妈富隆提高药物流产效果的随机双盲对照研究

Effect of Marvelon on Medical Abortion:a Randomized,Double-blind and Multi-center Control Study

目的:观察药物流产后及时服用妈富隆的临床效果。方法:在上海市区3个临床中心共招纳600例因非意愿妊娠要求药物流产的早孕(<49 d)健康妇女,采用随机双盲对照的多中心临床研究。各中心门诊按药物流产常规接纳对象,口服米非司酮配伍米索前列醇,孕囊排出后随机分为A组和B组,于当日起每晚加服A或B药(外包装相似)1片,连服21 d,定期随访完全流产率、阴道出血时间、月经恢复情况等。结果:完全按医嘱执行并纳入资料分析的共414例,统计后揭秘A药为妈富隆(去氧孕烯炔雌醇片),209例,B药为安慰剂(不含任何药物的淀粉剂),205例,妈富隆组完全流产率高、月经恢复时间和经期出血时间短,与对照组比较差异均有统计学意义(P<0.05)。结论:药物流产后及时连续口服妈富隆21 d,能提高完全流产率,促进月经恢复,缩短流产后出血时间、转经时间和行经时间。

Objective： To evaluate the clinical effect of Marvelon on the abortion induced by mifepristone and misoprostol.Methods： This was a randomized,double-blind,multi-center control study.Pregnant women meeting the criteria of medical abortion were enrolled in different outpatient centers（3 hospital） of Shanghai,China.After the gestational sac was discharged,all subjects were randomly assigned into two groups： group A based on that the subjects were administered medicine A and group B based on that the subjects was administered medicine B for the next continual 21 d.The complete abortion rate and the time of vaginal bleeding and menstruation recovery were followed up.Results： Total 414 subjects were recruited： group A——Marvelon（desogestrel ethinyl estradiol tablets） group,included 209 cases,and group B——the placebo（only starch） group,included 205 cases.Group A had significant high rate of complete abortion,short time of vaginal bleeding and menstruation recovery compared with group B（P0.05）.Conclusion： Oral administration of Marvelon for continual 21d just after medical abortion significantly enhances the rate of complete abortion and shortens the time of vaginal bleeding and menstruation recovery.