缺血性脑卒中中成药综合评价指标体系构建研究

A study on the construction of the comprehensive evaluation indicator system of Chinese patent medicines for ischemic stroke

目的建立缺血性脑卒中中成药综合评价指标体系,确定体系内各指标权重,为中成药有效性、安全性和经济性综合评价提供参考依据。方法通过两轮Delphi专家咨询构建缺血性脑卒中中成药综合评价指标体系,并采用层次分析法赋予各级指标权重。结果两轮咨询的专家积极系数分别是92.59%和96.00%,专家权威系数均大于0.70,总体指标的专家协调系数分别是0.224和0.370(P<0.001)。建立了缺血性脑卒中中成药综合评价三级指标体系,其中一级指标3个,分别是有效性、安全性和经济性,二级指标15个,三级指标33个。采用层次分析法确定的一级指标权重分别为0.6264、0.3012和0.0724。结论本研究建立了缺血性脑卒中中成药有效性、安全性和经济性综合评价指标体系,为综合评价治疗缺血性脑卒中中成药提供了基础和依据。该指标体系对缺血性脑卒中临床试验设计、系统评价开展、临床实践指南制订等如何选择结局指标均具有重要意义。

Objective To construct the comprehensive evaluation indicator system of Chinese patent medicines for ischemic stroke,to determine the weight of indicators,and to provide references for the comprehensive evaluation of the efficacy,safety,and economy of Chinese patent medicines.Methods Two rounds of expert consultation by Delphi method were applied to establish the comprehensive evaluation indicator system of Chinese patent medicines for ischemic stroke,and the weight of each indicator was determined by the analytic hierarchy process method.Results Questionnaire recovery rates of 2 rounds were 92.59% and 96.00%,the expert authority coefficient was greater than 0.7,and the coordination coefficients of experts in the total index were 0.224 and 0.370(P<0.001).A three-level comprehensive evaluation indicator system for Chinese patent medicines for ischemic stroke was established and the three first-level indicators included efficacy,safety,and economy.And there were 15 second-level indicators,and 33 third-level indicators.Through the analytic hierarchy process method,the weights of each first-level indicator were 0.6264,0.3012,and 0.0724,respectively.Conclusion The comprehensive evaluation indicator system contains efficacy,safety and economy,and provides a basis for a comprehensive evaluation of Chinese patent medicines for ischemic stroke.The indicator system is of great significance for the design of outcomes for clinical trials of ischemic stroke,the conduction of systematic reviews,and the development of clinical practice guidelines for ischemic stroke patients when selecting study outcomes.