当下新型冠状病毒肺炎中药临床研究的若干思考

Insights into current clinical research of Chinese medicine on COVID-19

中西医结合在新型冠状病毒肺炎(简称"新冠肺炎")防治中发挥出独特疗效。于此同时,国内一批新冠肺炎中药临床研究扎堆注册,科学性、规范性和可操作性问题已严重凸显。建议综合考虑中药研发特点、疫情实际情况及前期研究基础,理性开展临床研究立项。科学合理确定药物的临床定位是新冠肺炎中药开发的关键,来自一线可靠中医诊疗信息收集基础上的中医病机判断是确定临床定位的重要前提。中药临床研究不应囿于传统设计,应当坚持治疗优先、疫情防控优先,以患者最大获益为核心,在伦理和科学前提下合理制定具有可操作性的新冠肺炎中药临床研究方案。管理部门也要探索建立重大公共卫生事件中药新药应急审批制度;同时应当组织资源进行相关试验评估,整合研究力量集中攻关,让真正科学严谨的临床研究早日获得真实、可靠的研究结果。

Integrated Chinese and western medicine plays a unique role in the prevention and treatment of coronavirus disease 2019(COVID-19).At the same time,a lot of clinical research of Chinese medicine have been registered in China.A series of problems of scientific nature,standardization,and operability became emerging and disputed.The clinical researches should be conducted with overall consideration of the characteristics of Chinese medicine R&D,the dynamic epidemic condition and the scientific basis.Reasonable clinical indication is the key to the development of Chinese medicine against COVID-19,based on the collection of front-line reliable Chinese medicine diagnosis andtreatment information.With the patient’s maximum benefit as the core and under the premise of not affecting the epidemic prevention and control,operable and adaptable clinical research protocols are needed with scientific and ethical consideration.The scientific supervision system should also be established for emergency conduct of clinical trials of new Chinese medicines in major emerging public health events.Taken together,real and reliable research results of effectiveness and safety of Chinese medicines are anticipated by scientific and rigorous clinical researches.