GyneFix330和MCu110宫内节育器比较的系统评估

Clinical Performances of GyneFix330 Compared with MCu110 IUD:A Systematic Review

目的:评价GyneFix330与MCu110宫内节育器(IUD)的有效性、副反应和续用情况。方法:通过电子和手工检索查阅1990年1月～2009年11月国内外发表的相关文献,按照循证医学的方法对纳入文献进行分析评价,Meta分析采用RevMan 4.2.10软件。结果:共纳入5篇正式发表的随机对照临床试验性文章。有效性方面,置器后12个月和24个月,GyneFix330组与MCu110组的带器妊娠率和脱落率均低于2.00/100妇女。GyneFix330的带器妊娠率低于MCu110,但差异无统计学意义。副反应方面,置器后6个月、12个月和24个月,两组副反应各项观察指标的发生率逐渐降低。置器后12个月内,GyneFix330组腰/腹痛的发生率显著低于MCu110组,白带增多、不规则出血的发生率显著高于MCu110组。续用情况方面,置器后24个月内,两组IUD因症取出率均不超过8.00/100妇女,续用率接近95.00/100妇女。GyneFix330组12个月因症取出率显著低于MCu110 IUD,24个月内两组续用率接近。结论:GyneFix330 IUD的临床应用效果略优于MCu110 IUD,但需长期大样本临床观察予以确证。

Objective： To evaluate the effectiveness,side effects,and continuation situation of the functional intrauterine devices（IUD） GyneFix330 and MCu110.Methods：The electronic and hand search were used to identify the literatures（published between January 1990 and November 2009） on randomized controlled trials（RCTs） comparing GyneFix330 with MCu110.The included trials were systematically reviewed.The software of RevMan4.2.10 was used for meta-analysis.Results：A total of 5 published literatures of qualified RCTs were identified and included.During the first 12 months and 24 months after the insertion of IUDs,both the total cumulative pregnancy rate during IUD use and the expulsive rate of GyneFix330 and Mcu110 were lower than 2.00 per 100 women.However,the pregnancy rate during IUD use of GyneFix330 was somewhat lower than that of MCu110,showing no significant difference.During the first 6 months,12 months and 24 months of IUD use,the incidence of side effects decreased gradually.Compared with MCu110,the incidence of the lumbago/abdominal pain was significantly lower and the occurrence of leucorrhea and irregular vaginal bleeding were significantly higher during the first 12 months of IUD use.The removal rates of the two IUDs for medical reasons were less than 8% during 24 months of IUD use.The continuation rate was nearly 95.00 per 100 women.The removal rate of GyneFix330 for medical reasons was statistically significantly lower than that of MCu110 during 12 months of IUD use.The continuation rates of the two IUDs are similar during 24 months of IUD use.Conclusions： GyneFix330 is clinically somewhat better than Mcu110,while the long-term multicenter RCTs with the large sample size are needed.