证候类中药新药临床评价的靶式设计初探

Clinical Evaluation of New Chinese Herbal Medicines for Syndromes:A Preliminary Study on Target Design

当前证候类中药新药临床评价方法及评价模式存在一定局限性,尚缺乏符合中医药特点的临床评价体系。基于中医药“辨证论治”“方证对应”的特色,在病证结合基础上提出靶式设计模型、假说及其应用范围。在充分考虑病、证双重因素基础上,通过同一证型人群中不同证素的差异来区分“靶心”“中环”“外环”以判定证候符合程度的差异,进而将同一证候人群按照“靶心”“中环”“外环”分层分析,实现证候类中药新药的精准定位,尝试为中医药辨证论治、精准干预提供研究思路及方法。

There are certain limitations in the current clinical evaluation methods and evaluation modes of new Chinese herbal medicines for syndromes,and there is a lack of a clinical evaluation system that meets the characteristics of traditional Chinese medicine(TCM).Based on the characteristics of TCM"syndrome differentiation and treatment"and"correspondence of formulas and syndromes",the target design model,hypothesis and its scope of application are proposed on the basis of the combination of diseases and syndromes.On the basis of fully considering the dual factors of diseases and syndromes,we distinguished the"centre of the target","middle ring"and"outer ring"through the differences of different signs and symptoms in people with same syndrome,in order to determine the degree of conformity of the syndrome.Then,the population with same syndrome could be analysed according to the"centre of the target","middle ring"and"outer ring",so as to achieve the precise positioning of new Chinese herbal medicines for syndromes,and try to provide research ideas and methods for syndrome differentiation and treatment of TCM and precise intervention.