放置MYCuIUD与MCuⅡIUD 12个月效果观察

摘要

Objective: To observe the clinical effect and safety of MYCu intrauterine contraceptive device (MYCuIUD) containing 25mg indomethacin and MCu Ⅱ functional IUD ( MCu ⅡIUD). Methods: A multicenter study recruited 1,400 women, and two types of IUDs were randomly inserted, 700 women each IUD. The women were followed up 1, 3, 6, and 12 months after insertion. Results: Twelve months after insertion, in MYCu group and MCu Ⅱ group, the cumulative rate of pregnancy with IUD in situ was 0.43/100 and 0.73/100 women per year, respectively ( P > 0.05 ) ; the cumulative expulsion rate was 0.43/100 and 0. 44/100 women per year, respectively (P > 0. 05); the rate of IUD removal for medical reasons ( mainly bleeding and pain) was 1.30/100 and 1.88/100 women per year, respectively (P>0.05). 1 or 3 months after insertion, the occurrences of abnormal menstruation and low back/abdominal pain in MCu Ⅱ group were higher than those in MYCu group (P < 0.05). Conclusion: Both MYCuIUD and MCu Ⅱ IUD performed well in the study. MYCuIUD can reduce bleeding and pain at the early stage of insertion.%目的:观察MYCu宫内节育器(MYCuIUD)与MCuⅡ功能性宫内节育器(MCuⅡIUD)的临床效果及安全性.方法:多中心随机放置MYCuIUD(MYCu组)、MCuⅡIUD(MCuⅡ组)各700例,术后第1、3、6、12个月随访.结果:放置满12个月,MYCu组与MCuⅡ组累积带器妊娠率分别为0.43/百妇女年、0.73/百妇女年;累积脱落率分别为0.43/百妇女年、0.44/百妇女年;因医疗原因取出分别为1.30/百妇女年、1.88/百妇女年;主要副作用为出血和疼痛;以上差异均无统计学意义(P＞0.05).放置后1、3个月时月经异常及腰腹疼痛发生率MCuⅡ组高于MYCu组(P＜0.05).结论:MYCuIUD与MCuⅡIUD同样具有抗生育效果好、脱落率低、副作用发生率低的特点,放置MYCuIUD可减少IUD放置初期的出血和疼痛.