应用Delphi法建立抗慢性乙型肝炎类药品上市后评价指标体系

Establishment of an Index Evaluation System of the Anti-chronic Hepatitis B Drugs of Post-marketing with Delphi Method

目的:建立一套科学的抗慢性乙型肝炎类药品上市后评价指标体系,为开展抗慢性乙型肝炎类药品上市后再评价提供借鉴。方法:选择陕西省具有副高级及以上职称,在临床医学、药学、传染病学、流行病学和药事管理学等专业工作10年以上的专家50名,应用Delphi法进行两轮专家咨询,对指标进行筛选,根据专家对各指表的赋值情况,运用百分权重法确定各指标权重。结果:两轮调查专家权威系数较高,都在0.7以上;两轮咨询的回收率分别为80%和90%,表明专家积极程度较高;两轮调查专家协调系数分别为0.231,0.314,差异有统计学意义(P<0.01),表明专家对所有指标的协调性好,调查结果可取。最终确立7项一级指标,21项二级指标评价体系。结论:专家代表性较强、积极性较高、权威性、协调性较好,初步建立抗慢性乙型肝炎类药品上市后再评价指标体系。

Objective： To build up a set of scientific index evaluation system of the anti-chronic hepatitis B drugs of post-marketing and provide reference for carrying out reevaluation of the anti-chronic hepatitis B drugs of post-marketing. Methods：A total of 50 experts from Shaanxi province with professional academic titles of associate position or above en- gaged 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 indentifiod at percentage. Results ：The expert~ authority coefficient was over 0.7 after two rounds of consultation. The response rates of the two investigation were 80% and 90%, respective- ly, which showed high positive degree of experts. The harmonious coefficient were 0.213 and 0.314, respectively, and had its statistic significance （P 〈 0.01 ）. It explained expertsPopinion on the coordination of the overall evaluation bad good in- dication and the findings were advisable. There were 28 index remaining in the final index evaluation system, including 7 index at the first grade and 21 at the second grade. Conclusion：The enthusiasm, authority and harmony of the experts were good. An index evaluation system of the anti-chronic hepatitis B drugs of post-marketing has been set up.