米非司酮配伍米索前列醇终止16～24周妊娠临床多中心研究

Termination of second trimester pregnancy with mifepristone and misoprostol:a multi-center randomized controlled clinical trail

目的：探索米非司酮配伍米索前列醇终止16～24周妊娠的最佳给药方案。方法：将来自上海市8所医院607例要求终止16～24周妊娠的妇女随机分为3组。组Ⅰ第1天晨口服米非司酮200mg，第3天晨阴道放置米索前列醇400μg，12h重复1次，最多3次；组Ⅱ第1天晨口服米非司酮100mg，连用2d，第3天阴道放置米索前列醇400μg，使用方法同组Ⅰ；组Ⅲ第1天晨口服米非司酮200mg，第3天晨口服米索前列醇400μg，每6h重复1次，最多4次。结果：3组流产成功率分别为97．1％、96．0％和92．0％，差异有统计学意义（χ2=6．05，P=0．048）；流产成功577例，引流产时间为13．43±10．18h，3组间无统计学差异（F=1．01，P=0．36）；流产成功者中，米索前列醇用量组Ⅰ、组Ⅱ、组Ⅲ分别为616．33±317．26μg、634．99±307．88μg、797．85±395．56μg，组III使用量高于组Ⅰ、组Ⅱ（F=16．20，P=0．00）。胎儿娩出后2h内和2～24h阴道流血量3组差异均无统计学意义。用药后主要不良反应为胃肠道不适，程度轻且无需特殊处理。结论：单次口服米非司酮200mg配伍米索前列醇，每12h阴道给药400μg，是终止16～24周妊娠的理想用药方案。

Objective： To investigate the optimal medical regimen for terminating pregnancy in 16-24 weeks of gesta- tion. Methods： This is a multi-center randomized controlled trail with 8 hospitals in Shanghai. A total of 607 women with pregnancy in 16-24w gestation were randomized into three groups. Group Ⅰ took mifepristone 200mg on day 1 fol- lowed by 0.4mg of misoprostol administered vaginally on the third day morning, repeated every 12h （3 times in maxi- mum）; Group Ⅱ took 100mg of mifepristone once a day for two days, the administration of misoprostol was the sameas Group Ⅰ; Group Ⅲ took mifepristone 200mg on day 1 followed by 0.4mg of misoprostol administered orally on the third day morning and repeated every 6h （4 times in maximum）. Results.. Successful abortion rates in each group were 97.1% in group Ⅰ , 96.0%in group Ⅱ and 92.0% in group Ⅲ , with statistical significance （χ2 =6.05, P=0. 048）. Totally 577 women expelled their fetus successfully, and the average induction to abortion interval was 13.43±10.18 h, without statistical significance among groups （F= 1.01 ,P=0. 36）. The average amount of misoprostol used were 616.33±317.26 g,634. 99±307. 88 g.797. 85±395. 56 g in the three groups respectively （F=16.20, P=0.00）. No statistically significant differences were found for 2h and 24h post-abortion hemorrhage volumes among the three groups. Majority of side effects were gastrointestinal discomforts and most were mild cases with no need for interven- tion. Conclusion; Regimen of group Ⅰ （mifepristone 200mg po. ＋ misoprostol 400μg pv. ） is an optimal for medical a- bortion in pregnancy with 16-24 weeks of gestation.