国际生殖健康/计划生育杂志

国际生殖健康/计划生育 ›› 2016, Vol. 35 ›› Issue (5): 375-382.

• 论著 • 上一篇    下一篇

宫铜300 和MCu功能型宫内节育器有效性、安全性的系统评估

张敏，孙志明，张学宁，杨月华，许豪勤   

  1. 210036 南京，国家人口计生委计划生育药具不良反应监测中心，江苏省计划生育科学技术研究所
  • 收稿日期:1900-01-01 修回日期:1900-01-01 出版日期:2016-10-25 发布日期:2016-10-25
  • 通讯作者: 孙志明

Systemic Evaluation on the Efficacy and Safety of GT300 and MCu110

ZHANG Min，SUN Zhi-ming，ZHANG Xue-ning，YANG Yue-hua，XU Hao-qin   

  1. State Contraceptive Adverse reaction Surveillance Center，Jiangsu Institute of Planned Parenthood Research，Nanjing 210036，China
  • Received:1900-01-01 Revised:1900-01-01 Published:2016-10-25 Online:2016-10-25
  • Contact: SUN Zhi-ming

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摘要： 目的：系统评价宫铜300与MCu功能型宫内节育器（IUD）的有效性、安全性及可接受性。方法：通过文献检索PubMed、EMBASE、CENTRAL、POPLINE、中国生物医学文献数据库（CBMdisc）、中国生物医学期刊引文数据库（CMCI）、中国知网（CNKI）、维普全文数据库（VIP）、万方数据库（Wanfang）9种数据库收集宫铜300与MCu功能型IUD比较的相关文献，根据循证医学的纳入与排除标准筛选出符合要求的随机对照试验（RCT）。采用Revman 5.3.3软件进行数据的分析与合并。结果：共筛选出3篇相关文献。评估结果显示，在随访第12个月和第24个月宫铜300妊娠率高于MCu功能型IUD（RR=3.33，95%CI：1.35～8.25，RR=3.00，95%CI：1.28～7.01）。在随访第6，12，24个月宫铜300脱落率高于MCu功能型IUD（RR=6.00，95%CI：1.77～20.30；RR=5.55，95%CI：5.25～13.68；RR=3.75，95%CI：1.73～8.12）。在随访第6，12，24个月宫铜300不良反应发生率（包括白带增多、出血、疼痛）均高于MCu功能型IUD（均P＜0.05）。在随访第6，12，24个月宫铜300因症终止率高于MCu功能型IUD（RR=3.33，95%CI：1.35～8.25；RR=2.31，95%CI：1.21～4.39；RR=2.65，95%CI：1.60～4.38）。在随访第3，6，12，24个月宫铜300续用率低于MCu功能型IUD（RR=0.12，95%CI：0.01～0.96；RR=0.21，95%CI：0.10～0.41；RR=0.27，95%CI：0.17～0.44；RR=0.32，95%CI：0.22～0.46）。结论：与MCu功能型IUD相比较，能够证实宫铜300的有效性、安全性及可接受性的多中心RCT很少，尤其是缺少长期随访研究；故仍需开展大样本、多中心、方法科学和规范的高质量的RCT，以进一步验证两种IUD的安全性、有效性及可接受性。

关键词: 宫内避孕器, 铜, 避孕器械, 女用, Meta分析, 宫铜300, MCu功能型

Abstract: Objective: To evaluate the efficacy, safety and acceptability of GT300 and MCu intrauterine device（ＩＵＤ）. Methods：Databases including PubMed, EMBASE, CENTRAL, POPLINE, CBMdisc, CMCI, CNKI, VIP and Wanfang and websites including the Clinical Trials were used to search in this study. The inclusion and exclusion criteria were set according to the PICO-S principle. The meta-analysis was performed by the Revman 5.3.3 software. Results：Three articles matched to the criteria were recruited for meta-analysis. Within the 12 months and 24 months follow-up, the pregnant rate of GT300 IUD was significant higher than that of MCu IUD （RR=3.33，95%CI：1.35-8.25，RR=3.00，95%CI：1.28-7.01）. Within the 6 months, 12 months and 24 months follow-up, the expulsion rate of GT300 IUD was significant higher than that of MCu IUD （RR=6.00，95%CI：1.77-20.30；RR=5.55，95%CI：5.25-13.68；RR=3.75，95%CI：1.73-8.12). Within the 6 months, 12 months and 24 months follow-up, the rate of side effects of GT300 IUD（including bleeding, pain, and the occurrence of leucorrhea） was significant higher than that of MCu IUD（P＜0.05）. Within the 6 months, 12 months and 24 months follow-up, the rate of medical remove of GT300 IUD was significant higher than that of MCu IUD（RR=3.33，95%CI：1.35-8.25；RR=2.31，95%CI：1.21-4.39；RR=2.65，95%CI：1.60-4.38). Within the 3 months, 6 months, 12 months and 24 months follow-up, the continuation rate of GT300 was significant lower than that of MCu IUD（RR=0.12，95%CI：0.01-0.96；RR=0.21，95%CI：0.10-0.41；RR=0.27，95%CI：0.17-0.44；RR=0.32，95%CI: 0.22-0.46）. Conclusions：There are few RCT studies to assess the efficacy, safety and acceptability of GT300 IUD when compared with MCu IUD. It is necessary to have the multicenter RCT studies with the large samples, scientific methodology and standards, especially the high-quality and long-term studies, so as to evaluate the efficacy, safety and acceptability of two IUDs.

Key words: Intrauterine devices, copper, Contraceptive devices, female, Meta-analysis, GT300, MCu IUD