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

Randomised controlled prospective studies of mifepristone in small doses and levonorgestrel for emergency contraception

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。

Objective To observe the contraceptive efficacy,side effects,influences on menstruation and acceptability of mifepristone in small doses,comparing with levonorgestrel.Methods By using randomised controlled methods,200 women with unprotected intercourse within 72 hours were enrolled into two groups,GroupⅠand GroupⅡ.In GroupⅠ(n=100),patients were given mifepristone in a single dose of 25mg.In GroupⅡ(n=100),patients were given 0 75mg levonorgestrel;and twelve hours later,were given Ganother 0 75mg levonorgestrel.Both two groups' patients were told to receive follow-up survey on time,including their contraceptive efficacy,side effects and changes of menstruation.Results There was one pregnancy occurred in each group.According to the classic methods of Dixon,the effective rate of contraception was 88 29% in GroupⅠand 89 13% in GroupⅡ.There were no significant differences between the two groups (P>0 05) .The side effects were slight and there were no adverse reaction occurred.Conclusion Mifepristone in small doses for emergency contraception has the same effect as levonorgestrel.