflaro223 Following is a list of additional adverse reactions reported by the 1740 patients who received Teflaro in any clinical trial with incidences less than 2%. 224 Events are categorized by System Organ Class.225 Blood and lymphatic system disorders - Anemia, Eosinophilia, Neutropenia, Thrombocytopenia226 Cardiac disorders - Bradycardia, Palpitations227 Gastrointestinal disorders -Abdominal pain228 General disorders and administration site conditions - Pyrexia229 Hepatobiliary disorders - Hepatitis230 Immune system disorders - Hypersensitivity, Anaphylaxis231 Infections and infestations -Clostridium difficile colitis232 Metabolism and nutrition disorders - Hyperglycemia, Hyperkalemia233 Nervous system disorders -Dizziness, Convulsion234 Renal and urinary disorders - Renal failure235 Skin and subcutaneous tissue disorders - Urticaria236 7. DRUGINTERACTIONS237 No clinical drug-drug interaction studies have been conducted with Teflaro. There is minimal potential for drug-drug interactions between Teflaro and 238 CYP450 substrates, inhibitors, or inducers; drugs known to undergo active renal secretion; and drugs that may alter renal blood flow [see Clinical 239 Pharmacology (12.3)].240 8. USE IN SPECIFIC POPULATIONS241 8.1 Pregnancy242 Category B243 Developmental toxicity studies performed with ceftaroline fosamil in rats at IV doses up to 300 mg/kg demonstrated no maternal toxicity and no effects 244 on the fetus. A separate toxicokinetic study showed that ceftaroline exposure in rats (based on AUC) at this dose level was approximately 8 times the 245 exposure in humans given 600 mg every 12 hours. There were no drug-induced malformations in the offspring of rabbits given IV doses of 25, 50, and 246 100 mg/kg, despite maternal toxicity. Signs of maternal toxicity appeared secondary to the sensitivity of the rabbit gastrointestinal system to broad247 spectrum antibacterials and included changes in fecal output in all groups and dose-related reductions in body weight gain and food consumption at > 50 248 mg/kg; these were associated with an increase in spontaneous abortion at 50 and 100 mg/kg. The highest dose was also associated with maternal 249 moribundity and mortality. An increased incidence of a common rabbit skeletal variation, angulated hyoid alae, was also observed at the maternally toxic 250 doses of 50 and 100 mg/kg. A separate toxicokinetic study showed that ceftaroline exposure in rabbits (based on AUC) was approximately 0.8 times the 251 exposure in humans given 600 mg every 12 hours at 25 mg/kg and 1.5 times the human exposure at 50 mg/kg.252 Ceftaroline fosamil did not affect the postnatal development or reproductive performance of the offspring of rats given IV doses up to 450 mg/kg/day. 253 Results from a toxicokinetic study conducted in pregnant rats with doses up to 300 mg/kg suggest that exposure was ≥ 8 times the exposure in humans 254 given 600 mg every 12 hours.255 There are no adequate and well-controlled trials in pregnant women. Teflaro should be used during pregnancy only if the potential benefit justifies the 256 potential risk to the fetus.257 8.3 Nursing Mothers258 It is not known whether ceftaroline is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Teflaro 259 is administered to a nursing woman.260 8.4 Pediatric Use261 Safety and effectiveness in pediatric patients have not been established.262 8.5 Geriatric Use263 Of the 1300 patients treated with Teflaro in the Phase 3 ABSSSI and CABP trials, 397 (30.5%) were ≥65 years of age. The clinical cure rates in the 264 Teflaro group (Clinically Evaluable [CE] Population) were similar in patients ≥65 years of age compared with patients < 65 years of age in both the 265 ABSSSI and CABP trials.266 The adverse event profiles in patients ≥ 65 years of age and in patients < 65 years of age were similar. The percentage of patients in the Teflaro group who 267 had at least one adverse event was 52.4% in patients ≥ 65 years of age and 42.8% in patients < 65 years of age for the two indications combined.268 Ceftaroline is excreted primarily by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function. Because elderly 269 patients are more likely to have decreased renal function, care should be taken in dose selection in this age group and it may be useful to monitor renal 270 function. Elderly subjects had greater ceftaroline exposure relative to non-elderly subjects when administered the same single dose of Teflaro. However, 271 higher exposure in elderly subjects was mainly attributed to age-related changes in renal function. Dosage adjustment for elderly patients should be based 272 on renal function [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)].275 8.6 Patients with Renal Impairment276 Dosage adjustment is required in patients with moderate (CrCl > 30 to ≤50 mL/min) or severe (CrCl ≥ 15 to ≤30 mL/min) renal impairment and in 277 patients with end-stage renal disease (ESRD – defined as CrCl < 15 mL/min), including patients on hemodialysis (HD) [see Dosage and Administration 278 (2.2) and Clinical Pharmacology (12.3)].279 10. OVERDOSAGE280 In the event of overdose, Teflaro should be discontinued and general supportive treatment given.281 Ceftaroline can be removed by hemodialysis. In subjects with ESRD administered 400 mg of Teflaro, the mean total recovery of ceftaroline in the 282 dialysate following a 4-hour hemodialysis session started 4 hours after dosing was 76.5 mg (21.6% of the dose). However, no information is available on 283 the use of hemodialysis to treat overdosage [see Clinical Pharmacology (12.3)].284 11. DESCRIPTION285 Teflaro is a sterile, semi-synthetic, broad-spectrum, prodrug antibacterial of cephalosporin class of beta-lactams (β-lactams). Chemically, the prodrug, 286 ceftaroline fosamil monoacetate monohydrate is (6R,7R)-7-{(2Z)-2-(ethoxyimino)-2-[5-(phosphonoamino)-1,2,4-thiadiazol-3-yl]acetamido}-3-{[4-(1287 methylpyridin-1-ium-4-yl)-1,3-thiazol-2-yl]sulfanyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate monoacetate monohydrate. Its molecular 288 weight is 762.75. The empirical formula is C22H21N8O8PS4.C2H4O2.H2O.289 Figure 1: Chemical structure of ceftaroline fosamil290291292293294295296297298299300 301 302 Teflaro vials contain either 600 mg or 400 mg of anhydrous ceftaroline fosamil. The powder for injection is formulated from ceftaroline fosamil monoacetate monohydrate, a pale yellowish-white to light yellow sterile powder. All references to ceftaroline activity are expressed in terms of the prodrug, ceftaroline fosamil. The powder is constituted for IV injection [see Dosage and Administration (2.3)].303 Each vial of Teflaro contains ceftaroline fosamil and L-arginine, which results in a constituted solution at pH 4.8 to 6.5. 304 12. CLINICAL PHARMACOLOGY305 Ceftaroline fosamil is the water-soluble prodrug of the bioactive ceftaroline [see Clinical Pharmacology (12.3)]. 306 12.1 Mechanism of Action307 Ceftaroline is an antibacterial drug [see Clinical Pharmacology (12.4)].308 12.2 Pharmacodynamics309 310 311 As with other beta-lactam antimicrobial agents, the time that unbound plasma concentration of ceftaroline exceeds the minimum inhibitory concentration (MIC) of the infecting organism has been shown to best correlate with efficacy in a neutropenic murine thigh infection model with S. aureus and S. pneumoniae.312 313 314 Exposure-response analysis of Phase 2/3 ABSSSI trials supports the recommended dosage regimen of Teflaro 600 mg every 12 hours by IV infusion over 1 hour. For Phase 3 CABP trials, an exposure-response relationship could not be identified due to the limited range of ceftaroline exposures in the majority of patients.315 Cardiac Electrophysiology316 317 318 In a randomized, positive- and placebo-controlled crossover thorough QTc study, 54 healthy subjects were each administered a single dose of Teflaro 1500 mg, placebo, and a positive control by IV infusion over 1 hour. At the 1500 mg dose of Teflaro, no significant effect on QTc interval was detected at peak plasma concentration or at any other time.319 12.3 Pharmacokinetics320 321 322 The mean pharmacokinetic parameters of ceftaroline in healthy adults (n=6) with normal renal function after single and multiple 1-hour IV infusions of 600 mg ceftaroline fosamil administered every 12 hours are summarized in Table 5. Pharmacokinetic parameters were similar for single and multiple dose administration.323326 Table 5: Mean (Standard Deviation) Pharmacokinetic Parameters of Ceftaroline IV in Healthy AdultsParameter Single 600 mg Dose Administered asa 1-Hour Infusion(n=6)Multiple 600 mg Doses Administered Every12 Hours as 1-Hour Infusions for 14Days(n=6)C max (mcg/mL) 19.0 (0.71) 21.3 (4.10)T max (h)a 1.00 (0.92-1.25) 0.92 (0.92-1.08)AUC (mcg h/mL) b 56.8 (9.31) 56.3 (8.90)T1/2 (h) 1.60 (0.38) 2.66 (0.40)CL (L/h) 9.58 (1.85) 9.60 (1.40)a Reported as median (range)b AUC0-∞,for single-dose administration; AUC0-tau, for multiple-dose administration; C max, maximum observed concentration; T max, time of C max; AUC0-∞, area under concentration-time curve from time 0 to infinity; AUC0-tau, area under concentration-time curveover dosing interval (0-12 hours); T1/2, terminal elimination half-life; CL, plasma clearance327328 The C max and AUC of ceftaroline increase approximately in proportion to dose within the single dose range of 50 to 1000 mg. No appreciable 329 accumulation of ceftaroline is observed following multiple IV infusions of 600 mg administered every 12 hours for up to 14 days in healthy adults with 330 normal renal function.331 Distribution332 The average binding of ceftaroline to human plasma proteins is approximately 20% and decreases slightly with increasing concentrations over 1-50 333 mcg/mL (14.5-28.0%). The median (range) steady-state volume of distribution of ceftaroline in healthy adult males (n=6) following a single 600 mg IV 334 dose of radiolabeled ceftaroline fosamil was 20.3 L (18.3-21.6 L), similar to extracellular fluid volume.335 Metabolism336 Ceftaroline fosamil is converted into bioactive ceftaroline in plasma by a phosphatase enzyme and concentrations of the prodrug are measurable in plasma 337 primarily during IV infusion. Hydrolysis of the beta-lactam ring of ceftaroline occurs to form the microbiologically inactive, open-ring metabolite 338 ceftaroline M-1. The mean (SD) plasma ceftaroline M-1 to ceftaroline AUC0-∞ ratio following a single 600 mg IV infusion of ceftaroline fosamil in 339 healthy adults (n=6) with normal renal function is 28% (3.1%).340 When incubated with pooled human liver microsomes, ceftaroline was metabolically stable (< 12% metabolic turnover), indicating that ceftaroline is not a 341 substrate for hepatic CYP450 enzymes.342 Excretion343 Ceftaroline and its metabolites are primarily eliminated by the kidneys. Following administration of a single 600 mg IV dose of radiolabeled ceftaroline 344 fosamil to healthy male adults (n=6), approximately 88% of radioactivity was recovered in urine and 6% in feces within 48 hours. Of the radioactivity 345 recovered in urine approximately 64% was excreted as ceftaroline and approximately 2% as ceftaroline M-1. The mean (SD) renal clearance of ceftaroline 346 was 5.56 (0.20) L/h, suggesting that ceftaroline is predominantly eliminated by glomerular filtration.347 Specific Populations348 Renal Impairment349 Following administration of a single 600 mg IV dose of Teflaro, the geometric mean AUC0-∞ of ceftaroline in subjects with mild (CrCl > 50 to ≤ 80 350 mL/min, n=6) or moderate (CrCl > 30 to ≤50 mL/min, n=6) renal impairment was 19% and 52% higher, respectively, compared to healthy subjects with 351 normal renal function (CrCl > 80 mL/min, n=6). Following administration of a single 400 mg IV dose of Teflaro, the geometric mean AUC0-∞ of 352 ceftaroline in subjects with severe (CrCl ≥ 15 to ≤30 mL/min, n=6) renal impairment was 115% higher compared to healthy subjects with normal renal 353 function (CrCl > 80 mL/min, n=6). Dosage adjustment is recommended in patients with moderate and severe renal impairment [see Dosage and 354 Administration (2.2)].355 A single 400 mg dose of Teflaro was administered to subjects with ESRD (n=6) either 4 hours prior to or 1 hour after hemodialysis (HD). The geometric 356 mean ceftaroline AUC0-∞ following the post-HD infusion was 167% higher compared to healthy subjects with normal renal function (CrCl > 80 mL/min, 357 n=6). The mean recovery of ceftaroline in the dialysate following a 4-hour HD session was 76.5 mg, or 21.6% of the administered dose. Dosage 358 adjustment is recommended in patients with ESRD (defined as CrCL < 15 mL/min), including patients on HD [see Dosage and Administration (2.2)]. 359 Hepatic Impairment360 The pharmacokinetics of ceftaroline in patients with hepatic impairment have not been established. As ceftaroline does not appear to undergo significant 361 hepatic metabolism, the systemic clearance of ceftaroline is not expected to be significantly affected by hepatic impairment.362 Geriatric Patients363 Following administration of a single 600 mg IV dose of Teflaro to healthy elderly subjects (≥65 years of age, n=16), the geometric mean AUC0-∞ of 364 ceftaroline was ~33% higher compared to healthy young adult subjects (18-45 years of age, n=16). The difference in AUC0-∞ was mainly attributable to。
FDA工业指南 非青霉素β内酰胺类药品防止交叉污染的指导原则2013.4
工业指南非青霉素β-内酰胺类药品防止交叉污染的指导原则目录I.简介II.背景III.建议You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.本指南代表当前FDA对本议题的看法。
本指南并不授予任何人任何特权，也不对FDA或公众起任何约束作用。
如果有替代的方法能满足法律法规的要求，则可以使用该替代方法。
如果想要讨论替代方法，请与FDA负责实施该指南的工作人员联系。
如果不能与指定的合适FDA工作人员联系，请拨打该指南标题页列出的电话号码。
I. INTRODUCTIONI. 简介This guidance describes the importance of implementing manufacturing controls to prevent cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with non-penicillin beta-lactam drugs. This guidance also provides information regarding the relative health risk of, and the potential for, cross-reactivity in the classes of sensitizing beta-lactams (including both penicillins and non-penicillin beta-lactams). Finally, this guidance clarifies that manufacturers generally should utilize separate facilities for the manufacture of non-penicillin beta-lactams because those compounds pose health risks associated with cross-reactivity.本指南描述了对非青霉素β-内酰胺类成品和原料药的生产过程进行控制，以防止交叉污染的重要性。
抗菌肽的抗菌机制及其在反刍动物中应用的研究进展
抗菌肽（antimicrobial peptides,AMPs ）因其独特的抗细菌、真菌、病毒以及抗癌细胞等生物学功能且不易产生耐药性，使其成为最有前景的抗生素替代品之一。
从20世纪80年代瑞典科学家Hulmark 从惜古比天蚕（Hyalophora cecropia ）中分离出第一种抗菌肽，命名为天蚕素（Cecropin ）[1]，到目前为止抗菌肽数据库中已注册的抗菌肽序列已经超过3000个[2]。
抗菌肽是包括植物、动物和人类在内的所有生物体天然免疫反应的保守部分,是许多脊椎动物免疫系统的主要组成部分[3]，被定义为能够保护宿主免受细菌、病毒或真菌入侵的关键防御分子[4]。
抗菌肽是由基因编码、核糖体合成的多肽，通常具有短肽（30~60个氨基酸）、强阳离子（pI 8.9~10.7）、热稳定性（100℃,15min ）、不易产生耐药性、对真核细胞无影响等共同特征[5]。
根据其来源可以分为：植物源抗菌肽，如硫素（thionins ）、植物防御素(plant defensins)；动物源抗菌肽，如天蚕素、防御素；微抗菌肽的抗菌机制及其在反刍动物中应用的研究进展■纵瑞1胡忠泽1*张乃锋2段心明3(1.安徽科技学院动物科学学院，动物营养调控与健康安徽省重点实验室，安徽滁州233100；2.中国农业科学院饲料研究所，北京100081；3.农发苑（浙江）农业发展有限公司，浙江湖州313000)作者简介：纵瑞，硕士，研究方向为动物营养与饲料科学。
通讯作者：胡忠泽，教授。
收稿日期：2021-03-25基金项目：国家自然科学基金[31872385]；安徽省高校协同创新项目[GXXT-2019-035]；安徽省现代牛羊产业技术体系[AHCYTX-7]；滁州市科技计划项目[2019ZN003]摘要：抗菌肽（antimicrobial peptides,AMPs ）是自然界中广泛存在的多肽物质。
作为机体先天免疫的关键组成部分，具有抗细菌、真菌、肿瘤、病毒等生物学功能。
临床医学抗感染药物与临床合理使用
不适当预防用药 中位数35.44% 内科22.89％ 外科42.03% 产科71.86% 围手术期预防 乳腺手术平均用7.7~8.3天 胃大部分切除7.3~8.3天 子宫全切5.6~8.3天 2003年153家医院调查，2003年上海抽样
抗菌药物的联合应用要有明确指征
单一药物可有效治疗的感染，不需联合用药，仅在下列情况时有指征联合用药。 1. 原菌尚未查明的严重感染，包括免疫缺陷者的严重感染。 2. 单一抗菌药物不能控制的需氧菌及厌氧菌混合感染，2种或2种以上病原菌感染。 3. 单一抗菌药物不能有效控制的感染性心内膜炎或败血症等重症感染。 4. 需长程治疗，但病原菌易对某些抗菌药物产生耐药性的感染，如结核病、深部真菌病。 5. 由于药物协同抗菌作用，联合用药时应将毒性大的抗菌药物剂量减少。联合用药时宜选用具有协同或相加抗菌作用的药物联合，如青霉素类、头孢菌素类等其他β内酰胺类与氨基糖苷类联合，两性霉素B与氟胞嘧啶联合。
6)AUC/MIC 即24hAUC和MIC的比值。7)Peak或Cmax 血药峰浓度，给药后达到的最高血药浓度。8)Peak/MIC(Cmax/MIC) 抗菌药物峰浓度和MIC的比值。9)抗生素后效应(post antibiotic effect, PAE) 即去除抗菌药物后，能继续抑制细菌生长的时间。10)sub MIC effect 亚抑菌浓度作用，即在抗菌药物浓度小于MIC时，抗菌药物对细菌的抑制作用。
“抗生素”与“抗菌药”有何区别？
临床常用，经常混用。抗生素（antibiotics）完全由微生物生物合成的自然产物 ，即能抑制或杀灭其他微生物的化学物质，如青霉素G、红霉素、四环素、庆大霉素等。半合成抗生素（Semisynthetic antibiotics）以抗生素为基础对其结构进行改造，如氨苄西林、头孢唑啉、二甲胺四环素、利福平、阿米卡星等。现已纳入抗生素。抗菌药（antibacterial drug）完全由人工合成，如磺胺类、喹诺酮类、呋喃类 硝基咪唑类（甲硝唑、替硝唑），源于人工的产物。
14解立新重症感染生物标记物有无临床价值
PCT：2.39 (8.1) vs. 2.71(25) ng/ml，P = 0.693
Su LX, et al. BMC Infectious Diseases 2012, 12:157
15
Biomarkers for pneumonia
Biomarkers in respiratory infections for the detection of a clinically relevant bacterial infection
CRP及PCT水平在severe sepsis 与sepsis 或者SIRS组间差异无统计学意义
13
Diagnosing non-infectious fever
结论：PCT、CRP在鉴别ICU患者Sepsis和SIRS方面具有一定的价值
Su LX, et al. Mediators Inflamm.2013:969875.
Combination of biomarkers for the discrimination between bacterial and viral lower respiratory tract infections
Journal of Infection (2012) 65, 490e495
9
Diagnosing non-infectious fever
Current Opinion in Critical Care 2007, 13:578–585
10
Diagnosing non-infectious fever
FMF: familial Mediterranean fever
Journal of Infection(2010) 60, 409-416
医学专业英语短语
短语1.to excrete toxins--- 排出毒素2.health maintenance --- 健康保持3.a building block --- 基本构件4.waning of immunity --- 免疫力减弱5.recurrent jaundice --- 反复发作的黄疸6.exacerbate pathophysiology --- 加重病理生理状况7.aggressive treatment--- 积极治疗8.medical budget --- 医疗预算9.a clinical trial --- 临床试验10.widespread metastases --- 广泛转移11.anti-tumor agents--- 抗肿瘤的药剂12.medical literature --- 医学文献13. a health crisis --- 健康危机14.the Red Cross --- 红十字会15.anxiety and confusion--- 焦虑与困惑16. a malaria case --- 一个疟疾病例17.bilirubin metabolism --- 胆红素代谢18.blood pressure control --- 血压控制19.aggressive treatment--- 积极治疗20. a nursing station --- 护士站21.brain perfusion --- 大脑血灌注22. a 10-year follow-up study --- 10年的跟踪研究23.cardiovascular reactions--- 心血管反应24. a medical ward --- 内科病房25.casualty of war --- 战争中的人员伤亡26.blood pressure control --- 血压控制27. a typical office visit --- 典型的诊所就诊28.certification evaluations--- 证书评估29.bottled water--- 瓶装水30.agents of bioterrorism --- 生物恐怖活动病原31.childproof cap--- 防孩子打开的盖子32.an animal model --- 动物模型33.an internal medicine residency --- 内科实习期34.aggressive treatment--- 积极治疗plications or concomitant conditions--- 并发症与合并症36.an unknown pathogen --- 一种未知的病原体37.continuing medical education credits --- 继续医学教育学分38.an international humanitarian group --- 一个国际人道主义组织39.control group--- 对照组40.chronic illness--- 慢性病41.antibiotics and vaccine --- 抗生素和疫苗42.coordination of emotions --- 情绪协调43.Aorto-coronary arterial bypass --- 主动脉冠状动脉旁路44.dairy category--- 乳制品类45.be completely from sth immune --- 对某事完全免疫46.decaying teeth--- 蛀牙47.becoming bedridden --- 卧床不起48.diagnostic errors --- 诊断错误49.bedside manner --- 医生对患者的态度,临床举止50.diastolic blood pressure--- 舒张压51.bilateral infiltrates --- 双侧浸润52.dietary habits --- 饮食习惯53.brain function --- 脑功能54.emergency decisions--- 紧急状况下做的决定55.bubonic plague --- 腺鼠疫56.emergency relief efforts--- 紧急援助工作57.emergent disease --- 新现疾病58.caloric intake --- 热量摄入59.exclusive purview--- 专属领域60.childhood obesity --- 儿童肥胖症61.exposure to carriers of disease --- 接触带病者62.Chronic gastric ulcer --- 慢性胃溃疡63.foodborne infections--- 通过食物传播的传染病64.classic manifestations --- 典型临床表现65.fragile health--- 脆弱的健康66.exclusive purview--- 专属领域67.clinical course --- 临床病程68.genetic shift--- 基因改变69.exposure to carriers of disease --- 接触带病者70.genuine feelings and emotions --- 真情实感71.clinical ideal --- 临床理念72.in vivo pharmacology--- 体内药理学73.clinical investigation --- 临床调查74.incidence of relapse--- 复发率75.clinical maladies --- 临床疾患76.infectious disease--- 传染病77.genuine feelings and emotions --- 真情实感fort measures --- 舒适护理措施rmed treatment decision --- 知情治疗决定puterized tomography --- CT, 计算机断层描81.interferon gamma tests--- Y干扰素测试82.DEXA scan --- DEXA扫描83.intractable infectious diseases --- 难治的传染病84.dose regimen --- 剂量方案85.intravenous morphine--- 静脉注射吗啡86.drug resistance --- 抗药性bored breathing--- 呼吸困难88.drug toxicity --- 药物毒性tent tuberculosis --- 潜伏结核病90.electronic record --- 电子病历91.lean protein--- 精益蛋白质92.emotional solace --- 情感慰藉93.life-support machines--- 生命维持系统94.mammogram report --- 乳房X线检查报告95.energy and vitality --- 能量和活力96.neurological complications--- 神经性并发症97.ethical principles --- 伦理准则rmed treatment decision --- 知情治疗决定99.neuromuscular electrical stimulation --- 神经肌肉电刺激。
FDA医药英文词汇
戒断症状
accelｅｒａted aｐpｒovａl
加速批准
aｃceｓs to ｍedｉｃｉnｅ （ATＭ)
有药品可使用
ＡCCＦ = Amｅrｉcaｎ College oｆ Cａrｄioｌo 美国心脏病学会基金会
ｇy Ｆoundａｔion
aｃcreｄitｅd scｈool
立案学校
accuracy
准确度
Accutanｅ, ａ branｄ of iｓotretinoｉn
FDA Ｇlosｓary
Ｃompiｌed by: Yaw-Tsong Lee
Lａst updaｔｅd： November 2１， 2010
［Top] [Ｌaws & Reｇulaｔioｎs] [FDA Oｒgaｎiｚaｔபைடு நூலகம்ｏｎ］ [ＳFDA 国食药监]
食品和药物管理局局长玛格丽特•汉堡（Margaret Hamburg)
异维生素Ａ酸; 异维 A 酸;异维甲酸； 保肤灵
ACE inhibitors ＝ aｎgｉｏtensiｎ cｏnvertiｎg 血管紧张素转化酶抑制剂
ｅnzyme ｉｎhibitorｓ = ＡCEＩ
ａcetaminophen
扑热息痛; 对乙酰(ｘian）氨基酚
aｃid rｅflｕx
胃酸逆流
aｃiｄｉｆieｄ food
抗肿瘤坏死因子抑制剂 抗 TＮF-α 治疗 美国围手术注册护士协会
主动脉疾病 主动脉瓣狭窄 亚太经济合作组织 动植物卫生检验局
美国感染控制和流行病专业协会
原料药
再生障碍性贫血 适当的保护水平
批准 已批准药物
aｐpｒoximaｔｅ lｅthaｌ dｏse = ＡＬＤ ａprotｉｎin AQSIQ = China＇s Geｎeral Adｍｉnistｒaｔi ｏn fｏr Ｑｕａｌity Suｐerviｓion, Insｐectio ｎ ａnｄ Quarantine archｉval ｃｏpｙ Areａ Uｎdｅr the Curve ＝ AUC; ａｒea under ｔhe plasｍa ｃonceｎtrａｔion-time cuｒ ｖｅ
药学专业词汇英文
abbreviated or abridged applicat i on简略申请abnormal karyology异常核型absorbed moisture 吸附水acceptable daily intake可接受的日摄入量acceptable test加速试验acceptance criteria认可标准accuracy准确性accelerated/stress stability studies加速/强力破坏稳定性研究acetylation乙酰化作用achiral assay非手性测定achlorhydric elderly老年性胃酸缺乏症action limits内控限值active components/compound/moiety活性成分active ingredient活性组分adaption to specific culture conditions特定培养条件的适应additives添加剂adjuvant佐剂adventitious agents外源性因子adventitious contaminants 外来污染物adventitious viral or mycoplasma contamination外源性病毒或支原体污染adventitious viruses外源病毒adverse reaction不良反应aerobic microorganisms需氧微生物affinity 亲和力affinity chromatography亲和层析affinity column亲和柱agar and broth琼脂和肉汤aggregates聚合体aggregation聚集allergenic/allergic extracts过敏源抽提物altered conjugated forms改变的结合物形式ambient condition自然条件amino acid composition氨基酸组成amino acid sequence氨基酸序列amino acids氨基酸amino sugars氨基糖amino-terminal amino acids 氨基端氨基酸ammonia production Rates产氨率analyte被测物analytical procedure分析方法animal cell lines动物细胞系animal tissues or organs动物组织或器官anternnary profile触角形状antibiotic resistance genes抗生素耐药基因antibiotics抗生素antibody抗体antibody production tests抗体产生实验antisera抗血清applicant申报者ascites腹水assay含量测定assay procedure定量方法avian鸟类avidity亲和性background背景bacteria细菌batches批次batch-to-batch逐批between-assay variation试验间变异binary fission双数分裂binding assays结合试验bioburden生长量/生物负荷biochemical methods生化方法bioequivalency生物等效性biohazard information生物有害信息biological ativity生物活性biological products生物制品bioreactor生物反应器biotechnological/biological products生物技术/生物产品biotechnological products生物技术产品biphasic curve双相曲线blood plasma fators血浆因子body fluids体液bovine牛bovine spongiform encephalopathy(BSE)疯牛病bracketing括号法breeding conditions饲养条件by-prducts副产物calibrate标化canine犬cap liner瓶帽内垫capillary electrophoresis毛细管电泳carbohydrate碳水化合物carboxy-terminal amino acids碳基端氨基酸carrier载体/担体catalysts催化剂cell bank细胞库cell bank system细胞库系统cell banking procedures细胞建库过程cell banking system细胞库系统cell culture-derived impurities来源于细胞培养基的杂质cell cultures细胞培养物cell expansion细胞扩增cell lines细胞系cell metabolites细胞代谢物cell pooling细胞混合cell substrate-derived impurities来源于细胞培养基质的杂质cell substrates细胞基质cell viability细胞活力cell–derived biological products细胞来源的生物制品cell fusion细胞融合cellular blood components血细胞成分cemadsorbing viruses红细胞吸附病毒characterization and testing of cell banks细胞库鉴定及检测charcoal活性炭charge电荷chemical actinometric system化学光化线强度系统chemical reactivity化学反应性chemical syntheses化学合成chemically inert化学惰性chewable tablets咀嚼片chiral impurities手性杂质chromatograms色谱图chromatographic behavior色谱行为chromatographic procedures色谱方法chromatography columns色谱柱circular dichroism圆二色性clearance studies清除研究climatic zones气候带clinical research临床研究clinical trial application临床实验申请cloning克隆closure闭塞物code number编号coding sequence编码序列coefficient of variance变异系数collaborative studies协作实验研究colony isolation菌落分离colony-stimulating factors集落刺激因子combination product复方制剂components成分confidence interval置信区间confidence limits 可信限confirmatory studies确认研究conformance to specifications符合规范conformation构型conjugat ed product连接产物consistency一致性container容器container/closure容器/闭塞物container/closure integrity testing 容器/密封完整性实验contaminants污染物content uniformity含量均匀性control methodology控制方法学controlled released product控制制剂conventional vaccines传统疫苗conventional live virus vaccines传统的活病毒疫苗cool white fluorescent冷白荧光灯correction factor校正因子correlation coefficient相关系数covalent or noncovalent共价或非共价creams霜剂cross-contamination交叉污染cross-reactivity交叉反应cryopreservation冷冻保存cryoprotectants防冻剂crystals晶体culture components培养基成分culture media/medium培养基cyanogens bromide溴化氰cytogenetic细胞遗传学的cytokines细胞因子cytopathic细胞病的cytoplasmic A-and R-type particles细胞浆a型和r型颗粒dark control暗度对照deamidation 去氨基deaminated去酰胺化的decision flow chart/tree判断图definable and measurable biological activity明确和可测定的生物学活性degradant降解产物degradation降解degradation pathway降解途径degradation product降解产物degradation profile降解概况degree of aggregation 凝集程度degree of scatter离散程度delayed –release延迟释放deleterious有害的delivery systems给药体系derivatives衍生物description性状detection limit检测限度dilivery systems释放系统dilution ratio稀释倍数dimmers二聚体diode array二极管阵列diploid cells二倍体细胞dissociation解离dissolution testing 溶出实验dissolution time溶出时间dosage form剂型downstream purification下游纯化drug product制剂drug product components制剂组方drug substances原料药ectromelia virus脱脚病病毒elastomeric closures橡皮塞electron microscopy (EM)电镜electrophoresis电泳electrophoretic pattern电泳图谱elution profile洗脱方案embryonated eggs鸡胚enantiomer对映体enantiomeric对映异构体enantioselective对映体选择性encephalomyocarditis virus(EMC)脑心肌炎病毒endogenous agents内源性因子endogenous retrovirus内源性逆转录病毒endotoxins内毒素end-product sterility testing 最终产品的无菌试验enhancers增强子enveloped RNA viruses包膜RNA病毒environmental factors环境因素enzymatic reaction rates酶反应速率enzyme酶epitope表位Epstein-Barr virus(EBV)EB病毒equine马Erythropoietins促红细胞生成素ethnic origin种族起源eukaryotic cell真核细胞ex vivo体外excipient赋形剂excipient specifications赋形剂规范expiration date/dating 失效日期exposure level暴露程度exposure period光照时间expression constract表达构建体expression system表达系统expression vector表达载体extended-release延时释放extent of the virus test病毒测试程度extinction coefficient消光系数extrachromosomal染色体外extraneous contaminants 外源性污染物exprapolation外推法fermentation发酵fermantation products发酵产物fill volume装量filter aids过滤介质final manufacturing最终生产finished product成品flanking region侧翼区forced degradation testing 强制降解物质foreign matter异质性物质formal labeling 正式标签formal stability studies正式的稳定性研究formulation处方/配方fragmentation片段化freeze-dried product冻干产品friability脆硬度fungi真菌fusion partnters融合伴侣fusion protein融合蛋白gel filtration凝胶过滤gene amplification基因扩增gene therapy基因疗法generation of the cell substance细胞基质的产生genetic manipulation基因操作genomic dinucleotide repeats基因组双核苷酸重复数genomic DNA基因组DNAgenomic polymorphism pattern基因组形态类型glucose consumption rates耗糖率glycoforms糖化形式glycosylation糖基化goegrapgical origin地理起源growth factors生长因子growth hormones生长激素guanidine胍hamster antibody production (HAP) test仓鼠抗体产生实验Hantaan virus汗坦病毒Hardness硬度heavy metals重金属heparins肝素herbal products 草药herpes virus疱疹病毒heterogeneities异质性heterohybrid cell lines异种杂交细胞系high-resolution chromatography高分辨色谱homogeneity均一性host cell宿主细胞host cell banks宿主细胞库host cell DNA宿主细胞DNAhost cell proteins宿主细胞蛋白质hot-stage microscopy热阶显微镜human diploid fibroblasts人二倍体呈纤维细胞human polio virus人脊髓灰质炎病毒human tropism人向性humidity湿度humidity-protecting containers防湿容器hybridization techniques杂交技术hybridoma cell杂交瘤hybridomas水解物hydrolysates水解物hydrolytic enzymes水解酶hydrophobicity疏水性hygroscopic吸湿性idetification/identity鉴别immediate container/closure直接接触的容器/密闭物immediate pack内包装immediate release立即释放immortalization激活immune spleen cells免疫脾细胞immumoassay免疫检测immunochemical methods免疫化学方法immunochemical properties免疫化学性质immunoelectrophoresis免疫电泳immunogenicity免疫原性immunological interations免疫相互作用immunoreactivity免疫反应性impurity profile杂质概况in vitro and in vivo inoculation tests体内和体外接种试验in vitro assay体外检测in vitro cell age体外细胞传代期in vitro lifespan体外生命周期in vitro tests体外试验in vivo 体内in vivo assays体内检测inactivated vaccine灭活疫苗indentification test鉴别试验indicator cell指示细胞indicator organisms指示菌indoor indirect daylight室内间接日光inducers诱导剂infectious agents感染性因子influenza virus流感病毒inhalation dosage forms吸入剂型in-house内部的in-house criteria内控标准in-house primary reference material内部一级参比物质in-house working reference material内部参比物质initial filing原始文件initial submission最初申报initial text最初文件inoculation接种inorganic impurities无机杂质inorganic mineral无机矿物质inorganic salts无机盐in-process acceptance criteia生产过程认可标准in-process controls生产过程中控制in-process testing生产过程中检测insect昆虫insulins胰岛素intake摄入intended effect预期效果intended storage period预期的储藏期intentional degradation人为降解interactions相互作用interferon干扰素interleukins白细胞介素intermediate中间体intermediate precision中间精密度intermediates半成品international reference standards国际参比标准品intra-assay precision间隙含量精密度intracytoplasmic细胞浆内introduction of virus病毒介入inverted or horizontal position倒立或水平位置ion-exchange离子交换ionic content离子含量isoelectric focusing/isoelectrofocusing等电聚焦isoenzyme analysis同工酶分析isoform pattern异构体类型isomerized异构化的Jp /Ph.Eur./Usp.日本药局方/欧洲药典/美国药典K virus K病毒Karyology胞核学laboratory scale实验室规模lactate production rates乳糖产生速率litric deheydrogenase virus(LDM)乳酸脱氢酶病毒leachables沥出物ligand配位体/配体light光照light resistant packaging避光包装limit for in vitro cell age细胞体外传代限度limit of acceptance可接受的限度limit of in vitro cell age体外细胞代次limit test限度试验limulus amoebocyte lysate鲎试剂linear relation ship线性关系linearity线性liquid nitrogen液氮liquid oral dosage forms液体口服制剂live vaccine活疫苗living cells活细胞logarithmic scale对数级long term test长期试验long-time and accelerated stability长期和加速稳定性试验losses of activity活性丧失lot release批签发low molecular weight substances低分子量物质lower-observed effect level(LOEL)能观察到反应的最低量lymphocytic choriomeningitis virus(LCM)淋巴细胞性脉络丛脑膜炎病毒lyophilised cakes冻干粉饼lysate of cells细胞溶解物mammalian哺乳类manufacturing scale生产规模marker chromosome标志染色体marketing pack上市包装mass重量mass balance质量平衡mass spectrometry质谱master cell bank (MCB)主细胞库material balance物质平衡matrix基质、矩阵matrix system矩阵法matrixing 矩阵化设计maximum daily dose每日最大剂量mean kinetic temperature平均动力学温度metazoan cell culture后生动物细胞培养microbial cell culture微生物细胞培养microbial cells微生物细胞microbial contamination微生物污染microbial expression system微生物表达系统microbial limits微生物限度microbial metabolites微生物代谢物microbial proteases微生物蛋白酶microbial vaccine antigens微生物疫苗抗原microbiological testing微生物学试验minimum exposure time最低作用时间minimum of pilot plant试验规模minute virus of mice小鼠小病毒mirror image镜像mismatched S-S linked错连的S-S键mork run空白对照试验modified-/modifying release修饰释放modifying factor修正因子moisture level水分molar asorptivity克分子吸收molecular characteristics分子特性molecular confirmation分子构型molecular entities/entity分子实体molecular size分子大小monoclonal antibody单克隆抗体morphological analysis形态学分析mouse antibody production (MAP) test小鼠抗体产生试验mouse cytomegalovirus(MCMV)小鼠巨细胞病毒mouse encephalomyelitis virus(GDVⅡ)小鼠脑脊髓炎病毒mouse hepatitis virus(MHV)小鼠肝炎病毒mouse rotavirus(EDIM)小鼠小轮状病毒MuLV murine leukemia virus鼠白血病病毒murine hybridoma cell lines鼠杂交瘤细胞系mutations突变mycoplasma支原体myeloma cell line骨髓瘤细胞系national or international reference material国家或国际参比物质near ultraviolet lamp近紫外灯neural sugars中性糖new chemical entry 新化学体new dosage form新剂型new drug products/produce新药制剂new drug substance新原料药new molecular entities新分子体no effect level不产生反应的量noncovalent/convalent force非共价/共价键non-enveloped viruses非包膜病毒non-mammalian animal cell lines非哺乳动物细胞系non-recombinant cell-culture expression systems非重组细胞培养表达系统non-recombinant products/vaccines非重组制品/疫苗non-specific model virus 非特异模型病毒no-observed effect level不能观察到反应的量N-terminal sequencing N-端测序nuclear magnetic resonance核磁共振official procedure正式方法ointments软膏oligosaccharide pattern低聚核苷酸opacity浊度origins of replication复制起点osmolality摩尔渗透压浓度outdoor daylight室外阳光oxidation氧化oxygen consumption rates耗氧率package包装parainfluenza virus副流感病毒parallel control assays平行对照分析parent stability Guideline稳定性试验总指导原则patrental cell line母细胞系parenterals非肠道制剂particle size粒度particulate matter微粒parvoviruses细小病毒passage history of the cell line细胞系的传代史pathogenic agents致病因子pathogenicity致病性patterns of degradation降解方式peptide肽peptide map肽图percent recovery回收率periodic/skip testing定期检验/抽验permitted daily exposure允许的日接触量phage typing 噬菌体分型pharcodynamic studies药效学研究pharmacopoeial药典pharmacopoeial specifications药典规范pharmacopoeial standards药典标准phenotypic表型phosphorylation磷酸化作用photostability testing光稳定性试验physicochemical changes理化改变physicochemical methods物理化学方法physico-chemical properties物理化学特性pilot-plant scale试生产规模/中试规模piston release force活塞释放力piston travel force活塞移动力pivotal stability studies关键的稳定性研究plaque assays菌斑测定plasmid质粒plasmid banks质粒库plasminogen activators纤溶酶原激活素pneumonia virus of mice小鼠肺炎病毒Poisson distibution泊松分布polymorphic form多克隆抗体polymorphse chain reaction（PCR）聚合酶链式反应polymorphic form多晶性型polymorphs多晶型polyoma virus多瘤病毒pooled harvest集中回收population doubling细胞鼠倍增/群体倍增porcine猪post-approval批准后post-translational modification翻译后修饰post-translationally modified forms翻译后修饰形式potency效价potent功效potential adverse consequences潜在的不良后果potential excipients准赋形剂potential impurity潜在杂质potential new drug products准新药制剂potential new drug substances准新原料药potentiometric titrimetry电位滴定powders粉剂power outages and human error断电和人为错误preamble引言pre-approval or pre-liscense stage批准前或发证前阶段precision精密度preclinical and clinical studies临床前和临床研究precursors前体preliminary assessment初步评估preliminary cell bank初级细胞库preparation制剂preservative防腐剂primary cells原代细胞primary stability data主要稳定性数据primary stability study/formal study/formal stability study主要稳定性研究/正式研究/正式稳定性研究primary structure一级结构primer引物priming regimen(s)接种方式probability概率process characterization studies工艺鉴定研究process controls工艺控制process optimization工艺优化process parameters工艺参数process validation工艺确证process –related impurities工艺相关杂质product-related impurities产品相关杂质progenitor祖细胞prokaryotic cell原核细胞promoters启动子proposed commercial process模拟上市protected samples避光样品proteins蛋白质分析技术proteolysis蛋白水解protocol方案pseudopolymorphs伪多晶体pseudorabies virus假狂犬病毒purification纯化purified antigens纯化抗原purity纯度purity test纯度试验pyrogens热原试验qualification界定qualified 合格的quality standards质量标准quantal methods质反应测定法quantitation limit定量限度quantitative characteristics定量参数quantitative detection定量检测quantitative infectivity assays感染性定量测定quantitative method定量方法quantitative test定量试验quantitative virus病毒定量分析quantity含量racemate消旋体radiometers/lux meters测光仪/照度仪radiopharmaceutical放射性药物range范围rat antibody production (RAP) test大鼠抗体产生试验rationale基本原理raw material原材料raw material testing原材料测试rDNA technology重组DNA技术rDNA-modified cell substrates重组DNA修饰的细胞基质reagent试剂、反应物real condition真实条件real time 真实时间rebank 再建库receptor受体reclone再克隆recombinant cell-culture expression systems 重组细胞培养表达系统recombinant DNA protein products重组DNA蛋白质产品recomibinant-DNA-derived product重组DNA制品recombinant protein重组蛋白质reconstitution重新溶解redispersibility再分散性reduction factors下降因子reference material参比物质reference standard参比标准品regimen方案registration application注册申请regression analysis回归分析regulator/regulatory agencies管理机构related substances有关物质release limit出厂限度“relevant” viruses and “model” viruses“相关”病毒和“模型”病毒reovirus type3(Reo 3)呼吸肠病毒repeatability重复性reproducibility 重现性residual solvents残留溶剂residual sum of squares溶剂残留量resolution test分离度试验response factor响应因子restriction endonuclease mapping限制性内切酶图谱restriction fragment length polymorphism限制性片段长度多态性resuspension再悬浮retention time保留时间retest date再试验日期reverse transcriptase(RT)反转录酶reversed-phase chromatography反相色谱reverse-phase liquid chromatography反相液相色谱revived cells复苏的细胞rheological properties流体学特性risk-benefit analysis利弊分析robustness耐用性rodent retrovirus啮齿类动物逆转录病毒sampling采样scale-up放大scaling down缩小规模scope范围scrapie瘙痒病screening tests筛选试验SDS-PAGE/SDS-polyacrylamide gel electrophoresis十二烷基硫酸钠-聚丙烯酰胺凝胶电泳sealed ampoules密封安瓿secondary structure二级结构self-replicating agents自我复制因子semi-synthetic products半合成产品Sendai virus仙台病毒Sensitivity灵敏度Senescence老化Separation分离Serum血清Shear切变shelf life货价寿命shipment运输sialic acids唾液酸signal-to-noise信噪比Sindbis virus新德比病毒single-dose and multiple-dose packages单剂量和多剂量包装single-point measurements单点测定single-tiered banking system单级细胞库系统size exclusion chromatography分子排阻色谱skip lot testing随机试验slope of the regression line回归线的斜率solid oral doseage固体口服制剂solvates溶剂化物solvation溶剂化作用solvent溶剂species物种specific gravity比重specific objectionable bacteria控制菌specification规范specification limit规范限度specification –check质控规范specification-release出厂规范specifications规范specificity专属性specified impurities特定杂质specified light exposure特定的光照spectroscopic profiles光谱图spiked samples加料样品spiking experiments叠加试验splicing sequences剪接序列stabilizers稳定剂stability data稳定性资料stability evaluation稳定性评价stability proticol稳定性方案stability study duration稳定性试验期限stability testing稳定性试验stability-indicating profile反应稳定性指标standard deviation标准差standard stock solution标准储备液starting materials起始物statement/labeling说明/标签statistical analysis统计学分析sterility无菌storage condition放置条件strains品系stress condition强力破坏试验条件stress testing强力破坏试验storage conditions储存条件structural heterogeneity结构异质性subcultivations传代培养sulfhydryl groups and disulfide bridges巯基和二硫键sulfoxidation硫酰化support information辅助性资料surrogate test替代试验surrogates替代物suspensions混悬剂swine猪synthesis合成synthetic peptides合成肽syringeability灌注功能systemic exposure全身接触tablet cores片芯tandem repeats串联重复target molecule靶分子temperature changes温度变化terminology术语tertiary structure三级结构test criteria试验标准test intervals试验间隔test parameters试验参数testing frequency试验次数texture质地the method of least squares最小二乘法threshold limits阈值thymic virus胸腺病毒tip cap removal force滴帽移动力tissue-culture-infectious-dose(TCID)组织培养感染剂量titration滴定法tolerable daily intake可耐受的日摄入量toolan virus(Hi)图兰病毒topical formulations局部用药处方toxic impurity毒性杂质toxin毒素tranfection of matazoan cells后生动物细胞的转染transcrption转录transdermal systems透皮吸收系统transfection转染transfomation转化translational fidelity翻译的忠实性transmission electron microscopy电透镜transparent cover透明盖子truncated forms截短形式tumor necrosis factor肿瘤坏死因子tumorigenicity致瘤性two-tiered cell bank两级细胞库uncloned cell population未克隆的细胞群unicellular life forms单细胞生命形式unidentified impurities未确定杂质uniformity of content 含量均匀度uniformity of dosage units剂量单位的均匀度uniformity of fill装填均匀度uniformity of mass质量均匀度unitage单位universal tests/criteria常规试验/标准untransfected recipient cell line未转染的受体细胞系UV/visible wavelength紫外可见光波长Vacinnes疫苗Validation论证variant sequences变异序列variants 变异体vector载体vehicle载体/溶酶vesicular stomatitis virus小囊状口腔炎病毒viral clearance病毒清除viral clearance studies病毒清除研究viral contamination病毒污染viral geneme病毒基因组viral infectivity病毒感染性viral safety evaluation病毒安全评估viral vicinnes病毒性疫苗virucidal buffers杀病毒缓冲液virus load 病毒浓度virus titer病毒滴度viscosity粘度visible particulates可见颗粒visual appearance外观visual evaluation直观评价vitamins 维生素water of hydration结晶水well-defined testing program确定的试验项目western blot免疫印迹whole blood全血within-assay variation试验内变异working cell bank工作细胞库yeast酵母y-intercept y轴上的截距。
化学化工专业词汇
Aabscissa n. 横座标abundance n. 丰富, 充裕acceptor n. 接受体accumulator n. 储料器acetic acid n. 醋酸, 乙酸acknowledge v. &n. 致谢activation n. 活化acylation n. 酰化addition n. 加成反应adhesive n. 粘合剂advancement n. 进展，增长advantageous adj. 有利的aerosol n. 烟雾affinity n. 亲合力agent n. 试剂aldehyde n. 醛aldol n. 醛醇aliphatic acid n. 脂肪酸alkaline adj. 碱的alkaloid n. 生物碱alkane n. 烷烃alkene n. 烯烃alkylation n. 烃化, 烷基化alkyl halide n. 烷基卤, 卤烷alkyne n. 炔alphabetic adj. 依字母顺序ambiguity n. 模糊, 意义不明确amide n. 酰胺amine n. 胺amino acid n. 氨基酸amorphous adj. 无定形analogue n. 类似物anhydride n. 酸酐aniline n. 苯胺anion n. 阴离子anomaly n. 异常，反常antibiotics n. 抗菌素antifreezing agent n. 抗冻剂antioxidant n. 抗氧剂appreciable adj. 可估计的architect n. 建筑师, 设计师arene n. 芳烃aromatic adj. 芳香的aromatization n. 芳构化asymmetric adj. 不对称的autooxidation n. 自氧化awarenness n, 意识azeotrope n.共沸混合物azo dye n. 偶氮染料Bbackup n. /adj 备用设备base n. 碱, 基, 底beaker n. 烧杯benzene n. 苯biological degradation n. 生物降解biosynthesis vt. 生物合成bleach vt. 漂白bond n. 键branched chain n. 支链budget n. & v. 预算bubble-cap tower n. 泡罩塔buffer n. 缓冲,缓冲剂Ccarbanion n. 负碳离子, 阴碳离子carbene n. 碳烯, 卡宾carbide n. 碳化物, 碳化钙carbocation n. 正碳离子, 阳碳离子carbonyl group n. 羰基carboxy group n. 羧基carboxylic acid n. 羧酸carcinogenic adj. 致癌的β-carotene n. β胡萝卜素carrier n. 载体cartridge n. 软片暗盒catalysis n. 催化(作用) cation n. 阳离子cellulose n. 纤维素ceramic adj/n. 陶瓷(的) chemical shift n. 化学位移chirality n. 手性chlorination n. 氯化作用chlorohydrocarbon n. 氯代烃chromophore n. 发色团cis-trans isomer n. 顺反异构体classic adj. 经典的, 传统的cluster n. 蔟，一串，一束coherent adj. 黏附的，相干的(光学) coil n. 蛇管colorant n. 颜料，着色剂commodity n. 用品compensation n. 补偿competitive n. 竞争的complementary n. 补充的complex n. 络合物complication n. 复杂concerted reaction n. 协同反应condensation n. 缩合反应condiment n. 调味品conformation n. 构象conjugation n. 共轭construction n. 建设, 建筑consultant n. 顾问consumer n. 消耗container n. 容器containment n. 抑制cooler n. 冷却器corporate adj. 共同的correlate n. 相关的事物cosmetic n. 化妆品counteract vt. 抵消，抵抗coupling reaction n. 偶合反应covalent bond n. 共价键critical adj. 临界的cumulative adj. 累积的，累加的customary adj. 通常的, 常例的cycloparaffin n. 环烷烃Ddecolorant n. 脱色剂decolorize v. 脱色degradation n.降解dehydration n. 脱水作用dehydrogenation n. 脱氢作用delocalization n. 离域作用denatured alcohol n. 变性酒精denominator n. 分母derivation n. 衍生，由来derivative n. 衍生物desorption n. 解吸作用destructive distillation 分解蒸馏detergent n. 洗涤剂developer n. 显影剂dextrorotary adj. 右旋的diazonium salt n. 重氮盐diazotization n. 重氮化作用dielectric adj.不导电的，n.电介质dipole n. 偶极directory n. 地址录disclose vt. 揭露, 揭发discrete adj. 离散的，不连续的disposal vt. 排出, 处理director n. 定位基dissolve v.溶解distillation n. 蒸馏dominant adj. 支配的，统治的donor n. 给体drastic n. 激烈的, 猛烈的droplet n. 液滴dyestuff n. 染料Eelectrophilic reagent n. 亲电试剂electrophobic adj 疏电子的electronegative adj 电负性的electron withdrawing group n. 吸电子基electrostatic adj. 静电的elimination n. 消除反应emulsion n. 乳剂endothermic adj. 吸热的enantiomer n. 对映体enzyme n. 酶epoxy adj. 环氧化的essential oil n. (香)精油ester n. 酯esterification n. 酯化作用ethanol n. 乙醇ether n. 醚, 乙醚ethyl n. 乙基ethylene n. 乙烯ethynyl n. 乙炔基evaluation n. 评价，估价evaporation n. 蒸发excitation n. 激发态exothermic adj. 放热的extract vt. 萃取extrapolation n. 推断Ffermentation n. 发酵fiber n. 纤维filament n. 细丝，丝状体filter n.过滤器，滤色片flare v. & n. 闪耀, 闪烁flavoring n. 香剂, 调味剂fluorescent n. 荧光fore adj. 先时的, 前部的formaldehyde n. 甲醛fossil n. 化石fractional distillation n. 分馏free radical n. 自由基fumigant n. 熏蒸(消毒)剂functional group n. 官能团furan n. 呋喃Ggeneralization n. 一般(性), 普遍(性)genetic code n. 遗传密码geological adj. 地质(学)的geomatrical adj. 几何学的glacial acetic acid n. 冰醋酸glucose n. 葡萄糖glycerol n. 甘油, 丙三醇graphics n. 图，制图法Hhabituation n. 习惯作用, 毒瘾halogenation n. 卤化hazardous adj. 危险的, 有危害的herbicide n.除草剂heterocyclic compound n.杂环化合物heterogeneous adj. 非均相的, 多相的hexagon n. 六边形highlight n. 光线明亮处hold-up n. 塔储量, 容纳量homologous series n. 同系列hormone n. 激素humectant n. 润湿剂hybrid n. 杂化hydration n. 水合作用hydrogenation n. 氢化作用hydrolysis n. 水解hydrophobic adj. 疏水的hydroxyl group n. 羟基Iidealize vt. 理想化inasmuch as adv. 因为, 由于indicator n. 指示剂indiscriminate adj. 不加选择的indol n. 吲哚inductive effect n. 诱导效应ineffective adj. 无效的, 低效率的infrared spectroscopy n. 红外光谱ingenious adj. 坦率的, 天真的ingestion n. 吸收, 吸入inlet n. 进口, 入口insecticide n. 杀虫剂insulin n. 胰岛素integrate vt. 积分，使...一体化interchangeable adj. 可互换的intermediate n. 中间体ion n. 离子isoelectric point n. 等电点isomer n. 异构体Jjacket n. 套, 夹套justification n. 认为正当, 正当的理由Kketone n. 酮Llactic acid n. 乳酸leakage n. 泄漏lesser adj. 较小的, 更少的lime n. 石灰lining n. 衬里, 衬料, 衬套link vt. 连接，键合liquefy vt. 液化lubricating grease n. 润滑脂Mmanipulation n. 操作, 操纵manuscript n. 稿子, 手稿mass spectroscopy n. 质谱mechanism n. 机理, 历程medium n. 介质, 培养基metallurgical adj. 冶金(学)的methane n. 甲烷methnol n. 甲醇methodology n. 方法论micelle n. 胶粒microorganism n. 微生物migrate vi. 迁移miscible adj. 可溶混的modification n. 修饰monosaccharide n. 单糖multiplet n. 多重峰multiplicity n 多重性Nnaphthalene n. 萘nitration n. 硝化作用nitric acid n. 硝酸nitrile n. 腈noble adj. 贵重的, 惰性的nomenclacture n. 命名法noteworthy adj. 显著的nucleophile n. 亲核试剂nucleic acid n. 核酸neutralization n. 中和numerator n. (数学上) 分子nutrient n. 营养素, 养分Oobservable a. 可观察到的octane number n. 辛烷值olefin n. 烯烃optical activity n. 旋光性optics n. 光学optimum n. 最佳条件orbital n. 轨道organometallic compound 金属有机化合物originate vi./vt. 起源outermost adj. 最外层的，远离中心的overhead n. 塔顶馏出物overheat vt. 过热overlap vt. 重叠oxidation n. 氧化作用ozonide n. 臭氧化合物ozonolysis n. 臭氧分解Pparaffin n. 链烷烃, 石蜡peptide n. 肽peroxide n. 过氧化合物persistence n. 坚持, 固执pesticide n. 杀虫剂pharmaceuticals n. 药物phenol n. 苯酚phenoxide n. (苯)酚盐phenylsulfonic acid n. 苯磺酸phosphoric acid n. 磷酸photochemical reaction n. 光化学反应photochromism n. 光致变色photoconductivity n. 光电导性pigment n. 颜料pink n. 粉红色polyamide n. 聚酰胺polarization n. 极化作用polyhydric alcohol n. 多元醇polymerization n. 聚合作用precipitate vi. /n. 沉淀preservative n. 防腐剂prolong vt. 延长, 拖延propellant n. 推进剂prospective adj. 预期的, 有希望的protecting group n. 保护基purity n. 纯度pyridine n. 吡啶pyrolysis n. 热解pyrrole n. 吡咯Qquantify vt. 使量化，确定数量quaternary ammonium salt n. 季铵盐quench vt. 淬灭quinoline n. 喹啉Rracemization n. 外消旋作用reagent n. 试剂realization n. 实现recover vt. 回收recrystallization n. 重结晶rectifier n. 精馏器reduction n. 还原(作用)reflux n. 回流refract vt. 折射refrigerant n. 冷冻剂remainder n. 剩余物, 残余部分的replica n. 复制品，拷贝resolution n. 分辨, 拆开restrictive adj. 限制性的ribonucleic acid n. 核糖核酸(RNA) rigorous adj. 严厉(格)的Ssaccharin n. 糖精saponification n. 皂化(作用) screen n. 筛子, 屏幕seal n. 密封(垫) segment n. 部分, 链段selectivity n. 选择性settle vt. (使)沉淀, 澄清setup vt. 装置, 装配sewage n. 污水silica gel n. 硅胶singlet n. 单重峰skeleton n. 骨架solubility n. 溶解度solvant n. 溶剂化物solvent n. 溶剂, 有溶解力的sophistication n. 复杂spectroscopy n. 光谱spin-spin coupling n. 自旋-自旋偶合stabilization n. 稳定作用stereoisom erism n. 立体异构现象steric factors n. 位阻因素, 空间因素still pot n.蒸馏釜stoichiometric adj. 化学计算的straightforward adj.一直向前, 正直的substituent n. 取代基substitution reaction n. 取代反应sucrose n. 蔗糖sulfa drug n. 磺胺药sulfonation n.磺化作用sulfuric acid n. 硫酸supervisor n. 导师, 监督人, 主管人suspension n. 悬浮液sweetener n. 增甜剂symmetry n. 对称性symposium n. 座谈会syn addition n. 顺式加成Ttar n. 焦油(沥青)tartaric acid n. 酒石酸tautom erism n. 互变异构现象terpene n. 萜烯tertiary adj. 叔的, 第三的tetrahedron n. 四面体thiazole n. 噻唑thiophene n. 噻吩toluene n. 甲苯toxicity n. 毒性transesterification n. 酯交换反应transition state n. 过渡状态tray n. 盘, 分馏塔盘triplet n. 三重峰trivial adj. 轻微的Uultraviolet-visible spectroscopy n. 紫外-可见光谱unify vt. 统一urea n. 尿素Vvalidate vt. 使生效vaporize vt.蒸发versatile adj. 多方面的vice versa adj. 反之也然vinegar n. 醋violate vt. 破坏，侵害Wwhereas conj. 而, 却, 鉴于withdraw vt. 拉, 提取, 取出withdrawal n. 收回，撤回Xxerography n. 静电复印法Yyeast n. 酵母Zzymochemistry n. 酶化学。
住院药房新员工入职带教体会
住院药房新员工入职带教体会新员工入职，需要有带教老师指导其进行系统的学习，才能全面地了解各个岗位的工作流程和岗位职责，这几年通过带教新员工总结出一点感悟和体会，如指定带教老师首先让其迅速熟悉工作流程，深入学习处方管理办法，药品管理法，抗菌药物临床应用指导原则，麻醉、精神药品临床应用指导原则等，同时让其熟悉公司的各项规章制度，各个岗位职责，行为规范。
学习结束后，组织摸底考试。
通过这些理论培训和业务带教，使新员工由刚开始对药房的茫然到现在各方面都非常熟练，由最初的学生转变为专业素质和业务能力都非常过硬的药师，也为打造专业素质过硬的药师团队奠定了基础。
现在拿出这些带教体会和大家共同分享，共同提高。
[Abstract] New employees start to work in the hospital, and they are only given the study by teachers when they know the workflow and responsibility, the author summsing up the experiences of teaching in the past few years, for example, make the new employee study the workflow from teachers, learning prescription management methods, drug management law, the specified principles of clinical use of antibiotics, Anesthesia, clinical application of guidelines for psychotropic drugs. At the same time the rules and regulations, the job responsibility and the code of conduct of company also should be allowed. The diagnostics tests will be organized by hospital pharmacy tissue at the end of the study. After theoretical training and professional work teaching, the new employees begin to know a lot of all aspects of pharmacy from the vagueness. They become a pharmacist with the professional quality and professional ability from a student, and create the professional quality team of excellent basis for pharmacists.[Key words] Hospital pharmacy; Teaching; New employees; Experience本院作為一家综合性医院，除承担医疗、科研和护理外，还有一项重要的任务就是新员工带教。
2023年版支原体肺炎指南解读
重症推荐阿奇霉素静点，10mg/Kg/d，qd，连用7d左右， 间隔3～4d后开始第2个疗程，总疗程依据病情而定，多为 2～3个疗程，由静脉转换为口服给药的时机为患儿病情减 轻、临床症状改善、体温正常时。对婴幼儿，阿奇霉素的 使用尤其是静脉制剂要慎重。大环内酯类抗菌药物治疗后 72h，根据体温情况等初步评价药物疗效。
Background of Guidelines Issuance
肺炎支原体是什么
What is Mycoplasma pneumoniae
发病机制及流行病学
Pathogenesis and epidemiology
临床特点及影像学改变
Clinical characteristics and imaging changes
肺泡炎性改变则依肺泡受累的范围而异，可有磨玻璃样阴 影、斑片状、节段乃至大叶性实变，常见肺不张，可伴有 肺门影增大，重者可合并胸腔积液。
单侧病变较双侧多见，病灶内可伴或不伴支气管充气征， 肺实变时呈现中-高密度阴影，实变面积越大、受累肺叶越 多则密度越高。
4. 临 床 特 点 及 影 像 学 改 变
cus aureus，SA）等细菌引起的重症肺炎常在病程初期尤
其是3d内出现白细胞总数、中性粒细胞占比、CRP、PCT
明显升高。细菌性肺炎引起的空洞常发生于病程1周左右，
而MPP多在2周以后，鉴别主要依据病原学检查。MP可与
细菌混合感染。
5. 诊 断 与 鉴 别 诊 断
03 01
与肺结核相鉴 别
03 肺结核病史相对较长，咳嗽相对不重。影像学表现为：原
大容量注射剂工艺流程
大容量注射剂工艺流程英文回答：The process for manufacturing large volume injections involves several steps to ensure the quality and safety of the product. I will outline the general process below.1. Formulation and Preparation: The first step is to formulate the injection solution. This involves selecting the active pharmaceutical ingredient (API) and other excipients, such as preservatives and stabilizers, to ensure the stability and effectiveness of the product. The API and excipients are then mixed together in appropriate proportions and dissolved in a suitable solvent.For example, when formulating a saline solution, I would mix sodium chloride with water to achieve the desired concentration. This is a common formulation used for intravenous injections.2. Sterilization: Once the formulation is prepared, it needs to be sterilized to eliminate any potential microbial contamination. Sterilization can be achieved throughvarious methods, such as autoclaving, filtration, or radiation.For instance, if I were producing a large volume injection of antibiotics, I would use autoclaving to ensure the sterility of the product. Autoclaving involvessubjecting the solution to high pressure and temperature to kill any microorganisms present.3. Filling and Packaging: After sterilization, the injection solution is filled into individual containers, such as vials or ampoules, and sealed to maintain sterility. The containers are then labeled with necessary information, such as the name of the drug, dosage, and expiration date.To illustrate, let's say I am filling a large volume injection of a painkiller into vials. I would use a filling machine to accurately dispense the desired volume of the solution into each vial. The vials would then be sealedwith a rubber stopper and aluminum cap to prevent any contamination.4. Quality Control: Throughout the manufacturing process, quality control tests are conducted to ensure the product meets the required standards. These tests may include visual inspection, pH measurement, sterility testing, and potency assays.For example, during the quality control process, I would visually inspect the filled vials for any particles or discoloration. I would also test the pH of the solution to ensure it falls within the acceptable range. Additionally, I would perform sterility testing to confirm the absence of microbial contamination.中文回答：大容量注射剂的生产过程包括多个步骤，以确保产品的质量和安全性。
大环内酯类药物的非抗菌效应
致病微生物入侵与定植
炎症类型的特殊性
根据致病因素的不同，炎性细胞的成分不同。
细胞毒性 神经毒性
嗜酸细胞产生细胞因子释放（IL-4,5GM-CSF，ECP， BP…）
MC脱颗粒
嗜酸细胞与细胞因子进一步产生与释放
Steinke JW,et al. Cysteinyl leukotriece expression in chronic hyperplastic sinusitis-nasal polyposis: importance to eosinophils and asthma. J Allergy Clin Immunol 2003;111:342-349
大环内酯类抗生素降低单核细胞内NO活性
Gao XG, et al. Pulmonary Pharmacology & Therapeutics 23 (2010) 97–106
甘露糖受体
甘露糖受体属于C型凝集素超家族成员，广泛分布于巨噬细胞，可通过胞外区识别和结合特定的糖类分子(如酵母甘露聚糖、细菌荚膜、LPS和脂质阿拉伯甘露聚糖等)，在识别病原体、递呈抗原和保持内环境稳定中发挥作用。
阿奇霉素的“特洛伊木马现象”
特殊的靶向释药：吞噬细胞/白细胞摄取和炎症部位转运
吞噬细胞内高浓度AZM的放大效应： 吞噬细胞将递送药物至感染部位 被吞噬病原体（胞内菌和胞外菌）暴露于吞噬细胞内高药物浓度作用下 药物释放至细胞外，在病灶局部间质液的药物浓度明显高于血清药物浓度，使胞外菌仍然暴露在高药物浓度作用下 对胞内菌和胞外菌都发挥抗菌作用
IL-1,6,8, TGF-b, CSF(集落细胞刺激因子）等
内源性、外源性因素（生物性、机械性）
Bishai WR et al. Expert Rev Anti Infect Ther, 2006;4(3):405-16.
莆田地区社区获得性肺炎的细菌学探究
Ｋｅｙ ｗｏｒｄｓ: Ｐｕｔｉａｎꎻ ｃｏｍｍｕｎｉｔｙ￣ａｃｑｕｉｒｅｄ ｐｎｅｕｍｏｎｉａꎻ ｂａｃｔｅｒｉｏｌｏｇｙꎻ ｅｐｉｄｅｍｉｏｌｏｇｉｃａｌ ｃｈａｒａｃｔｅｒｉｓｔｉｃｓ
伏期内发病的肺炎 [１] ꎮ 北美和欧洲国家的每年
林群英ꎬ 林少刚ꎬ 吴良宁ꎬ 郑丽钦ꎬ 陈 烨ꎬ 黄珊珊
( 莆田学院附属医院 呼吸与危重症医学科ꎬ 福建 莆田 ３５１１００ )
摘 要: 分析莆田地区社区获得性肺炎( ＣＡＰ) 病原学流行特征ꎬ 收集 ２５２ 例莆田地区 ＣＡＰ 患者痰液及肺
泡灌洗液标本ꎬ 采用传统培养与液态芯片法检测致病菌ꎮ 结果: 液态芯片法细菌检出率明显优于传统培养
( 莆卫医政[２பைடு நூலகம்１５]２１３ 号)
作者简介: 林群英(１９６３￣ ) ꎬ女ꎬ福建莆田人ꎬ教授、主任医师ꎬ主要从事呼吸系统疾病研究ꎮ
１４
２０１９ 年 １０ 月
莆 田 学 院 学 报
的大医院提供ꎬ 缺少乡村医院的病原学资料ꎻ 老
年和罹患基础疾病 ＣＡＰ 患者的病原学缺乏ꎻ 国
显示新出现的斑片状浸润影、 叶 / 段实变影、 磨
( Ｄｅｐａｒｔｍｅｎｔ ｏｆ Ｒｅｓｐｉｒａｔｏｒｙ Ｍｅｄｉｃｉｎｅꎬ Ｔｈｅ Ａｆｆｉｌｉａｔｅｄ Ｈｏｓｐｉｔａｌ ｏｆ Ｐｕｔｉａｎ Ｕｎｉｖｅｒｓｉｔｙꎬ Ｐｕｔｉａｎ Ｆｕｊｉａｎ ３５１１００ꎬ Ｃｈｉｎａ )
Ａｂｓｔｒａｃｔ: Ｔｈｅ ｅｐｉｄｅｍｉｏｌｏｇｉｃａｌ ｃｈａｒａｃｔｅｒｉｓｔｉｃｓ ｏｆ ＣＡＰ ｉｎ Ｐｕｔｉａｎ ｗｅｒｅ ａｎａｌｙｚｅｄ ｉｎ ｔｈｉｓ ｐａｐｅｒ. Ｔｈｅ ｓｐｕｔｕｍ ａｎｄ
usher in翻译
usher in翻译usher in的意思是“引领进入；开创；拉开序幕”。
下面是一些关于usher in的用法和中英文对照例句：1. The new president's speech ushered in a new era of hope and change.新总统的演讲拉开了一个充满希望和变革的新时代。
2. The invention of the Internet ushered in a digital revolution.互联网的发明引领了一场数字革命。
3. The ringing of the church bells will usher in the beginning of the wedding ceremony.教堂钟声将拉开婚礼仪式的序幕。
4. The announcement of the new product will usher in a wave of excitement among consumers.新产品的发布将在消费者中引发一股激动的浪潮。
5. The arrival of spring ushers in warmer weather and blooming flowers.春天的到来带来了更暖和的天气和盛开的花朵。
6. The new law will usher in stricter regulations for the financial industry.新法律将为金融业引入更严格的监管规定。
7. The discovery of antibiotics ushered in a new era of modern medicine.抗生素的发现开创了现代医学的新纪元。
8. The opening ceremony of the Olympics will usher in two weeks of intense competition among athletes from around the world.奥运会的开幕式将引领来自世界各地的运动员进入两周的激烈竞争。
1例腹腔感染合并肺部感染患者的病例分析
1例腹腔感染合并肺部感染患者的病例分析发布时间：2022-11-25T10:02:48.564Z 来源：《医师在线》2022年7月13期作者：蔡定格[导读]1例腹腔感染合并肺部感染患者的病例分析蔡定格（云南中医药大学第二附属医院；云南昆明650041）腹腔感染是由于机体固有黏膜防御屏障缺损，使得肠道正常菌群侵染腹腔所致的腹部外科常见疾病。
可继发于消化道的穿孔、坏死与坏疽、腹部外科手术、外伤等，通常由多种微⽣物引起，可致腹腔脓肿或继发性腹膜炎 [1,2]。
入住ICU的患者，除原发感染病灶外，随着病程迁延还可能合并其他感染，本文就1例外伤致腹腔感染合并肺部感染患者的病例进行分析与讨论，以期为腹腔感染合并肺部感染患者的诊治提供临床思路。
一、病例介绍患者2小时前因高处坠落损伤致意识不清，呕吐数次，无抽搐，至我院急诊就诊，头颅CT示：颅内多发骨折，多发大脑挫裂伤，颅内出血。
急诊以“重症颅脑损伤”于2022年3月8日收入院，并于当日行“左、右额颞硬膜下出血清除＋去骨瓣减压术＋右枕部硬膜外引流”术，术后患者昏迷，间断发热，肺部感染加重，并电解质紊乱、左侧肺部广泛肺气肿、气管切开呼吸机脱机拔管困难，于3月14日转入ICU专科诊治。
入室时，患者昏迷状态，GCS评分5分。
气管切开呼吸机辅助呼吸，FIO2：60%，SPO2：100%。
查体不合作，言语不能，生命征：T：36.7℃，P：87次/分，R：14次/分，BP：108/57mmHg，一般情况差，瞳孔对光反射迟钝，左肺呼吸音低，左下肺、右肺可闻及湿罗音，腹部平软，右侧中上腹压痛，无明显反跳痛。
胸腹CT示胆囊壁增厚、毛躁。
腹腔部分小肠走行紊乱，肠壁增厚，肠管节段性积气积液扩张表现，见气液平面，周围脂肪密度增高、浑浊改变。
右侧膈下及腹腔内散在游离气体影，腹盆腔少量积液。
普外二科医师就上述影像学资料会诊后，考虑患者空腔脏器穿孔可能，有剖腹探查指征，遂于3月15日02：31分行“空肠切除、肠吻合术+腹腔冲洗引流术”，术中见空肠距屈氏韧带约40cm处有约10cm肠管坏死，肠壁菲薄，无张力，局部穿孔，腹腔盆腔内有脓液约200ml，距离坏死肠管远近端约10cm行空肠切除。
学术英语单词
学术英语〔医学〕课后词组Unit 11.neuron overload 神经过载2.a typical office visit 典型的诊所就诊3.DEXA scan DEXA扫描4.medical practice 行医5.blood pressure control 血压控制6.health maintenance 安康保持7.mammogram report 乳房X线检查报告8.physical examination 体检9.side effect of a medication 药物的副作用10.perpetual panic 永久的恐慌11.practicing physicians 职业医生12.transplant field 移植领域13.medical budget 医疗预算14.paracetamol tablet 扑热息痛药片15.childproof cap 防孩子翻开的盖子16.randomized clinical trial 随机临床试验17.random allocation 随机分配18.patient prognosis 病人的预后19.control group 对照组20.a 10-year follow-up study 10年的跟踪研究21.a medical ward 科病房22.infectious hepatitis 传染性肝炎23.Severe malaise 身体严重不适24.bilirubin metabolism 胆红素代25.permanent liver damage 永久的肝损伤26.exacerbate pathophysiology 加重病理生理状况27.medical literature 医学文献28.clinical investigation 临床调查29.incidence of relapse 复发率30.clinical epidemiology 临床流行病学31.strict bed rest 严格的卧床休息32.hospital stay 住院33.recurrent jaundice 反复发作的黄疸34.clinical course 临床病程35.intravenous morphine 静脉注射吗啡36.diastolic blood pressure 舒压37.brain perfusion 大脑血灌输38.primary care初级保健39.aorto-coronary arterial bypass主动脉冠状动脉旁路rmed treatment decision知情治疗决41.an international humanitarian group 一个国际人道组织42.the Red Cross 红十字会43.the first major relief effort第一次重大援助工作44.casualty of war 战争中的人员伤亡45.emergency relief efforts 紧急援助Unit 21.re-emerging/re-emergent/resurgent disease(再现疾病)2.new flu strain新流感变种3.antibiotics and vaccine抗生素和疫苗4.infectious disease传染病5.emergent/emergent disease新现疾病6.prevention strategy预防策略7.bubonic plague腺鼠疫8.pathogenic microbes病原微生物9.public heath authority公共卫生机构10.drug resistance抗药性11.an course of antibiotic therapy抗生素治疗疗程12.scarlet fever猩红热13.the level of virulence毒性水平14.flu pandemic流感大流行15.surface antigen 外表抗原16.genetic shift基因改变17.neurological complications 神经性并发症18.waning of immunity免疫力减弱19.public health infrastructure公共卫生根底设施20.a malaria case一个疟疾病例21.swine flu猪流感22.tuberculosis bacillus结核杆菌23.the level of morbidity/incident发病率水平24.health professional保健专业人士tent tuberculosis潜伏结核病26.tuberculin skin test结核素皮试27.screening programmes筛查计划28.interferon gamma tests γ干扰素测试29.drug toxicity药物毒性30.an curable disease一种可治愈的病31,intractable infectious disease难治的传染病32.an unknown pathogen一种未知的病原体33.chronic gastric ulcer慢性胃溃疡34.exposure to carries of disease接触带病者35,genetic recombination基因重组36.agent of bioterrorism生物恐惧活动病原37.foodborne infections通过食物传播的传染病Unit 31.the surge of adrenaline 肾上腺素激增2.an internal medicine residency 科实习期3.an autoimmune disease 自体免疫4.loss of stamina 丧失持久力5.transient weakness 短暂的虚弱6.becoming bedridden 卧床不起7.a building block根本构件8.an animal model 动物模型9.to slow neurodegeneration减缓神经退化10.to excrete toxins排除毒素11.to optimize nutrition 优化营养12.toxic load毒素载量13.the risk of relapse 复发危险14.physician self-experimentation医生自我实验15.a clinical trial 临床试验16.neuromuscular electrical stimulation 神经肌肉电刺激17.physical therapist 理疗师18.the impact of micronutrient 微量营养素的影响19.brain function 脑功能20.track the emotional flow 跟踪情绪波动21.coordination of emotions 情绪协调22.cardiovascular reactions 心血管反响23.feeling of rapport 亲密感觉24.rapid synchronization 迅速同步25.emotional contagion 情绪传染26.to mutually regulate 互相调节27.a psychobiological unit生物心理单元28.emotional solace 情感慰藉29.functional magnetic resonance imaging功能性磁共振30.to activate brain zones激活该脑部区域31.to make it mandatory使之成为强制性32.a dubious project 无把握的项目33.medical background 医学背景34.proof of concept 概念验证35.dose regimen 剂量方案36 plication or concomitant conditions并发症与合并症37.anti-tumor agents 抗肿瘤的药剂38.standard therapy标准疗法39.pharmacological properties 药理学特性40.poor solubility 溶解性差41.in vivo pharmacology 体药理学Unit 4plementary medicine 补充医学2.alternative medicine 替代医学3.a medical paradigm 医疗模式4.acupuncture and herbs 针灸和草药5.adjunct treatment 辅助治疗6.nausea and vomiting 恶心，呕吐7.post-operative dental pain 术后牙痛8.clinical trials 临床试验9.physical therapy 物理疗法，理疗10.therapeutic modalities 治疗方法11.a therapeutic intervention治疗干预12.research design 研究设计13.magnetic resonance 磁共振14.positron emission tomography 正电子发射型计算机断层成像15.analgesia effect 止痛效果16.biomedical establishment 生物医学界17.rehabilitation unit康复中心18.licensed acupuncturist 持照针灸师19.therapeutic strategy治疗策略20.herbal formula草药配方21.a wide array of complications 各式各样的并发症22.integrative East-West medicine 中西医结合23.acute abdominal pain 急性腹痛24.to administer medicines 施药，用药25.surgical procedure 外科手术26.scientific evaluation 科学评估27.prevalence statistics患病率统计28.conventional therapies 传统疗法29.evidence-based models of care询证医学模式30.stress management 压力处理31.peripheral nervous system 周围神经系统32.physiologic mechanism生理机制33.mechanistic and reductionistic studies 机制和复原式研究34.cost-effectiveness research 效益研究35.clinical outcomes 临床结果36.preclinical and clinical studies 临床前及临床研究37.plausible mechanisms可能的机制38.manipulative therapies 推拿治疗39.homeopathic medicine 顺势疗法40.naturopathic medicine 自然疗法41.meditation and yoga冥想与瑜伽Unit 51.a health crisis 安康危机2.physical symptom 身体病症3.energy and vitality 能量和活力4.be completely immune from sth.对某事完全免疫5.virus of falseness 虚假的病毒6.stressful lifestyle 有压力的生活方式7.robust emotion 健全的感情8.fragile health 脆弱的安康9.to balance our mind ,body and spirit 平衡心理、身体和精神10.spiritual life精神生活11.the blockage to wellness 通向身心安康的“路障〞12.repressed emotions 被压抑的感情13.genuine feelings and emotion真情实感14.physiological influences 心理影响15.fully integrated human beings 十全十美的人16.decaying teeth 蛀牙17.nutrition professor 营养教授18.burgeoning waistline 迅速膨胀的腰围19.bottled water 瓶装水20.caloric intake 热量摄入21.to curb appetite 节制食欲22.grains and protein 谷物和蛋白质23.childhood obesity 儿童肥胖症24.lean protein 精益蛋白质25.dietary habits 饮食习惯26.quality of life 生活质量27.diary category 乳制品类28.prevention of diabetes糖尿病的预防29.sodium content 钠的含量Unit 61.nursing homes养老院2.hospice/end-of-life care临终关心3.congestive heart failure充血性心衰4.available around-the-clock 24小时随叫随到5.coronary care unit冠心病监护室6.to respond to treatment对治疗有反响7.skilled nursing facility专业护理机构8.end-of-life/hospice care生命终末期护理fort care舒适护理10.hospital discharge planner出院计划专员11.symptom care病症护理12.palliative care姑息疗法13.fatal illness绝症14.chronic obstructive pulmonary disease慢性阻塞性肺病15.experimental treatments实验性治疗16.spiritual advisor精神参谋17.to discontinue all treatment终止所有治疗18.to go through dialysis经历透析19.a PAP smear巴氏涂片检查20.patient-doctor relationship医患关系21.to provide care-as-usual提供常规医护22.preventive examinations预防性检查23.off the beaten path离开熟路，另辟蹊径24.to mold into a shape塑形25.To renew a prescription照旧处方再开药26.in vitro fertilization体外受精27.basic biology根底生物学28.embryonic stem cell research胚胎干细胞研究29.to collaborate with an outside与圈外人合作30.a test-tube baby试管婴儿31.reproductive sciences生殖科学32.to administer hormone施用激素33.to isolate immature eggs 别离未成熟卵子34.empirical observations经历观察35.pioneering work首创研究36.a fibre-optic endoscope光导纤维窥镜37.ethical guidelines伦理原那么38.societal concern社会关注39.infertile couples不孕不育夫妇40.inherited disease遗传疾病41.cystic fibrosis囊泡性纤维症42.ethical dilemma伦理困境Unit 71.a nursing station 护士站2.life-support machines 生命维持系统fort measure 舒适护理措施4.to withdraw treatments 停止治疗5.paternalistic decision-making process 家长式决策程序6.patient empowerment 给病人授权7.medical ethicist 医学伦理学家8.ethical principle 伦理准那么9.clinical ideal 临床理念10.patient-centered care 以病人为中心的护理11.patient autonomy 病人自主权12.treatment option 治疗选择13.exclusive purview 专属领域14.emergency decisions 紧急状况下做的决定15.physician restraint 对医生的限制16.anxiety and confusion 焦虑与困惑17.ethical transgression 违背伦理18.family practice 家庭医疗19.widespread metastases 广泛转移20.aggressive treatment 积极治疗21.primary lesion 原发病灶22.to recommend follow-up 建议随访23.electronic record 电子病历24.pulmonary emboli 肺栓塞puterized tomography 计算机断层扫描CT26.bilateral infiltrates 双侧浸润27.a chest X-ray X线胸片28.left lower-lobe pneumonia 左下肺叶肺炎bored breathing 呼吸困难30.the hospice team 临终关心团队31.chronic illness 慢性病32.psychosocial aspects 社会心理学领域33.evidence-based guideline 循证临床指南34.to implement a plan of care 实施治疗方案Unit 81.human subject 人体研究对象2.biomedical research 生物医学研究3.accepted therapy 公认的治疗4.a formal protocol 正式方案5.the principle of beneficence 有利原那么6.the principle of justice 公正原那么7.autonomous agents 有自主能力的行为者8.diminished autonomy 自主性减弱9.be exposed to risk of harm 使……面临受害危险10.Hippocratic Oath 希波克拉底誓言11.fairness in distribution 分配的公正性rmed consent 知情同意13.fair procedure and outcomes 公正的程序和结果14.the operating table 手术台15.an ethical obligation 伦理责任16.a pediatric neurosurgeon 儿科神经外科医生17.to perform the surgery 做手术18.blood flow 血流19.intensive care 重症监护20.adoptive father 义父21.biological father 生父22.psychological needs 心理需要23.medical judgment 医学判断24.occupational therapy 职业疗法25.to contract meningitis 感染脑膜炎26.to die of an infection 死于感染27.blood vessel 血管28.imbalances in circulation 循环的不平衡29.the welfare of human research subjects 人类研究对象的安宁30.to approve or disapprove all research activities 批准或不批准所有的研究活动31.to review a protocol 审查一个研究计划32.at risk of civil or criminal liability 有民事或刑事责任的危险。