我国治疗新冠肺炎药物临床研究现状浅析  

Drug clinical trial of COVID-19 in China:A brief analysis

作　　者：穆鑫[1,2] 赵颖[1,2] 张兰[3] 崔一民[4] 张永祥 杜冠华[1] MU Xin;ZHAO Ying;ZHANG Lan;CUI Yimin;ZHANG Yongxiang;DU Guanhua(Institute of Materia Medica,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100050,China;Chinese Pharmacological Society,Beijing 100050,China;Department of Pharmacy,Xuanwu Hospital Capital Medical University,National Clinical Research Center for Geriatric Diseases,Beijing 100053 China;Institute of Clinical Pharmacology,Peking University,Beijing 100034,China;Academy of Military Medical Sciences,Beijing 100850,China)

机构地区：[1]中国医学科学院北京协和医学院药物研究所,北京100050 [2]中国药理学会,北京100050 [3]首都医科大学宣武医院药学部国家老年疾病临床医学研究中心,北京100053 [4]北京大学临床药理研究所,北京100034 [5]军事科学院军事医学研究院,北京100850

出　　处：《中国临床药理学与治疗学》2020年第8期869-877,共9页Chinese Journal of Clinical Pharmacology and Therapeutics

基　　金：中国医学科学院新型冠状病毒肺炎应急项目(2020HY320001)。

摘　　要：目的:分析疫情期间我国开展的新型冠状病毒肺炎(以下简称“新冠肺炎”)治疗药物临床试验的特点,提出防治新冠肺炎药物研发的建议。方法:在中国临床试验注册中心网站检索关于新冠肺炎的药物临床试验项目,对药物类别、研究目标、方案设计等进行分析。结果:截至2020年7月1日,与药物相关的临床试验项目共有271项。注册进行临床试验的药物主要是已上市药物,包括化学药、中药及生物制品,有些是药物联合应用。这些研究主要采取了随机或非随机平行对照试验设计,另外还有些是单臂、连续入组、析因分组等。结论:疫情期间应急开展药物临床试验、尽快发现有效的防治药物是应对疫情的重要措施,但同时本次新冠肺炎药物临床试验也暴露出在试验设计、实施及监管等方面存在的一些不足和短板,建议采取加强候选药物的科学性评价、规范研究者发起药物临床研究、建立由多学科组成的国家级抗病毒药物研发平台及协同创新攻关机制等措施,提升我国抗病毒药物的研发能力和水平。AIM:To provide suggestion for research and development of drugs against coronavirus disease 2019(COVID-19)by analyzing the characteristics of the drug clinical trial registration information of COVID-19 in China.METHODS:The clinical trials of COVID-19 were searched from Chinese Clinical Trial Registry,and the type,purpose,and design of the studies were analyzed.RESULTS:Totally 271 drug clinical trials have been registered till July 1st,2020.Most of the drugs are marketed ones,including chemical drugs,traditional Chinese medicines,and biologics.Combined applications were adopted in some projects.Randomized or non-randomized parallel control trials were conducted in most projects.Others included single arm,sequential,and factorial design.CONCLUSION:To deal with the epidemic,it is important to conduct emergent drug clinical trials to find out effective drugs as soon as possible.However,some weaknesses and deficiencies on trials design,conduct and supervision were exposed in the drug clinical trials against COVID-19.It is suggested to enhance the scientific evaluation of candidate drugs,standardize the investigator initiated trials,and establish the national multi-subject research and development platform,and the collaborative and innovative key-task tackling mechanism,thus to improve the ability and level of antiviral drug research and development.

关 键 词：新型冠状病毒 临床试验 化学药 中药 生物制品 

分 类 号：R563.1[医药卫生—呼吸系统] R511[医药卫生—内科学]