生脉胶囊治疗慢性充血性心力衰竭临床疗效的多属性综合评价

Synthetical evaluation of the Shengmai capsule’s clinical effect in the chronic congestive heart failure therapy

目的:探讨中药(新药)临床试验研究的临床疗效综合评价方法和技术路线。方法:应用层次分析法(analytic hierarchy process,AHP)与理想点法(technique for order preference by similarity to ideal solution TOPSIS)两种多属性综合评价的方法,通过"生脉胶囊治疗慢性充血性心力衰竭的多中心双盲随机对照临床试验",进行生脉胶囊临床疗效的多属性(多指标)综合评价。结果:生脉胶囊对慢性充血性心力衰竭的临床治疗作用是正向性的,排序结果表明治疗组的临床疗效优于安慰剂组。讨论:可以建立合理的方法和模型来综合评价中药(新药)的临床疗效并为其疗效等级排序。

Objective：Inquiry into the clinical curative effect synthetical evaluation method and technique route of the Chinese herbal medicine（new medicine）clinical trial research.Method：Applying the AHP（analytic hierarchy process）and the TOPSIS（technique for order preference by similarity to ideal solution）two methods of the synthetical evaluation,evaluate the clinical curative effect through＂Double-blind,randomized,placebo-controlled clinical trail＂on Chronic Congestive Heart Failure with Shengmai capsule treatment.Result：Shengmai capsule function is positive.The treatment group’s clinical curative effect is better than placebo group;Discussion：Tthe reasonable method can be established to evaluate the Chinese herbal medicine（new medicine）with stable evaluation model and preface the clinical curative effect and its curative effect grade row.