小剂量米非司酮用于紧急避孕200例的临床观察

200 Case Clinical trial of mifepristone in low doses for emergency contraception

目的 比较米非司酮25mg和10mg用于紧急避孕的有效性、副反应、对月经周期的影响。方法 采用双盲随机比较试验方法,共接纳合格妇女200例1次无防护性交72小时内随机进入第一组和第二组,第一组一次性口服米非司酮25mg和安慰剂1片;第二组一次性口服米非司酮10mg。随访至月经来潮,了解避孕效果、副反应、月经周期的变化。结果两组分别有2例和1例妊娠,失败率分别为2％和1％,避孕有效率分别为82.21％和90.18％,p>0.05,无统计学意义;副反应很轻微,发生率很低;服药时间对月经周期有影响;两种药量对月经周期没影响。结论 小剂量米非司酮25mg和10mg用于紧急避孕同样有效,并且效果良好。

ObjectiveTo compare the efficacy, side effects and the influence to menstruation in mifepristone 25 mg or 10mg for emergency contraception. Methods; The study was a doubel-blind randomized comparative trial. 200 health women,who were after 72 hours of unprotected intercourse,were allocated to either group 1 or 2 for treatment, each group conisists of 100 women In group 1 mifepristone 25mg(l tablet)and placebo 1 tablet were taken. In group 2 mifepristone 2 tablets of 5mg was taken. In order to evaluate the contraceptive efficacy, side effects of mifepristone and the changes of menstruation. Results; In group 1 two women was pregnant and In group 2 one woman was pregnant. The failure rate was 2% in group 1 and 1% in group 2. Contraceptive rate was 82. 21% in group 1 and 90. 18% in group 2. There was no statistical difference between two groups(P>0. 05). The side effects were mild and rare occurred. The effect was found to menstruation in the time of taking mifepristone,but its doses has not any effect to the menstruation. Conclusion: It is equally effective and safe to use low dose of mifepristone 25mg and lOmg in emergency contraception.