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MCu IUD放置8年多中心临床比较性研究 被引量:14

A multicenter clinical trial of MCu intrauterine device (IUD) and TCu380A IUD use for eight years
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摘要 目的:观察MCu IUD的临床效果及安全性。方法:国内6个临床中心按统一标准选择1100例要求使用IUD避孕的妇女,随机放置MCu IUD与TCu380A IUD各550例,定期随访观察96个月。结果:放置满96个月时,MCu组与TCu380A组的继续使用率分别为每百妇女年77.09,72.18(P>0.05);带器妊娠率分别为每百妇女年2.50,3.42(P>0.05);脱落率分别为每百妇女年1.07,5.73,差异有极显著性意义(P<0.001);因出血/疼痛取出率分别为每百妇女年5.66,7.77(P>0.05);有副反应主诉分别为每百妇女年4.48,5.54(P<0.05);因计划妊娠取器后足月妊娠分娩两组分别为82.5%,81.08%,总妊娠率均在90%以上。结论:MCu IUD脱落率低、避孕效果和可逆性好,是比较理想的IUD。 Objective:To observe the clinical effects and safety of the new type of MCu intrauterine device(IUD).Methods:A total of 1 100 women who were seeking for IUD use were enrolled according to the consistent standard in six clinical centers and randomly divided into two groups:the MCu IUD group(n=550)and TCu380A IUD group(n=550).They were followed-up regularly for 96 months.Results:The continuation rates were 77.09 and 72.18 per 100 women-years in the MCu IUD group and the TCu380A IUD group(P0.05);the total cumulative pregnancy rates during IUD use were 2.50 and3.42 per 100 women-years(P0.05);the expulsion rates were 1.07 and 5.73 per 100 women-years,showing significant difference between the two groups(P0.05);the removal rates of the two IUDs for medical reasons(bleeding and ache)were 5.66 and 7.77 per100 women-years(P0.05);the incidences of side effects were 4.48 and 5.54 per100 women-years,showing significant difference between the two groups(P0.05);the on-time delivery rates were 82.56% and 81.08% after removing IUD for planned pregnancy.The total pregnancy rates of the two groups were all more than 90%.Conclusion:MCu IUD with low ex-pulsion rate as well as good effective and reversibility is an ideal contraceptive.
出处 《中国计划生育学杂志》 北大核心 2010年第5期293-295,共3页 Chinese Journal of Family Planning
关键词 MCUIUD TCU380AIUD 临床效果 多中心研究 MCu intrauterine device TCu380A intrauterine device Clinical effects Multicenter trial
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