证候类中药新药临床评价方法的思考

临床疗效评价是证候类中药新药研发的重要环节和难点所在。本文在回顾现有临床疗效评价方法的基础上,针对中药新药临床评价中遇到的问题,探讨在证病结合的模式下证候类中药新药临床疗效的评价方法。主要围绕证候评价与疾病评价的关系,疗效评价指标的设定,证候评价方法如四级标准法、量表法的使用,以及自评、他评模式的结合运用,疗程的设置、安全性指标的选择等问题进行探讨。

Thoughts on the Clinical Evaluation Methodology of New Medicine of Syndrome TCM

Clinical curative effect evaluation is an important and difficult part for the research of new medicine of syndrome TCM.Based on the review of existing clinical curative effect evaluation methods,we explore the new method in the mode of disease combined with syndrome.We mainly include the relationship between syndrome evaluation and disease evaluation,the setting of the curative effect e-valuation index,the use of syndrome evaluation methods such as 4 level standard method and scale,the combination of self-evaluation and other-evaluation,the setting of treatment period,the choice of safety indicators and so on.