新型冠状病毒感染肺炎注册药物临床研究分析

目的:对新型冠状病毒感染肺炎(COVID-19)注册药物临床研究进行归纳分析。方法:检索在中国临床试验注册中心(chictr.org.cn)和美国临床试验注册网站(clinicaltrials.gov)上注册的在中国开展的COVID-19药物临床研究,对开展地点、研究设计、涉及药物等进行分析。检索时间截至2020年3月31日。结果:共检索到247项研究。武汉同济医院,武汉中南医院和武汉协和医院作为组长单位或研究中心参加临床研究数量最多。随机平行对照研究最多,有171项,占69.23%。涉及药物包括化学药物、生物制剂、中草药和中成药、细胞制品和血浆制品、疫苗等。结论:中国的临床研究意识以及临床研究注册意识得到了很大的提升,但疫情期间发起的药物临床研究需要关注科学性和伦理学等问题,要合理配置和整合资源。期待中国的高质量的COVID-19药物临床研究能率先为世界人民找到有效、安全、经济的新药。

Analysis of registered drug clinical research of Coronavirus Disease 2019

OBJECTIVE To summarize and analyze the clinical studies of registered drugs for novel coronavirus pneumonia (COVID-19).METHODS The search was performed in the COVID-19 drug clinical study carried out in China registered on the Chinese Clinical Trial Registry (chictr.org.cn) and the US Clinical Trials Registry website (clinicaltrials.gov),and the site of implementation,study design,and drugs involved were analyzed.The search period was up to March 31,2020.RESULTS A total of 247 studies were retrieved.Wuhan Tongji Hospital,Wuhan Zhongnan Hospital and Wuhan Union Hospital participated in the largest number of clinical studies as the leading unit or study site.There were 171 randomized parallel controlled studies,accounting for 69.23%.The drugs involved include chemical drugs,biological agents,Chinese herbal medicines and Chinese patent medicines,cell products and plasma products,vaccines,etc.CONCLUSION The awareness of clinical study and clinical study registration in China has been greatly improved,but the clinical study of drugs initiated during the epidemic period should pay attention to scientificity and ethics,and resources should be reasonably allocated and integrated.We look forward to the high-quality clinical study of COVID-19 drugs in China to take the lead in developing effective,safe and economical new drugs for the people of the world.