宫铜300宫内节育器副反应及其影响因素的Meta分析  

A Meta-Analysis of the Association between the Side-Effect and Its Influence Factors of GCu300

作　　者：巴磊[1] 孙志明[1] 张学宁[1] 许豪勤 王冠融 

机构地区：[1]江苏省计划生育科学技术研究所国家卫计委计划生育药具不良反应监测中心,江苏南京210036

出　　处：《实用妇产科杂志》2017年第7期525-529,共5页Journal of Practical Obstetrics and Gynecology

基　　金：美国中华医学基金会(CMB)"中国卫生技术评估联合项目"开放基金课题(编号:13-153);江苏省计划生育科研所启动基金项目(编号:JSFP2014003)

摘　　要：目的:通过Meta分析方法评价使用宫铜300宫内节育器(IUD)副反应发生情况及其相关影响因素,为安全使用提供科学依据。方法:利用计算机检索Pub Med、Embase、Central等9种数据库和世界卫生组织(WHO)、美国食品药品监督管理局(FDA)、IUD生产企业、临床试验注册相关网站,采用Openmeta analyst软件对数据进行分析与合并。结果:共检索到6062篇文献,根据纳入及排除标准,最终纳入涉及宫铜300 IUD副反应的文献12篇,均为RCT或准RCT,共计8666例观察对象,其中宫铜300 IUD组3611例。Mtea分析表明,出血与疼痛的发生率均随使用时间延长呈现下降趋势。人工流产术后即时放置组,在放置后3个月和6个月时,出血的发生率[45.0%(95%CI 35.2~54.8)和34.0%(95%CI 24.7~43.3)]均显著高于正常月经间期放置组[21.2%(95%CI 15.0~27.3)和17.6%(95%CI 11.9~23.4)](P<0.05);城市组在放置后6个月出血发生率[20.9%(95%CI 8.5~33.4)]显著高于农村组[7.0%(95%CI 5.7~8.4)](P<0.05)。结论:宫铜300 IUD放置初期应关注出血的处理,若为人工流产后即时放置的对象还应加强后期随访。Objective：Meta-analysis method was used to evaluate the side-effect rate of GCu300 IUD and re- lated influence factors, providing scientific evidence for safe use of IUD. Methods：English databases including PubMed, Embase, Central, websites including Current Controlled Meta Register, FDA, WHO and related enterpri- ses,and Chinese databases including CBMdisc, CMCI, CNKI, VIP and Wanfang were searched. Software of Open-meta analyst was used to analyse and incorporate data. Results： A total of 6062 Chinese and English litera- tures were searched preliminarily,of which only 12 RCTs and quasi-RCTs of GCu300 were recruited for further a- nalysis according to the inclusion and exclusion criteria. There were a total of 8666 women, including 3611 IUD us- ers in GCu300 group. With the increase of time of GCu300 IUD using, the bleeding and pain rate of GCu300 showed a downward trend. The bleeding rate of GCu300 IUD inserted immediately after artificial abortion [45.0% （95% CI 35.2 -54.8）and 34.0% （95%CI 24.7 -43.3） ] was significantly higher than that during the intermen- strual period[21.2% （95%CI 15.0 -27. 3）and 17.6% （95%CI 11.9 -23. 4） 1 at third month and sixth month follow-up（ P 〈 0.05）. At sixth month follow-up, statistical significante differences between urban [ 20.9% （95% CI 8.5 -33.4） land ruralET. 0% （95%CI 5.7 -8. 4） ]was found on the bleeding rate（P〈0.05）. Conclusions：Cli- nician should pay attention to bleeding in the early stage after GCu300 placement and should strengthen follow-up for women inserted IUD immediately after artificial abortion.

关 键 词：META分析 宫铜300 宫内节育器 副反应 

分 类 号：R169.41[医药卫生—公共卫生与预防医学]