不同剂量米非司酮用于紧急避孕的临床多中心研究  

Low Doses of Mifepristone for Emergency Contraception

作　　者：程利南[1] 童伟良[1] 

机构地区：[1]中国福利会国际和平妇幼保健院

出　　处：《中华妇产科杂志》1999年第6期335-338,共4页Chinese Journal of Obstetrics and Gynecology

摘　　要：目的评价３种小剂量米非司酮用于紧急避孕的临床效果、副反应和对月经的影响。方法将６３９例年龄在１８～４５岁、无避孕或避孕措施失败性交后５天（１２０小时）以内，要求采用补救措施以防止意外妊娠的健康妇女，随机分为３组。组Ⅰ口服米非司酮５０ｍｇ；组Ⅱ口服２５ｍｇ；组Ⅲ口服１０ｍｇ。用门诊随访形式，观察用药后的副反应和妊娠与否。结果３组紧急避孕的临床效果分别为：９３．４％、９３．３％和９３．８％（Ｐ＞０．０５）。口服米非司酮后恶心、呕吐等副反应程度都较轻，无需特殊处理。无副反应者的比率，随着米非司酮用药剂量的减少而明显增加（Ｐ＜０．０５）。１２％～１４％月经提前来潮，２５％～２８％月经来潮延迟。组Ⅰ月经延迟的平均天数（１１天）比组Ⅲ（８天）明显增加（Ｐ＜０．０５）。结论米非司酮３种剂量（５０ｍｇ、２５ｍｇ和１０ｍｇ）用于性交后５天内紧急避孕都能安全。Objective To investigate the efficacy of three different low doses of mifepristone for emergency contraception, the side effects and the influence to the next menstruation. Methods A randomized multicentre trial was conducted in Shanghai. 639 women with regular cycles and history of unprotected intercourse within 120h of attendance were recruited, and they were randomly assigned to three groups. Group (n=214) mifepristone 50mg was given, group (n=214) 25mg and group (n=211) 10 mg. Results There were eight pregnancies totally, 2 cases in group , 1 in group and 5 in group . After correction for method failure there was only 1 pregnancy in each group and the contraceptive effectiveness rate were 93.4%, 93.3% and93.8% respectively. The side effects of mifepristone were slight and tolerable and there was significant difference between the 50mg group and the lower doses (25mg and 10mg) groups (P<0.05) in women with no complaints. There were about 12%14% women had a early onset of menses and about 25%28% had a late one, but no significant differences were found among the 3 groups. The average days of delayed onset of next menstruation were significant longer in group than that in group (P<0.05). Conclusion All the 3 doses of mifepristone could be used as an effective emergency contraception.

关 键 词：米非司酮 避孕 紧急避孕 

分 类 号：R169.41[医药卫生—公共卫生与预防医学] R984