新型冠状病毒肺炎注册临床试验分析及存在的问题与建议

Analysis of Registered Clinical Trials of Coronavirus Disease 2019:Existing Problems and Suggestions

目的对国内外临床试验注册中心关于新型冠状病毒肺炎(简称“新冠肺炎”)已注册的临床试验研究进行分析,总结存在的问题并提出建议。方法检索2019年12月1日至2020年2月17日在中国临床试验注册中心和美国临床试验注册网站(ClinicalTrials.gov)上注册的新冠肺炎临床试验,提取其中关键信息并进行评价,在此基础上分析存在的问题。结果共纳入已注册研究164项,其中中国临床试验注册中心140项,ClinicalTrials.gov 24项。湖北省注册数量最多(53项),其次为浙江省(21项);干预性研究108项(65.85%),观察性研究46项(28.05%),预防性研究和诊断性研究10项(6.10%);西医领域117项(71.34%),中医领域35项(21.34%),中西医结合12项(7.32%);中医药干预措施中,以中医综合治疗方案、中西医结合方案及中医辨证论治为主。研究总样本量最小为10例,最多为400例;128项试验以轻型、普通型为研究对象。干预性临床研究中,评价指标以病毒转阴时间或转阴率最多(52项),其次为临床痊愈/临床缓解(41项)、肺功能以及肺部影像学指标(32项)、病死率以及重症、危重症转化率(23项)等。结论目前已注册的新冠肺炎临床研究呈现多样化特点,建议进一步深入挖掘中医药在重症、危重症治疗上的优势,关注恢复期的中医药治疗,加强反映中医病因病机的证候流行病学调查研究。

Objective To analyze the registered clinical trials of coronavirus disease 2019(COVID-19)in China and abroad and to summarize existing problems and make suggestions.Methods The COVID-19 clinical trials registered at the Chinese Clinical Trial Registry and clinical trial resitration in the United States(clinicaltrials.gov)from December 1st 2019 to February 17th,2020 were retrieved,and the key information was extracted and evaluated to analyze problems.Results A total of 164 registered studies were enrolled including 140 at Chinese clinical trial registration centers and 24 at clinicaltrials.gov.Hubei had the largest number of registrations(53),followed by Zhejiang(21);108(65.85%)interventional studies,46(28.05%)observational studies,10(6.10%)preventive and diagnostic studies;117(71.34%)Western medicine related studies,35(21.34%)Chinese medicine related studies,12(7.32%)integrated traditional Chinese and Western medicine related studies.Among the intervention measures of TCM,the comprehensive treatment of traditional Chinese medicine(TCM),integrated traditional Chinese and Western medicine treatment and the treatment based on syndrome differentiation were the main ones.The total sample size of the study was from 10 cases to 400 cases;128 trials took mild and common types as the research objects.In interventional clinical studies,52 studies took time or rate of negative conversion of the virus as the outcome,followed by 41 studies on clinical recovery/clinical remission,32 studies on lung function,lung imaging indicators,and 23 studies on mortality rate and the critically ill or critically ill conversion rate.Conclusion The currently registered clinical studies on COVID-19 show diversified characteristics.It is recommended to further explore the advantages of TCM in treatment of severe and critical illness,pay attention to TCM treatment in the recovery period,and strengthen the epidemiological investigation and stuides on syndromes related to the etiology and pathogenesis of TCM.