芙蓉Cu200C宫内节育器系统评估

目的：系统评估芙蓉（FR）Cu200C 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1988年4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：共检索到22篇相关文献，按标准纳入5篇。纳入文献的结果显示。置器后1年，FRCu200C IUD的累积妊娠率略高于母体乐（ML）Cu375 IUD，因症取出率也趋向高于MLCu375 IUD；FRCu200C IUD的经量增多发生率低于MLCu375 IUD；置器后1、2、5年FRCu200C IUD的累积续用率均趋向低于MLCu375 IUD。结论：FRCu200C IUD的临床效果，尤其是有效性，接近或略差于MLCu375 IUD。建议在推广使用FRCu200C IUD前，对其开展多中心随机对照临床研究，进一步证实其安全性、有效性和可接受性；建议由非FRCu200C IUD研制单位主持临床试验，观察年限应≥5年。

Systematic Evaluation of Comparison between FRCu200C and MLCu375 IUD

Objective: To systematically evaluate the safety, effectiveness and acceptability of FRCu200C IUD. Methods: Electronic and hand searches were used to identify relevant literatures published between April 1988 and May 2006. Included papers were systematically selected and evaluated according to established guidelines of evidence-based medicine. Results: Twenty-two relevant papers were identified, and five of them were included. The cumulative one-year pregnancy rate of FRCu200C was slightly higher than that of MLCu375. The FRCu200C's cumulative terminated rate due to medical reasons was higher than that of MLCu375 at the end of one-year. During the first year of use, the percentage of the increased amount of menstrual bleeding of FRCu200C was lower than that of MLCu375. The cumulative one-year, two-year and five-year continuation rates of FRCu200C were lower than that of MLCu375. Conclusion: The overall clinical effect of FRCu200C is equal or somewhat inferior to MLCu375. It is recommended that more RCTs (randomized controlled clinical trials) should be done to evaluate its safety, effectiveness and acceptability, and follow-up survey be continued at least five years before the expansion of FRCu200C. And the RCTs should not be carried out by FRCu200C IUD manufacturer.