国际生殖健康/计划生育杂志

国际生殖健康/计划生育 ›› 2018, Vol. 37 ›› Issue (6): 467-473.

• 论著 • 上一篇    下一篇

不同时期放置宫铜200宫内节育器副反应的Meta分析

周健，杨月华，孙志明，张学宁，施雯慧，陈颖，许豪勤   

  1. 210036  南京，江苏省计划生育科学技术研究所，国家卫生计生委计划生育药具不良反应监测中心
  • 收稿日期:2018-09-12 修回日期:2018-10-16 出版日期:2018-11-15 发布日期:2018-11-15
  • 通讯作者: 许豪勤，E-mail：1325825613@qq.com E-mail:jsjss277@aliyun.com
  • 基金资助:
    江苏省青年医学重点人才项目（QNRC2016556）；江苏省卫生计生委科研课题（Q201603）；江苏省妇幼健康重点学科项目（FXK55）；国家卫生计生委卫生技术评估重点实验室开放基金课题（FHTA2017-06）

A Meta-analysis of Side Effects of GCu200 Intrauterine Device in Different Periods of Insertion

ZHOU Jian，YANG Yue-hua，SUN Zhi-ming，ZHANG Xue-ning，SHI Wen-hui，CHEN Ying，XU Hao-qin   

  1.  Jiangsu Institute of Planned Parenthood Research，NHFPC Contraceptives Adverse Reaction Monitoring Center，Nanjing Jiangsu 210036，China
  • Received:2018-09-12 Revised:2018-10-16 Published:2018-11-15 Online:2018-11-15
  • Contact: XU Hao-qin，E-mail：1325825613@qq.com E-mail:jsjss277@aliyun.com

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摘要： 目的：运用Meta分析评价不同时期放置宫铜200宫内节育器（intrauterine device，IUD）的副反应发生率，为安全避孕提供依据。方法：计算机检索PubMed、EMBASE、CENTRAL等9种数据库和世界卫生组织/美国食品药品监督管理局/临床试验注册中心（WHO/FDA/ClinicalTrials）等相关网站，经质量评价后，采用Open Meta-Analyst软件进行合并分析。结果：共检索到6 864篇文献，根据纳入及排除标准，最终纳入10篇文献，均为随机对照试验（randomized controlled trial，RCT）或准RCT（quasi-RCT）。放置宫铜200 IUD后出血与疼痛的发生率均随使用时间的延长而呈现下降趋势；而感染发生率在使用后的12个月内无差异，至24个月时明显较低。放置宫铜200 IUD后不同随访时间，哺乳期放置组出血发生率低于月经间期放置组和人工流产术后即时放置组，差异均有统计学意义（P＜0.05），而疼痛和感染发生率的差异均无统计学意义（P＞0.05）。结论：出血是使用宫铜200 IUD的主要副反应，放置IUD后应加强随访，尤其是对宫铜200 IUD使用者应加强使用初期出血的防治，以减少因症取出率。哺乳期放置出血发生率更少，建议选择哺乳期放置。考虑到不同放置时期放置宫铜200 IUD比较的纳入文献较少，该结论还需开展高质量的真实世界研究加以佐证。

关键词: 宫内节育器, 铜, 副反应, 随访研究, Meta分析

Abstract: Objective：To evaluate the rate of side effects of GCu200 intrauterine device (IUD) in different periods of insertion, as the safety reference of contraception. Methods：Nine electronic databases including PubMed, EMBASE and CENTRAL, as well as related websites including WHO, FDA and ClinicalTrials, were searched. All literatures were screened according to the inclusion and exclusion criteria by two reviewers. Meta-analysis was conducted using Open Meta-Analyst software. Results：6 864 Chinese literatures were preliminarily retrieved, 10 RCT or quasi-RCT studies were recruited finally. Meta-analysis demonstrated that the rates bleeding and pain were gradually decreased as time went on, and that the infection rate was insignificantly changed within 12 months. At 24 months, the total rate of those side effects was actually very low. The bleeding rate of GCu200 in lactation period insertion was significantly lower than that in intermenstrual period or post-abortion period insertion (P＜0.05), while there were no significant differences in the rates of pain and infection (both P＞0.05). Conclusions：Bleeding was the main side effect in the use of GCu200. Since the insertion during lactation period had lower bleeding rate, this insertion period should be recommended if possible. The follow-up should be strengthened, and the early bleeding after the insertion of GCu200 should be prevented and treated especially, so as to reduce the removal due to side effects.

Key words: Intrauterine devices, copper, Side effects, Follow-up studies, Meta-analysis