【摘要】 观察米非司酮配伍不同前列腺素拟似物的药物流产方法在我国广大城乡推广使用时的流产效果、安全性及可接受性;同时 ,探索计划生育科学研究与技术服务相结合以及组织实施大型规范化引入性研究的经验。本研究由预初试验和主体试验组成。17523例自愿要求终止早孕妇女采用分次口服米非司酮150mg后加用卡波前列素 (PG05)或米索前列醇终止妊娠 ,随访至月经恢复或手术终止妊娠。结果显示 :分次口服米非司酮配伍PG05和米索前列醇的流产效果相仿 ,完全流产率为93.2 %和93.3 %。流产效果与对象的年龄和孕次高度相关。17523例受试者中绝大多数无明显药物不良反应。给予PG05栓组的腹泻和呕吐发生率 (53.4 %和34.9 % )明显高于米索前列醇组 (32.2 %与27.4 % ) (P<0.001)。其他药物不良反应有恶心(50.8 %)、头晕头痛(19.4 %)、乏力(29.6 %)、腰酸(3.2 %) ,两组发生率相近。1例对象使用米索前列醇后发生过敏性休克 ,8例因不全流产所致大量出血而输血急救 ,均痊愈。84.5 %的用药妇女明确表示 ,如再发生意外妊娠 ,仍乐意采用本法终止早孕。结论 :米非司酮配伍前列腺素是一种高效、安全的终止早孕方法 ,有良好的可接受性。但必须在具备急诊刮宫、输液、输血等急救条件的医疗单位进行 ,给予前列腺素后必须留院观察。更多还原

【Abstract】 To ascertain the efficacy, safety, and acceptability of mifepristone plus different prostaglandin for terminating early pregnancy while widely use in urban and rural area in China, and to search the way to link family planning research and service together for implementation of introductory field study. The present study consisted of two parts - pilot and main trials. 17523 healthy women requested to terminate early pregnancy voluntarily were recruited after obtaining consents. A total dose of mifepristone 150 mg was given orally in a separated regimen, followed by PG05 1mg vaginal supository or oral administration of misoprostol 600 μg. All subjects were followed up till menstruation recovery or stopping pregnancy by curettage. Results: Similar treatment outcome was found in the above two regimen, with complete abortion rates of 93.2% and 93.3%. There were significant correlation between abortion rate and subject’s age, and gravidity. Most women showed no obvious side effects. The incidence of diarrhoea and vomitting were higher in PG05 group (53.4% and 34.9%) than that in misoprostol group (32.2% and 27.4%)(P<0.001). The complaints of nausea, dizziness, fatigue and aching lumbus were slight and similar in two groups. One case suffered from allergic shock after taking misoprostol and 8 subjects needed blood transfusion due to incomplete abortion, all above patients were recovered well. In selfe-assessment, 84.5% of subjects expressed their willing to use medical abortion in the case they need to terminate undesired early pregnancy in the future. Conclusion: The combination therapy both of mifepristone with PG05 and misoprostol was highly effective, safe and ease for induced abortion of early pregnancy whatever in urban and/or rural area in China. But the medical abortion should only be performed under close supervision with all necessary facilities for emergency treatment.更多还原