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目的系统评价活性γ型宫内节育器(γ-IUD)与同类宫内节育器(IUD)用于避孕的有效性。方法计算机检索CBMdisc(1986~2005)、VIP(1989~2005)、CNKI(1994~2005)和Cochrane图书馆(2005年第4期),并手检相关杂志10种。纳入活性γ-IUD与其他IUD比较的随机对照试验和半随机对照试验,质量评价后进行Meta分析。结果共10篇已发表研究符合纳入标准,合计8381例。Meta分析结果[用Peto OR(累计妊娠率、累计脱落率、累计因症取出率)或OR(续用率)及95%CI表示]显示与药铜环165比较,活性γ-25,200累计妊娠率较低(随访3年间差异有统计学意义[0·31(0·15,0·64);0·31(0·17,0·54);0·31(0·19,0·51)])、累计脱落率较低(随访5年间差异均有统计学意义[0·26(0·17,0·40);0·28(0·20,0·41);0·30(0·21,0·42);0·29(0·19,0·44);0·32(0·21,0·48)])、累计因症取出率较低(随访第4年差异有统计学意义[0·57(0·36,0·92)])、续用率较高(随访5年间差异均有统计学意义[3·35(2·29,4·89);2·76(2·06,3·69);2·41(1·89,3·08);2·22(1·69,2·91);1·99(1·55,2·55)])。与TCu220比较,活性γ-25,200累计妊娠率较低(随访2、3年差异有统计学意义[0·46(0·25,0·87);0·48(0·27,0·85)])、累计脱落率较低(随访1年差异有统计学意义[0·58(0·35,0·97)])、累计因症取出率较低、续用率较高(随访5年间差异均有统计学意义,分别为[0·37(0·23,0·59);0·38(0·26,0·56);0·45(0·32,0·64);0·47(0·30,0·73);0·58(0·39,0·87)]和[2·15(1·61,2·87);2·02(1·56,2·63);1·72(1·34,2·20);1·44(1·08,1·91);1·39(1·07,1·80)])。与宫铜比较,活性γ-25,200续用率较高,随访1年差异有统计学意义[0·51(0·34,0·77)]。与MLCu375比较,随访第3年,活性γ-25,200累计因症取出率较低[0·22(0·09,0·52)]、续用率较高[2·84(1·64,4·94)],差异均有统计学意义。与TCu380A比较,随访1、2年,活性γ-25,380累计因症取出率较低[0·36(0·18,0·73);0·29(0·12,0·70)]、续用率较高[3·06(1·72,5·44);3·61(1·75,7·47)],其差异均有统计学意义。结论活性γ-IUD用于避孕的有效性优于或等于其他目前常用的许多IUD,但此结论还需更多高质量随机对照试验和更长时间随访进一步证实。
Objective To evaluate the effectiveness of γ-IUD (γ-IUD) and similar intrauterine devices (IUD) for contraception. Methods CBMdisc (1986 ~ 2005), VIP (1989 ~ 2005), CNKI (1994 ~ 2005) and Cochrane Library (No. 4, 2005) were searched by computer. Randomized controlled trials and semi-randomized controlled trials comparing active γ-IUD with other IUDs were included, and meta-analyzes were performed after quality assessment. Results A total of 10 published studies met the inclusion criteria, a total of 8381 cases. Meta-analysis [Peto OR (cumulative pregnancy rate, cumulative rate of exacerbation, cumulative exacerbation rate) or OR (continuation rate) and 95% CI showed a cumulative pregnancy rate of [gamma] -25,200 (Follow-up of 3 years showed a significant difference [0 · 31 (0 · 15,0 · 64) · 0 · 31 · 0 · 17,0 · 54 · 0 · 31 · 0 · 19 · 0 · 51) ]), The cumulative rate of exfoliation was low (the difference was statistically significant at follow-up of 5 years [0 · 26 (0 · 17,0 · 40) · 0 · 28 (0 · 20, 0 · 41) · 0 · 30 (0 · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · · ·) Statistical significance [0 · 57 (0 · 36, 0 · 92)]), high reutilization rate (5 years follow-up were statistically significant differences [3.35 (2.29,4.89; 76 (2 · 06, 3.69); 2.41 (1.89, 3.08); 2.22 (1.69, 2.91); 1.99 (1.55, 2.55) ). Compared with TCu220, the cumulative pregnancy rate of active γ-25,200 was low (the difference was significant at follow-up of 2 and 3 years [0 · 46 (0 · 25, 0 · 87)] and 0 · 48 (0 · 27, 0 · 85) ]), The cumulative shedding rate was low (follow-up one year difference was statistically significant [0 · 58 (0 · 35, 0 · 97)]), the cumulative withdrawal rate was low, the high rate of follow-up The difference was statistically significant, respectively [0 · 37 (0 · 23,0 · 59); 0 · 38 (0 · 26,0 · 56); 0 · 45 (0 · 32, 0 · 64); 0 · 47 (0.30, 0.73); 0.58 (0.39, 0.87)] and [2.15 (1.61, 2.87); 2.02 63); 1.72 (1.34, 2.20); 1.44 (1.08, 1.91); 1.39 (1.07, 1.80)]). Compared with uterine copper, the activity of γ-25,200 continued higher rates of follow-up of 1 year difference was statistically significant [0 · 51 (0.34,0 · 77)]. Compared with MLCu375, in the third year of follow-up, cumulative cumulative rate of active γ-25,200 was lower [0.22 (0.09,0.52)] and higher follow-up rate [2.84 · 94)], the differences were statistically significant. Compared with TCu380A, cumulative cumulative rates of active γ-25,380 due to follow-up for 1 to 2 years were lower [0 · 36 (0 · 18, 0 · 73); 0 · 29 (0 · 12, 0 · 70)], The rates of utilization were higher (3.06 (1.72,5.44); 3.61 (1.75,75.77)], and the differences were statistically significant. Conclusions The effectiveness of active γ-IUD for contraception is better than or equal to that of many other commonly used IUDs. However, this conclusion is further confirmed by more high-quality randomized controlled trials and longer follow-up.