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左炔诺孕酮和小剂量米非司酮用于紧急避孕的临床观察 被引量:49

A Randomized, Doubleblind, Multicentre Study on Comparing Levonorgestrel and Mifepristone for Emergency Contraception
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摘要 目的观察单方左炔诺孕酮和小剂量米非司酮用于紧急避孕的效果、副反应及对月经的影响。方法采用随机、双盲的多中心对比方法,将在未保护性交或避孕失败72小时内要求紧急避孕的妇女随机分为左炔诺孕酮(左炔)组(643例)和米非司酮(米非)组(633例),左炔组每次服用左炔诺孕酮0.75mg,间隔12小时,共2次;米非组单次服用米非司酮10mg,12小时后服空白片。于预期下次月经第7天随诊,判断避孕效果,记录副反应和月经情况。避孕有效率以Dixon预期妊娠概率计算。结果两组的实际妊娠数分别为20例和9例,失败率为3.1%和1.4%,实际有效率为59.2%和79.7%,差异有显著性(P<0.05)。用药后两组各种副反应发生率均未超过10.0%,程度轻微,两组间差异无显著性。下次月经按期来潮者在左炔组和米非组分别为72.4%和67.8%,与平时月经量相似者分别为77.7%和78.5%,经期在7天内者分别为95.0%和93.3%。结论两种药物用于紧急避孕均有效。 Objective To compare the efficacy, side effects and the effect on next menstruation of levonorgestrel(LNG) to low dose mifepristone in emergency contraception. Methods The study is a randomized doubleblind multicenter comparative trial. The clients who have unprotected intercourse within 72 hours were allocated to one of the two study groups. In LNG group, 0.75 mg LNG was taken twice with 12 hours apart. In mifepristone (Mife) group, single dose of 10 mg mifepristone was taken and a placebo 12 hours after. Followup visit was paid on the seventh day of the expected next menstruation to evaluate the contraceptive efficacy and to record side effects and menstruation. Contraceptive efficacy was calculated by Dixon's method. ResultsThe total valid subjects in LNG and Mife group were 643 and 633, respectively. There were 20 and 9 pregnancies occurred respectively in each group. The failure rate was 3.1% and 1.4%. Contraceptive efficacy rate of preventing pregnancy was 59.2% and 79.7%, the difference was statistically significant (P<0.05).The incidence of various side effects was less than 10.0% which were mild. There was no statistically difference between the two groups. The percentage of subjects who had their next menstruation before or after their expected menstruation 3 days in LNG group and Mife group was 77.7% and 78.5% respectively. The menstrual period less than 7 days was 95.0% and 93.3%. Conclusion Use of levonorgestrel or low dose mifepristone for emergency contraception is effective and safe.
出处 《中华妇产科杂志》 CAS CSCD 北大核心 1999年第6期327-330,共4页 Chinese Journal of Obstetrics and Gynecology
基金 国家计划生育委员会资助
关键词 避孕 左炔诺孕酮 米非司酮 紧急避孕 Contraception LevonorgestrelMifepristoneRandomized controlled trial
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