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 assessment index system for intrauterine devices (IUDs) and determine the weight of each index, and evaluate the risk of common IUDs by various comprehensive evaluation methods based on objective data to provide a reference for government procurement decision-making. Methods The IUD risk assessment index system was constructed by reviewing literature, long-term monitoring, large sample randomized controlled trials (RCTs) and two rounds of Delphi expert consultation. Weight of each index was determined by subjective scoring method and CRITIC objective weighting method. (RCT) and secondary research data (reported in the literature) were used to evaluate the risk of IUD by AHP, TOPSIS and comprehensive score respectively. Based on the three methods and the evaluation results , Come to a comprehensive ranking of various IUD. Results Two levels of IUD risk assessment indicators were successfully established. Seven of the seven primary indicators were unwanted pregnancy, shedding, menstrual problems, pain, IUD ectopic, location and shape changes, and other health problems. Twenty-six secondary indicators were included. Through the primary and objective weighting method, the weights of the first-level indicators are respectively 0.1475, 0.1644, 0.1407, 0.1748, 0.1632, 0.1328 and 0.0966. The risk of TCu380A, MLCu375 and Yuangong 365 three kinds of IUDs in multi-center RCT were evaluated comprehensively by using the established index system. AHP, TOPSIS and comprehensive score method all showed that the three types of IUDs had the lowest risk of Yuangong 365, followed by TCu380A and MLCu375 evaluated the risk of 14 types of IUDs reported in the literature by using three comprehensive evaluation methods. The combination of the three methods showed the least risk of active type IUD, HCu280, MG365, Gyne IUD, maximum. Conclusion The IUD risk assessment index system established in this study has a wide range of coverage, a certain degree of representation and credibility; the index weight coefficient is determined scientifically and comprehensively and the results are accurate; the evaluation results of the various evaluation methods are basically the same. Active γ-type IUD and HCu280 have entered the 2009 version of family planning contraceptives government procurement directory, if the IUD price is reasonable, it is recommended Yuan Palace 365 and Gyne IUD included in the national procurement directory for women of childbearing age more evidence-based informed choice.