基于德尔菲法构建中药注射剂上市后再评价指标体系  

Constructing post-marketing re-evaluation indicator system for traditional Chinese medicine injection by Delphi method

作　　者：王绚[1] 张永[1] 许静[1] WANG Xuan;ZHANG Yong;XU Jing(Affiliated Children's Hospital,Nanjing Medical University,Jiangsu Nanjing 210008,China)

机构地区：[1]南京医科大学附属儿童医院,江苏南京210008

出　　处：《中国医院药学杂志》2021年第1期85-88,共4页Chinese Journal of Hospital Pharmacy

基　　金：十三五南京市卫生青年人才培养工程第三层次(编号:QRX17173);南京药学会—常州四药医院药学科研基金(编号:2019YX026)。

摘　　要：目的:拟建立中药注射剂上市后再评价指标体系,完善中药注射剂上市后再评价的基本框架,为推动中药上市后再评价工作提供参考依据。方法:应用德尔菲法,选择与中药注射剂上市后再评价研究相关的来自政府机构、医院、企业、学校及科研机构等行业的专家共40名,进行2轮调查,对上市后再评价指标进行筛选。结果:经两轮调查后专家权威系数平均值为0.87;回收率分别为87.5%、84.3%,表明专家的积极程度较高;一级指标专家协调系数为0.615(P<0.01),二级指标专家协调系数为0.293(P<0.01),表明专家意见对总体指标评价的协调性较好;最终建立8项一级指标,35项二级指标的评价指标体系。结论:所选专家代表性强、权威性高,对指标体系的意见一致性较好,故综合应用德尔菲法是构建中药注射剂上市后再评价指标体系的有效方法,可靠性高,具有一定的推广应用价值。OBJECTIVE To establish and optimize post-marketing re-evaluation indicator system of traditional Chinese medicine injection(TCMI)and provide references for promoting post-marketing evaluations of TCMI.METHODS A two-round Delphi consultation was held for evaluating the index of TCMI post-marketing in establishing the related re-evaluation index system.A total of 40 experts familiar with TCMI post-marketing re-evaluations were assembled from government departments,hospitals,enterprises,universities and research institutions.RESULTS The experts’authority coefficient was 0.87 after two rounds of consultation and the recovery rate of each round was 87.5%and 84.3%respectively.It indicated a high positive degree of experts.The coordination coefficient of experts was 0.615(P<0.01)in first-level indicators and 0.293(P<0.01)in second-level ones,indicating an excellent coordination on overall evaluations of expert opinions.The final evaluation system was comprised of 8 indices in first-level indicators and 35 indices in second-level ones.CONCLUSION All selected experts assume high authority and representativeness and their suggestions have an excellent consistency.The integrated application of Delphi method is both effective and reliable for post-marketing re-evaluation indicator system of TCMI.It is worthy of wider promotions.

关 键 词：德尔菲法 中药注射剂 上市后再评价 指标体系 

分 类 号：R195[医药卫生—卫生统计学]