中医临床疗效评价终点指标选择的思路与方法

分析中医临床疗效评价终点指标选择现状,指出目前存在终点指标的研究较少,终点指标的概念和特点认识不清,终点指标的选择缺乏依据和方法指导等问题。基于终点指标的特点及适用范围,结合中医药复杂干预整体调节的特色,借鉴西医选择终点指标的经验,推荐使用联合指标全面评价临床疗效。针对终点指标具有客观性的特点,主观性选择方法不适合终点指标的选择,且单一选择方法难免存在偏倚,宜结合多种选择方法,如首先采用文献调查法初步筛选,然后借助大规模临床流行病学调查收集数据,最后运用数学模型构建中医药临床疗效评价的终点指标集合。本文通过对终点指标选择思路与方法的探讨,为终点指标的选择提供方法学参考。

Ideas and Methods of Endpoint Selection for Clinical Efficacy Evaluation of Traditional Chinese Medicine

This paper analyzed the present situation of the endpoint selection for clinical efficacy evaluation of traditional Chinese medicine. And also this paper pointed out some problems such as there were few studies on the endpoint,the concept and characteristics of endpoint were not clear,the endpoint selection lacked of evidence and method to guide and so on. In this paper,we recommended to use the combined endpoint to obtain the comprehensive evaluation of clinical efficacy which was based on the characteristics and application scope of the endpoint,referencing the experience from western medicine and combined with the characteristics of complex intervention and whole regulation of Chinese medicine. The endpoint is objective while subjective selection method will inevitably exist bias. So the endpoint should be combined with a variety of selection methods such as:firstly,preliminary selection of literature survey method,and then through the large-scale clinical epidemiological survey to collect data,and finally the use of mathematical models to build the evaluation of the efficacy of traditional Chinese medicine in the endpoint. In this paper,through the discussion on the ideas and methods of the endpoint selection,the author provides a methodological reference for the endpoint selection.