宫内节育器风险评价指标体系及综合评价方法研究  

A Study on Risk Evaluation Indicator System and Comprehensive Evaluation Method for Intrauterine Device

作　　者：李玲[1] 文进[2] 李幼平[1] 李瑛[3,4] 王莉[1] 高霑[1] 成岚[1] 袁强[1] 

机构地区：[1]四川大学华西医院中国循证医学中心,成都610041 [2]四川大学华西医院医院管理与卫生政策教研室,成都610041 [3]国家人口计生委计划生育药具不良反应监测中心,南京210036 [4]江苏省计划生育科学技术研究所,南京210036

出　　处：《中国循证医学杂志》2011年第7期753-762,共10页Chinese Journal of Evidence-based Medicine

基　　金："十一五"国家科技支撑计划课题"避孕药具上市后监测和风险再评价研究"(编号:2006BAI15B07)

摘　　要：目的建立宫内节育器(IUD)风险评价指标体系,确定各指标的权重,并根据客观数据采用多种综合评价方法评价常用IUD的风险,为政府采购决策提供参考依据。方法通过复习国内外文献、长期监测、大样本随机对照试验(RCT)和两轮Delphi专家咨询,构建IUD风险评价指标体系;通过主观评分法和CRITIC客观赋权法共同确定各指标权重;利用建立的指标体系和原始研究(大样本多中心RCT)、二次研究数据(文献报道数据),分别采用层次分析法(AHP)、TOPSIS和综合评分法评价IUD的风险,综合3种方法和评估结果,得出各种IUD的综合排名。结果成功建立两级IUD风险评价指标,其中7个一级指标分别为非意愿妊娠、脱落、月经问题、疼痛、IUD异位、位置和形状改变及其它健康问题,二级指标共26个。通过主、客观赋权法,确定的一级指标权重分别为0.1475、0.1443、0.1407、0.1748、0.1632、0.1328和0.0966。用所建立的指标体系综合评价多中心RCT中TCu380A、MLCu375和元宫365三种IUD的风险,AHP、TOPSIS和综合评分法均表明,三种IUD中,元宫365风险最小,其次是TCu380A和MLCu375,使用三种综合评价方法评价文献中报道的14种节育器的风险,三种方法的组合结果显示活性γ型IUD风险最小,HCu280、元宫365、Gyne IUD次之,药铜环165风险最大。结论本研究所建立的IUD风险评估指标体系覆盖面广,有一定的代表性和可信度;所确定的指标权重系数方法科学、考虑全面、结果较准确;各种评价方法的评价结果基本一致。活性γ型IUD和HCu280已进入2009版计划生育避孕药具政府采购目录,若IUD价格合理,建议将元宫365和Gyne IUD纳入国家采购目录,以供育龄妇女多方面循证知情选择。Objective To establish a risk evaluation indicator system for intrauterine device（IUD）,to determine the weight of indicators,to comprehensively evaluate the risk of IUDs by using a variety of comprehensive evaluation methods according to the data of IUDs,so as to provide references for the government purchasing decision-making.Methods The literature review,long-term monitoring of IUD adverse events,large sample randomized controlled trials（RCTs） and Delphi methods were applied to establish the risk evaluation indicator system for IUD.The weight of each indicator was determined by jointly using the subjective scoring method and CRITIC method.Based on the established indicator system,primary research（RCT） data and secondary research data（literature data）,the analytic hierarchy process（AHP）,technique for order preference by similarity to ideal solution（TOPSIS） and synthetical scored method were used to assess the risk of IUDs respectively,and then the assessment results of three methods were integrated to obtain a comprehensive rank of various IUDs.Results A two-level risk evaluation indicator system for IUD was established and the seven 1st level indicators included unwanted pregnancy,expulsion,menstruation problems,pain,IUD ectopia,position and shape changes as well as total health problems,which were divided into 26 2nd level indicators.Through the subjective and objective weighting method,the weights of each 1st level indicator were 0.147 5,0.144 3,0.140 7,0.174 8,0.163 2,0.132 8,and 0.096 6,respectively.The risk evaluation of the above three methods showed that among the three kinds of IUD in a multicenter RCT,yuangong365 was with the lowest risk,followed by TCu380A and MLCu375.The risk evaluation showed that among the 14 kinds of IUD from literatures,medicated γ IUD was with the lowest risk,followed by HCu280,yuangong365,and Gyne IUD,while the medicated stainless steel ring 165 was with the highest risk.Conclusion The established indicator system has a good representation and credibili

关 键 词：宫内节育器 风险评价 指标体系 综合评价 

分 类 号：R169.4[医药卫生—公共卫生与预防医学]