第二代爱母牌功能性宫内节育器1000例临床应用研究

A clinical study on the application of MCuⅡ IUD

目的探讨第二代爱母牌功能性宫内节育器(MCuⅡIUD)的临床效果及安全性。方法 2005年12月至2006年3月在国内临床多中心按统一标准选择2000例要求使用IUD避孕的育龄妇女,随机放置MCuⅡIUD与TCu380AIUD各1000例,放置后1、3、6、12个月定期随访观察。结果放置满12个月时,MCuⅡIUD组与TCu380AIUD组比较,继续使用率分别为96.36%、92.15%,差异有统计学意义(P<0.05);累积脱落率分别为0.51%、2.15%,差异有统计学意义(P<0.05);累积带器妊娠率分别为0.41%、0.63%,差异无统计学意义(P>0.05);因症取出率分别为2.01%、4.14%,差异有统计学意义(P<0.05);4次随访主诉发生率差异均有统计学意义(P<0.05)。结论 MCuⅡIUD脱落率低、抗生育效果好,置取方便,置器后副反应小,是效果比较理想的IUD。

Objective To study the safety and effect of applying MCu Ⅱ IUD. Methods 2000 child-bearing age women who required IUD for contraception from 5 Hospitals were choiced between Dec 2005 and Mar 2006, they were randomly divided into two groups, one group using MCu Ⅱ IUD, the other using TCu380AIUD, all women were followed up 1,3,6, 12 months after using IUD. Results Till 12 months after using IUD, the applying rate of the MCu Ⅱ IUD group was obviously higher than that of TCu380AIUD group （P 〈 0. 05 ） , the rate of falling off of MCu Ⅱ IUD group was obviously lower than that of TCu380AIUD group（ P 〈 0. 05 ）. The pregnant rates of the two groups were of no obvious difference. The rate of pulling out and the oeeurance of complications of MCu Ⅱ IUD group were both lower than that of TCu380AIUD group （ P 〈 0. 05 ）. Conclusion MCu Ⅱ IUD is a kind of new IUD with lower falling off rate, more better contraceptive effect, and less complications.