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米索前列醇对于流产后护理而言,是一种安全、有效且可接受的手动真空吸引术替代方法吗?来自西非布基纳法索一项随机试验的结果。

Is misoprostol a safe, effective and acceptable alternative to manual vacuum aspiration for postabortion care? Results from a randomised trial in Burkina Faso, West Africa.

作者信息

Dao B, Blum J, Thieba B, Raghavan S, Ouedraego M, Lankoande J, Winikoff B

机构信息

Centre Hospitalier National Souro Sanou, Bobo Dioulasso, Burkina Faso.

出版信息

BJOG. 2007 Nov;114(11):1368-75. doi: 10.1111/j.1471-0528.2007.01468.x. Epub 2007 Sep 5.

Abstract

OBJECTIVES

Previous research has demonstrated the effectiveness of misoprostol for treatment of incomplete abortion; however, few studies have systematically compared misoprostol's effectiveness with that of standard surgical care. This study documents the effectiveness of a single 600 micrograms dose of oral misoprostol versus manual vacuum aspiration (MVA) for treatment of incomplete abortion in a developing country setting.

DESIGN

Open-label randomised controlled trial.

SETTING

Two university teaching hospitals in Burkina Faso, West Africa.

POPULATION

Women of reproductive age presenting with incomplete abortion.

METHODS

From April 2004 through October 2004, 447 consenting women with incomplete abortion were randomised to either a single dose of 600 micrograms oral misoprostol or MVA for treatment of their condition.

MAIN OUTCOME MEASURE

Completed abortion following initial treatment.

RESULTS

Regardless of treatment assigned, nearly all participants had a complete uterine evacuation (misoprostol = 94.5%, MVA = 99.1%; relative risk [RR] = 0.95 [95% CI 0.92-0.99]). Acceptability and satisfaction ratings were similar and high for both misoprostol and MVA, with three out of four women indicating that the treatment's adverse effects were tolerable (misoprostol = 72.9%, MVA = 75.8%; RR = 0.96 [95% CI 0.86-1.07]). The majority of women were 'satisfied' or 'very satisfied' with the method they received (misoprostol = 96.8%, MVA = 97.7%; RR = 0.99 [95% CI 0.96-1.02]), expressed a desire to choose that method again (misoprostol = 94.5%, MVA = 86.6%; RR = 1.09 [95% CI 1.03-1.16]) and to recommend it to a friend (misoprostol = 94.5%, MVA = 85.2%; RR = 1.11 [95% CI 1.04-1.18]).

CONCLUSION

Six hundred micrograms of oral misoprostol is as safe and acceptable as MVA for the treatment of incomplete abortion. Operations research is needed to ascertain the role of misoprostol within postabortion care programmes worldwide.

摘要

目的

以往研究已证明米索前列醇治疗不完全流产的有效性;然而,很少有研究系统地将米索前列醇的有效性与标准手术治疗进行比较。本研究记录了在发展中国家环境中,单次口服600微克米索前列醇与人工负压吸引术(MVA)治疗不完全流产的有效性。

设计

开放标签随机对照试验。

地点

西非布基纳法索的两家大学教学医院。

研究对象

出现不完全流产的育龄妇女。

方法

从2004年4月至2004年10月,447名同意参与研究的不完全流产妇女被随机分为单次口服600微克米索前列醇组或人工负压吸引术组进行治疗。

主要观察指标

初始治疗后的完全流产情况。

结果

无论分配何种治疗,几乎所有参与者都实现了子宫完全排空(米索前列醇组 = 94.5%,人工负压吸引术组 = 99.1%;相对风险[RR] = 0.95[95%可信区间0.92 - 0.99])。米索前列醇和人工负压吸引术的可接受性和满意度评分相似且都很高,四分之三的妇女表示治疗的不良反应是可耐受的(米索前列醇组 = 72.9%,人工负压吸引术组 = 75.8%;RR = 0.96[95%可信区间0.86 - 1.07])。大多数妇女对她们接受的治疗方法“满意”或“非常满意”(米索前列醇组 = 96.8%,人工负压吸引术组 = 97.7%;RR = 0.99[95%可信区间0.96 - 1.02]),表示希望再次选择该方法(米索前列醇组 = 94.5%,人工负压吸引术组 = 86.6%;RR = 1.09[95%可信区间1.03 - 1.16])并推荐给朋友(米索前列醇组 = 94.5%,人工负压吸引术组 = 85.2%;RR = 1.11[95%可信区间1.04 - 1.18])。

结论

600微克口服米索前列醇在治疗不完全流产方面与人工负压吸引术一样安全且可接受。需要进行运筹学研究以确定米索前列醇在全球流产后护理项目中的作用。

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