中医临床疗效评价替代指标的选择思路与方法

Thoughts and methods for selecting alternative indicators for efficacy evaluation of TCM clinic

针对中医临床疗效评价替代指标的应用现状,指出当前替代指标应用存在的问题,阐明替代指标的选择思路应该基于中医临床真实世界的终点事件和疾病复杂的病理机制,结合中医药"整体调节"和"复杂干预"的特点,综合考虑替代指标的客观性、敏感性、经济性以及易获取性。采用文献调查法构建中医临床疗效评价替代指标集;开展巢式病例对照研究,建立中医临床疗效评价替代指标与终点指标数据库;运用Cox、Logistic回归模型优选替代指标,相关性强的替代指标综合成为一个替代指标集,为中医临床疗效评价替代指标的选择提供方法学参考。

This article analyzes the current status of the application of alternative indicators in TCM clinic,and points out the current problems in the application of alternative indicators.The selection of alternative indicators should be based on the real-world outcomes of traditional Chinese medicine(TCM)clinical practice and the complex pathological mechanisms of the disease,combine with the characteristics of’overall adjustment’and’complex intervention’of TCM,and consider of the objectivity,sensitivity,economy,economics,and easy accessibility.In this article,the literature survey method is used to collect alternative indicators;the nested case-control study is conducted to establish a database of alternative indicators and outcome indicators;the Cox and Logistic regression models are applied to select alternative indicators.Then the relevant alternative indicators are integrated into a substitute indicator aggregate.This study aims to provide a methodological reference for the selection of alternative indicators in clinical efficacy evaluation of TCM.