新型冠状病毒肺炎药物干预型临床试验统计与分析

Statistics and Analysis of Drug Intervention Clinical Trials of COVID-19

关键词:  新型冠状病毒肺炎  临床试验  药物研究  统计分析

Key words:  COVID-19  clinical trials  drug research  statistical analysis

摘要:

目的 通过对新型冠状病毒肺炎药物干预型临床试验进行统计和分析，对相关试验药物研究基础进行归纳和总结，为临床试验的注册和开展提供参考。方法 以中国临床试验注册中心和美国临床试验注册中心数据库为数据来源，结合国内外文献调研，对药物干预型试验的注册时间、研究类型与设计、纳入标准、样本量、研究实施地点、主要评价指标、特殊人群试验进行统计分析，并对相关药物在抗病毒、呼吸系统疾病等方面的研究进行总结。结果 截至2020年3月5日，共注册350项临床试验，其中药物干预型研究199项，其中化学药物干预占比30%，中药干预占比23%，生物制品干预占比25%，联合用药干预占比9%；随机平行对照试验占75%；涉及药物包括蛋白酶抑制剂、广谱抗病毒药物、对症治疗药物、中成药及生物制剂。结论 目前临床试验注册数量较多，有利于较快筛选出有效的临床用药，但应重点关注临床试验的伦理审查，并采取有效的措施确保临床试验科学有序的开展，促进将临床试验和临床救治的密切结合。

Abstract:

OBJECTIVE To provide reference for the registration and development of clinical trials based on the statistics and analysis of the drug intervention clinical trials of COVID-19, summarizes the preliminary research basis of related experimental drugs. METHODS Taking the database of Chinese Clinical Trial Registry Center and U.S. National Library of Medicine Clinical Trials as the registration data source, combined with the domestic and foreign literature research, made statistical analysis on the registration time, research type and design, inclusion criteria, sample size, research implementation site, main evaluation indexes, special population test of drug intervention test, and conducted a total study on the antiviral and respiratory diseases of related drugs. RESULTS Till March 5, 2020, 350 clinical trials had been registered, including 199 drug intervention trials, including 30% of chemical drug intervention, 23% of traditional Chinese medicine intervention, 25% of biological product intervention, 9% of combined drug intervention, 75% of randomized parallel control trials, including protease inhibitors, broad-spectrum antiviral drugs, symptomatic treatment drugs, proprietary Chinese medicine and biological agent. CONCLUSION At present, there are a large number of clinical trials registered, which is conducive to the rapid screening of effective clinical drugs, but it is necessary to focus on the ethical review of clinical trials and take effective measures to ensure the scientific and orderly development of clinical trials, and promote the close combination of clinical trials and clinical treatment.