中医临床疗效评价替代指标的替代机制研究思路

Thought about research on the substitution mechanism of surrogate end point for traditional Chinese medicine clinical efficacy evaluation

通过对中医临床疗效评价替代指标应用的现状分析,强调只有构建中医临床疗效评价替代指标的替代机制,才能使替代指标有更高的信度、效度和反应度。文章基于前期研究,根据优选替代指标的数据类型和特征,结合临床实践,选取贝叶斯网络模型探讨替代指标与终点事件的因果关系,采用概率定量来表示因果关系的强度,并纳入相加模型分析替代指标间的协同关系,以慢性心力衰竭为例,探讨构建慢性心力衰竭中医临床疗效评价替代指标的替代机制。

Through the analysis of the status quo of surrogate end points for clinical efficacy evaluation of traditional Chinese medicine,it is emphasized that only by constructing an substitute mechanism for surrogate end points of clinical efficacy evaluation of traditional Chinese medicine,can the surrogate end points have higher reliability,validity and responsiveness.Based on the previous research,according to the data types and characteristics of the preferred surrogate end points,and combined with clinical practice,this paper selects the Bayesian network model to explore the causal relationship between the surrogate end points and the end-point event,and uses probabilistic quantification to express the strength of the causal relationship.The additive model analyzes the synergistic relationship between the surrogate end points.Take chronic heart failure as an example,in order to construct a substitution mechanism of surrogate end points for clinical efficacy evaluation of chronic heart failure in traditional Chinese medicine.