花式(HCu280)和TCu220C宫内节育器比较的系统评估

目的系统评估HCu280宫内节育器(IUD)的安全性、有效性和可接受性。方法通过电子和手工检索查阅1991年1月~2006年5月国内外发表的相关文献,按照循证医学的原则进行筛选和评估。结果共获得HCu280IUD相关文献4篇,入选3篇。放置1年时HCu280IUD与TCu220CIUD的累积妊娠率、累积续用率接近;HCu280IUD的累积脱落率低于TCu220CIUD;HCu280IUD的副反应发生率略低于TCu220CIUD。结论置器后1年内,HCu280IUD的临床效果等于或略优于TCu220CIUD。建议由非HCu280IUD研制单位开展随机对照临床试验,并以含铜≥300mm2的IUD为研究参照,观察年限不少于5年。

Systematic Evaluation of Comparison between HCu280 and TCu220C IUD

Objective: To systematically evaluate the safety, effectiveness and acceptability of HCu280 IUD. Methods: Electronic and hand search were used to identify relevant literatures which were published between January 1991 and May 2006. Included papers were systematically selected and evaluated according to established guidelines for evidence based medicine. Results: Four relevant papers were identified,and three of them were selected. One-year cumulative pregnancy rate and continuation rate were similar between HCu280 and TCu220C. The cumulative one-year expulsion rate of HCu280 was lower than that of TCu220C. During the first year of use, the overall side-effect rate of HCu280 was slightly lower than that of TCu220C. Conclusion: The clinical performance of HCu280 IUD in the first year is equal or somewhat superior to TCu220C IUD. It is recommended that more RCTs (randomized controlled clinical trials) should be done controlled by IUDs containing copper ≥300mm, and follow-up survey be continued at least five years. However, the RCTs should not be carried out by HCu280 IUD manufacturer.