两种紧急避孕方法比较性研究

Mifepristone in Combination with Misoprostol vs. Low Dose Mifepristone Alone in Emergency Contraception: a Multicenter Double-blind Randomized Clinical Trial

目的 :比较不同低剂量米非司酮配伍米索前列醇与单服米非司酮用于紧急避孕的效果及其副反应。方法 :运用随机双盲多中心临床比较 ,研究 899例健康妇女在无保护性性交后 1 2 0 h内 ,随机分为 3组。组 (3 0 0例 ) :口服 2 5 mg米非司酮 ,2 4 h后口服 0 .2 mg米索前列醇 ;组 (2 99例 ) :口服 1 0 mg米非司酮 ,2 4 h后口服 0 .2 mg米索前列醇 ;组 (3 0 0例 ) :单服米非司酮 1 0 mg。按 Dixon法推算避孕有效率。结果 :899例妇女中总妊娠数 1 1例 :组 2例 ,组 2例 ,组 7例 ;方法失败 :组 1例 ,组 0例 ,组 5例 ;避孕有效率分别为 95 .5 %、1 0 0 %、76 .9%。组 加组 与组 相比有极显著差异 (P<0 .0 1 )。副反应较轻均可耐受 ,无严重副反应。米非司酮配伍米索前列醇与单服米非司酮组间副反应也无显著差异。结论 :应用低剂量米非司酮和米索前列醇作为紧急避孕是有效安全的紧急避孕方案 ,且对月经周期无明显干扰。

Objective: To compare the effectiveness and side-effects of different low dose Mifepristone in combination with Misoprostol and low doses Mifepristone alone in emergency contraception. Methods: This is a randomized double-blind multicenter comparative clinical trial, 899 healthy womenwere allocated into this trial. They were randomly divided into 3 groups. They were orally administrated with different emergency contraceptives with 120 h after unprotected intercourse.GroupⅠ(n=300): 25 mg Mifepristone plus 0.2 mg Misoprostol after 24 hours. GroupⅡ(n=299): 10 mg Mifepristone plus 0.2 mg Misoprostol after 24 hours. GroupⅢ(n=300): 10 mg Mifepristone alone. The effective rates of contraceptives were calculated with Dixon method. Results:There were 11 pregnancies totally,2 cases in GroupⅠ,2 cases in GroupⅡ, 7 cases in GroupⅢ. After correction with method failure, there was only 1 case in GroupⅠ,0 case in GroupⅡ,5 cases in Group Ⅲ,and the contraceptive effectiveness rate was 95.5% ,100% and 76.9% respectively. The pregnancy rate was significantly lower in group Ⅰ and group Ⅱ than that of group Ⅲ(P<0.01) . The side effects were slight and tolerable, and there was no significant difference between Mifepristone in combination with Misoprostol and Mifepristone alone(P>0.05). Conclusion:Use of low dose Mifepristone(25 mg,10 mg) in combination with 0.2 mg Misoprostol was an effective and safe treatment regimen for emergency contraception with no prominent side effects.