人工流产术后即时放置三种宫内节育器的多中心随机对照研究  

A multi-center randomized controlled trial of three types of intrauterine device inserted immediately after vacuum aspiration

机构地区：[1]宫内节育器失败原因及预防技术对策的研究课题组

出　　处：《中华妇产科杂志》2010年第6期434-439,共6页Chinese Journal of Obstetrics and Gynecology

基　　金：基金项目：“十五”国家科技攻关计划（2004BA720A31）

摘　　要：目的 了解3种常用宫内节育器（IUD）在人工流产术后即时放置的临床效果和安全性.方法 通过前瞻性随机对照临床研究,对来自全国7个省市的12个协作中心的1800例研究对象于人工流产术后即时放置IUD,放置的IUD类型分为宫形含铜IUD宫铜200、T形含铜IUDTCu380A和活性γ型IUD 3种,每种分别观察600例,并随访12个月.结果 1798例完成了使用12个月的随访,2例失访（失访率为0.11%,2/1800）;17例不符合纳入标准的未产妇资料在进行数据统计分析时被剔除.3种IUD使用者均未发生妊娠（或带器妊娠）,且均无子宫穿孔、IUD异位等并发症发生.活性γ型IUD的医疗原因终止率为1.02/百妇女年,低于宫铜200、TCu380A（分别为3.60/百妇女年、2.25/百妇女年）,3者比较,差异有统计学意义（P=0.015）.宫铜200、TCu380A和活性.y型IUD中,与IUD使用相关的终止率分别为7.58/百妇女年、7.30/百妇女年和3.72/百妇女年,3者比较,差异有统计学意义（P=0.008）.结论 人工流产术后即时放置宫铜200、TCu380A和活性γ型IUD的避孕效果均良好,均安全可行,尤其是国产活性γ型IUD,值得推广.Objective To compare the safety and effectiveness of three types intrauterine device（IUD） insertion immediately after vacuum aspiration, and to provide evidence for women fulfilling contraception and reducing repeat abortion. Methods A multi-center randomized controlled clinical trial was performed in 12 medical institutions or family planning service stations located in China. Total 1800 eligible women were inserted G-Cu200, TCu380A or active γ-IUD randomly after vacuum aspiration immediately,and they were followed up for 12 months. Results Except for 2 cases who dropped out （ loss rate is 0.11%,2/1800） and 17 cases who didn＇t match the including standard, the data of 1781 cases was analyzed. No any uterine perforation or ectopic IUD was found. During followed up 12 months, there was also no any pregnancy or pregnancy with IUD in situ occurred in the three groups. The medical removal rate for bleeding or （and） pain of active γ-IUD was the lowest （1.02/hundred women year） among three groups, and there were significant difference （P =0.015 ）. The rate of expulsion rate and discontinuation rate of active γ-IUD was 2.73/hundred women year, which was also the lowest among the three IUD, but there was no significantly statistical difference （ P 〉 0.05 ）. Conclusions The results showed that there are perfect clinical safety and effectiveness for three types of IUD immediately after vacuum aspiration. Active γ-IUD is superior to other two types IUD for its low medical removal rate which may be worthy to use widely immediately after vacuum aspiration.

关 键 词：宫内避孕器 随机对照试验 流产 人工 

分 类 号：R169.4[医药卫生—公共卫生与预防医学]