宫铜200宫内节育器意外妊娠发生率的meta分析

A meta-analysis of unwanted pregnancy rate of intrauterine device GCu200

目的运用meta分析方法评价宫铜200宫内节育器(intrauterine derice,IUD)妊娠率及其影响因素,通过与其它含铜IUD比较,对宫铜200有效性进行综合评估。方法通过计算机检索Pub Med、EMBASE、CENTRAL等9种数据库和WHO/FDA/IUD生产企业/临床试验注册相关网站,使用Open Metaanalyst和Rev Man 5.3.3进行数据分析与合并。结果共检索到5 986篇文献,根据纳入及排除标准,最终纳入14篇文献,均为随机对照试验(randomized controlled trial,RCT)或准RCT。分析结果显示:(1)宫铜200放置12、24和36个月时妊娠率分别为0.2%(95%CI:0%,0.3%)、1.8%(95%CI:0.3%,3.2%)、2.1%(95%CI:0.7%,3.5%)。(2)月经间期、人流术后即时、哺乳期等不同时期放置宫铜200 IUD 1年时妊娠率间未见差异有统计学意义(P>0.05)。(3)放置1年时宫铜200妊娠发生率显著低于TCu 220 C(P<0.05),放置2年时宫铜200妊娠率显著高于元宫220(P<0.05);放置3年时宫铜200妊娠率显著低于活性165(P<0.05)。与TCu 380 A、母体乐250、宫铜300、活性γ型、MCu功能型等IUD比较,在不同放置时间的宫铜200妊娠率未发现差异有统计学意义(P>0.05)。结论宫铜200妊娠率与其他类型IUD妊娠率相似。

Objectives To evaluate the pregnancy rate of IUD GCu200 and its influence factors by comparing with other copper -bearing IUDs, and to assess the efficacy of IUD GCu200 comprehensively. Methods 9 electronic databases such as PubMed, EMBASE, CENTRAL and several related websites such as Clinical - Trials, Current Controlled MetaRegister, Chinese clinical trial registry, WHO and FDA were searched. Analysis were conducted by Open Meta - analyst and RevMan 5.3.3. Results 5 986 literatures were searched preliminarily, a total of 14 RCTs and quasi RCTs studies of IUD GCu200 were recruited according to the inclusion and exclusion criteria. The results showed that：① The pregnancy rate of GCu200 was 0. 2% （95%CI：0% , 0. 3% ）, 1.8% （95% CI：0. 3%, 3.2% ）, 2. 1% （95% CI：0. 7%, 3.5% ） at 1 year, 2 years and 3 years follow - up separately. ② There was no significant difference in pregnancy rates of GCu200 among insertion after spontaneous abortion, during interval and lactation period. ③ The pregnancy rate of GCu200 was significantly lower than that of TCu220C at 1 year follow - up （ P 〈 0.05 ） and lower than active - 165 at 3 years follow - up（ P 〈 0. 05 ）, but higher than YuanGong220 at 2 years follow - up（ P 〈 0.05 ）. While compared to TCu380A, MLCu250, GCu300, active -γ and MCu, there was no significant difference in any term of insertion. Conclusions The efficacy of GCu200 for contraception is similar as other copper- bearing IUDs.