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目的:观察第二代爱母含铜宫内节育器(AiMu MCuⅡIUD)的临床效果。方法:对要求使用IUD避孕的825例育龄妇女,随机放置MCuⅡIUD(408例)与TCu380A IUD(417例),放置后3个月、6个月、12个月、24个月、36个月定期随访,记录IUD使用情况。结果:随访36个月时MCuⅡ与TCu380A组随访率分别为98.78%、98.57%。MCuⅡ组3个月、36个月的副反应主诉率分别为20.34%和8.28%,除了36个月外,4次随访副反应主诉率均低于TCu380A IUD组,差异有统计学意义(P<0.05)。随访12个月、36个月MCuⅡ组带器妊娠率分别为0.98/100妇女、1.96/100妇女,5次随访MCuⅡ组带器妊娠率均高于TCu380A IUD组,但无统计学差异(P>0.05)。MCuⅡ组6个月的因症取出率和36个月的终止率分别为7.60%和22.06%,MCuⅡ组因症取出率及终止率均低于TCu380A IUD组,除了3个月外,其余4次随访比较均有显著性差异(P<0.05)。结论:MCuⅡIUD副反应少、续用率高,避孕效果与TCu380A相当,是当前可供选择的有效IUD。
Objective: To observe the clinical effect of the second generation AiMu MCu Ⅱ IUD. METHODS: A total of 825 women of childbearing age who required IUD contraception were randomized to receive MCuIIIUD (408 cases) and TCu380A IUD (417 cases) randomly. Periodically, 3 months, 6 months, 12 months, 24 months and 36 months after placement Follow up, record IUD usage. Results: The follow-up rates of MCuⅡ and TCu380A groups at follow-up of 36 months were 98.78% and 98.57% respectively. The main complaint rates of side effects in MCuⅡgroup at 3 months and 36 months were 20.34% and 8.28%, respectively. Except for 36 months, the main complaint rate of 4 side effects were lower than that of TCu380A IUD group (P < 0.05). The follow-up of 12 months, 36 months MCu Ⅱ group pregnancy rate was 0.98 / 100 women, 1.96 / 100 women, 5 follow-up MCu Ⅱ group pregnancy rate was higher than TCu380A IUD group, but no significant difference (P> 0.05). MCuⅡ group 6 months withdrawal rate and 36-month termination rates were 7.60% and 22.06%, MCu Ⅱ group withdrawal rate and termination rate were lower than TCu380A IUD group, except for 3 months, the remaining 4 times Follow-up comparison showed significant difference (P <0.05). Conclusion: MCu Ⅱ IUD less side effects, high reusability, contraception and TCu380A equivalent, is currently available effective IUD.