“病证结合”多主要终点评价法在中医药临床研究中的应用

摘要

The development of a scientific evaluation tool is a prerequisite to reflect the efficacy of traditional Chinese medicine (TCM).At present,separate analysis of each outcome is the most commonly used method in randomized controlled trials (RCTs) of TCM,while this method has been reported to have some limitations.Evaluation of multiple primary endpoints which include diseases and symptoms outcomes can reflect the effectiveness of TCM comprehensively and objectively.In recent years,despite the great development of multiple primary endpoints in the field of statistical methods,there are still some challenges in choosing methods,calculating sample size and employing statistical software.In this article,we introduced several multiple primary endpoints evaluation methods,in the expectation of appropriate use of those methods by TCM researchers as well as methodological support for comprehensive assessment of the characteristics and advantages of TCM.%中医药治疗效果需要科学的评价方法彰显.当前单指标评价法不足以全面体现中医药治疗优势,“病证结合”的多主要终点评价法为全面客观显示中医药疗效提供可能.尽管近年来多主要终点评价在统计学方法领域上有较大发展,但在其方法选择、样本量计算、统计软件使用等方面仍有很多挑战.因此本文对几种多主要终点评价方法进行介绍,以期指导中医药临床研究者正确选择和使用多主要终点评价法,为全面评价中医药特色与优势提供方法学支撑.