米非司酮配伍不同给药途径米索前列醇用于终止5周内妊娠的临床观察  

A randomized clinical trial of mifepristone plus different routes of administration of misoprostol for terminating a pregnancy within 5 weeks

作　　者：裴开颜[1] 邵文祺 雷贞武[3] 李奕[4] 黄紫蓉[5] 马文侠 经小平[7] 贾孟春[1] 

机构地区：[1]国家人口计生委科学技术研究所,北京100081 [2]青岛市计划生育科学技术研究所,青岛266071 [3]成都中医药大学生殖医学院,成都610041 [4]天津市医科大学第二附属医院,天津300211 [5]复旦大学医学院附属妇产科医院,上海200011 [6]河南省人口和计划生育科研院,郑州450000 [7]首都医科大学附属北京朝阳医院,北京100020

出　　处：《生殖医学杂志》2011年第4期304-308,共5页Journal of Reproductive Medicine

基　　金：国家科技支撑项目(2006BAl03B10)

摘　　要：目的通过与常规药物流产方法进行对比分析，探讨400μg米索前列醇舌下给药用于早期流产的效果。方法2008年6月至2009年9月接收就诊于全国6个研究中心停经〈37d要求药物流产的受试者，随机分为两组：A组：第1天晨空腹服米非司酮50mg，8～12h后再服25mg，第2天按照第1天同样方法服用，首次服米非司酮后36～48h口服米索前列醇600μg；B组：第1天顿服米非司酮150mg，服药后36-48h舌下含服米索前列醇400μg。观察两组的流产效果。结果根据纳入及排除标准，共接收575例受试者，其中4例失访。A组完全流产267例（93．4%），失败16例；B组完全流产262例（91．0％），失败26例，两组比较差异无统计学意义（x^2=2．3846，P〉0．05）。约〉80％妇女有恶心、呕吐、头晕、乏力、头痛和乳胀的反应，两组副反应比较无显著性差异（P均〉0．05）。服药后两组出血分别为（9．08士3．49）和（9．04±3．43）d，差异无统计学意义（t=0．15，P〉0．05）。两组受试者满意度调查的有效问卷回收率为97．3％，对研究方法的满意率分别为88．1％（245／278）和92．0％（256／278），差异无统计学意义（P〉0．05）。结论400μg米索前列醇舌下用药用于早期流产可获得较好的效果，且副反应较少。Objective： To explore the efficacy of 400 μg of misoprostol administered sublingually on medical abortion for early pregnancy by comparing with routine administration of mosoprostol. Methods： Women presenting for termination of early pregnancy, whose gestational ages were not more than 37 days, were randomly allocated into two groups. Women in group A were given 50mg of mifepristone and 25 mg 8 to 12 hours later orally on the first day. The schedule on the second day was as the same as above followed by 400μg of misoprostol orally On the third day. Women in group B were given a dose of 150 mg of mifepristone orally followed by 400/ig of misoprostol sublingually 36 to 48 hours later. Both completed abortion rates and side effects were evaluated. Results： A total of 575 women were enrolled and four women were lost to follow-up. The completed abortion rates were 93.4% in group A and 91.0% in group B, showing no significant difference （ x^2= 2. 3846,P〉0.05）. About 80% of the women experienced nausea, vomit, dizziness, headache and breast tenderness. There were no significant differences （P 〉 0.05） in side effects of the two groups. The duration of vaginal bleeding in the two groups were （9.08±3.49） days and （9.04±3.43） days, showing no significant difference （t= 0. 15, P〉 0. 05）. About 97. 3% of validated questionnaires on patient satisfaction were recovered. The proportions of patient satisfaction were 88.1% in group A and 92. 0% in group B, showing no significant difference （P〉0.05）. Conclusions： Administration of 400 μg of misoprostol sublingually could be more suitable for termination of early pregnancy due to its higher complete abortion rate and less side effects.

关 键 词：药物流产 米索前列醇 舌下用药 完全流产率 副反应 

分 类 号：R[医药卫生]