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

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

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。

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.