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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。
Objective: To observe the clinical effect, safety and acceptability of new IUD MCu IUD. Methods: Six clinical centers in China were involved. Randomly placed 550 cases of MCu IUD and TCu380A IUD respectively. The clinical effects were compared. Results: The pregnancy rates of the devices with MCuI UD and TCu380A IUD were 0.37 / 100 women and 0.19 / 100 women respectively at the 12 months of age. The rates of abortion were 0.0 / 100 women and 1.48 / Including due to illness) were 2.01 / 100 women, 1.84 / 100 women, the continued use rate was 97.63 / 100 women, 96.52 / 100 women. There was no significant difference (P> 0.05) except for the difference in the rate of shedding after statistical analysis (P <0.05). When placed for 12 months, the incidences of menstrual changes in MCu IUD group and TCu380A IUD group were 13.4% and 21.4%, respectively (P <0.01). Conclusion: MCu IUD set, take convenient, safe and effective, is the current results of the ideal IUD.