提升中医药防治新型冠状病毒肺炎临床研究质量的思考

How to Improve the Quality of Clinical Researches on Traditional Chinese Medicine for Prevention and Treatment of COVID-19

中医药在新型冠状病毒肺炎(简称新冠肺炎)疫情中早期介入,并发挥了全过程、全方位的积极治疗作用,充分显示了中医药优势和特长。在梳理现有中医药防治新冠肺炎相关研究的基础上,发现现有研究存在研究结果的临床证据等级偏低问题。基于此,提出中医药防治型冠肺炎临床研究应重视“四个解读”和“一个提升”,即解读中医药在抗病毒、免疫调节、抑制炎症因子风暴、改善病理损害四个方面发挥的作用,提升中医药临床研究的质量和循证证据等级;同时以中医药临床研究的实际问题为切入点,结合新冠肺炎疫情不同阶段的特点,分析中医药临床研究中的问题与对策,提出从确定研究目标及目标人群、确定干预措施及对照措施与变量、选择疗效指标与结局、控制临床质量及伦理要求等方面,合理选择临床研究方法的思考,为提升中医药临床研究质量提供思路,也为提升中医药在国际中的认同度提出建议。

Traditional Chinese medicine(TCM)has been used in the early stage of the coronavirus disease 2019(COVID-19),and has played a positive role in the whole process and in all directions,giving full play to the strengths of TCM.When analyzing the existing researches on TCM for COVID-19,however,it was found that the clinical evidence of the existing researches were at a relatively low level.Therefore,this paper proposed that more attention should be paid to“four interpretations”and“one promotion”,that was,interpreting the role of TCM in antivirus,immune regulation,suppression of inflammatory factor storms,and improvement of pathological damage,so as to improve the quality of clinical researches on TCM and the level of evidence.Simultaneously,the actual problems in the clinical researches of TCM,as well as the characteristics of different stages of COVID-19 are put focus on,and the problems and countermeasures are summarized.It is put forward that the clinical research methods should be selected rationally from the aspects of identifying the research objectives and target population,determining intervention and control measures and variables,selecting therapeutic outcomes,controlling clinical quality and meeting ethical requirements.Furthermore,this paper may provide ideas for improving the quality of clinical researches of TCM and promoting the recognition of TCM across the world.