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应用Delphi法建立药品上市后风险评价指标体系
Study of the Establishment of an Index Evaluation System of the Risk of Post marketing Drugs with Delphi Method
  
DOI:
中文关键词:  Delphi法  药品风险  指标体系
英文关键词:Delphi method  Drug risk  Index system
基金项目:
作者单位
任虹莉 山西医科大学药学院 (太原 030001)
 
李青 山西医科大学第一附属医院药剂科 
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中文摘要:
      摘 要 目的:建立一套科学的药品上市后风险评价指标体系。方法:选择具有副高级及以上职称,相关专业工作10年以上的临床医学、药学、流行病学和管理学专家21名,应用Delphi专家咨询法进行了两轮咨询,对指标进行筛选,根据专家对各指标的赋值情况,运用百分权重法确定各指标的权重。 结果:两轮咨询的回收率分别为84.62%和95.45%,专家权威程度分别为0.74和0.75,经过两轮咨询后,专家协调系数为0.330,差异显著(P<0.01),最终确定药品上市后风险评价指标体系共有指标29项,其中一级指标3项,二级指标26项。其中人体、药物、疾病3项一级指标的权重系数分别为0.327 1、0.396 2、0.276 7。结论:专家的代表性较强、积极性较高、权威性、协调性较好,初步建立了药品上市后风险评价指标体系。
英文摘要:
      ABSTRACT Objective:To build up a set of scientific index evaluation system of the risk of post marketing drugs. Method:A total of 21 experts with professional academic titles of associate position or above engaged in clinical medicine, pharmacology, epidemiology and management for more than ten years were selected. The index system was selected by using the Delphi method and two rounds of expert consultation. According to the evaluation of the experts about each index, the weight of every index was identified at percentage. Result:The response rates of thetwo investigations were 84.62% and 95.45%, respectively. The authority means of the two rounds were 0.74 and 0.75, respectively. After the two investigations, the harmonious coefficient was 0.330 and had its statistic significance (P<0.01). There were 29 indexes remaining in the final index evaluation system of the risk of post-marketing drugs, including 3 indexes at the first grade and 26 at the second grade. The weight coefficients of humans, drugs and diseases in the first grade indexes were 0.327 1, 0.396 2 and 0.276 7, respectively. Conclusion:The enthusiasm, authority and harmony of the experts were good. An initial index system of evaluating the risk of post marketing drugs has been set up.
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