Objective:To explore the efficacy and safety of mifepristone combined with different regimens of misoprostol to terminate pregnancy at 8-16 weeks of gestation.Methods:120 women were recruited and randomized to receive 200mg mifepristone orally (100 mg of mifepristone at the first and the second day,respectively),then they were given six different regimens of misoprostol after taken the first mifepristone 36 hours later.The outcome measures were the rate of successful abortion,induction to abortion interval,the amount of vaginal bleeding and the adverse events.Results:There were no significant differences in the rate of successful abortion (from 90％ to 100％,P=0.465) and induction to abortion intervals (from 4.2h to 9.5h,P=0.253) among the groups.The rate of successful abortion after first dose of misoprostol of women in vaginal groups was significantly higher than that of women in oral groups.The average amount of bleeding after placenta expulsion was 67.4ml within 2h and 37.7ml between 2h and 24h.The emergency curettage rate was 11.8％.There were no serious adverse events(SAE),the adverse events(AE)related to drugs were mild or moderate,and there were no statistical significant different (P =0.686) in the study.The overall satisfaction rate was 84.6％.Conclusion:This preliminary result of the study may suggest different regimens of misoprostol combined with mifepristone are all effective and safe to terminate pregnancy at 8-16 weeks of gestation.Yet,the sample size should be expanded to explore the optimal regimen.%目的:探索米非司酮配伍不同方案米索前列醇(简称米索)终止孕8～16周妊娠的有效性和安全性.方法:研究共纳入受试者120例,第1、2天分别顿服米非司酮100mg,首次口服米非司酮36h后给予6种不同方案的米索,观察流产有效率,胎儿排出时间、阴道流血量及安全性等.结果:不同用药方案流产有效率均达90％～100％,胎儿排出时间4.2～9.5h,无统计学差异(P=0.465,0.253);米索一次用药流产率阴道组高于口服组;胎盘娩出后平均出血量2h内67.4ml、2～24h内37.7ml,紧急清宫率11.8％;研究期间无严重不良事件,药物相关不良反应均为轻中度,各组间均无差异(P=0.686);药物流产总体满意度84.6％.结论:本研究初步结果提示米非司酮配伍不同方案米索可能均有效、安全地终止8～16周妊娠,但作为小样本前期研究,还需扩大样本进一步探索优选方案、规范临床应用.
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