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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。
Objective: To establish a set of scientific risk assessment index system after listing. Methods: Twenty-one experts in clinical medicine, pharmacy, epidemiology and management who had more than 10 years of associate professorship and senior professional titles were selected. Two rounds of counseling were conducted using the Delphi expert consultation method to screen the indicators. According to the experts The valuation of the indicators, the use of percentage weight method to determine the weight of each indicator. Results: The recovery rates of the two rounds of consultation were 84.62% and 95.45% respectively, and the experts’ authority was 0.74 and 0.75. After two rounds of consultation, the expert coordination coefficient was 0.330, with significant difference (P <0.01) There are 29 indicators of risk assessment index system, including one of the three indicators, two indicators of 26. The weight coefficients of the three first-level indexes of human body, medicine and disease are 0.327 1,0.396 2,0.276 7 respectively. Conclusion: The experts are more representative, more motivated, more authoritative and more coordinated, and initially set up a risk assessment index system after the drug listing.