MCu IUD放置8年多中心临床比较性研究  

A multicenter clinical trial of MCu intrauterine device (IUD) and TCu380A IUD use for eight years

作　　者：辛丽梅 钟春琍 孙立人 牛志凤 刘忠 李桂芬 

机构地区：[1]贵州省人口和计划生育科学研究技术指导所,贵阳550004 [2]辽宁省抚顺市清原满族自治县计划生育服务站 [3]辽宁省朝阳市喀喇沁左翼蒙古族自治县计划生育服务站 [4]内蒙古自治区宁城县计划生育服务站 [5]新疆维吾尔自治区计划生育科学研究所

出　　处：《中国计划生育学杂志》2010年第5期293-295,共3页Chinese Journal of Family Planning

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.

关 键 词：MCUIUD TCU380AIUD 临床效果 多中心研究 

分 类 号：R169.4[医药卫生—公共卫生与预防医学]