小剂量米非司酮分次口服用于紧急避孕的临床观察

Clincal trial of taking lower dose of mifepristone twice for emergency contraception

目的 比较顿服米非司酮 10 mg和米非司酮 2 0 mg分次口服用于紧急避孕的有效性、副作用及对月经的影响。 方法 采用双盲随机比较试验方法 ,共接纳符合要求条件的育龄妇女 10 0例随机进入 组 ( n=5 0 )和 组 ( n=5 0 ) ,予以治疗。于预期下次月经日期的第 7d随访 ,了解避孕效果、副作用及月经的变化。 结果 按 Dixon法计算两组避孕有效率分别为 6 7.3%及 10 0 %,两组间比较有显著性差异 ( P<0 .0 5 )。各种副作用发生率较低 ,均在 10 %以内 ,两组相近 ;月经变化两组间无显著性差异 ( P>0 .0 5 )。 结论 米非司酮 10 mg口服 ,12 h加服 10 m g的用法与顿服米非司酮 10 m g相比 ,明显提高了紧急避孕有效率 ,而且副作用小 ,可以安全使用。

Objective To compare the efficacy, side effects and the influences on menstruation by taking orally mifepristone 10 mg once or twice a day at the interval of 12 hours for emergency contraception. Methods The study was a double blind randomized comparative trial. 100 eligible women were allocated to either group Ⅰ or Ⅱ for treatment, each group consisted of 50 women. Follow up was performed on the 7th day of the next expected period of menstruation in order to evaluate the contraceptive efficacy, side effects of mifepristone and the changes of menstruation. Results Contraceptive rate was calculated with Dixon method, the contraceptive rate was 67.3% in group Ⅰ and 100% in group Ⅱ, with statistically significant difference (P<0.05). The side effects were mild and its incidence was less than 10% in both groups in the change of menstruation (P> 0.05). Conclusions Mifepristone of lower dosage can improve the efficacy of emergency contraception, and its side effects are mild.