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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。
The re-evaluation of TCM efficacy after listing is a necessary complement to the evaluation of the efficacy of the pre-IPO syndrome. Due to the change of the research phase and the research goal, it is doomed to make some breakthroughs and innovations in the evaluation method. Considering the TCM syndrome theory Academic characteristics around the key aspects of the design and implementation process of syndrome evaluation and analysis of common problems in syndrome evaluation are the urgent needs to change the current research status of syndrome evaluation. By analyzing the types and levels of TCM efficacy evaluation, this paper explains the status quo and needs of re-evaluation of efficacy of TCM syndromes after listing, and puts forward the importance of symptomatic studies on syndrome re-evaluation after TCM listing, including symptom unit study, standardized symptom presentation, symptoms Screening and optimization, drawing on the validity of registered research design, combined with the study of causal relationship research ideas, etc., in order to establish the listing of Chinese medicine syndrome after the efficacy of revaluation methodologies have some enlightenment.