摘要
目的 评估 10mg米非司酮在临床扩大研究中用于紧急避孕的效果和副反应。 方法对全国 18个省市中 31个研究中心接收的 ,在 12 0h之内仅有过 1次无保护性生活的 4 94 5例妇女 ,应用 10mg米非司酮。观察妊娠率、影响妊娠的危险性因素、服药副反应及服药后月经的情况等。 结果4 94 5例中 2 8例失访。根据随访的 4 917例的资料分析 ,妊娠率为 1 4 % [95 %可信限为 1 1(低值 ) ,1 8(高值 ) ,下同 ],预防妊娠的有效率为 82 2 % ,( 95 %可信限为 77 5 ,86 2 )。在 12 0h之内 ,随着时间的延迟 ,妊娠率无增加趋势。如在服药后再有无保护性生活 ,妊娠危险系数可增加 11 1倍。年龄、体重指数、无保护性生活时的月经时相及生育史等因素 ,对妊娠危险性有影响。 4 917例妇女中 ,仅790例 ( 16 1% )发生副反应且副反应较轻 ,恶心、呕吐为 9 2 % ,其他副反应为 0 7%～ 3 7%。服药后月经延迟 7d以上的妇女为 6 5 %。结论 10mg米非司酮用于紧急避孕是安全、有效的。
Objective To evaluate the effectiveness of 10mg mifepristone used for emergency contraception in a large population in China A total of 4945 women was recruited in 31 clinical centers in 18 provinces and municipalities in China in a descriptive clinical trial with one dose treatment Method A single dose of 10 mg of mifepristone was given to women who has one episode of unprotected intercourse within 120 hours Results There were 28 cases lost to follow up An analysis of 4917 cases showed a pregnancy rate of 1 4% (95 CI 1 1, 1 8) and an effectiveness of prevention of pregnancy 82 2% (95% CI 77 5, 86 2) No trend of increase of pregnancies with delay of treatment was found Increase of risk of pregnancy in women who had unprotected intercourse after treatment is about 11 1 times higher Other factors,such as age, body mass index, menstrual phases when unprotected intercourse occur and previous live birth also affect the risk of pregnancy Side effects were mild and in small proportion of women, such as nausea and vomiting in 9 2% and other side effects in 0 7%～3 7% of women. Delay of menstruation over 7 days occurred in 6 5% of women Conclusions The expanded study further confirmed the high efficacy of 10 mg mifepristone for emergency contraception It is also safe and acceptable
出处
《中华妇产科杂志》
CAS
CSCD
北大核心
2004年第1期35-38,共4页
Chinese Journal of Obstetrics and Gynecology
基金
洛氏基金会基金资助项目
