A randomized double-blind multicenter study on comparing levonorgestrel and mifepristone for emergency contraception

Objective: To compare the efficacy and side effects of levonorgestrel and low dose mifepristone in emergency contraception. Method: The study is a randomized double--blind multicenter comparative trial. A total of 1, 276 women with unprotected intercourse within 72 hours were allocated to one of the two study groups. In the levonorgestrel (LNG) group, 0. 75 mg LNG was taken twice, 12 hours apart, whereas in the mifepristone (Mife) group, a single dose of 10 mg mifepristone was taken and a placebo 12 hours after. Follow--up visit was paid on the seventh day of the expected next menstruation to evaluate the contraceptive efficacy and side effects. Contraceptive efficacy was calculated by Dixon’s method. Result:In the LNG group 20 pregnancies occurred among 643 women, while in the Mife group 9 pregnancies occurred among 633 women. The pregnancy rates were 3. 10% and 1. 43% respectively. Contraceptive efficacy rate of preventing pregnancy was 59. 16% and 79. 73%, the difference was statistically significant (P<O. 05). The incidence of various side effects, which were mild, was less than 10%. There was no statistical difference between the two groups. The percentage of subjects who had their next menstruation 3 days earlier or later than their expected menstruation in LNG group and Mife group was 77. 7% and 78. 5% respectively. Conclusion: Use of levonorgestrel or low dose mifepristone for emergency contraception is effective and safe.

三种不同剂量米非司酮用于紧急事后避孕随机对比临床观察

为探索米非司酮用于紧急事后避孕的最低有效剂量,接纳无保护房事后120小时内要求紧急服药避孕者共150例,随机分成三组,分别为600mg组49例;50mg组51例及10mg组50例,均为一次服药,比较避孕有效率,副反应发生率及对下次月经来潮的影响。结果仅10mg组有1例妊娠,按Dixon法计算出三组相应的避孕有效率:600mg组、50mg组均为100％,10mg组为75.8％。副反应轻微,月经延迟发生率在7天以上者,三组分别为12.3％、11.7％及8.2％。研究结果证明低剂量米非司酮10mg和50mg用作紧急事后避孕和高剂量600mg同样有效。

小剂量米非司酮用于紧急避孕200例的临床观察

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。

小剂量米非司酮和左炔诺孕酮用于紧急避孕的随机对照研究

目的 以左炔诺孕酮为参比制剂 ,观察 2 5mg米非司酮用于紧急避孕的临床效果、副反应及可接受性。方法 采用开放性随机对照性试验方法 ,按研究方案接纳单次无保护性交 72小时内要求紧急避孕的妇女 2 0 0例 ,随机分配到观察组 (n =10 0 )和对照组 (n =10 0 )。观察组单次口服 2 5mg米非司酮 (1片 ) ;对照组口服左炔诺孕酮 (毓婷 ) 0 75mg(1片 ) ,12小时后再服左炔诺孕酮 0 75mg(1片 )。服药后嘱两组对象按期随访直至月经来潮 ,并观察其避孕效果 ,副反应 ,对月经的影响及药物可接受情况。结果 采用经典Dixon方法计算 ,两组对象各有 1例妊娠 ,观察组避孕效果达 88 2 9% ,对照组为 89 13 % ,统计学上无明显差异 ;两组副反应轻 ,无任何不良反应发生。

不同剂量米非司酮用于紧急避孕的临床比较观察

目的 比较米非司酮 2 5mg和 10mg用于紧急避孕的有效性、副反应及可接受性。 方法 采用双盲随机比较试验方法 ,共接纳合格妇女 2 0 0例 1次无防护性交后 72小时内随机进入Ⅰ组 (n =10 0 )和Ⅱ组 (n =10 0 ) ,予以治疗。Ⅰ组一次性服用米非司酮 1片 (每片 2 5mg)及安慰剂 1片 ;Ⅱ组一次性服用米非司酮 2片 (每片5mg) ,总量为 10mg。于预期下次月经日期的第 7天随访 ,了解避孕效果、副反应及月经的变化。 结果 两组各发生 1例妊娠 ,失败率均为 1% ,避孕有效率分别为 89 6 5 %和 90 40 % ,P >0 0 5 ,无统计学差异 ;各种副反应发生率较低 ,均在 10 %以内 ,两组相近 ;月经趋于正常者两组分别为 86 %和 88% ,P >0 0 5。结论 低剂量米非司酮 2 5mg ,乃至 10mg用于紧急避孕同样是安全有效的。