GDC-0834_Racemate_COA_12298_MedChemExpress
橙皮苷对DOCA
网络出版时间:2023-08-3014:39:20 网络出版地址:https://link.cnki.net/urlid/34.1086.R.20230830.1153.002橙皮苷对DOCA/Salt高血压大鼠心肾组织损害的保护作用杨 彬1,陈 哲2,全虹翰1,高海英1,朱 青1(1.广东药科大学中医药研究院,2.广州中医药大学科技创新中心,广东广州 510006)收稿日期:2023-03-10,修回日期:2023-06-20基金项目:国家自然科学基金资助项目(No81770707)作者简介:杨 彬(1996-),女,硕士,研究方向:高血压及肾脏疾病的中医药防治,E mail:young9612@163.com;朱 青(1980-),男,博士,教授,硕士生导师,研究方向:高血压及肾脏药理学,通信作者,E mail:zyq973@hotmail.comdoi:10.12360/CPB202208041文献标志码:A文章编号:1001-1978(2023)09-1705-06中国图书分类号:R 332;R284 1;R322 11;R322 61;R364 5;R544 1摘要:目的 探讨橙皮苷(hesperidin,HES)对高血压大鼠心肾损害的保护作用及可能机制。
方法 雄性SD大鼠18只随机分为3组:对照组(Ctrl)、高血压模型组(DOCA/Salt)、橙皮苷给药组(DOCA/Salt+HES)。
HES持续给药4周,检测血压、血清肌酐、尿素氮等指标,HE、马松和天狼星红染色观察心、肾组织病理改变,Westernblot检测α SMA、collagenⅠ和TGF β等蛋白表达,qRT PCR分别检测Nlrp3、TNF α、IL 1β、IL 6和NOXs的mRNA表达。
结果 与模型组比较,HES给药明显减缓DOCA/Salt高血压的发生,改善高血压大鼠肾功能指标,减少肾脏和心脏组织纤维化,降低α SMA、collagenⅠ和TGF β的表达,抑制Nlrp3,TNF α、IL 1β和IL 6等炎症因子释放,减少肾脏和心脏组织中NOXs表达。
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LetPub-JCR2012-期刊
0239-7528 1851-2372 1224-2780 2146-3123 1860-5397 1876-2883 1757-6180 1369-703X 1934-8630 0791-7945 1996-3599 0324-1130 0525-1931 0144-8617 0008-6223 1897-5593 1664-3828 1634-0744 1842-4090 2044-4753 0920-5861 1933-6918 2045-3701 1478-811X 2228-5806 2211-1247 0008-8846 1895-1066 1733-7178 2081-9900 1868-4904 0008-8994 0272-8842 0862-5468 0173-9913 1584-8663 0352-9568 1612-1872 1752-153X 1359-7345 0275-7540 0098-6445 1385-8947 0009-2347 0255-2701 0360-7275 0263-8762 0009-2509 0930-7516 0009-2460 0009-3122 1451-9372 0009-3068 0251-0790
B POL ACAD SCI-TECH B SOC ARGENT BOT BALK J GEOM APPL BALK MED J BEILSTEIN J ORG CHEM BENEF MICROBES BIOANALYSIS BIOCHEM ENG J BIOINTERPHASES BIOL ENVIRON BUILD SIMUL-CHINA BULG CHEM COMMUN BUNSEKI KAGAKU CARBOHYD POLYM CARBON CARDIOL J CARDIORENAL MED CARNETS GEOL CARPATH J EARTH ENV CATAL SCI TECHNOL CATAL TODAY CELL ADHES MIGR CELL BIOSCI CELL COMMUN SIGNAL CELL J CELL REP CEMENT CONCRETE RES CENT EUR J CHEM CENT EUR J ENERG MAT CENT EUR J GEOSCI CENT EUR NEUROSURG CENTAURUS CERAM INT CERAM-SILIKATY CFI-CERAM FORUM INT CHALCOGENIDE LETT CHEM BIOCHEM ENG Q CHEM BIODIVERS CHEM CENT J CHEM COMMUN CHEM ECOL CHEM ENG COMMUN CHEM ENG J CHEM ENG NEWS CHEM ENG PROCESS CHEM ENG PROG CHEM ENG RES DES CHEM ENG SCI CHEM ENG TECHNOL CHEM ENG-NEW YORK CHEM HETEROCYCL COM+ CHEM IND CHEM ENG Q CHEM IND-LONDON CHEM J CHINESE U
大动脉炎患者外周血单个核细胞RT-qPCR内参基因的选择
January 2021Vol.41 No.12021 年 1 月 第 41 卷 第 1 期基础医学与临床Basic & Clinical Medicine文章编号:1001-6325 ( 2021 ) 01-0087-06研究论文大动脉炎患者外周血单个核细胞RT-qPCR 内参基因的选择田苡箫,李菁*收稿日期:2019-11-18 修回日期:2020-04-30*通信作者(corresponding author ) :lijing6515@ (中国医学科学院北京协和医学院北京协和医院风湿免疫科风湿免疫病学教育部重点实验室国家皮肤与免疫疾病临床医学研究中心,北京100032)扌摘要:目的筛选适于在大动脉炎(TAK )患者和健康人群(HC )之间比较外周血单个核细胞(PBMC )中mRNA 表达水平的内参基因。
方法提取PBMC 中的总RNA,应用RT-qPCR ,分别采用geNorm 、NormFinder 、BestKeeper 3种软 件程序,分析 3-glucuronidase ,GAPDH ,ACTB ,SDHA ,HPRT1,RPL13A ,B2M , YWHAZ 和 PKG1 9 个基因的 mRNA 表达稳定性。
以T-bet 、GATA3和RORC 作为目的基因,比较不同稳定性的内参基因对mRNA 相对丰度的影响。
结果geNorm 筛选得到的基因组合为B 2M-SDHA , Nor^nFinder 和BestKeeper 筛选出最稳定的内参基因均为HPRT1 ; 3种方法均显示GAPDH 的稳定性较差。
结论自身免疫病患者在接受免疫抑制药物治疗时,原本稳定表达的基因可能会 上调或下调;在样本量较小时,稳定性更好的内参基因可能更有助于检测组间差异。
关键词:大动脉炎;实时定量聚合酶链式反应;RNA 稳定性;内参基因选择中图分类号:R593.2 文献标志码:AValidation of reference genes for the normalization of the RT-qPCRin peripheral blood mononuclear cells of patients with Takayasu arteritisTIAN Yi-xiao , LI Jing *(Department of Rheumatology and Immunology , Key Laboratory of Rheumatology and Clinical Immunology , Ministry of Education ,National Clinical Research Center for Dermatologic and Immunologic Diseases ( NCRC-DID ),Peking Union Medical College Hospital , CAMS & PUMC , Beijing 100032, China)Abstract : Objective To validate proper reference genes for quantitative real-time polymerase chain reaction ( RT-qPCR) used for comparing mRNA expression levels in Takayasu arteritis" (TAK) and healthy controls' ( HC ) pe ripheral blood mononuclear cells ( PBMC ). Methods Total RNA in PBMCs was extracted and used RT-qPCR to determine the profiles of 9 candidate genes , including 0-glucuronidase, GAPDH , ACTB , SDHA , HPRT1, RPL13A , B2M , YWHAZ and PKG1. Then compared their transcription stability by geNorm , NormFinder , and Best Keeper. Afterwards , with T-bet , GATA3 and RORC as the targeted genes , explored the influence of reference genes with different stability on mRNA relative abundance. Results The gene combination of B2M-SDHA was selected bygeNorm , and HPRT1 was the most stable one in analysis results of NormFinder and BestKeeper , while GAPDH was less stable. Conclusions Genes that have been expressed stably may be upregulated or downregulated whenpatients with autoimmune diseases received immunosuppressive drugs. When the sample size is small , the more sta ble internal reference may facilitate the identification of inter-groups difference.Key words : Takayasu arteritis ; real-time polymerase chain reaction ; RNA stability ; selection of reference gene88基础医学与临床Basic&Clinical Medicine2021.41(1)反转录实时荧光定量聚合酶链式反应(reverse quantitative real-time polymerase chain reaction,RT-qPCR)是目前分析基因表达水平的黄金标准,却经常表现出重复性欠佳的问题,选取合适的内参基因有助于改善这一情况[1]。
人基质质控血清
注释:
®:注册商标
(1). 只适用于德国。
根据德国内科医生联邦议院的方针制订范围(中文说明已略,如需请另行参见英文说明)。
(2). 德国内科医生联邦议院官方认可的参考实验室测定的浓度值。
(3). DGKC:德国临床化学协会
(4). IFCC:国际临床化学联盟
(5). SCE:斯堪的纳维亚酶委员会
使用说明
朗道的人基质质控血清为冻干品,用于临床准确性或者重复性质量控制。
朗道供应2种水平的质控血清。
赋值
每一批质控血清都要送到参考实验室,根据国际参考标准进行赋值。
若没有国际参考标准,就使用参考方法。
朗道也将质控血清送到全世界3000多家实验室,然后将结果用相同的统计分析赋值。
质控范围值是平均值±2S.D.。
该结果非常准确可靠,实验室尽可放心使用。
准备
1. 小心打开瓶盖,避免内容物的任何损失。
2. 在20-25℃的室温下,准确量取5ml蒸馏水复溶1瓶质控血清。
3. 盖上橡皮塞,拧紧瓶盖,使用前避光放置30分钟。
4. 轻轻旋转,确保内容物完全溶解。
5. 将小瓶倒置,确保所有的冻干物完全溶解。
6. 勿摇晃小瓶。
复溶后的血清既可以用于手工测试,也可以用于全自动生化分析仪。
该血清只能按照上述步骤复溶。
稳定性
该血清自生产之日起,在4℃下保存可以稳定4年。
效期标在试剂盒的侧面。
该血清一旦复溶,在25℃下可以稳定24小时,在4℃下可以稳定7天,在-20℃至少可以稳定1个月(见受限情况)。
外泌体在风湿病中作用的研究进展
外泌体在风湿病中作用的研究进展作者:郭晓萱李大可来源:《风湿病与关节炎》2023年第10期【摘要】外泌体是一种纳米囊泡,不同类型的细胞均可以释放,在正常情况下可以从血液、尿液等多种体液中分离得到。
外泌体及其组成成分在细胞间通讯中起着重要作用。
现如今越来越多的研究已经证实,外泌体可以将其所含成分转移到受体细胞中,从而改变受体细胞的生物活性,与各种风湿病的病理生理过程有关,并在疾病治疗和诊断中有着潜在作用。
【关键词】风湿病;外泌体;微小RNA;研究进展;综述外泌体是一种直径为30~120 nm的由磷脂双分子层膜包裹的囊泡,可以参与细胞间的信息传递[1]。
外泌体的成分包括DNA、RNA、蛋白质及脂质物质,其中微小RNA (miRNA)是一种长度为21~23个核苷酸的单链非编码小分子RNA,在人体中通过转录后抑制蛋白质编码基因的表达参与多种生物学途径的调节[2]。
长链非编码RNA(lncRNA)是一类长度超过200个核苷酸的非编码RNA,与多种自身免疫性疾病的发生、发展有关。
近期的研究表明,外泌体或许可以作为疾病诊断和预后的新生物标志物,并为多种疾病提供新的治疗方向。
1 外泌体与类风湿关节炎(rheumatoid arthritis,RA)在RA的病理过程中,外泌体主要参与抗原呈递、炎性细胞因子和miRNA的传递以及成纤维样滑膜细胞(FLS)的激活[3]。
RA患者滑膜外泌体具有较高的破骨潜能,这可能导致了其特征性的骨质侵蚀[4]。
FLS来源的外泌体可显著诱导T细胞分化,使辅助性T细胞(Th17)增加,调节性T细胞(Treg)细胞减少,通过调节Treg/Th17平衡影响RA临床症状,因此,可以作为RA的潜在治疗靶点[5]。
程明等[6]实验发现,人骨髓间充质干细胞(hBMSCs)来源外泌体miRNA-320a对CXC趋化因子配体9有负调控作用,从而抑制RA-FLS增殖和迁移能力。
外泌体来源的miR-155可能通过对趋化因子的调节而促进炎性细胞在RA滑膜中的募集和滞留,进而参与RA的发病[7]。
GDC-0834_SDS_MedChemExpress
Inhibitors, Agonists, Screening LibrariesSafety Data Sheet Revision Date:Jun.-08-2017Print Date:Jun.-08-20171. PRODUCT AND COMPANY IDENTIFICATION1.1 Product identifierProduct name :GDC-0834Catalog No. :HY-15427CAS No. :1133432-49-11.2 Relevant identified uses of the substance or mixture and uses advised againstIdentified uses :Laboratory chemicals, manufacture of substances.1.3 Details of the supplier of the safety data sheetCompany:MedChemExpress USATel:609-228-6898Fax:609-228-5909E-mail:sales@1.4 Emergency telephone numberEmergency Phone #:609-228-68982. HAZARDS IDENTIFICATION2.1 Classification of the substance or mixtureNot a hazardous substance or mixture.2.2 GHS Label elements, including precautionary statementsNot a hazardous substance or mixture.2.3 Other hazardsNone.3. COMPOSITION/INFORMATION ON INGREDIENTS3.1 SubstancesSynonyms:GDC 0834; GDC0834Formula:C33H36N6O3SMolecular Weight:596.74CAS No. :1133432-49-14. FIRST AID MEASURES4.1 Description of first aid measuresEye contactRemove any contact lenses, locate eye-wash station, and flush eyes immediately with large amounts of water. Separate eyelids with fingers to ensure adequate flushing. Promptly call a physician.Skin contactRinse skin thoroughly with large amounts of water. Remove contaminated clothing and shoes and call a physician.InhalationImmediately relocate self or casualty to fresh air. If breathing is difficult, give cardiopulmonary resuscitation (CPR). Avoid mouth-to-mouth resuscitation.IngestionWash out mouth with water; Do NOT induce vomiting; call a physician.4.2 Most important symptoms and effects, both acute and delayedThe most important known symptoms and effects are described in the labelling (see section 2.2).4.3 Indication of any immediate medical attention and special treatment neededTreat symptomatically.5. FIRE FIGHTING MEASURES5.1 Extinguishing mediaSuitable extinguishing mediaUse water spray, dry chemical, foam, and carbon dioxide fire extinguisher.5.2 Special hazards arising from the substance or mixtureDuring combustion, may emit irritant fumes.5.3 Advice for firefightersWear self-contained breathing apparatus and protective clothing.6. ACCIDENTAL RELEASE MEASURES6.1 Personal precautions, protective equipment and emergency proceduresUse full personal protective equipment. Avoid breathing vapors, mist, dust or gas. Ensure adequate ventilation. Evacuate personnel to safe areas.Refer to protective measures listed in sections 8.6.2 Environmental precautionsTry to prevent further leakage or spillage. Keep the product away from drains or water courses.6.3 Methods and materials for containment and cleaning upAbsorb solutions with finely-powdered liquid-binding material (diatomite, universal binders); Decontaminate surfaces and equipment by scrubbing with alcohol; Dispose of contaminated material according to Section 13.7. HANDLING AND STORAGE7.1 Precautions for safe handlingAvoid inhalation, contact with eyes and skin. Avoid dust and aerosol formation. Use only in areas with appropriate exhaust ventilation.7.2 Conditions for safe storage, including any incompatibilitiesKeep container tightly sealed in cool, well-ventilated area. Keep away from direct sunlight and sources of ignition.Recommended storage temperature:Powder-20°C 3 years4°C 2 yearsIn solvent-80°C 6 months-20°C 1 monthShipping at room temperature if less than 2 weeks.7.3 Specific end use(s)No data available.8. EXPOSURE CONTROLS/PERSONAL PROTECTION8.1 Control parametersComponents with workplace control parametersThis product contains no substances with occupational exposure limit values.8.2 Exposure controlsEngineering controlsEnsure adequate ventilation. Provide accessible safety shower and eye wash station.Personal protective equipmentEye protection Safety goggles with side-shields.Hand protection Protective gloves.Skin and body protection Impervious clothing.Respiratory protection Suitable respirator.Environmental exposure controls Keep the product away from drains, water courses or the soil. Cleanspillages in a safe way as soon as possible.9. PHYSICAL AND CHEMICAL PROPERTIES9.1 Information on basic physical and chemical propertiesAppearance Light yellow to yellow (Solid)Odor No data availableOdor threshold No data availablepH No data availableMelting/freezing point No data availableBoiling point/range No data availableFlash point No data availableEvaporation rate No data availableFlammability (solid, gas)No data availableUpper/lower flammability or explosive limits No data availableVapor pressure No data availableVapor density No data availableRelative density No data availableWater Solubility No data availablePartition coefficient No data availableAuto-ignition temperature No data availableDecomposition temperature No data availableViscosity No data availableExplosive properties No data availableOxidizing properties No data available9.2 Other safety informationNo data available.10. STABILITY AND REACTIVITY10.1 ReactivityNo data available.10.2 Chemical stabilityStable under recommended storage conditions.10.3 Possibility of hazardous reactionsNo data available.10.4 Conditions to avoidNo data available.10.5 Incompatible materialsStrong acids/alkalis, strong oxidising/reducing agents.10.6 Hazardous decomposition productsUnder fire conditions, may decompose and emit toxic fumes.Other decomposition products - no data available.11.TOXICOLOGICAL INFORMATION11.1 Information on toxicological effectsAcute toxicityClassified based on available data. For more details, see section 2Skin corrosion/irritationClassified based on available data. For more details, see section 2Serious eye damage/irritationClassified based on available data. For more details, see section 2Respiratory or skin sensitizationClassified based on available data. For more details, see section 2Germ cell mutagenicityClassified based on available data. For more details, see section 2CarcinogenicityIARC: No component of this product present at a level equal to or greater than 0.1% is identified as probable, possible or confirmed human carcinogen by IARC.ACGIH: No component of this product present at a level equal to or greater than 0.1% is identified as a potential or confirmed carcinogen by ACGIH.NTP: No component of this product present at a level equal to or greater than 0.1% is identified as a anticipated or confirmed carcinogen by NTP.OSHA: No component of this product present at a level equal to or greater than 0.1% is identified as a potential or confirmed carcinogen by OSHA.Reproductive toxicityClassified based on available data. For more details, see section 2Specific target organ toxicity - single exposureClassified based on available data. For more details, see section 2Specific target organ toxicity - repeated exposureClassified based on available data. For more details, see section 2Aspiration hazardClassified based on available data. For more details, see section 212. ECOLOGICAL INFORMATION12.1 ToxicityNo data available.12.2 Persistence and degradabilityNo data available.12.3 Bioaccumlative potentialNo data available.12.4 Mobility in soilNo data available.12.5 Results of PBT and vPvB assessmentPBT/vPvB assessment unavailable as chemical safety assessment not required or not conducted.12.6 Other adverse effectsNo data available.13. DISPOSAL CONSIDERATIONS13.1 Waste treatment methodsProductDispose substance in accordance with prevailing country, federal, state and local regulations.Contaminated packagingConduct recycling or disposal in accordance with prevailing country, federal, state and local regulations.14. TRANSPORT INFORMATIONDOT (US)This substance is considered to be non-hazardous for transport.IMDGThis substance is considered to be non-hazardous for transport.IATAThis substance is considered to be non-hazardous for transport.15. REGULATORY INFORMATIONSARA 302 Components:No chemicals in this material are subject to the reporting requirements of SARA Title III, Section 302.SARA 313 Components:This material does not contain any chemical components with known CAS numbers that exceed the threshold (De Minimis) reporting levels established by SARA Title III, Section 313.SARA 311/312 Hazards:No SARA Hazards.Massachusetts Right To Know Components:No components are subject to the Massachusetts Right to Know Act.Pennsylvania Right To Know Components:No components are subject to the Pennsylvania Right to Know Act.New Jersey Right To Know Components:No components are subject to the New Jersey Right to Know Act.California Prop. 65 Components:This product does not contain any chemicals known to State of California to cause cancer, birth defects, or anyother reproductive harm.16. OTHER INFORMATIONCopyright 2017 MedChemExpress. The above information is correct to the best of our present knowledge but does not purport to be all inclusive and should be used only as a guide. The product is for research use only and for experienced personnel. It must only be handled by suitably qualified experienced scientists in appropriately equipped and authorized facilities. The burden of safe use of this material rests entirely with the user. MedChemExpress disclaims all liability for any damage resulting from handling or from contact with this product.Caution: Product has not been fully validated for medical applications. For research use only.Tel: 609-228-6898 Fax: 609-228-5909 E-mail: tech@Address: 1 Deer Park Dr, Suite Q, Monmouth Junction, NJ 08852, USA。
医学词典
医学词典.txt人和人的心最近又最远,真诚是中间的通道。
试金可以用火,试女人可以用金,试男人可以用女人--往往都经不起那么一试。
A145N-乙氧碳基氨甲基-L-异亮氨酸A2780人卵巢癌细胞细胞系A549人肺腺癌细胞系aberrant异常abortion流产acceleration加速access访问accessible可访问的acetylaminofluorene乙酰氨基芴(致癌物)aclacinon山之内的商品名adriblastine阿霉素affect影响affection疾患、病、影响alafloxacin阿拉沙星albacort地塞米松amenorrhea闭经amerantrone蒽二酮aminoazotoluene氨基偶氮甲笨(肝脏致癌剂)amniocentesis羊膜穿刺amnion羊膜amnioscope羊膜镜amnioscopy羊膜镜检查amniotomy人工破膜amoxicillin阿莫西林;羟氨苄青霉素amphiregulin双调素,为表皮生长因子家族的成员之一ampulla壶腹部anastomosis吻合术anastrozole阿纳托唑,选择性非甾体类芳香化酶抑制剂。
androblastoma男性母细胞瘤androgen雄激素Anesthetist麻醉医师aneuploid非整倍体angiostatin血管抑制素anitratum硝酸盐阴性(不动杆菌)anovulation不排卵anteflexion前屈antibody抗体antigen抗原antineoplaston抗肿瘤治疗antiretroviral抗逆转录病毒的antisignaling抗信号药物appendix阑尾approximation对合arabitin阿糖腺苷,腺嘌呤阿糖甙Aredia阿可达,帕米膦酸钠(pamidronate)的商品名,Novartis公司出品arimedex芳香化酶抑制剂arimidex新的芳香化酶抑制剂arteriography动脉造影atelectasis肺不张atopic变态反应性autocrineloops自泌环autoinvasive自身侵袭性autosome常染色体AY62013环氧甘醚,乙环氧啶azimexone羧胺氰丙啶(BRMs)B16黑色素瘤细胞系(小鼠)BAK椎体间融合器Ball公司名称;波尔公司;金属制品;网址baseline基线baumanii鲍曼不动杆菌BCDFB细胞分化因子(BRMs)bednet臭虫behavior行为Bel7402人肝癌细胞系Biaoroubixing表阿霉素bioassay生物测定biopsy活检boolean布尔bromoacetoxylphenylhexan溴乙酰己烷雌酚,内消旋3bromodeoxyuridine溴脱氧尿嘧啶,在DNA合成过程中渗入细胞,用于作为进入或经历DNA合成期(S期)的标记,代表DNA合成水平bronchicanis支气管败血症(Bordetella bronchiseptica支气管败血症博代氏菌)BSLi西非单叶豆凝集素,对B型血球专一BSN次硝酸铋(诱导正常组织产生金属硫蛋白,降低化疗药物毒性);bowel sounds normal 肠鸣音正常BTIC氯乙基三氮烯咪唑酰胺BU2231A泰来霉素(博莱霉素衍生物,是一种霉菌产生的糖肽化合物)C12U核酸抗癌剂干扰素诱导剂cabergoline卡麦角林(镇痛药)cackexia恶液质CAI羧基胺基咪唑,是一种细胞信号传导抑制剂,能够阻滞配体受体依赖性Ca2+的内流,改变包括内皮细胞在内的多种细胞的生物行为,如运动、侵袭、酶解和构建血管等,在体内外抑制血管形成calciifolinas亚叶酸calcoacelicus醋酸钙(不动杆菌)Calprotectin钙卫蛋白:钙卫蛋白是近年发现的与钙结合的不均一的复合蛋白质,由2重链及1轻链构成,主要来源于嗜中性粒细胞和单核细胞,分布于粒单细胞、上皮细胞、角质细胞内及各种组织和体液中,具有抗微生物、抗增殖等多种生物学功能。
ADC药物研发现状
Title Originator Highest Dev Status 111In-capromab pendetide Cytogen Corp Launched111In-imciromab pentetate Janssen Biotech Inc Launched131I-chTNT-1/B Peregrine Pharmaceuticals Inc Launched131I-metuximab Fourth Military Medical University PLA Launchedbrentuximab vedotin Seattle Genetics Inc Launchedgemtuzumab Wyeth Research Launchedibritumomab tiuxetan IDEC Pharmaceuticals Corp Launchedtrastuzumab emtansine Genentech Inc LaunchedATL-101, ATLAB Cornell University Phase 3 Clinical inotuzumab ozogamicin Wyeth Research Phase 3 Clinical oportuzumab monatox (intratumoral, head and neck cancer), Viventia University of Zurich Phase 3 ClinicalRIGS CC49Navidea Biopharmaceuticals Inc Phase 3 ClinicalABT-414Abbott Laboratories Phase 2 ClinicalCDX-1401Celldex Therapeutics Inc (pre-merger)Phase 2 Clinical glembatumumab vedotin CuraGen Corp Phase 2 ClinicalLMB-2National Cancer Institute Phase 2 Clinical lorvotuzumab mertansine ImmunoGen Inc Phase 2 Clinical moxetumomab pasudotox National Cancer Institute Phase 2 Clinical oportuzumab monatox (intravesicular, bladder cancer), Viventia University of Zurich Phase 2 ClinicalPSMA-ADC Cytogen Corp Phase 2 ClinicalRG-7593Genentech Inc Phase 2 ClinicalRG-7596Genentech Inc Phase 2 ClinicalSAR-3419ImmunoGen Inc Phase 2 Clinical212-Pb-TCMC-trastuzumab National Cancer Institute Phase 1 ClinicalActimab-A PDL BioPharma Inc Phase 1 ClinicalAGS-16M8F Agensys Inc Phase 1 Clinicalanti-CD3/anti-CD20 bispecific antibody-armed activated T-cells (non-Hodgkin's lymphoma), Wayne State University/Barbara Ann KarmanosCancer Institute Barbara Ann Karmanos Cancer Institute Phase 1 ClinicalASG-5ME Agensys Inc Phase 1 ClinicalBAY-79-4620MorphoSys AG Phase 1 Clinical citatuzumab bogatox Viventia Biotech Inc Phase 1 Clinical doxorubicin-loaded anti-EGFR immunoliposomes (solid tumors), UniversityHospital Basel University Hospital of Basel Phase 1 ClinicalHuM195/rGel (intravenous infusion, AML/CML/meylodisplastic syndrome),Targa Therapeutics Memorial Sloan-Kettering Cancer Center Phase 1 ClinicalIMGN-529ImmunoGen Inc Phase 1 ClinicalIMGN-853ImmunoGen Inc Phase 1 ClinicalIMMU-132Immunomedics Inc Phase 1 Clinical labetuzumab-SN-38Immunomedics Inc Phase 1 ClinicalNHS-IL-12National Cancer Institute Phase 1 ClinicalRG-7450Genentech Inc Phase 1 ClinicalRG-7458Genentech Inc Phase 1 Clinical RG-7598Genentech Inc Phase 1 Clinical RG-7599Genentech Inc Phase 1 Clinical RG-7600Genentech Inc Phase 1 Clinical RG-7636Genentech Inc Phase 1 Clinical SAR-566658ImmunoGen Inc Phase 1 Clinical T-Guard University Medical Center St Radboud Phase 1 Clinical vorsetuzumab mafodotin Seattle Genetics Inc Phase 1 Clinical 131I-catuximab (colorectal cancer), Pacific Meinuoke Fourth Military Medical University PLA Discovery177Lu-tetraxetan-tetulomab (non-Hodgkin's lymphoma), Nordic Nanovector Nordic Nanovector AS Discovery227Th-epratuzumab (hematological cancer), Algeta Algeta ASA Discovery227Th-rituximab (cancer), Algeta Algeta ASA Discovery227Th-trastuzumab (cancer), Algeta Algeta ASA Discovery4s3-0014s3 Bioscience Inc Discovery4s3-0024s3 Bioscience Inc Discovery64Cu-NOTA-ALT-836Altor BioScience Corp DiscoveryAA-A225Actinium Pharmaceuticals Inc Discovery AbGn-107AbGenomics Corp Discovery Actimab-B Fred Hutchinson Cancer Research Center Discovery Actimab-C Actinium Pharmaceuticals Inc Discovery Actimab-P Actinium Pharmaceuticals Inc Discovery adalimumab + anti-Ang2 Zybody (rheumatoid arthritis/inflammatory boweldisease), Zyngenia Zyngenia Inc DiscoveryAGS-15E ADC Agensys Inc DiscoveryAGT-160ArmaGen Technologies Inc DiscoveryAGT-185ArmaGen Technologies Inc DiscoveryAGT-190ArmaGen Technologies Inc Discovery amanitin-trastuzumab conjugate (cancer), Heidelberg Pharma Heidelberg Pharma Holding Ltd Discoveryanti-CD133-immunotoxin conjugates (photochemical internalization, cancer),PCI Biotech PCI Biotech Holding ASA Discoveryanti-ET8R-MC-vc-PAB-MMAE Genentech Inc Discoveryanti-NaPi3b antibody-drug conjugate (cancer), Genentech/Roche Genentech Inc Discovery antibody drug conjugates (cancer), Sanofi Sanofi Discovery antibody-drug conjugates (cancer), ADC Therapeutics ADC Therapeutics Sarl Discovery antibody-drug conjugates (cancer), Seattle Genetics/Oxford BioTherapeutics Seattle Genetics Inc Discovery antibody-drug conjugates (TAP, cancer), Lilly Eli Lilly & Co Discovery antibody-IFN lambda conjugates (cancer), Immunomedics Immunomedics Inc Discovery anticancer therapy (TAP technology), Amgen Amgen Inc DiscoveryAPH-0912Aphios Corp Discovery Aurixin BioIntegrator DiscoveryAZ-05Allozyne Inc Discovery BIOO-1BIOO Therapeutics DiscoveryBIOO-2BIOO Therapeutics Discovery BIOO-3BIOO Therapeutics Discovery BIOO-4BIOO Therapeutics Discovery BIOO-5BIOO Therapeutics Discovery BIOO-6BIOO Therapeutics Discovery BIOO-7BIOO Therapeutics Discovery botulinum toxin B inhibitor (injectable, heteropolymer mAbs, botulism),Immunome Immunome Inc Discovery BT-2111biOasis Technologies Inc Discovery C2-2b-2b Immunomedics Inc Discovery CDX-014CuraGen Corp Discovery chiHEA-125-Ama Heidelberg Pharma Holding Ltd Discovery CK-22-(20)-(20)Immunomedics Inc Discovery complement factor H-derived short consensus repeat-antibody constructs(infection), LysoVac University of Innsbruck Discovery Cymac-001Cytoguide ApS Discovery CYP-Ab Cytune Pharma Discovery D2C7-based immunotoxins (glioma), Duke University Duke University Discovery EGFR modulators (antibody conjugates, PIT, cancer), Aspyrian Aspyrian Therapeutics Inc Discovery engineered cysteine drug conjugates mAbs (cancer), Seattle Genetics Seattle Genetics Inc Discovery epratuzumab-SN-38Immunomedics Inc Discovery ETBs (cancer), Molecular Templates/ Imclone Molecular Templates Inc Discovery Fluorescent-labeled bevacizumab (imaging, ocular disease), Mivenion mivenion Gmbh Discovery gemcitabine + paclitaxel (prodrug, nanomAb, cancer), ImmunePharmaceuticals Immune Pharmaceuticals Corp Discovery Herceptin:Endostatin-P125A University of Miami Discovery hLL1-CL2A-SN-38Immunomedics Inc Discovery hPAM4-CL2A-SN-38Immunomedics Inc Discovery human monoclonal antibody-toxin conjugates (myocardial infarction), Celdara Celdara Medical LLC Discovery HuMax-TF-ADC Genmab A/S Discovery IFNalpha-fused mAbs (HBV infection), Roche Roche Holding AG Discovery IL-13 receptor alpha 2 inhibitors (iv, cancer), Pfizer Pfizer Inc Discovery IMGN-289ImmunoGen Inc Discovery intracellular antibodies (Intraphilin, inflammatory diseases/infectiousdiseases/ophthalmic diseases), Permeon Biologics Permeon Biologics Inc Discovery mapp-66Mapp Biopharmaceutical Inc Discovery MB-2003Mapp Biopharmaceutical Inc Discovery monoclonal antibody-drug conjugates, Chirogenix/ImmunoGen/Celltrion Chirogenix Co Ltd Discovery MP-Ter-ADC MediaPharma Srl Discovery N01-OX2Intellect Neurosciences Inc Discovery PC-91ProCell Therapeutics Inc Discovery ProstaLite PhotoBiotics Ltd Discoveryrecombinant mAb-biocide fusion proteins (oral/Directed Biocide,cryptosporidium infection), ioGenetics ioGenetics Inc Discovery SGN-CD33A Seattle Genetics Inc Discovery SGN-LIV1A Seattle Genetics Inc Discovery SL-101Stemline Therapeutics Inc Discovery SYD-983Synthon Biopharmaceuticals Discovery T01-OX2Intellect Neurosciences Inc Discovery TBL-0306L Transgene Biotek Ltd Discovery TBL-0306M Transgene Biotek Ltd Discovery TBL-0805E Transgene Biotek Ltd Discovery thio-trastuzumab-mpeo-DM1Genentech Inc Discovery trastuzumab-PNU-159682 antibody-drug conjugate (cancer), Genentech Genentech Inc Discovery veltuzumab-IFN alpha 2b conjugate (cancer), IBC/Immunomedics IBC Pharmaceuticals Inc Discovery BIIB-015Biogen Inc Suspended Pretarget technology (gastrointestinal adenocarcinoma), NeoRx Poniard Pharmaceuticals Inc Suspended125I-AnnA1 IgG Sidney Kimmel Cancer Center No Development Reported131I-CC49-SCA Enzon Labs Inc No Development Reported177Lu-capromab pendetide Cytogen Corp No Development Reported90Y-capromab pendetide Cytogen Corp No Development Reported99mTC-BERH2Medac GmbH No Development Reportedanti-CD133-vcMMAF Seattle Genetics Inc No Development Reportedanti-CD22 antibody drug-conjugates, Medarex/BMS Medarex Inc No Development Reportedanti-PSMA antibody-drug conjugates (cancer), Medarex Medarex Inc No Development Reportedantibody-drug conjugates (solid tumors), Daiichi Sankyo Seattle Genetics Inc No Development ReportedAVE-9633ImmunoGen Inc No Development Reportedbectumomab Immunomedics Inc No Development ReportedCA125/MUC16-targeting antibody-drug conjugate (ovarian cancer),Genentech Genentech Inc No Development Reportedcathepsin B-sensitive prodrugs, BMS Bristol-Myers Squibb Pharmaceutical ResearchInstituteNo DevelopmentReportedCC49 humanized radioimmunoconjugates, National Cancer Institute,University of Alabama at Birmingham National Cancer Institute No Development ReportedCD4-BFFI Roche Holding AG No Development ReportedCHB-111ViRexx Medical Corp No Development ReportedCHT-25University College London No Development ReportedCMD-193Wyeth No Development ReportedCNTO-95 immunoconjugates (cancer), Centocor Janssen Biotech Inc No Development Reportedconjugated PEI/anti-CD133 mAb plasmid-based gene therapy (brain tumor),Discovery genomics Discovery Genomics Inc No Development ReportedcT84.66City of Hope No Development Reporteddelta 9-cadherin targeting antibody (gastric cancer), Actinium Helmholtz Zentrum München No Development Reporteddiphtheria toxin, RCT Research Corporation Technologies No Development Reporteddoxorubicin-C225 conjugate (STEALTH), SEQUUS SEQUUS Pharmaceuticals Inc No Development ReportedDTPA-BrE-3University of Colorado System No Development ReportedDXL-625InNexus Biotechnology Inc No Development ReportedG3.519-PAP-S Tanox Inc No Development ReportedhuHMFG1-caspase Antisoma plc No Development ReportedIMGN-007ImmunoGen Inc No Development ReportedIMGN-009ImmunoGen Inc No Development Reportedimmunoconjugate (cancer MN), Bayer Bayer AG No Development ReportedImmuRAID-AFP-99mTc, Immunomedics Immunomedics Inc No Development ReportedIMTOX 22-97A University of Texas Southwestern MedicalCenterNo DevelopmentReportedKSB-201KS Biomedix Holdings plc No Development ReportedLA22-radioimmunoconjugates (cancer), Welson/Peking University Welson Pharmaceuticals Inc No Development Reportedlabetuzumab Immunomedics Inc No Development ReportedLMB-1, NIH National Institutes of Health No Development ReportedLu-177-trastuzumab Tarbiat Modares University No Development ReportedLymphoScan Immunomedics Inc No Development ReportedMDX-11Medarex Inc No Development ReportedMDX-1203Medarex Inc No Development ReportedMDX-1206Medarex Inc No Development Reportedmonoclonal-porphyrins, Quadra Logic QLT Inc No Development Reportedmonoclonals, Quest Quest Biotechnology Inc No Development ReportedNogo receptor modulators, Biogen Idec Yale University No Development ReportedONS-1210Oncobiologics Inc No Development ReportedOP-06 program (cancer), Onco-Pharmakon Onco-Pharmakon Inc No Development Reportedpaclitaxel analogs and immunoconjugates (cancer), Bioxel Bioxel Pharma Inc No Development ReportedPE38-conjugated anti-CD30 immunotoxin, NCI National Cancer Institute No Development Reportedprostate-specific MAb, NIH National Institutes of Health No Development ReportedR-1549The UK Imperial Cancer Research Fund No Development Reportedradiolabeled Tx3.833Beth Israel Deaconess Medical Center No Development Reportedscu-PA-59D8Bristol-Myers Squibb Co No Development ReportedSGN-17/19Seattle Genetics Inc No Development Reportedtaxane-monoclonal antibody conjugates, ImClone ImClone Systems Inc No Development Reportedtranscobalamin (vitamin B12) receptor-targeting mAbTCR23-saporinconjugate (cancer), Kyto Kyto Biopharma Inc No Development Reportedtrastuzumab-autophilic peptide conjugate (breast cancer), InNexusBiotechnology InNexus Biotechnology Inc No Development Reportedtrastuzumab-MC-vc-PAB-MMAF Genentech Inc No Development ReportedTRP-targeted antibody conjugate (Yttrium 90/MX-DTPA), SomantaPharmaceuticals Immunodex Inc No Development Reportedtucotuzumab celmoleukin EMD Lexigen Research Center Corp No Development ReportedVB4-011Viventia Biotech Inc No Development ReportedVB6-011Viventia Biotech Inc No Development ReportedVB6-050Viventia Biotech Inc No Development ReportedXomaZyme-791XOMA Corp No Development Reportednofetumomab Poniard Pharmaceuticals Inc Withdrawn 131I-81C6Duke University Discontinued 131I-ImmuRAIT-HCG, Immunomedics Immunomedics Inc Discontinued B-B4-DC1ImmunoGen Inc Discontinued CC49 radioimmunoconjugates, University of Alabama at Birmingham University of Alabama at Birmingham Discontinued CD5 monoclonals/RIPs, Italfarmaco Italfarmaco SpA Discontinued CVX-045CovX Pharmaceuticals Inc Discontinued CVX-060CovX Pharmaceuticals Inc Discontinued CVX-241CovX Pharmaceuticals Inc Discontinued CVX-343CovX Pharmaceuticals Inc Discontinued doxorubicin-BR96 conjugate, BMS Bristol-Myers Squibb Co Discontinued doxorubicin-CEA conjugate, Immunomedics Immunomedics Inc Discontinued doxorubicin-LL2 conjugate, Immunomedics Immunomedics Inc Discontinued FAP5-DM1Boehringer Ingelheim Corp Discontinued FGFR4-CovX-Body CovX Pharmaceuticals Inc Discontinued HuM-195-Bi-213PDL BioPharma Inc Discontinued human placental growth factor 1-CVX-2000 monoclonal antibody conjugatedtherapeutic (CovX-body, cancer), CovX CovX Pharmaceuticals Inc Discontinued huN901-CC-1065ImmunoGen Inc Discontinued huN901-DC1ImmunoGen Inc Discontinued ImmuRAID-HCG-99mTc, Immunomedics Immunomedics Inc Discontinued ImmuRAIT-CEA-rhenium-188, Immunomedics Immunomedics Inc Discontinued MDX-214Medarex Inc Discontinued MEDI-547MedImmune LLC Discontinued MLN-2704Cornell University Discontinued Oncolym Peregrine Pharmaceuticals Inc Discontinued Oncolysin B Dana-Farber Cancer Institute Inc DiscontinuedOncolysin CD6Dana-Farber Cancer Institute Inc Discontinued Oncolysin M Dana-Farber Cancer Institute Inc Discontinued Oncolysin S Dana-Farber Cancer Institute Inc Discontinued Oncopurge Poniard Pharmaceuticals Inc Discontinued rhenium-188-LL2, Immunomedics Immunomedics Inc Discontinued SMART ABL-364Novartis AG Discontinued targeted ranpirnase conjugates (cancer), Alfacell Tamir Biotechnology Inc DiscontinuedHighest Dev Status。
Oracle Health Sciences InForm EDC 平台介绍说明书
Oracle Health Sciences InForm EDC PlatformDeliver Higher-Quality Data, Faster and with Less Effort, Cost and Risk INFORM AT A GLANCEDrive effciencies with integratedand automated workfows andself-service, one-click studydeployment Integration with Oracle Argus increases productivity and speeds safety reporting 50%Cut weeks or months off time to database lock with InForm Data ViewerIntegration with Oracle IRT RTSMsolution reduces data entryand data reconciliation acrossapplications by up to 90%#1 in global site satisfaction means faster study startups with less risk #1Integration with Data Management Workbench reduces time and effort to clean and transform data by up to 60%INCREASE EFFICIENCY • Design trials in just a few days and auto-deploy with one click• Assess , review , and lock a site or entire study in minutes• Streamline workfows with fully integrated CDM, IRT , medical coding, safety and moreIMPROVE DATA QUALITY• Identify problems and take corrective action more quickly with real-time visibility to data• Conduct effective risk-based monitoring• Incorporate mid-study revisions without migrating data like other EDC systemsREDUCE COST• Integrated workfows require far less time and manualeffort50% • Streamlined monitoring and faster time to database lockreduces costly and unnecessary steps• Flexible pricing and delivery models bring capabilities ofmarket-leading InForm EDC to virtually any organizationBROADEST PLATFORMInForm offers the industry’s broadest platform of integrated systems and workfows to drive greater efficiency and data quality while reducing costClinical Data ManagementPhysiologic DataIRT ePROCTMS Clinical BiomarkersMedication AdherenceInForm Site Payments SafetyeTMF Medical Coding Risk-based MonitoringORACLE HEALTH SCIENCES INFORM EDC PLATFORMThe market-leading EDC system and the #1 preferred choice of investigator sites worldwide.For more information visit our clinical data management solutionsJoin our communitiesCopyright © 2015, Oracle and/or its affiliates. All rights reserved. Oracle and Java are registered trademarks of Oracle and/or its affiliates. Other names may be trademarks of their respective owners. 150916。
德谷门冬双胰岛素注射液治疗2_型糖尿病临床效果及安全性探讨
DOI:10.16658/ki.1672-4062.2023.17.098德谷门冬双胰岛素注射液治疗2型糖尿病临床效果及安全性探讨林生,谢平,陈予福州市长乐区人民医院内分泌科,福建福州350200[摘要]目的研究德谷门冬双胰岛素注射液治疗2型糖尿病的临床效果及安全性。
方法选取于2022年7月—2023年4月福州市长乐区人民医院收治的2型糖尿病患者98例为研究对象,采用随机抓阄法分为两组,每组49例。
两组均联用常规降糖药物治疗,对照组采用甘精胰岛素注射液治疗,观察组采用德谷门冬双胰岛素注射液治疗。
对比两组临床治疗效果、临床症状好转时间和胰岛素用量情况、糖代谢指标、胰岛素功能指标、不良反应发生情况、心血管不良事件发生情况。
结果观察组总有效率高于对照组,差异有统计学意义(P<0.05)。
观察组尿酮体转阴时间、血糖达标时间、胰岛素用量均优于对照组,差异有统计学意义(P< 0.05)。
观察组空腹血糖、餐后2 h血糖、糖化血红蛋白均低于对照组,差异有统计学意义(P<0.05)。
观察组胰岛β细胞功能指数高于对照组,胰岛素抵抗指数、空腹胰岛素低于对照组,差异有统计学意义(P<0.05)。
两组恶心呕吐、倦怠乏力、低血糖总发生率比较,差异无统计学意义(P>0.05)。
两组心绞痛、心力衰竭总发生率比较,差异无统计学意义(P>0.05)。
结论德谷门冬双胰岛素注射液治疗2型糖尿病临床效果显著优于甘精胰岛素注射液,但是治疗安全性无显著变化。
[关键词] 2型糖尿病;德谷门冬双胰岛素注射液;不良反应;心血管不良事件[中图分类号] R59 [文献标识码] A [文章编号] 1672-4062(2023)09(a)-0098-04Discussion on the Clinical Effect and Safety of Insulin Degludec and Insu⁃lin Aspart Injection in the Treatment of Type 2 Diabetes MellitusLIN Sheng, XIE Ping, CHEN YuDepartment of Endocrinology, Changle District People's Hospital, Fuzhou, Fujian Province, 350200 China[Abstract] Objective To study the clinical effect and safety of insulin degludec and insulin aspart injection in the treatment of type 2 diabetes mellitus. Methods A total of 98 patients with type 2 diabetes admitted to Fuzhou Changle District People's Hospital from July 2022 to April 2023 were selected as the study objects and divided into two groups with 49 cases in each group by random lottery method. Both groups were treated with conventional hypoglycemic drugs, the control group was treated with insulin glargine injection, and the observation group was treated with Degu asparton double insulin injection. The clinical therapeutic effect, time of improvement of clinical symptoms, insulin dosage, glucose metabolism index, insulin function index, occurrence of adverse reactions and cardiovascular adverse events were compared between the two groups. Results The total effective rate of the observation group was higher than that of the control group, and the difference was statistically significant (P<0.05). The time of urine ketone body turning negative, blood glucose reaching standard and insulin dosage in observation group were better than those in control group, and the differences were statistically significant (P<0.05). Fasting plasma glucose, 2-hour postprandial blood glucose and glycated hemoglobin in the observation group were lower than those in the control group, and the differences were statistically significant (P<0.05). The function index of islet β cells in observation group was higher than that in control group, the insulin resistance index and fasting insulin was lower than that in control group, the dif⁃ference was statistically significant (P<0.05). There was no statistically significant difference in the total incidence of [作者简介]林生(1981-),男,本科,副主任医师,研究方向为糖尿病及其并发症的相关临床研究。
E14 Guideline (R3) - questions and answers说明书
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 555525 January 2016EMA/CHMP/ICH/310133/2008Committee for Human Medicinal ProductsICH guideline E14: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (R3) - questions and answersStep 5E14 Q&As (R3) Document HistoryICH guideline E14: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (R3) - questions and answersICH guideline E14 (R3) - questions and answersTable of contents1E lectrocardiograms methodology (4)2G ender (9)3P ositive control (10)4S tudy design (12)5U se of concentration response modeling of QTc data (13)6S pecial cases (16)7E lectrocardiograms monitoring in late stage clinical trials (17)ICH guideline E14 (R3) - questions and answers1Electrocardiograms methodologyICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 4/20ICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 5/20ICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 6/20ICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 7/20ICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 8/202GenderICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 9/203Positive controlICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 10/20ICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 11/204Study designICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 12/205Use of concentration response modeling of QTc dataICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 13/20ICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 14/20ICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 15/20ICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 16/20 6 Special cases6.1 March2014 The ICH E14 Guideline states that in certain cases a conventional thoroughQT study might not be feasible. In suchcases what other methods should beused for evaluation of QT/QTc andproarrhythmic potential? In certain cases the conventional “thorough QT/QTc” study design (a crossover study in healthy volunteers with short-term administration of the usual maximum dose and one higher dose with placebo and positive control) might need to be modified for a drug or active metabolite with a long half-life or delayed QT effect, or because of safety, tolerability or practical issues that preclude use in healthy subjects. In most cases alternative designs can be used that may affect power considerations, but do notcompromise study interpretation. For example, multiple doses can be studied in aparallel design trial or can use patients with the disease for which the drug is intendedrather than healthy volunteers.Where a placebo-controlled comparison using appropriate doses is not possible,alternative study d esigns should incorporate as many of the usual “thorough QT/QTc”design features as possible, and the quality and extent of the pre-clinical evaluation (ICHS7B Guideline) is particularly critical. Other useful supplementary data might includeintensive ECG data acquisition in early phase single or multiple ascending dose studies,utilisation of concentration-response analysis, and evaluation of exposures that aregreater than are anticipated with the intended marketed dose.A single dose of a positive control is generally sufficient, even if it precedes theinvestigational drug treatment. In the absence of a positive control, there is reluctanceto draw conclusions of lack of an effect; however, if the upper bound of the two-sided90% confidence interval around the estimated maximal effect on QTc is less than 10 ms,it is unlikely to have an actual mean effect as large as 20 ms.When a thorough QTc study of usual or modified design is not feasible, the intensity oflate phase ECG monitoring will be dependent upon the quality and extent of the non-clinical and clinical evaluation. In situations where it is not possible to study higherexposures than are anticipated with the intended marketed dose, more intensive ECGmonitoring might be necessary during Phase 3 trials. When the non-clinical and early7Electrocardiograms monitoring in late stage clinical trialsICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 17/20ICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 18/20ICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 19/20ICH guideline E14 (R3) - questions and answersEMA/CHMP/ICH/310133/2008 Page 20/20。
依达拉奉右莰醇联合溶栓治疗对急性缺血性脑卒中患者的神经功能保护作用及机制研究
依达拉奉右莰醇联合溶栓治疗对急性缺血性脑卒中患者的神经功能保护作用及机制研究陈小妮,谭会会,陈蕊西安市第三医院神经内科,陕西西安710021【摘要】目的探讨依达拉奉右莰醇联合溶栓治疗对急性缺血性脑卒中患者的神经功能保护作用及其作用机制。
方法选择2020年12月至2022年1月西安市第三医院神经内科收治的90例急性缺血性脑卒中患者展开研究,按随机数表法分为观察组和对照组各45例。
两组患者均接受静脉溶栓治疗,对照组患者在溶栓后使用依达拉奉注射液治疗,观察组患者溶栓后则使用依达拉奉右莰醇注射用浓溶液治疗,两组均治疗两周。
比较两组患者治疗两周后的临床疗效,治疗前及治疗两周后的美国国立卫生研究院卒中量表(NIHSS)评分、巴氏量表(Barthel 指数)、血清谷胱甘肽过氧化物酶(GSH-Px)、超氧化物歧化酶(SOD)、丙二醛(MDA)、肿瘤坏死因子-α(TNF -α)、白细胞介素-1β(IL -1β)水平及治疗期间的不良反应发生情况。
结果治疗后,观察组患者的临床疗效总有效率为91.11%,明显高于对照组的73.33%,差异有统计学意义(P <0.05);治疗后,观察组患者的NIHSS 评分为(7.90±1.34)分,明显低于对照组的(9.42±1.68)分,Barthel 指数为(67.14±5.18)分,明显高于对照组的(62.89±4.67)分,差异均有统计学意义(P <0.05);治疗后,观察组患者的血清GSH-Px 、SOD 水平分别为(234.09±21.57)mg/L 、(95.23±17.45)U/mL ,明显高于对照组的(205.63±18.32)mg/L 、(79.56±14.18)U/mL ,血清MDA 、TNF -α、IL -1β水平分别为(4.65±0.89)μmol/L 、(86.52±15.40)ng/L 、(86.52±15.40)pg/mL ,明显低于对照组的(6.42±1.10)μmol/L 、(113.67±16.05)ng/L 、(288.51±31.27)pg/mL ,差异均有统计学意义(P <0.05);两组患者治疗期间均无明显不良反应发生。
康莱特注射液联合化疗治疗晚期肺腺癌的临床研究
康莱特注射液联合化疗治疗晚期肺腺癌的临床研究张育荣,桑蝶,范善民,赵晓慧(北京市朝阳区三环肿瘤医院内科,北京100122)摘要:目的探讨康莱特注射液联合贝伐珠单抗+培美曲塞+顺铂方案治疗晚期肺腺癌的疗效与安全性。
方法选取2016年9月至2019年9月本院收治的92例肺腺癌患者,随机分为研究组(n=47)和对照组(n=45),两组均给予贝伐珠单抗+培美曲塞+顺铂方案治疗,研究组患者在化疗基础上联合康莱特注射液治疗,比较两组患者的疗效、不良反应及生存情况。
结果两组客观有效率、疾病控制率比较差异无统计学意义。
研究组Ⅰ~Ⅲ度白细胞下降、血小板下降及恶心、呕吐的发生率明显低于对照组,差异有统计学意义(P<0.05)。
研究组血红蛋白减少、转氨酶升高及高血压发生率分别为53.2%,8.5%,21.3%,均为Ⅰ~Ⅱ度,对照组分别为48.9%,15.6%,22.2%,两组比较差异均无统计学意义。
研究组和对照组患者的1年生存率分别为81.9%、72.1%,2年生存率分别为60.4%、56.6%,差异无统计学意义。
结论康莱特注射液联合化疗治疗晚期肺腺癌患者可在一定程度上减少化疗不良反应,提高生活质量。
关键词:康莱特注射液;化疗;疗效;不良反应Kanglaite injection combined with chemotherapy in the treatment of advanced adenocarcinoma of lungZHANG Yurong,SANG Die,FAN Shanmin,ZHAO Xiaohui(Department of Medical Oncology,Beijing Chaoyang District Sanhuan Cancer Hospital,Beijing,100122,China) Abstract:Objective To investigate the efficacy and safety of kanglaite injection combined with bevacizumab+pemetrexed+cisplatin in the treatment of advanced lung adenocarcinoma.Methods92patients with lung adenocarcinoma admitted to our hospital from September2016to Sep-tember2019were selected and randomly divided into study group(n=47)and control group(n=45).Both groups were treated with bevacizumab+ pemetrexed+cisplatin.The study group was treated with kanglaite injection on the basis of chemotherapy.The efficacy,adverse reactions and survival between the two groups were compared.Results There was no significant difference in objective effective rate and disease control rate between the two groups.The incidence of grade I-III leukopenia,thrombocytopenia,nausea and vomiting in the study group were significantly lower than those in the control group(P<0.05).The incidences of hemoglobin decrease,transaminase increase and hypertension in the study group were53.2%,8.5% and21.3%respectively,which were grade I-II,while those in the control group were48.9%,15.6%and22.2%,respectively.There was no significant difference between the two groups.The1-year survival rates of the study group and the control group were81.9%and72.1%,respectively,and the2-year survival rates were60.4%and56.6%,respectively.Conclusion Kanglaite injection combined with chemotherapy in the treatment of advanced lung adenocarcinoma can certain extent reduce the adverse reactions of chemotherapy and improve the quality of life.Key words:Kanglaite injection;Chemotherapy;Curative effect;Adverse reactions肺癌是全世界发病率和死亡率最高的恶性肿瘤,整体5年生存率约为13%,预后较差[1]。
基于GEO数据库结合网络药理学及分子对接逆向挖掘干预肝癌的中药
基于GEO数据库结合网络药理学及分子对接逆向挖掘干预肝癌的中药魏泽坤;杨雨洁;刘双;王燕;董红敬;刘春梅【期刊名称】《山东科学》【年(卷),期】2024(37)3【摘要】基于GEO(gene expression omnibus)数据库结合网络药理学及分子对接,从分子水平逆向挖掘具有抗肝癌活性的中药。
通过GEO、GeneCards、OMIM 和TTD等疾病靶点数据库获取肝癌的重要靶点。
利用STRING平台获取核心靶点,结合TCMIP(integrative pharmacology-based research platform of traditonal Chinese medicine)和TCMID(traditional Chinese medicine integraive database)数据库筛选核心成分,采用TCMSP(traditonal Chinese medicine system pharmacology database and analysis platform)数据库筛选核心中药,通过分子对接和细胞实验验证筛选结果。
从疾病靶点数据库得到398个肝癌的重要靶点,进一步筛选出8个核心靶点、11个核心成分和1味核心中药葛根;分子对接结果表明葛根的3个核心成分(槲皮素、黄岑素、豆甾醇)可以与部分核心靶点(CDK1、CDC20)自发地结合;细胞实验结果表明葛根提取物可以有效抑制肝癌细胞HepG2的增殖。
该结果可以为葛根的研究与开发提供参考,为葛根抗肝癌活性成分的挖掘提供理论依据。
【总页数】9页(P39-47)【作者】魏泽坤;杨雨洁;刘双;王燕;董红敬;刘春梅【作者单位】山东中医药大学中医学院;山东中医药大学附属医院;齐鲁工业大学(山东省科学院)山东省分析测试中心【正文语种】中文【中图分类】R285【相关文献】1.基于GEO芯片挖掘联合网络药理学分析解毒化瘀颗粒治疗肝癌的分子机制2.基于网络药理学联合GEO数据库及分子对接技术探讨化瘀丸治疗乳腺癌的作用机制3.基于GEO芯片挖掘联合网络药理学及分子对接探讨当归补血汤治疗股骨头坏死分子机制4.基于网络药理学联合GEO数据库及分子对接探究脑安胶囊治疗缺血性脑卒中的作用5.基于网络药理学和分子对接技术结合GEO芯片探究补中清利汤治疗IgA肾病的作用机制因版权原因,仅展示原文概要,查看原文内容请购买。
靶点B-Raf的抑制剂GDC-0834的介绍
GDC-0879是一种新型,有效的,选择性的B-Raf抑制剂,IC50为0.13 nM,对c-Raf也有抑制作用;对其他蛋白激酶没有抑制作用。
体外研究,在V600E B-Raf 突变的A375黑色素瘤和V600E B-Raf突变的Colo205结肠癌细胞系中,GDC-0879抑制MEK1磷酸化作用时IC50分别为59和29 nM。
GDC-0879有效抑制Malme3M细胞的B-raf V600E 酶促作用,IC50为0.75 μM。
用GDC-0879处理,EC50值<0.5的细胞都表达B-raf V600E 致癌等位基因
(A375,624,SK-MEL-28,Malme3M, C32, 928, 888, G-361, Colo205, Colo206, SW1417, CL34,及Colo201)。
体内:GDC-0879处理的鼠细胞系和病患衍生的B-raf V600E肿瘤,显示更强和更持久的药效抑制性(处理8小时,>90%) 且与突变型KRAS-表达的肿瘤相比具有更高的生存力。
Ras诱导肿瘤形成时有激活的Raf信号,但是用GDC-0879处理后,观察到一些KRAS-突变肿瘤的生长进展很慢。
GDC-0879调节的高效性完全与BRAFV600E 的状况有关,抑制MEK减弱表达野生型B-raf肿瘤的生长和增殖。
通过PI3K通路活性的药理学和基因的调节,可以很明显地改变BRAFV600E 黑色素瘤细胞对GDC-0879的反应性。
气相色谱-质谱联用法测定人血浆中双氯芬酸钠的含量的开题报告
气相色谱-质谱联用法测定人血浆中双氯芬酸钠的含量的开题报告一、选题背景及意义双氯芬酸钠是一种常用的非甾体抗炎药物,常用于缓解轻至中度疼痛、发热以及各种炎症所引起的不适。
随着双氯芬酸钠的广泛应用,其药代动力学和药效学研究也变得十分重要。
气相色谱-质谱联用技术(GC-MS)是一种高灵敏度、高分辨率的检测方法,已被广泛用于生物样品中药物含量的定量分析。
因此,利用GC-MS技术对人血浆中双氯芬酸钠的含量进行精准测定,对于深入了解其行为与代谢机制具有重要的意义。
二、文献综述目前已有很多研究使用GC-MS测定双氯芬酸钠在生物样品中的含量。
例如,一项研究使用ODS镀硅烷化液相色谱-质谱联用技术(LC-MS/MS)测定人血浆中双氯芬酸钠的含量,结果表明,该方法具有高灵敏度、高选择性和准确性,可用于临床前药代动力学和生物等效性研究。
但该方法需要较长的分析时间和复杂的操作过程,因此不太适用于临床的快速检测。
相比之下,GC-MS技术具有更快的分析速度和更高的灵敏度,可用于临床的快速检测。
三、研究计划及方法本研究旨在建立一种使用GC-MS测定人血浆中双氯芬酸钠含量的方法,具体步骤如下:1.样品制备:收集20份人血浆样品,加入内标氯苯甲酸钠,经蛋白沉淀、液液萃取等步骤制备样品。
2.峰面积的选择:使用NIST MS搜索库鉴定双氯芬酸钠和氯苯甲酸钠的质谱离子,通过研究不同离子峰的面积发现,以m/z 193和227离子峰进行测定时,信噪比最高。
3.分析条件的优化:选择一系列的分析条件,包括柱温、进样量、进样方式、质谱扫描方式等,对分析条件进行优化。
4.检测方法的验证:测定20个血清样品,进行精密度、准确度、线性范围、检测限和定量限等方面的检测方法验证。
四、预期结果及意义本研究预期建立一种快速、准确、重复性高的GC-MS测定人血浆中双氯芬酸钠的方法。
该方法可用于临床的快速检测,深入了解其药代动力学和药效学研究具有重要意义。