米非司酮配伍米索前列醇不同给药方式终止早孕的临床随机比较研究

目的研究米非司酮配伍米索前列醇舌下含服及口服的药物流产效果。方法将158例早孕妇女(停经≤56天)随机分为2组,连续口服米非司酮2天,3次/d,每次25mg,第3天上午使用米索前列醇(本文简称米索)口服400μg同时阴道给400μg(组Ⅰ),或者舌下含400μg同时阴道给400μg(组Ⅱ)以终止妊娠。结果总体完全流产率为94.9%,组I为92.5%,组Ⅱ为97.4%,两组无显著性差异(P>0.05);总体不全流产率为4.43%,组I为7.5%(6/80),高于组Ⅱ1.28%(1/78),但两组无显著性差异(P>0.05);总体失败率为0.63%,其中组Ⅰ为0,组Ⅱ为1.28%,两组亦无显著性差异(P>0.05);组Ⅰ从应用米索至孕囊排出时间为(2.39±1.20)h,明显低于组Ⅱ(2.98±1.33)h(P<0.01)。结论组I终止早孕的不全流产率高于组Ⅱ(但无明显组间差异,可能与样本较小有关),可能与舌下含服米索可使有效血药浓度维持时间较长,生物利用度较高有关,故在药物流产中米非司酮配伍舌下含服米索是1种很有前景的用药方法。

A randomized clinical study of mifepristone in combination with various administration of misoprostol for medical abortion

Objective:To evaluate the efficacy of mifepristone in combination with various administration of misoprostol for medical abortion.Methods:A total of 158 healthy women requesting medical abortion and up to 56 days gestation were recruited into this study. To terminate pregnancy they took 25 mg mifepristone orally t.i.d, for two days. Following mifepristone, women were randomized to use on 3rd morning:(1)oral misoprostol 400 μg and vaginal misoprostol 400 μg or (2) sublingual misoprostol 400 μg and vaginal misoprostol 400 μg.Results:In total, the complete abortion rate was 94.9~4, while 92.5% and 97.4% respectively in oral group and sublingual group (P>0.05); The failure rate was 0.63%, while zero and 1.28% respectively in oral group and sublingual group (P>0.05); The incomplete abortion rate was 4.43%, while in oral group it was 7.5% (6/80), much higher than that in sublingual group (1/78, 1.28%) (P>0.05), however, there was no significant difference between two groups. The mean induction-to-abortion interval was 2.39±1.20 h in the oral group, significantly shorter than that in the sublingual group (2.98±1.33) h (P<0.01).There was significant difference between two groups.Conclusion:Mifepristone in combination with sublingual misoprostol results in lower incomplete abortion rate as compared with mifepristone plus oral misoprostol (though the difference was insignificant probably due to small sample size).The reason may be that sublingual misoprostol can maintain the effective serum concentration for longer time, and has the highest bioavailability.So the sublingual administration of misoprostol would become a promising method of medical abortion.