中药上市后证候疗效再评价是对上市前证候疗效评价的必要补充,由于研究阶段及研究目标的转变,注定其需要在评价方法上有所突破和创新,而考虑中医药证候理论的学术特色,围绕证候疗效评价设计与实施过程的关键环节,分析证候疗效评价中普遍存在的共性问题,是改变当前证候疗效评价研究现状的迫切需求。通过分析中医药疗效评价的类型及层次,阐释中药上市后证候疗效再评价的现状及需求,进而提出重视中药上市后证候疗效再评价症状学研究,包括症状单元研究、规范症状表述、症状筛选及优化等,借鉴有效性登记式研究设计,结合探讨因果关系研究理念等,以期对建立中药上市后证候疗效再评价方法学有所启迪。

Revaluation of syndrome therapeutic effect of post-marketing Chinese materia medica (CMM) is a necessary complement to pre-ipo syndrome therapeutic effect evaluation. With the transition of research stage and research target, the evaluation method needs a breakthrough and innovation. So considering the academic characteristics of syndrome theory of traditional Chinese medicine (TCM), concerning the key link in the process of design and implementation in syndrome curative effect evaluation, and analyzing the common problems in syndrome curative effect evaluation are the urgent needs to change the current syndrome curative effect evaluation. Through analyzing the type and level of efficacy evaluation in TCM and interpreting the current situation and demand of syndrome therapeutic effect revaluation for post-marketing CMM, here this paper tried to put forward the research of revaluation of syndrome therapeutic effect for post-marketing CMM, which involved in research of symptoms unit, expression of specification symptoms, and symptoms of selection and optimization. Then drawing lessons from study design with effective registration and combining the concept of causality research could list some inspiration for how to establish the syndrome therapeutic effect revaluation for post-marketing CMM.