中国妇女使用宫内节育器的多中心随机对照研究

A multi-center randomized controlled trial of intrauterine device use in Chinese women

目的 通过母体乐-375、TCu380A和元宫-365 3种宫内节育器（IUD）的大样本上市后多中心随机对照试验,评价中国妇女使用IUD的安全性和有效性,为我国IUD荐优汰劣提供参考依据.方法 应用多中心随机对照临床试验对24 000例健康已婚育龄妇女进行健康筛查,采用分层区组随机分配3种IUD；在置器后的1～3、6、12个月进行随访,观察IUD的使用终止率.结果 3种IUD 1年的总终止率不同,元宫-365 IUD最低,为4.21％；TCu380A其次,为8.42％；母体乐-375最高,为13.91％（P＜0.01）；3种IUD 1年的意外妊娠发生率、脱落率、出血终止率和下移取出率均有差异.使用母体乐-375、有不良反应无医学处理、随访次数少、宫腔较深、IUD失败后再次使用是使用终止的高风险因素.结论元宫-365 IUD是发生终止风险最小的IUD种类；规范随访,及时处理不良反应可较大程度地减少发生终止的风险.

： Objective To assess the safety and effectiveness of intrauterine device in Chinese women.Methods In this multicenter randomized controlled trial,a total of 24 000 women were randomly （1∶1∶ 1）into 3 groups of Yuangong Cu 365（YCu365）,Copper T 380A（TCu380A）and Multiload Cu 375 （MLCu375）.Clinical outcomes were assessed at 12 months post-insertion,including discontinuation due to pregnancy,expulsion,hemorrhage and downward displacement,etc.The overall and causal-specific discontinuation rates for adverse events were calculated.Results At the end of the first year,the discontinuation rate of YCu365（4.21%）was the lowest,followed by TCu380A（8.42%）and MLCu375 （13.91%）（P 〈0.01）.The differences of discontinuation rates for pregnancy,expulsion,hemorrhage and downward displacement between these IUDs were also significant.MLCu375,side effect without medical treatment,fewer follow-ups,deeper uterine cavity and previous IUD failure were significantly associated with an increased risk of IUD discontinuation.Conclusion The newly developed indomethacin-releasing YCu365 IUD appears to perform the best.However,its long-term safety and cost-effectiveness should be further evaluated.