中药上市后证候疗效再评价的研究思路及方法探讨

发布时间：2018-04-01 09:39

本文选题：中药　切入点：证候　出处：《中草药》2015年14期

【摘要】：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。
[Abstract]:The re-evaluation of syndromes efficacy after the listing of traditional Chinese medicine is a necessary supplement to the evaluation of pre-market syndromes. Due to the change of research stage and research goal, it is doomed to have a breakthrough and innovation in the evaluation method. Considering the academic characteristics of TCM syndrome theory, the common problems in the evaluation of syndromes efficacy are analyzed around the key links in the process of design and implementation of syndromes curative effect evaluation. It is an urgent need to change the current research situation of syndromes curative effect evaluation. By analyzing the types and levels of TCM curative effect evaluation, this paper explains the present situation and demand of the reevaluation of TCM syndrome curative effect after listing. Further more, the author puts forward that we should pay more attention to the reevaluation of syndromes, including symptom unit research, standard symptom expression, symptom screening and optimization, and use for reference the design of effective registration, and discuss the concept of causality, etc. With a view to the establishment of Chinese medicine after the listing of syndromes re-evaluation methodology has enlightenment.
【作者单位】：陕西中医药大学;
【分类号】：F426.72;R28

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