10mg米非司酮紧急避孕102例临床观察

目的:观察10mg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:对无防护性生活5天以内的102例要求紧急避孕的妇女口服米非司酮10mg,并嘱其在服药后7~10天、月经来潮或延迟不来时随诊。结果:102例妇女中有2例妊娠,妊娠率(即避孕失败率)1.96%,其副反应及对月经影响均不明显。结论:10mg米非司酮用于紧急避孕是安全、有效的。     

1.5mg左炔诺孕酮肠溶胶囊用于紧急避孕的临床多中心研究

目的:比较1.5 mg左炔诺孕酮(LNG)肠溶胶囊和口服片剂用于紧急避孕的临床效果、副作用和对月经的影响。方法:在全国30个医疗或计划生育技术服务机构进行随机对照性研究。将符合条件并在无保护性生活后72h内要求紧急避孕的2 880例妇女随机分配于口服1.5 mg LNG肠溶胶囊组(胶囊组)和口服1.5 mg LNG片组(片剂组),门诊随访的方式观察两组用药后不良反应的发生情况及妊娠情况。结果:在2 880例妇女中失访5例,最终有2 868例纳入效果分析,其中胶囊组1 908例,片剂组960例。每组各有7例妊娠,妊娠率分别为0.37%和0.73%。与片剂相比,胶囊剂的相对危险度为0.5,双侧检验95%的可信区间为0.18~1.43。两种药物可预防91%~95%未经治疗的预期妊娠。随服药时间的延迟,效果有下降的趋势;若服药后再有无保护性生活,妊娠率几乎增加了1倍。服药后24h内及1h内恶心、呕吐的发生率,片剂组显著高于胶囊组,其中胶囊组无妊娠,片剂组2例妊娠,妊娠率为5.9%。其他方面不良反应及阴道流血发生率较低。胶囊组与片剂组下次月经按期来潮者分别为73.5%和70%,与平时月经相似者分别为84.3%和80.3%,经期在7d内者分别为98.3%和98.7%。结论:1.5 mgLNG肠溶胶囊用于紧急避孕安全有效,可减少胃肠道不良反应。     

新型紧急避孕药醋酸尤力司特

<正>紧急避孕是在无保护性生活后的几小时或几天内采用药物或器具以防止非意愿妊娠的一种避孕措施,它在常规避孕方法失误或未采取避孕方法时再次为妇女提供了保护。目前,我国可使用的紧急避孕措施主要包括在无保护性生活后72h(3d)内口服1.5mg左炔诺孕酮(LNG)片或10mg米非司酮片以及在120h(5d)内放置含铜宫内节育器(IUD)。     

使用母体乐375 SL IUD与左炔诺孕酮紧急避孕的临床研究

目的:评价母体乐375 SL IUD用于紧急避孕的安全性、有效性和可接受性。方法:以100例无保护性生活后120小时内放置MLCu375 SLIUD者为IUD组,术前行尿妊娠试验检查,排除已有妊娠;另110例无保护性生活后72小时内口服LNG 0.75mg,12小时后再服0.75mg者为LNG组,服药前行尿妊娠试验排除已有妊娠。结果:IUD组经产妇高于LNG组(P<0.05),紧急避孕距性生活的时间及其它一般情况两组无差别;IUD组避孕有效率为100％,LNG组为91.40％,两组的实际妊娠数均明显低于预期妊娠数(P<0.05);IUD组在排卵日及其后置器者19.14有点滴出血,但无盆腔炎及大出血的发生。LNG组18％有恶心等副作用但不需处理,其中有36.36％妇女有月经延迟现象,无需特殊处理。讨论:本文提示含铜IUD用于紧急避孕安全有效,最好在性生活5日内放置,且可以长期避孕。对于未产妇和有生殖器炎症放置IUD禁忌者可建议口服LNG等紧急避孕药物。     

左炔诺孕酮(左旋18-甲基炔诺酮)紧急避孕

<正> 1997年10月15日中国医药工业公司为匈牙利吉瑞药厂生产的紧急避孕药“保仕安”(Postinor)进口召开了座谈会。世界卫生组织人类生殖规划处官员Helena von Hertzen博士介绍了WHO组织的紧急避孕多中心随机临床试验的初步结果。该研究在14个国家21个中心进行,比较了左炔诺孕酮(LNG)与经典Yuzpe方案用于紧急避孕。中国有3个中心参加,共接纳500例。给药方案为无保护性生活后72小时内首次给药。随机分为两组:一组给LNG 0.75mg另一组给炔雌醇0.1mg+LNG 0.5mg,两组均于12小时后重复一次同样剂量药物。一共接纳有效病例1955例。     

低剂量米非司酮用于紧急避孕的临床观察

为探索米非司酮用于紧急避孕的临床效果、最低有效剂量及对月经的影响,将避孕失败或未保护性生活后120 h内要求紧急避孕的279例妇女随机分为2组,研究组149例,对照组130例,分别单次口服米非司酮10 mg或25 mg,以服药后月经来潮为成功标准.结果显示两组各妊娠2例,均明显低于预期妊娠数,其避孕有效率分别为84.12%和81.01%,组间无明显差异(P＞0.05).副反应发生率低;对月经周期、经期与经量影响较小;经间期出血的发生率对照组明显高于研究组(18.75%、0.68%),其发生与服药的时期有关,组间有极显著性差异(P＜0.01).对月经的影响,研究组更优于对照组.提示10 mg米非司酮用于紧急避孕亦是安全、有效的.     

不同剂量米非司酮用于紧急避孕的结果研究

目的研究探讨不同剂量米非司酮用于紧急避孕的结果,总结其临床用药经验及临床意义。方法选取我院2009年8月至2011年8月避孕失败或者无保护下性交后120h内就诊的妇女84例,均给予米非司酮进行紧急避孕处理,按照使用剂量分为四组,各21例,A组(单次给药10mg)、B组(单次给药25mg)、C组(单次给药75mg)、D组(单次给药150mg),观察比较四组的避孕成功率,药物副反应发生率及阴道点滴出血率、月经延迟发生率。结果在避孕成功率方面,以D组最高,与A组比较有明显差异(X2=9.62,P<0.01),具有统计学意义;在药物副反应(恶心、呕吐、下腹痛、头晕、乳房胀痛等轻微症状,均无需特殊处理,能自行缓解)发生率方面,以D组最高,其次为C组,皆明显高于A、B组,差异显著(X2=116.40,101.96,11.83,6.07,P<0.05),具有统计学意义。结论不同剂量米非司酮用于紧急避孕皆有良好的效果,但临床认为使用小剂量(单次给药10mg、15mg)米非司酮进行紧急避孕能够明显减少药物的副反应,且效果也肯定,属于较为理想的用药方案,但不同剂量的米非司酮对于月经改变的研究仍缺少有力依据,仍待进一步考究。     

低剂量米非司酮用于紧急避孕的临床观察

为探索米非司酮用于紧急避孕的临床效果、最低有效剂量及对月经的影响 ,将避孕失败或未保护性生活后 12 0 h内要求紧急避孕的 2 79例妇女随机分为 2组 ,研究组 14 9例 ,对照组 13 0例 ,分别单次口服米非司酮 10 mg或 2 5mg,以服药后月经来潮为成功标准。结果显示 :两组各妊娠 2例 ,均明显低于预期妊娠数 ,其避孕有效率分别为 84.12 %和 81.0 1% ,组间无明显差异 (P>0 .0 5)。副反应发生率低 ;对月经周期、经期与经量影响较小 ;经间期出血的发生率对照组明显高于研究组 (18.75%、0 .68% ) ,其发生与服药的时期有关 ,组间有极显著性差异 (P<0 .0 1)。对月经的影响 ,研究组更优于对照组。提示 10 mg米非司酮用于紧急避孕亦是安全、有效的     

用复方米非司酮配伍米索前列醇避孕的临床研究

目的:探讨女性黄体期应用复方米非司酮配伍米索前列醇进行避孕的有效性和安全性。方法:选择多次无避孕性生活或无避孕性生活结束超过120 h要求紧急避孕的142例妇女,于预期月经来潮前10天内服用复方米非司酮,并于服用复方米非司酮48h后加服米索前列醇。观察是否妊娠和下次月经的情况。结果:142例妇女妊娠2例,失败率1.5%。140例均有月经来潮,黄体早期组开始出血时间显著早于其他两组(P0.05),出血持续时间3组间无显著性差异,与正常月经经期基本一致。结论:在黄体期使用复方米非司酮配伍米索前列醇,是一种安全、有效的避孕补救方法。     

三种不同剂量米非司酮用于紧急避孕的临床观察

为探索小剂量米非司酮用于紧急避孕的效果,观察291例健康、月经规律妇女,在避孕失败或无保护的性生活后72小时内服药,并随机分为3组,组1(n=99)单次口服25mg米非司酮;组Ⅱ(n=92)单次服用10mg米非司酮;组Ⅲ(n=100)单次服用5mg米非司酮。3组共4例失败。避孕有效率分别为83.8％、84.92％和70.5％,三组间无明显差异。服低剂量米非司酮后副反应发生率低,对月经影响小。观察5例服用5mg米非司酮妇女子宫内膜形态,3例出现子宫内膜发育不同步,2例变化不明显。结果表明,5mg米非司酮用于紧急避孕,临床上虽有一定成功率,但对子宫内膜影响不肯定,尚需进一步研究,故应谨慎用于临床。     

10mg米非司酮与左炔诺酮用于紧急避孕的效果对比研究

通过米非司酮与左炔诺酮的临床效果对比,探讨米非司酮用于紧急避孕的最低有效剂量。选择接收无保护同房或避孕失败后72h内要求紧急避孕的健康育龄妇女400例,年龄29±6岁。米非司酮组200例,单次口服10mg(10mg/片);左炔诺酮组200例,首次口服0.75mg(0.75mg/片),间隔12h后再服0.75mg。以服药后月经来潮为成功标准,以Dixon表格计算避孕有效率。两组各妊娠2例,均明显低于预期妊娠数(15.46与10.84),有非常显著意义(P<0.01)。米非司酮组避孕有效率87.06％,与左炔诺酮组的81.55％相比无显著差异(P>0.05)。米非司酮组用药后副反应及对下次月经的影响均较轻微,且单次口服易于被接受,说明10mg米非司酮用于紧急避孕安全、有效、简便。     

Comparative evaluation of the effectiveness and safety of two regimens of levonorgestrel for emergency contraception in Nigerians

Emergency contraception was introduced in Nigeria over two decades ago, but few women have used this method even in emergency situations because of the side effects. To find an acceptable levonorgestrel regimen for emergency contraception in our community, the two-dose regimen 0.75-mg levonorgestrel 12 h apart (group A) and the single dose 1.5-mg levonorgestrel (group B) were studied in 1118 volunteers. Mild side effects such as nausea, vomiting, lower abdominal pains, menorrhagia, dizziness, headache, and breast tenderness were reported. Significantly more women in the high-dose group reported headache, breast tenderness, and heavy menstrual flow. Eleven pregnancies (1.0%) were reported (7 in group A and 4 in group B). The crude relative risk of pregnancies was similar in the two groups (RR = 0.71, 95% CI = 0.32-1.55; p > 0.05) [corrected]. On the other hand, the estimated effectiveness rate of 86.80% in group A was significantly lower than the 92.99% for group B (p < 0.05). The pregnancy rates increased with delay in starting treatment and if further acts of unprotected sexual intercourse took place after treatment. It was concluded that both regimens were effective and safe.     

A randomized, double-blind, noninferiority study to compare two regimens of levonorgestrel for emergency contraception in Nigeria

Background

Unplanned pregnancies are common in Nigeria. Much of the unplanned pregnancies is due to low contraceptive prevalence and high contraceptive user failure rates. High user failure rates suggest the important role of emergency contraception to prevent unplanned pregnancy.

Study Design

Randomized, controlled, double-blind, multicenter, noninferiority trial comparing efficacy and side effects of two emergency contraceptive regimens up to 5 days after unprotected intercourse among 3022 Nigerian women: levonorgestrel administered in two doses of 0.75 mg given 12 h apart and levonorgestrel administered in a single dose of 1.5 mg.

Results

Efficacy was similar between the treatment groups; post-treatment pregnancy proportions were 0.57% in the two-dose regimen vs. 0.64% in the single-dose regimen (risk difference 0.07% (95% CI −0.50 to 0.64). The majority of women menstruated the first day of expected menses and the groups did not differ regarding reported side effects.

Conclusions

This study shows the simplified emergency contraceptive regimen of single-dose levonorgestrel is not inferior in efficacy to the two-dose regimen among Nigerian women.     

含铜IUD,小剂量米非司酮与单方左炔诺孕酮用于紧急避孕的临床？…

为观察米非司酮（Ｒｕ４８６）、左炔诺孕酮以及活性ＩＵＤ用于紧急避孕（ＥＣ）的临床效果、副反应、对月经的影响和活性ＩＵＤ的长期避孕效果，对１５０例身体健康、月经规律、未避孕或避孕失败１２０ｈ以内的妇女按自愿的方式分为放置ＩＵＤ组或服药组，服药组，服药组按随机方法给予口服Ｒｕ４８６或左炔诺孕酮。结果发现Ｒｕ４８６组和活性ＩＵＤ组有效率为１００％，左炔诺孕酮组为７６．８％（均按Ｄｉｘｏｎ方法计算），对月     

Meta-analyses of randomized trials comparing different doses of mifepristone in emergency contraception

There is some evidence from randomized trials that different doses of mifepristone for emergency contraception do not differ in efficacy in the range from 10 mg to 600 mg. Lower doses have a better side effect profile and are cheaper and therefore they would be preferable in the absence of a dose effect. However, the lack of significance is not evidence of absence of an effect. More evidence can be obtained by combining results of trials. We present meta-analyses of randomized trials comparing doses of mifepristone for emergency contraception from 5 mg to 600 mg, with regard to the efficacy to prevent unwanted pregnancies. We use two approaches for analysis, one using only within-trial information and another one combining within-trial with between-trial information. We discuss the results in terms of equivalence. There is some evidence of a small dose effect on efficacy in the lower range of doses (<50 mg). The pregnancy rate increases by a factor of 1.6 when the dose of 10 mg is used instead of 25 mg (95% confidence interval: 1.1–2.4). In terms of the number of women needed to treat, however, using 10 mg in the place of 25 mg implies having one extra pregnancy every 146 women requesting emergency contraception, which might be a low cost compared to the benefit of more women having access to treatment.     

最小剂量米非司酮配伍米索前列醇抗早孕临床预试验报告

为探索米非司酮抗早孕的最小有效剂量,对100例停经≤56天孕妇服不同剂量米非司酮进行了临床预试验。分为四组停经≤35天受试者分次服米非司酮7mg,配伍米索600μg,完全流产率95.4％;35天<停经≤56天受试者分次服米非司酮100mg,及125mg两组完全流产率均高于93％,而顿服米非司酮100mg完全流产率仅73.3％,与另三组有显著差异。提示:①米非司酮75mg分次服抗早孕具有良好的抗早孕前景,副反应小,可节省服药妇女经费。②顿服米非司酮100mg临床效果不佳。③分次服米非司酮100mg,停经天数可延长到56天,仍有良好流产效果。     

The antiprogestational agent RU 486 as an abortifacient in early human pregnancy: a comparison of three dose regimens

Three different regimens of RU 486, a progesterone receptor blocking agent, were compared for their ability to terminate early human pregnancy. One-hundred-fifty-three healthy women with a gestational length less than 49 days from the last menstrual period were recruited to the study and randomly allocated to one of three treatment regimens: 1) RU 486 10 mg x 2 for seven days; 2) RU 486 25 mg x 2 for seven days; or 3) RU 486 50 mg x 2 for seven days. No significant difference in efficacy was seen between the three dose regimens. Treatment with 10 mg x 2 x VII resulted in 73 per cent complete abortions, 25 mg x 2 x VII in 66 per cent and 50 mg x 2 x VII in 64 per cent complete abortions. Response to treatment, measured as reported onset of bleeding and passage of products of conception, however, occurred significantly later on the 10 mg x 2 regimen than on the other two dose regimens. In each treatment group, women who subsequently aborted completely had significantly lower pretreatment levels of hCG than women with incomplete abortion or continuing pregnancy. The treatment was well tolerated by the women and except for one woman who experienced a profound bleeding necessitating a blood transfusion, no serious side effects were seen.     

低剂量米非司酮用于紧急避孕临床观察

目的:进一步确认米非司酮25mg用于紧急避孕的有效性。在全国11个省市的计划生育技术指导站及综合医院妇产科观察了622例紧急避孕的临床效果,均为避孕失败或无保护性生活后72小时内就诊并符合条件的健康妇女,单次口服米非司酮25mg。结果:失败5例,按Dixon法计算,避孕有效率为91.25％。受试者的月经周期无明显改变且未出现明显副作用。此研究进一步证实米非司酮25mg单次口服可作为理想的紧急避孕药物。     

Termination of early pregnancy by two regimens of mifepristone with misoprostol and mifepristone with PG05—a multicentre randomized clinical trial in China

A multicentre randomized open clinical trial was conducted to compare the efficacy and side effects of two regimens of mifepristone with misoprostol, and mifepristone with PG05 for termination of early pregnancy (amenorrhoea < = 49 days). Six-hundred women in early pregnancy, who requested medical abortion were randomly allocated into 3 groups. In group 1 (n = 301), an initial dose of mifepristone 50 mg was given, followed by 25 mg every 12 hours up to a total dose of 150 mg mifepristone, plus a single oral dose of misoprostol 600 μg in the morning of the third day. In group 2 (n = 150), the same regimen of mifepristone was given, but dl-15-methyl PGF₂ (PG05) 1 mg vaginal suppository was inserted on the third day. In group 3 (n = 149), a single dose of mifepristone 200 mg was given and misoprostol 600 μg was used as in group 1. The complete abortion rate were 94.4%, 97.3%, and 94.6% for group 1, 2 and 3, respectively. 3.0, 2.0 and 2.7% of women had incomplete abortion, and 1.7, 0.7 and 2.0% of women in the 3 groups were treatment failures; in the remaining 1% in group 1 and 0.7% in group 3, treatment outcome could not be determined. There were no significant differences among the 3 groups. Lower abdominal pain was the main complaint which was reported by 82% of the subjects after PGs administration. The incidence of diarrhoea in PG05 group (38.7%) was significantly higher than that in the other two groups (21.6 and 20.1%) (P < 0.001), and so was vomiting. It was concluded that misoprostol, as an orally effective prostaglandin, in combination with mifepristone for induced abortion of early pregnancy was as effective as PG05 vaginal suppository. Besides, it has advantages of convenience of use, less side effects, easy storage and transfer, and low cost.     

Mechanisms of action of mifepristone when used for emergency contraception

An emergency contraceptive method is used after coitus but before pregnancy occurs. The use of emergency contraception is largely underutilized worldwide. Recently, treatment with 10 mg mifepristone as a single dose has emerged as one of the most effective hormonal methods for emergency contraception, with very low side effects. However, the mechanism of action of mifepristone in humans when used for contraceptive purposes and especially for emergency contraception remains largely unknown. The objective of this review is to summarize available data on the effect of mifepristone on female reproductive functions relevant to emergency use of the compound. Taken together, available data from studies in humans indicate that the contraceptive effect of mifepristone used as a single low dose for emergency contraception is mainly due to impairment of ovarian function, either by blocking or postponing the luteinizing hormone surge, rather than to inhibiting of implantation.