宫铜200宫内节育器因症终止结局的meta分析

A meta-analysis of medical removal of GCu200 intrauterine device

目的运用meta分析方法评价宫铜200宫内节育器(intrauterine device,IUD)的因症终止率,通过与其它含铜IUD的比较,对宫铜200 IUD的安全性进行综合评估。方法采用计算机检索Pub Med、EMBASE、CENTRAL等9种数据库和WHO/FDA/临床试验注册相关网站,纳入宫铜200与其他含铜IUD比较的随机对照试验(randomized controlled trial,RCT),经质量评价后,使用Revman 5.3.3进行meta分析。结果共检索到5 986篇文献,根据纳入及排除标准,最终纳入12篇文献,涉及13 274例观察对象。分析表明:(1)宫铜200的因症终止率与TCu 220 C相比,差异无统计学意义(P>0.05);(2)与TCu 380 A相比,随访1年时宫铜200的因症终止率偏高,但差异无统计学意义[RR 1.75,95%CI(0.86~3.58)];(3)宫铜200的因症终止率高于活性γ型,随访1年时差异有统计学意义[RR 2.37,95%CI(1.62~3.48)]。结论本研究提示宫铜200在安全性方面劣于活性γ型,与TCu 220 C、TCu 380 A尚未见差异,建议尽量避免在月经量较多、有痛经、子宫敏感性较高的妇女中使用宫铜200;考虑到纳入文献时间随访均较短,该结论还需开展多中心长随访时间的RCT加以证实。

Objective To evaluate the medical removal rate of GCu200 intrauterine device （IUD） , and compare GCu200 with other copper- bearing IUDs on safety in order to provide scientific evidence for safe contraception. Methods 9 electronic databases including PubMed, EMBASE, CNKI and Wanfang as well as related websites including Current Controlled MetaRegister, FDA and WHO were searched. All literatures were screened according to the inclusion and exclusion criteria by two reviews, as well as quality assessment and data retrieving. Meta - analysis was conducted by RevMan 5.3.3. Results 5 986 Chinese literatures were preliminarily retrieved, 11 studies were recruited finally, including 12 literatures with 13 274 IUD users. Meta -analysis results demonstrate that ① Compared with TCu220C, the difference of medical removal rate was not statistically significant; ② Compared with TCu380A, GCu200 had a high rate of medical removal at 1 year follow - up, but the difference was not statistically significant [ RR 1.75, 95%CI（0. 86 -3.58） ] ; ③ The medical removal rate of GCu200 was higher than that of Active - γ, and the difference was statistically significant at 1 year follow - up[ RR 2. 37,95% CI（ 1.62 - 3.48 ） ]. Conclusion GCu200 in terms of safety is inferior to the Active-γ, and has no difference to TCu220C and TCn380A. It is recommended to avoid using GCu200 in women with more menstrual flow, dysmenorrheal and uterine sensitivity ; Considering that the time of follow - up in the literatures were short, larger and long period muhicenter randomized comparative trials are needed to provide evidence.