MCu110和TCu220C、TCu380A宫内节育器比较的系统评估  

Systematic Review of the Comparison between MCu110 and TCu220C as well as TCu380A

作　　者：张磊[1] 何杨 毛燕燕[1] 车焱[1] 周维谨[1] 

机构地区：[1]上海市计划生育科学研究所,200032 [2]重庆市计划生育科学研究院,200032

出　　处：《中国计划生育学杂志》2009年第5期262-266,共5页Chinese Journal of Family Planning

基　　金：国家科技支撑计划<农村卫生服务适宜技术收集与应用>(课题编号:2007BAI07A01)

摘　　要：目的:评价MCu110功能性宫内节育器的有效性、副反应和可接受性。方法:通过电子和手工检索查阅2000年1月～2008年12月国内外发表的相关文献,并依照循证医学的方法对纳入评估的文献进行筛选、评价和分析。结果:共获得合格文献10篇,均为随机对照临床试验且正式发表。评估结果显示,置器后12月和24月,MCu110的临床综合效果优于TCu220C;脱落率略低于TCu380A,可接受性略优于TCu380A,副反应各项指标二者互有优劣,而带器妊娠率差别未发现有统计学意义。结论:与TCu380A相比,能够证实MCu110有效性、副反应和可接受性的多中心随机对照试验并不多,尤其是长期随访研究;建议由非MCu110研制单位组织开展多中心随机对照试验,观察年限不少于5年。Objective： To evaluate the effectivity, side effects, and acceptability of functional intrauterine device （IUD） MCu110. Methods. Relevant literatures published at home and abroad during January 2000 and October 2008 were searched through electronic and manual inspection. And the included literatures were screened, evaluated and analyzed according to the criteria of evidence- based medicine. Results： 10 qualified papers were obtained, all of which were randomized controlled clinical trials （RCTs） and puhlished formally. The evaluation results showed that, with IUD placement for 12 months and 24 months, the comprehensive clinical effects of MCu110 were better than TCu220C for lower expulsion rate and better acceptability than TCu380A. Compared the two groups, the different indexes of side effects had different advantages and disadvantages, but there were no statistical differences of pregnancy rate and pregnancy rate with IUD. Conclusion： Compared with TCu380A, the multicentre RCTs which can eontirm the effectivity, side effects and acceptability of MCu110 are much fewer, especially the long term follow - up study. It is suggested that more multieentre RCTs should be organized and developed by non -MCu110 manufacturer with follow -up survey for 5 or more years.

关 键 词：宫内节育器 MCu110 TCU380A TCU220C META分析 

分 类 号：R169.4[医药卫生—公共卫生与预防医学]