6种宫内节育器12个月临床效果观察

The clinical efficacy of 6 types of intrauterine device during12 months

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 investigate the safety and efficacy of 6 types of IUD which were widely used in Henan province. Methods： A multi - center, randomized and Controlled clinical research mothod was used. All 300 cases in 3 selected family plan- ning service of Henan province were randomly put into 6 types of IUD from July 1, 2004 to June 31, 2005, each 50 cases for one type of IUD. The contraception effect and safety of the 300 cases were analyzed at the end of 1, 3, 6, 12 months since inserting. Results： The fol- low ratio at the end of 12 months was 98.33%. The rates of pregnancy with IUD shaped Cu200 IUD, Tcu380a IUD, YGCu220 IUD, uter- ine shaped Cu300 IUD were all 0%. The rate of pregnancy with IUD shaped MTLCu375 and Tcu220 was 2. 17% and 2.04% respectively. （P 〉 0.05） . Cumulative events ratio due to expulse of Cu200 IUD, Tcu380a IUD, YGCu220 IUD, Tcu220 IUD, MTLCu375 IUD, Cu300 IUD was 8.28%, 6. 30%, 4. 13% , 4. 09% , 4.04% and 0% respectively （P 〉0.05） . Cumulative events ratio due to medical reason of YGCu220 IUD, Cu200 IUD, Tcu380a IUD, uterine shaped Cu300 IUD, MTLCu375 IUD, Tcu220 IUD was 8.09%, 4. 09% , 4. 09%, 4.08%, 2.0% and 0% respectively （P 〉 0.05 ） . Conclusion： Cu200 IUD, Tcu380a IUD, YGCu220 IUD, uterine shaped Cu300 IUD have a lower rate of pregnancy with IUD. Tcu220, MTLCu375 have a lower rate of cumulative events.