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目的观察MCuⅡ功能性宫内节育器(intrauterine contraceptive device,IUD)的临床避孕效果和不良反应。方法选用国产普通型TCu220CIUD作对照,采用随机比较性研究。结果自2010年2月至2011年8月,共接收对象600例(观察组与对照组各300例),1年随访率>98.00%。使用12个月结果表明:MCuⅡIUD组与TCu220CIUD组累积妊娠率均为0.34%;因不良反应取出率分别为1.34%、2.36%,差异均无统计学意义(P>0.05);累积脱落/下移率分别为0.67%、3.03%;与IUD有关终止率分别为2.35%、5.72%;随访12个月受试者满意率分别为94.30%、82.15%,上述3方面的差异均有统计学意义(P<0.05)。结论 MCuⅡIUD是一种设计合理、抗生育效应强、脱落率低、不良反应小、使用安全、续用率高的IUD,值得推广。
Objective To observe the clinical contraceptive effects and adverse reactions of MCUⅡ functional intrauterine contraceptive device (IUD). Method selection made common TCu220CIUD as a control, a randomized comparative study. Results From February 2010 to August 2011, a total of 600 subjects (300 in observation group and control group) were enrolled. The follow-up rate was> 98.00% at 1 year. The results of 12 months showed that the cumulative pregnancy rates of MCuⅡIUD group and TCu220CIUD group were both 0.34%; the rate of adverse reactions was 1.34% and 2.36%, respectively, with no significant difference (P> 0.05); cumulative shedding / The rates of termination with IUD were 2.35% and 5.72%, respectively. The satisfaction rates of subjects who were followed up for 12 months were 94.30% and 82.15%, respectively. The differences among the above three aspects were statistically significant P <0.05). Conclusion MCu Ⅱ IUD is a well-designed, anti-fertility effect, low rate of shedding, adverse reactions, safe use, high recovery rate of IUD, worth promoting.