MCu宫内节育器12个月临床试验效果观察

目的:观察新型宫内节育器MCu IUD的临床效果、安全性、可接受性。方法:由国内6个临床中心参加,随机放置MCu IUD与TCu380A IUD各550例,对比观察临床效果。结果:放置满12个月时,MCuI UD组与TCu380A IUD组的带器妊娠率分别为0.37/百妇女、0.19/百妇女;脱落率分别为0.0/百妇女、1.48/百妇女;取出率(包括因症取出)分别为2.01/百妇女、1.84/百妇女,继续使用率分别为97.63/百妇女、96.52/百妇女。经统计学处理,除脱落率差异显著(P<0.05),其他均无显著性差异(P>0.05)。放置满12个月时,MCu IUD组与TCu380A IUD组的月经改变发生率分别为13.4％、21.4％,差异极显著(P<0.01)。结论:MCu IUD置、取方便,安全、有效,是当前效果比较理想的IUD。

Study on the New Intrauterine Device-MCuIUD's Clinical Performances,Acceptability and Safety

Objective: To study the new intrauterine device - MCuIUD' s clinical performances, acceptability and safety. Meth-ods : We selected six clinical centers and inserted MCuIUD and TCu380AIUD each 550cases. Then through random sampling to make observation of each term's clinical performances. Results: 12 months after inserting, we can see that the continuous u-sing rates of the MCuIUD term and TCu380A term were 97. 63 pre 100 women respectively and 96. 52 pre 100 women respec-tively , the rates of pregnancy with IUD is 0. 37 pre 100 women respectively and 0. 19 pre 100 women respectively, the rates of expulsion is 0. 0 pre 100 women respectively and 1. 48 pre 100 women respectively, the removal rates (including for medical reasons) is 2. 01 pre 100 women respectively and 1. 84 pre 100 women respectively. After statistics analysis, the expulsion rate has significance of difference P <0. 05, the others have no significance of difference, P >0. 05. In the two terms menstru-ation change rates is 13. 4 percent and 21. 4 percent, and it has significance of difference, P <0. 01. All these tell me that the side effects of MCuIUD is minor and its incidence rates is lowest. Conclusion: For MCuIUD, it is simple to insert and take out. As an IUD, MCuIUD is safe and effctive and maybe the better IUD in the IUD history.