基于核心指标集（COS）的中医药治疗新冠肺炎证据链构建与评价研究

采用循证医学理论和方法，提供中医药有效性和安全性高质量证据成为中医药守正创新、振兴发展需要突破的瓶颈。本研究以“三药三方”治疗新型冠状病毒肺炎（COVID-19）为切入点，开展方法学创新和示范应用研究，建立基于核心指标集（COS）的有效性和安全性证据链，将散在的证据转换成关联的高质量证据，彰显中医药优势。本研究主要内容包括：“三药三方”治疗COVID-19临床与基础研究证据系统评价/Meta分析；研制中医药治疗COVID-19的COS；“三药三方”治疗COVID-19证据链的形成与评价。通过研究，拟解决证据质量与临床价值关联性、基础和临床研究脱节、证据链条形成与评价等3个关键问题。本研究将形成中医药治疗COVID-19的核心指标集，构建“三药三方”治疗新型冠状病毒肺炎证据链并回答中医药治疗COVID-19的效应强度和作用机制。在此基础上，形成可推广的证据链条形成和评价规范。

Using the theory and method of evidence-based medicine to provide high-quality evidence of effectiveness and safety of traditional Chinese medicine (TCM) has become a bottleneck that needs to be broken in the innovation and revitalization of TCM. This study will take "three drugs and three prescriptions" for treating coronavirus disease 2019 (COVID-19) as a breakthrough point, and will carry out methodological innovation. The evidence chain of efficacy and safety based on core outcome set (COS) will be developed to transform scattered evidence into related high-quality evidence, which can highlight the advantages of TCM. The main research contents mainly include: conducting systematic reviews and Meta-analyses of clinical and experimental data of "three drugs and three prescriptions" for the treatment of COVID-19; developing a core outcome set of TCM for COVID-19; constructing and evaluating the evidence chain of "three drugs and three prescriptions" for COVID-19. This study is proposed to solve three key problems: the relationship between evidence quality and clinical value, the disconnection between experimental researches and clinical studies, and the formation and evaluation of evidence chain. After completing this study, we will develop a core outcome set of TCM for COVID-19, develop the evidence chain of "three drugs and three prescriptions" for the treatment of COVID-19 and answer the strength and mechanism of TCM for COVID-19. Further more, we will develop generalizable evidence chain formation and evaluation specifications.