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Vaginal misoprostol administered 1, 2, or 3 days after mifepristone for early medical abortion: A randomized trial.
早期药物流产后 1 、 2 或 3 天阴道服用米索前列醇: 一项随机试验。

摘要

CONTEXT:The conventional timing of misoprostol administration after mifepristone for medical abortion is 2 days, but more flexible intervals, which may make the regimen more convenient, have not been studied.
OBJECTIVE:To determine whether vaginal misoprostol administered 1, 2, or 3 days after mifepristone influences safety or effectiveness for abortion at up to 56 days' gestation.
DESIGN:Prospective, randomized, open-label trial conducted from March 1998 to June 1999.
SETTING:Sixteen US primary care and referral abortion facilities.
PATIENTS:A total of 2295 healthy patients aged 18 years or older who were 56 or fewer days pregnant. Forty (1.7%) were lost to follow-up.
INTERVENTIONS:Patients received 200 mg of oral mifepristone and were randomly assigned to self-administer 800 microg of vaginal misoprostol at home 1 (n = 745), 2 (n = 778), or 3 (n = 772) days later. Women returned to the clinic up to 8 days after mifepristone for ultrasonographic evaluation. A second dose of misoprostol was administered if the abortion was not complete. Patients with continuing pregnancy, excessive bleeding, or retained pregnancy tissue 5 weeks later received an aspiration curettage.
MAIN OUTCOME MEASURES:Effectiveness of the procedure (ie, a complete medical abortion without surgical intervention), adverse effects, acceptability of the procedure based on patient questionnaires, reasons for surgical intervention, and adverse outcomes, compared among the study groups.
RESULTS:Of the 2255 women completing follow-up, complete medical abortion rates were 98% (95% confidence interval [CI], 97%-99%) among those using misoprostol after 1 day, 98% (95% CI, 97%-99%) for those using misoprostol after 2 days, and 96% (95% CI, 95%-97%) among those using misoprostol after 3 days. Fifty-five subjects aborted before taking misoprostol, 9 had early surgery, and 103 did not take misoprostol on their assigned day. No blood transfusions were required. Cramping and nausea were the most common adverse effects reported, with similar percentages of patients in all 3 groups reporting such effects. Thirteen unexpected or serious adverse events occurred: 6 in those using misoprostol after 1 day; 4 in those using it after 2 days; and 3 in those using it after 3 days. Nearly all women (>90%) found the procedure to be acceptable.
CONCLUSIONS:Our results suggest that vaginal misoprostol, 800 microg, can be used from 1 to 3 days after mifepristone, 200 mg, for early medical abortion, and need not be administered strictly 48 hours after mifepristone. JAMA. 2000;284:1948-1953.

译文

背景: 传统的药物流产后米索前列醇给药的时间是 2 天,但更灵活的间隔,这可能使方案更方便,尚未研究。
目的: 确定阴道米索前列醇在米非司酮治疗后 1 、 2 或 3 天是否影响妊娠 56 天流产的安全性或有效性。
设计: 从 1998年3月到 1999年6月进行的前瞻性、随机、开放标签试验。
设置: 16 个美国初级保健和转诊堕胎设施。
患者: 共有 2295 名年龄在 18 岁或以上且怀孕 56 天或以下的健康患者。40 人 (1.7%) 失去了随访。
干预: 患者接受了 200 毫克口服米非司酮,并被随机分配在家 1 (n = 800),2 (n = 745) 自行服用 778 微克阴道米索前列醇, 或者 3 (n = 772) 天后。妇女在米非司酮治疗后 8 天内返回诊所进行超声检查。如果流产未完成,则给予第二剂米索前列醇。5 周后继续妊娠、出血过多或妊娠组织残留的患者接受了吸刮术。
主要结果测量: 手术的有效性 (即,没有手术干预的完全药物流产),不良反应,基于患者问卷的手术可接受性,手术干预的原因, 和不良结局,在研究组之间进行比较。
结果: 在完成随访的 2255 名妇女中,在 1 天后使用米索前列醇的妇女中,完全药物流产率为 98% (95% 置信区间 [CI],97%-99%), 2 天后使用米索前列醇者占 98% (95% CI,97%-99%),3 天后使用米索前列醇者占 96% (95% CI,95%-97%)。55 名受试者在服用米索前列醇前流产,9 名进行了早期手术,103 的受试者在指定的日期没有服用米索前列醇。不需要输血。抽筋和恶心是最常见的不良反应,在所有 3 组中报告这种效果的患者比例相似。13 起意外或严重不良事件发生: 1 天后使用米索前列醇的 6 起; 2 天后使用米索前列醇的 4 起; 3 天后使用米索前列醇的 3 起。几乎所有的女性 (> 90%) 都认为这个程序是可以接受的。
结论: 我们的结果表明,阴道米索前列醇,800 微克,可以在米非司酮 200 毫克后 1 到 3 天内用于早期药物流产, 并且不需要在米非司酮 48 小时后严格服用。JAMA。2000; 284: 1948-1953。

medical abortion

妇产 终止妊娠 治疗方法
概述  :  

药物流产是一种常见的妊娠终止手段, 早孕妇女经药物流产后, 子宫内膜血管会在一定时间内发生水肿, 并可导致滋养细胞变性, 由此达到终止妊娠的目的。米非司酮、米索前列醇均是现阶段药物流产的常用药物, 前者为孕酮拮抗剂, 对宫颈有软化作用, 且可促进子宫蜕膜变性、坏死, 而后者是一种合成型前列腺素E1衍生物, 具有兴奋子宫、调节宫缩以及促进妊娠物排出的作用。二者配伍使用, 能够明显提升宫缩强度, 舒张子宫口, 流产效果明显优于单一用药。 适应症1. 早期妊娠≤49日

medical  英 ['medɪk(ə)l]  美 ['mɛdɪkl]

       adj. 医学的;药的;内科的

同根词   词根:medic

adj.medicative 有药效的;可治病的;有治疗作用的

adv.medically 医学上地;医药上地

       House, school and medical insurance all link together with it. 房子,学校和医疗保险都和它联系在一起。

 

abortion  英 [ə'bɔ:ʃ(ə)n]  美 [ə'bɔrʃən]

       n. 流产,堕胎,小产;流产的胎儿;(计划等)失败,夭折

同根词   词根: abort

adj. abortive 失败的;流产的;堕胎的

adv. abortively 失败地;流产地

       They are discussing the morality of abortion. 他们正在讨论堕胎的道德性。

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