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米非司酮加阴道用米索前列醇与单用阴道用米索前列醇用于尼泊尔妇女妊娠63天及以内的药物流产:一项半随机对照试验

Mifepristone plus vaginal misoprostol vs vaginal misoprostol alone for medical abortion in gestation 63 days or less in Nepalese women: a quasi-randomized controlled trial.

作者信息

Chawdhary Rashmi, Rana Ashma, Pradhan Neelam

机构信息

Department of Obstetrics and Gynecology, Tribhuvan University Teaching Hospital, Institute of Medicine, Kathmandu, Nepal.

出版信息

J Obstet Gynaecol Res. 2009 Feb;35(1):78-85. doi: 10.1111/j.1447-0756.2008.00864.x.

Abstract

AIM

To compare the efficacy of mifepristone and vaginal misoprostol with misoprostol alone for pregnancy termination up to 63 days.

METHOD

This exploratory study was conducted in the Department of Obstetrics and Gynecology, Tribhuvan University Teaching Hospital, Kathmandu, Nepal as a part of a thesis study for a period of one year from April 2005-2006. After confirming a pregnancy < or =63 days gestation by transvaginal ultrasound, an equal number of women (50) were randomized into (i) group A, women who received 200 mg oral mifepristone (RU 486) on day 1 and vaginal misoprostol 800 microg on day 3; and (ii) group B, women who received vaginal misoprostol (800 microg) on day 1 and 3 (total dose 1600 microg). The primary study outcome measure was complete abortion without surgical intervention making comparisons between these two groups in terms of complete abortion rate, need for manual vacuum aspiration for incomplete abortion and pregnancy continuation after reconfirming the diagnosis on transvaginal ultrasound, besides comparing the side effects/complications.

RESULTS

Fewer side effects and a more complete abortion rate (94%) was observed in group A (mifepristone and vaginal misoprostol) in comparison to vaginal misoprostol alone (total dose 1600 microg) giving a complete abortion rate of 86% along with a significant hematocrit drop on follow-up day 10 (P = 0.03) besides having increased duration of bleeding (P = 0.017).

CONCLUSION

Mifepristone oral (200 mg) followed by vaginal misoprostol (800 microg) on day 3 provides a better success rate (94%) with fewer complications than vaginal misoprostol 800 microg used on days 1 and 3 for medical abortion of pregnancies up to 63 days.

摘要

目的

比较米非司酮与阴道用米索前列醇联合用药和单用米索前列醇终止妊娠63天内妊娠的疗效。

方法

本探索性研究于2005年4月至2006年在尼泊尔加德满都特里布万大学教学医院妇产科进行,为期一年,作为一项论文研究的一部分。经阴道超声确认妊娠≤63天后,将同等数量的妇女(50名)随机分为:(i)A组,第1天口服200mg米非司酮(RU 486),第3天阴道用800μg米索前列醇的妇女;(ii)B组,第1天和第3天阴道用米索前列醇(800μg)(总剂量1600μg)的妇女。主要研究结局指标是无需手术干预的完全流产,比较两组的完全流产率、不完全流产需行人工负压吸引的情况以及经阴道超声再次确认诊断后的妊娠继续情况,同时比较副作用/并发症。

结果

与单用阴道米索前列醇(总剂量1600μg)相比,A组(米非司酮与阴道米索前列醇联合用药)副作用更少,完全流产率更高(94%),单用阴道米索前列醇完全流产率为86%,且在随访第10天血红蛋白显著下降(P = 0.03),此外出血时间延长(P = 0.017)。

结论

对于妊娠63天内的药物流产,第1天口服200mg米非司酮,第3天阴道用800μg米索前列醇,比第1天和第3天使用800μg阴道米索前列醇成功率更高(94%),并发症更少。

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