Objective To compare the effectiveness of active γ-IUD with MLCu375.Methods The electronic and hand searches were used to identify the literatures about the comparison of active γ-IUD with MLCu375 (published between January1993 and December 2012) on randomly controlled trials (RCTs).The included trials were systematically reviewed.The software of RecMan4.2.10 was used for meta-analysis.Results A total of 5 published literatures of qualified RCTs were identified and included,and 4 503 cases were metaanalyzed.Compared with MLCu375 IUD,one-to-three geans follow-up revealed that cumulative pregnancy rates were similar and one-to-three years cumulative expulsion rates were significantly lower with IUD in situ of active γ-IUD.Moreover,compared with MLCu375 IUD,one-to-three years follow-up revealed that cumulative side effects rates,cumulative failed rates and continuation rates of active γ-IUD were significantly lower.Conclusion Active γ-IUD is clinically somewhat better than MLCu375 and is worth using widely,while the long-term multicenter RCTs with the large sample size are needed.%目的 系统评价活性γ型与母体乐(MLCu375)宫内节育器(IUD)的有效性.方法 计算机检索Cochrane Database of systematic Reviews,MEDLILNE,EMbase.PEDro,OpenSIGLE,National Technical Information Service (NTIS),CNKI,VIP,万方数据库和CBM中,关于活性γ型和MLCu375的随机对照试验,同时追索纳入文献的参考文献.检索时限为1993年至2012年.由3名研究者根据GRADE系统推荐分级方法,对纳入研究的治疗进行严格评价和资料提取,对符合质量标准的RCT进行Meta分析.统计学分析采用RevMan 5.0.25软件.结果 共纳入5个RCT,合计4 503例.Meta分析的6个结果显示:MLCu375的有效性与活性γ型相比,随访1～3 a的带器妊娠率的差异无统计学意义(P＞0.05),续用率、总使用相关的失败和因症取器的差异有统计学意义(P＜0.05),但是脱落率仅在随访1a和3a差异有统计学意义(P＜0.05).结论 现有研究显示,自主研发的活性γ型IUD与国际IUD产品MLCu375在避孕方面的效果,即带器妊娠方面效果相当.但是在其他导致使用相关的失败方面,包括脱落相关和因症取器活性γ型IUD效果要好于MLCu375,对不同个体的适用性较好,临床医生在实际操作中可以更广泛使用.但是鉴于纳入研究较少,各研究评价方法变异性较大,并且不同研究开展的时间相距较长,故仍需开展大样本、多中心、方法科学和规范的高质量RCT,以求进一步验证两类IUD的实际有效性.
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