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目的验证复方米非司酮制剂配方的合理性。方法将妊娠≤49d的早孕妇女随机分为观察组和对照组,按照药品说明书服药,测定各项临床指标,结合几种药物成分的作用机制,分析药物剂型的合理性。结果从完全流产率、孕囊排出时间、出血时间、出血量和不良反应方面分析比较,复方米非司酮诱导流产的效果及安全性要优于单独使用米非司酮。结论从临床疗效方面评价,复方米非司酮制剂配方科学、合理。
Objective To verify the rationality of compound mifepristone formulation. Methods Pregnant women with pregnancy less than 49d were randomly divided into observation group and control group. According to the instructions of medicine, the clinical indexes were determined and the mechanism of several drug components were combined to analyze the rationality of drug formulation. Results From the analysis of complete abortion rate, gestational sac excretion time, bleeding time, blood loss and adverse reactions, the effect and safety of compound mifepristone induced abortion were better than that of mifepristone alone. Conclusion From the clinical efficacy evaluation, the compound mifepristone formulation is scientific and reasonable.