宫铜300宫内节育器安全性有效性的系统评估

目的评价宫铜300宫内节育器(intrauterine device,IUD)的安全性和有效性,比较宫铜300与其他IUD的使用效果,为群众安全避孕提供科学依据。方法通过检索PubMed、Embase、CENTRAL、POPLINE、CBMDisc、CMCI、CNKI等数据库,收集宫铜300安全性有效性的相关文献,按照PICOS原则制定的纳入和排除标准筛选文献;使用EpiData 3.1、RevMan5.3.3等软件进行Meta分析。利用"偏倚风险评估"标准进行文献方法学质量评价,并采用GRADE系统进行证据质量的分级。结果初检文献6 062篇,最终纳入18个涉及宫铜300的随机对照试验(randomized controlled trial,RCT)和准RCT对比研究,包括自1995至2014年正式发表的20篇文献。研究对象共20 968例。Meta分析结果显示,在安全性评价指标中,宫铜300各指标的终止率及不良反应发生率均高于活性γ型;宫铜300的因症取出率高于TCu 220C、TCu 380A和元宫220;总不良反应发生率高于HCu 280。以上差异均有统计学意义(P0.05)。在有效性评价指标中,宫铜300的妊娠率与其他IUD比较,在1年随访时未发现差异有统计学意义(P0.05)。结论宫铜300使用1年的近期安全性低于TCu 220C、TCu 380A、元宫220、活性γ型,在指导避孕方法使用时可考虑更优选择。

A systematic assessment of the safety and effectiveness of uterine cavity shaped device Cu300

Objective To evaluate the safety and efficacy of UCD Cu 300 intrauterine device ( IUD) by comparing with other IUDs in order to provide scientific evidence for safe contraception .Methods Databases including PubMed , Embase, CENTRAL, POPLINE, CBMDisc, CMCI, CNKI, VIP and Wanfang were searched .The inclusion and exclusion criteria were set according to the PICOS principle.The data was extracted and managed by EpiData 3.1.Meta-analysis was conducted by RevMan 5.3.3.The criteria on assessing risk of bias were used for methodological quality of literatures .The GRADE system was used for grading of evidence quality.Results 6062 literatures were preliminarily retrieved , 18 RCTs and quasi -RCTs studies involving UCD Cu300 IUD were recruited, including 20 literatures formally published from 1995 to 2014.There were a total of 20968 IUD users in the pool.Results:UCD Cu300 were inferior to active γ-IUDall over the safety indexes .The medical removal rate of UCD Cu 300 was significantly higher than TCu 220 C, TCu 380 A and YGCu 220 when followed up after 1 years whose side effects rate was higher than HCu 280.The differences were of statistical significance (P<0.05).However, no statistical difference was found on pregnancy rate when compared UCD Cu300 with other IUDs .Conclusion The short -term safety of UCD Cu300 is inferior to active γ-IUD, TCu 220 C, TCu 380 A and YGCu 220, we suggest better IUDs instead .