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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 被引量:7

A randomized clinical trial of mifepristone plus different routes of administration of misoprostol for terminating a pregnancy within 5 weeks
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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.
出处 《生殖医学杂志》 CAS 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)
关键词 药物流产 米索前列醇 舌下用药 完全流产率 副反应 Medical abortion Misoprostol Sublingual administration Completed abortion rate Side effect
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