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目的:了解6种宫内节育器有效性、安全性。方法:采用多中心随机对照临床研究方法,对2004年7月～2005年6月河南省3个计划生育服务机构符合研究标准的观察对象随机放置6种宫内节育器,每种IUD观察50例,共观察300例,于放置后1、3、6、12个月进行随访,比较其避孕效果及安全性。结果:12个月随访率为98.33%。带器妊娠率:宫Cu200、Tcu380A、元宫药Cu220、宫Cu300 4种IUD为0,MTLCu375、Tcu220分别为2.17%、2.04%,各组间差别无统计学意义(P>0.05);脱落相关终止率:宫Cu200、Tcu380A、元宫药Cu220、Tcu220、MTLCu375、宫Cu300 6种IUD脱落和下移分别为8.28%、6.30%、4.13%、4.09%、4.04%、0.00%,各组间差别无统计学意义(P>0.05);因症取出率:元宫药Cu220、宫Cu200、Tcu380A、宫Cu300、MTLCu375、Tcu220因症取出率分别为8.09%、4.09%、4.09%、4.08%、2.0%、0%,各组间差别无统计学意义(P>0.05)。结论:6种宫内节育器中宫Cu200、Tcu380A、元宫药Cu220、宫Cu300带器妊娠率低,宫Cu300脱落率低,Tcu220、MTLCu375因症取出率较低。
Objective: To understand the effectiveness and safety of six kinds of IUD. Methods: A multicenter randomized controlled clinical study was conducted in which 6 kinds of IUDs were randomly placed on observational objects in 3 family planning service institutions of Henan Province from July 2004 to June 2005, and 50 cases , A total of 300 cases were observed, at 1,3,6,12 months after placement for follow-up comparison of contraceptive effectiveness and safety. Results: The 12-month follow-up rate was 98.33%. There were no significant differences among the three groups (P> 0.05). There was no significant difference between the two groups (P> 0.05). The pregnancy rates of the two devices were: Cu200, Tcu380A, Cu220, Cu300, Cu300, MTU375 and Tcu220 were 2.17% and 2.04% The termination rates of six types of IUDs, including Cu200, Tcu380A, Cu220, Cu220, Tcu220, MTLCu375 and Cu300, were 8.28%, 6.30%, 4.13%, 4.09%, 4.04% and 0.00% (P> 0.05). The rate of removal of the disease was 8.09%, 4.09%, 4.09%, 4.08% and 2.08 respectively for Cu220, Gong Cu200, Tcu380A, Gong Cu300, MTLCu375 and Tcu220 %, 0%, the difference between the groups was not statistically significant (P> 0.05). Conclusions: The pregnancy rates of Cu200, Tcu380A, Cu220 and Cu300 in 6 kinds of IUD are low, the shedding rate of Cu300 is low, and the removal rate of Tcu220 and MTLCu375 is low.