GyneFix330和TCu220C、TCu380A宫内节育器比较的系统评估

Comparison of GyneFix330 intrauterine device with TCu220C and TCu380A intrauterine devices:A systematic review

目的：评价GyneFix330与TCu220C、TCu380A宫内节育器（IUD）的有效性、副反应和续用情况。方法：电子和手工检索1990年1月~2009年11月中英文发表的相关文献,按循证医学方法对纳入文献进行分析评价。结果：纳入26篇正式发表的随机对照临床试验文献。与TCu220C IUD相比,GyneFix330IUD的12个月和24个月带器妊娠率和脱落率较低;6个月、12个月和24个月的经期延长、经量增多、腰腹痛和不规则出血发生率较低;12个月因症取出率较低,续用率则较高。GyneFix330和TCu380A IUD12个月、24个月、36个月和9年的带器妊娠率均低于2.50/100妇女。两组6个月、12个月、24个月和36个月的月经量增多、白带增多和不规则出血发生率互有优劣。与TCu380A IUD相比,Gyne-Fix330IUD12个月和24个月的因症取出率接近,续用率略高。结论：GyneFix330IUD临床应用效果优于TCu220C IUD,与TCu380A IUD相差不大,仍需长期大样本临床观察予以确证。

Objective：To explore the effectiveness,side effects,and the continuation rates of GyneFix330 and TCu220C and TCu380A intrauterine devices（IUDs）.Methods：Electronic and hand searches were used to identify relevant literature published in Chinese and English between January 1990 and November 2009.Relevant papers were evaluated and selected according to the criteria of evidence-based medicine.Results：A total of twenty-six randomized controlled clinical trials（RCTs）were included in this review.Compared with TCu220C IUD,GyneFix330 IUD had lower expulsion and pregnancy rates with IUD in situ at 12 months and 24 months of use;while it was less likely to introduce prolonged menstrual bleeding,heavy menstrual bleeding,irregular vaginal bleeding and low back-abdominal pain during 6,12 and 24 months of the observation,and lower rate of discontinuation due to medical reasons and higher continuation rate at 12 months of use.The one-year,two-year,three-year and nine-year pregnancy rates with IUD in situ of both GyneFix330 and TCu380A IUDs were lower than 2.50 per hundred women.The likelihood of increasing duration of menstrual bleeding,heavy menstrual bleeding and irregular vaginal bleeding was similar between GyneFix330 and TCu380A IUDs.The removal rate due to medical reasons of GyneFix330 IUD was similar to that of TCu380A IUD.However,the continuation rate of GyneFix330 IUD was slightly higher than its counterpart.Conclusion：The effectiveness,side effects and continuation rate of GyneFix330 IUD were similar to those of TCu380A IUD.These measurements were demonstrated to be better for Gynefix330 IUD than for TCu220C IUD.However,more large-scale RCTs with high quality of research need to be done to confirm this conclusion.