小剂量米非司酮胶囊配伍米索前列醇终止早孕的临床研究

目的:观察小剂量米非司酮胶囊(75mg)配伍米索前列醇终止早期妊娠的效果。方法:共纳入120例自愿终止妊娠的孕妇(≤7孕周),采用米非司酮75mg分次口服,第3天顿服米索前列醇600μg的方案,分析临床效果。结果:完全流产率91.67%(110/120),不全流产率6.66%(8/120),继续妊娠率1.67%(2/120);1.7%(2/120)服用米非司酮胶囊后孕囊即排出,75.0%(90/120)服用米索前列醇后孕囊排出,23.3%(28/120)观察期间未见孕囊排出;平均孕囊排出时间为2.77h,流产6h内阴道流血量43.4ml,无一例输血或应用止痛药。随访发现药物流产后阴道流血时间12.2±7.7d,其中点滴出血时间8.1±7.3d;药物流产后至第1次月经复潮的时间35.8±9.1d。受试者对米非司酮和米索前列醇的药物耐受性较好,无严重不良事件发生,各种副反应无须特殊处理。结论:75mg米非司酮胶囊配伍米索前列醇600μg终止≤49d早期妊娠具有较好的临床效果,建议开展较大规模的随机对照临床试验进一步验证。

A pilot study of low dose of mifepristone capsule in combination with misoprostol for termination of early pregnancy

Objective： To explore the efficacy of low dose of mifepristone capsule （75mg） in combination with misoprostol for termination of early pregnancy. Methods： A pilot study was performed in four hospital of Shanghai. One hundred and twenty women within 49 days＇ gastation were treated with 75mg of mifepristone capsule and 600ug of misoprostol . Results： The complete abortion rate was 91.67% （110/120）, incomplete abortion rate was 6.66% （8/120） and continuing pregnancy rate was 1.67% （2/120）. The mean abortion interval was 2.77 hours and the amount of vaginal bleeding was 43.4ml. No one had blood transfusion or analgesic. The follow-up results showed the vaginal bleeding days were 12.2±7.7 days, including 8.1±7.3 days of spotting time . No serious side effects were reported. Conclusions： The pilot study showed the regimen of mifepristone capsule （75mg） in combination with misoprostol is a good alternative for termination of early pregnancy. But the results should be confirmed by a large sample randomized controlled trials.