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一项在孕中期药物流产中比较米非司酮给药后米索前列醇两种给药间隔的随机试验。

A randomized trial to compare two dosing intervals of misoprostol following mifepristone administration in second trimester medical abortion.

作者信息

Chai J, Tang O S, Hong Q Q, Chen Q F, Cheng L N, Ng E, Ho P C

机构信息

Department of Obstetrics and Gynaecology, University of Hong Kong, Hong Kong Special Administrative Region, China.

出版信息

Hum Reprod. 2009 Feb;24(2):320-4. doi: 10.1093/humrep/den425. Epub 2008 Dec 1.

Abstract

BACKGROUND

The conventional timing of misoprostol administration after mifepristone for second trimester medical abortion is 36-48 h, but simultaneous administration, which may make the regimen more convenient, has not been studied. The objective of this randomized comparison study is to compare two intervals of administration of misoprostol after pretreatment with mifepristone for second trimester medical abortion.

METHODS

Eligible women with gestational age between 12 and 20 weeks were randomized to receive mifepristone 200 mg orally followed by 600 microg misoprostol vaginally either immediately or 36-38 h later, followed by 400 microg vaginal misoprostol every 3 h for a maximum of four doses. The primary outcome measure was the success rate at 24 h after the start of misoprostol treatment and the secondary outcome measures were the induction-to-abortion interval and the frequency of side effects.

RESULTS

There was a significant difference in the success rate at 24 h (36-38 h: 100%; immediate: 91.5%). The median induction-to-abortion interval was significantly shorter in the 36-38 h regimen (4.9 h) compared with the immediate regimen (10 h). Side effects in terms of febrile episodes and chills/rigors were significantly higher in the immediate administration group.

CONCLUSIONS

Simultaneous use of mifepristone and misoprostol for second trimester medical abortion is not as effective as the regimen using a 36-38 h dosing interval.

摘要

背景

米非司酮用于孕中期药物流产后,米索前列醇的传统给药时间为36 - 48小时,但尚未对可使方案更便捷的同时给药进行研究。本随机对照研究的目的是比较米非司酮预处理后米索前列醇用于孕中期药物流产的两种给药间隔。

方法

孕周在12至20周之间的符合条件的女性被随机分组,一组口服200毫克米非司酮,随后立即或在36 - 38小时后经阴道给予600微克米索前列醇,然后每3小时经阴道给予400微克米索前列醇,最多四剂。主要结局指标是米索前列醇治疗开始后24小时的成功率,次要结局指标是引产至流产的间隔时间和副作用发生频率。

结果

24小时成功率存在显著差异(36 - 38小时组:100%;立即给药组:91.5%)。与立即给药方案(10小时)相比,36 - 38小时方案的引产至流产间隔时间中位数显著更短(4.9小时)。立即给药组发热发作和寒战/寒战方面的副作用显著更高。

结论

米非司酮和米索前列醇同时用于孕中期药物流产的效果不如采用36 - 38小时给药间隔的方案。

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