不同剂量米非司酮及合并双炔失碳酯用于紧急避孕的多中心随机临床研究

目的了解在无保护性交后９６小时内应用不同剂量米非司酮及与双炔失碳配伍用于紧急避孕的效果及其副反应。方法将无保护性交后９６小时内的２４００例健康育龄妇女随机分为４组（每组６００例）,分别予单次口服２５ｍｇ米非司酮、２５ｍｇ米非司酮加７．５ｍｇ双炔失碳酯、１０ｍｇ米非司酮加５ｍｇ双炔失碳酯及１０ｍｇ米非司酮。按Ｄｉｘｏｎ法推算避孕有效率。结果除２例接纳错误和１１例失访外,２３８７例妇女的总预期妊娠数为１７１．９例,实际妊娠３２例。４组的避孕有效率分别为８０．９％、８５．３％、９０．６％和６７．３％。１０ｍｇ米非司酮配伍５ｍｇ双炔失碳酯的避孕失败率０．７％,显著低于单次口服１０ｍｇ米非司酮者（２．２％）（Ｐ＜０．０５）。４组的诱导性出血发生率分别为９．２％、４．９％、３．４％和６．７％,配伍双炔失碳酯后诱导性出血发生率明显低于单次口服米非司酮者（Ｐ＜０．０１）。结论２５ｍｇ米非司酮或者１０ｍｇ米非司酮合并５ｍｇ双炔失碳酯为安全有效的紧急避孕方案,无严重副反应及对月经周期的明显干扰     

米非司酮用于紧急避孕的临床观察

目的：探讨米非司酮单独应用与以炔失碳失碳酯合并应用的紧避孕效果。方法：将避孕失败或无保护性生活后７２小时内有的３００例健康妇女随机分为３组。组Ｉ（１００例），口服米非司酮２５ｍｇ，１２小时后重复１次，组Ⅱ（９９例），口服米非司酮２５ｍｇ１次；组Ⅲ（１０１例），１次口服米非司司酮２５ｍｇ及双炔失碳酯７．５ｍｇ。结果：组Ｉ无妊娠发生，组Ⅱ、组Ⅲ各妊娠１例；避孕有效率３组依次为１００．０％，８３．８％，     

米非司酮单独或合并双炔失碳酯用于紧急避孕的临床比较研究

探讨低剂量米非司酮单独或合并双炔失碳酯应用于紧急避孕的临床效果。将避孕失败或无保护性生活后９６ｈ内就诊的２６０例健康妇女随机分为４组,组Ⅰ（６５例）：单次口服米非司酮２５ｍｇ;组Ⅱ（６５例）：单次同时口服米非同酮２５ｍｇ,双炔失碳酯７．５ｍｇ;组Ⅲ（６５例）：单次同时口服米非司酮１０ｍｇ,双炔失碳酯５ｍｇ;组Ⅳ（６５例）：单次口服米非司酮１０ｍｇ。结果显示各组均有一例妊娠,失败率均为１．５４％,避孕有效率４组依次为７６．１５％、７９．３６％、８１．９４％、８１．９５％,各组间差异无显著性（Ｐ＞０．０５）。服药后月经周期改变少,且与服药时间有关,副反应发生比例低。表明单次服用低剂量米非司酮２５ｍｇ或１０ｍｇ都可作为有效紧急避孕方法,米非司酮与双炔失碳酯合用未显示出协同作用。     

米非司酮单独或与双炔失碳酯联合用于紧急避孕的临床观察

米非司酮单独或与双炔失碳酯联合用于紧急避孕的临床观察韩学军，翁梨驹，肖碧莲（北京朝阳医院妇产科，北京，１０００２０）（国家计生委科研所，北京，１０００８１）本文的目的是评价和比较５０ｍｇ或２５ｍｇ米非司酮单独服用以及２５ｍｇ米非司酮与７．５ｍｇ双炔失...     

不同剂量米非司酮用于紧急避孕的临床多中心研究

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组紧急际的临床效果分别为：９３．４％、９３．３％和９３．８％。口服米非     

左炔诺孕酮和小剂量米非司酮用于紧急避孕的临床观察

目的 观察单方左炔诺孕酮和小剂量米非司酮用于紧急避妥的效果、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,交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,地预期下次月经第７天随诊,判断避孕效果,记     

口服10 mg米非司酮用于紧急避孕的临床研究

在目前进行的口服药物紧急避孕研究中，国外推荐使用三类药物［１］，雌孕激素复合片、纯孕激素（左炔诺孕酮）和米非司酮。与雌孕激素复合片和纯孕激素相比，米非司酮仅服一次，并可将前两类药物房事后７２ｈ应用延长到５ｄ（１２０ｈ），是很有希望的紧急避孕药物；但通常用于流产剂量的息隐类米非司酮剂量大、副反应重；探索低剂量安全有效的米非司酮紧急避孕方法已势在必行。本研究在有关米非司酮减量至５０ｍｇ、２５ｍｇ用于紧急避孕的相关基础［２～５］上，使用１０ｍｇ米非司酮单次口服用于紧急避孕，收到良好效果，现总结如下。对…     

小剂量米非司酮用于紧急避孕的研究

目的：探讨一次性小剂量米非司酮25mg用于紧急避孕的效果及可接受性。方法：征集无保护性交或避孕措施失败后72小时内来院就诊的健康发女100例,单次口服米非司酮25mg,服药后按时随访并观察药物副反应及下次月经情况,保证月经复潮前禁欲或采用避孕套避孕。结果：根据Dixon方法计算,预期妊娠数为8．845,实际妊娠数为2例,避孕有效率为77．4％。实际妊娠与预期妊娠相比,有显著差异（P＜0．05）。结论：小剂量米非司酮用于紧急避孕是非常简便、安全、有效的方法。     

米非司酮用于子宫肌瘤患者治疗及避孕的研究

目的：探讨子宫肌瘤患者应用米非司酮治疗和避孕的效果。方法：将１１４例随机分为两组。第１组（６８例）,子宫＜妊娠７周大。在月经第８至１５天给予米非司酮２５ｍｇ／ｄ,第１６至２３天,每天给予甲地孕酮１ｍｇ合并乙炔雌二醇０．０２５ｍｇ。３个月经周期为一疗程,停药２个周期后继续用药。第２组（４６例）,子宫相当妊娠７～１２周大,每天服用米非司酮１０ｍｇ,１２周为一疗程,在２次转经后继续服用。用阴道超声了解治疗前和２个疗程后肌瘤的变化,服药期间不用其它方法避孕。结果：服药组无意外妊娠发生。２个疗程后,两组肌瘤平均体积均较前显著缩小（Ｐ＜０．０１）。血清ＰＲＬ、ＡＣＴＨ、皮质醇和肝肾功能均正常。结论：长期间断序贯应用米非司酮和甲地孕酮加乙炔雌二醇和米非司酮１０ｍｇ连续应用１２ｗ的方案,可成为子宫肌瘤患者及避孕和治疗的方法,且无明显副作用。     

米非司酮与双炔失碳酯联合用于紧急避孕的临床观察

目的探讨低剂量米非司酮配伍双炔失碳酯应用于紧急避孕的效果。方法将142例月经规律的合格妇女随机分为2组，观察组(66例)在避孕失败或无保护性性交后72h内开始服用米非司酮10mg 双炔失碳酯5mg，对照组(76例)在避孕失败或无保护性性交后72h内开始服用单剂量米非司酮10mg，观察两组避孕效果、不良反应及月经情况。结果采用经典Dixon法计算，观察组避孕有效率为90．6％，对照组避孕有效率为67．4％，观察组诱导出血率低于对照组，但月经变化及不良反应无明显差异。结论米非司酮10mg 双炔失碳酯5mg为安全有效、服用简便的紧急避孕方法。     

两种低剂量米非司酮用于房事后紧急避孕的临床研究

为探索米非司酮作为紧急避孕的合适剂量,本研究对避孕失败或未避孕同房７２ ｈ 内要求紧急避孕的６６０例妇女,随机单次服米非司酮１０ ｍ ｇ 或２５ ｍ ｇ。结果：１０ ｍ ｇ 组３２１例中妊娠３例,２５ ｍ ｇ 组３３９例中妊娠４例,均明显低于预期妊娠数,组间差异不明显。避孕有效率分别为８８．２４％ 和８３．４３％ ,副反应轻微。两组分别有１４．１５％ 和２１．１９％ 的服药者周期延长３天以上,组间差异显著（Ｐ＜ ０．０５）。本研究提示１０ ｍ ｇ 和２５ ｍ ｇ 两种剂量的米非司酮皆为合适的紧急避孕剂量。对月经的影响而言１０ ｍ ｇ 组优于２５ ｍ ｇ 组。     

两种紧急避孕方法比较性研究

目的 :比较不同低剂量米非司酮配伍米索前列醇与单服米非司酮用于紧急避孕的效果及其副反应。方法 :运用随机双盲多中心临床比较 ,研究 899例健康妇女在无保护性性交后 1 2 0 h内 ,随机分为 3组。组 (3 0 0例 ) :口服 2 5 mg米非司酮 ,2 4 h后口服 0 .2 mg米索前列醇 ;组 (2 99例 ) :口服 1 0 mg米非司酮 ,2 4 h后口服 0 .2 mg米索前列醇 ;组 (3 0 0例 ) :单服米非司酮 1 0 mg。按 Dixon法推算避孕有效率。结果 :899例妇女中总妊娠数 1 1例 :组 2例 ,组 2例 ,组 7例 ;方法失败 :组 1例 ,组 0例 ,组 5例 ;避孕有效率分别为 95 .5 %、1 0 0 %、76 .9%。组 加组 与组 相比有极显著差异 (P<0 .0 1 )。副反应较轻均可耐受 ,无严重副反应。米非司酮配伍米索前列醇与单服米非司酮组间副反应也无显著差异。结论 :应用低剂量米非司酮和米索前列醇作为紧急避孕是有效安全的紧急避孕方案 ,且对月经周期无明显干扰。     

Comparison of three single doses of mifepristone as emergency contraception: a randomised controlled trial

BACKGROUND: This is an analysis of the Australian component of a large World Health Organization multicentre dose-finding study of mifepristone for emergency contraception and the first clinical study of this controversial drug in Australia. AIMS: To compare the effectiveness and side-effects of three single doses of mifepristone taken within 120 h after unprotected coitus as emergency contraception. DESIGN: Double-blind, randomised controlled trial. SUBJECTS AND METHODS: One hundred fifty healthy women with regular menstrual cycles who requested emergency contraception. Participants were allocated randomly to one of the three doses (10, 50 and 600 mg). The primary outcome was confirmed pregnancy, and secondary outcome measures included side-effects and delay in the onset of the next menses. RESULTS: Pregnancy rates for mifepristone 10, 50 and 600 mg were 2.0, 2.1 and 2.1%, respectively, with no significant difference between groups. No major side-effects occurred, except an unpredictable delay in the onset of the next menses. Mifepristone 600 mg caused a significantly longer delay in the onset of the next menses than either the 10 or the 50 mg dose. CONCLUSION: Lowering the dose of mifepristone from 600 to 10 mg did not significantly impair its effectiveness as an emergency contraceptive, and caused less delay in the onset of the next menses. Therefore, a dose as low as 10 mg may be preferable to 600 mg for emergency contraception. This is very much lower than the dose required to terminate a pregnancy.     

米非司酮用于紧急避孕600例临床观察

探讨小剂量米非司酮150mg、50mg及25mg应用于紧急避孕的效果.对避孕失败或无避孕措施的性交后72h内就诊的健康妇女6o0例,随机分成3组.Ⅰ组:单次口服米非司酮150mg.Ⅱ组:单次口服米非司酮50mg.Ⅲ组:单次口服米非司酮25mg.结果:Ⅰ组200例.3例妊娠.Ⅱ组200例,4例妊娠.Ⅲ组200例,3例妊娠.均明显低于预期妊娠数(3组相应预期妊娠数分别为17.O30、15.000、14.868),两者之间存在显著差异(P<0.01).避孕有效率Ⅰ组为82.3%、Ⅱ组为73.3%、Ⅲ组为79.8%,3组之间无显著差异.服药后下次月经周期的改变,3组中以Ⅰ组变化较大;Ⅱ、Ⅲ组变化较小,Ⅰ组与Ⅱ、Ⅲ组之间存在显著差异(P<0.01),但3组总共有80.3%月经周期无改变,从总体上看对月经影响较少.仅有4.8%的人有轻微的副反应.表明150mg、50mg或25mg米非司酮作为性交后72h内的紧急避孕是有效的.建议用25mg米非司酮作为紧急避孕药.     

A randomised study comparing a low dose of mifepristone and the Yuzpe regimen for emergency contraception

Objective To compare 100 mg mifepristone with the standard Yuzpe regimen for emergency contraception.
Design Randomised controlled trial.
Setting Family Planning Clinic, Aberdeen.
Sample One thousand women seeking emergency contraception within 72 hours after an episode of unprotected sexual intercourse.
Methods Women were randomised to receive either 100 mg (half tablet) of mifepristone as a single dose or the Yuzpe regimen (two tablets each with 50 μg ethinyloestradiol and 0.25 mg levonorgestrel, to be repeated 12 hours later).
Outcome measures Crude pregnancy rates, proportion of pregnancies prevented, side effects and patient acceptability.
Results The crude pregnancy rates (95% CI) for the Yuzpe regimen and mifepristone were 3.6% (2.3–5.7) and 0.6% (0.2–1.8), respectively, with a significant difference between the two groups (RR 6.04; 95% CI 1.75–20.75). Mifepristone prevented 92% of pregnancies and the Yuzpe regimen preventing 56%. An increasing coitus to treatment interval was associated with contraceptive failure in the Yuzpe group (   P = 0.03  ) with no association seen with mifepristone. Following administration of mifepristone 24.5% and 13.1% given the Yuzpe regimen had a delayed period (RR 2.14; 95% CI 1.46–3.15). Overall, mifepristone was better tolerated than the Yuzpe regimen with significantly fewer side effects. More women were satisfied (   P < 0.0001  ) with mifepristone as an emergency contraceptive and would recommend it to a friend (   P = 0.02  ).
Conclusion Mifepristone administered in a 100 mg dose is a highly effective post-coital contraceptive with high patient acceptability and fewer side effects compared with the standard Yuzpe regimen. Delay in the onset of menstruation did not decrease patient acceptability.