主 办:北 京 中 医 药 大 学
ISSN 1006-2157 CN 11-3574/R

北京中医药大学学报 ›› 2020, Vol. 43 ›› Issue (5): 368-372.doi: 10.3969/j.issn.1006-2157.2020.05.003

• 新冠肺炎专题 • 上一篇    下一篇

新型冠状病毒肺炎中医临床研究设计存在问题及对策刍议*

王玉光1, 程金莲1, 闫世艳2#   

  1. 1.首都医科大学附属北京中医医院 北京 100010;
    2.中国中医科学院中医临床基础医学研究所
  • 收稿日期:2020-03-02 发布日期:2020-06-08
  • 通讯作者: #闫世艳,女,博士,副研究员,主要研究方向:中医药临床研究设计及疗效评价,E-mail:yanshiyan0927@sina.com
  • 作者简介:王玉光,男,博士,教授,主任医师,博士生导师
  • 基金资助:
    *国家自然科学基金面上项目(No.81973713),国家“十三五”重大新药创制专项(No.2019ZX09734001),北京市医院管理局"登峰"计划专项(No.DFL20150902)

Commentary on the study designs of clinical trials using traditional Chinese medicine in the treatment of COVID-19: problems and suggestions*

Wang Yuguang1, Cheng Jinlian1, Yan Shiyan2#   

  1. 1. Beijing Hospital of Traditional Chinese Medicine, Capital Medical University,Beijing 100010, China;
    2. Institute of clinical basic medicine, Chinese Academy of Medical Sciences, Beijing 100700,China
  • Received:2020-03-02 Published:2020-06-08
  • Contact: A/Prof. Yan shiyan. Address: Institute of clinical basic medicine of traditional Chinese medicine, Chinese Academy of Sciences,Beijing 100700,China. E-mail: yanshiyan0927@sina.com
  • Supported by:
    General Projectof National Natural Science Foundation of China (NSFC) (No.81973713); National “13thfive year” Major New Drug InnovationProject (No.2019zx09734001); Special Project of “Dengfeng” of Beijing Municipal Hospital Administration (No.DFL20150902)

摘要: 目前,新型冠状病毒肺炎(COVID-19),仍无特效治疗药物。大量COVID-19临床试验的及时开展有利于尽快找到有效药物,但整体上也存在研究设计不够严谨、针对性不强、试验监管不够等问题。基于此,我们对中医COVID-19临床试验中存在的问题进行分析并提出对策,建议COVID-19中医临床试验设计时应首先以新发、突发传染病的基本特征为出发点,明辨COVID-19病因、探求核心病机,结合急性传染病病程的阶段性特点,遵循中医疫病认识论规律,根据疫情不同的发展阶段,设立不同的研究目标,开展中医证候流行病学调查、观察性研究、随机对照试验以及典型案例等多种研究设计相结合的中医临床研究。找准中医定位,在早期干预轻症、普通型病人的同时,充分发挥中医在重症、危重症中的作用;加强监管、统一部署,严格遵守伦理学原则和科学严谨的科研态度。

关键词: 新型冠状病毒肺炎, 临床试验, 中医药

Abstract: There has been no specific treatment for coronavirus disease 2019 (COVID-19). Quite a number of ongoing clinical trials are conducted to search for efficacious medicine against COVID-19. Meanwhile there are concerns about study design rigor,non-specific target and adequate oversight of these trials.This paper analyzed the problems observed in current COVID-19 clinical trials investigating the efficacy of traditional Chinese medicine (TCM) therapies and then offered suggestions for possible solutions. Design of COVID-19 clinical trials should be based on the nature of COVID-19 as an emergent and acute epidemic disease.Investigators should discern the TCM understanding of COVID-19 in terms of its pathogenic factors and mechanism, combining the stage characteristics of the course of acute infectious diseases, while following TCM general understanding of pestilential diseases. Multiple clinical study designs could be employed for different objective set at different stage of epidemic disease, including epidemiological study of TCM patterns, observational study, randomized controlled trials and case studies, etc. TCM should be properly positioned in playing its effective role in intervention with severe and critical cases and not limited to mild or common types only. Meanwhile, surveillance with unified deployment needs to be in place to ensure strong ethical grounds and rigorous scientific research attitude.

Key words: COVID-19, clinical trial, traditional Chinese medicine

中图分类号: 

  • R285.6