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米索前列醇与宫颈扩张凝胶联合小剂量米非司酮用于引产的随机试验。

Randomized trial of misoprostol and cervagem in combination with a reduced dose of mifepristone for induction of abortion.

作者信息

Baird D T, Sukcharoen N, Thong K J

机构信息

Department of Obstetrics and Gynaecology, University of Edinburg, UK.

出版信息

Hum Reprod. 1995 Jun;10(6):1521-7. doi: 10.1093/humrep/10.6.1521.

DOI:10.1093/humrep/10.6.1521
PMID:7593528
Abstract

Mifepristone (600 mg) in combination with a prostaglandin has been demonstrated to be a safe, acceptable alternative to vacuum aspiration for induction of abortion in the first 9 weeks of pregnancy. However, the efficacy and side-effects of different prostaglandins used in combination with mifepristone have not been assessed in a randomized trial. In this study, 800 women seeking an abortion at gestational age < or = 63 days amenorrhoea were randomized to receive either 0.5 mg gemeprost by vaginal pessary (group I) or 600 micrograms misoprostol (group II) by mouth approximately 48 h after taking 200 mg mifepristone by mouth. The side-effects and number of complete abortions were used as measures of efficacy. There was no significant difference in the rate of complete abortion between group I [96.7%; 95% confidence interval (CI) 94.9-98.5%, n = 391] and group II (94.6%; 95% CI 92.3-96.9, n = 386). It was not possible to assess the outcome with certainty in the remaining 23 women. However, there were significantly more ongoing pregnancies in the women who received misoprostol than in those who received gemeprost (nine versus one, P < 0.01) and in eight of these 10 women the gestation was > 49 days. Fewer women in group II required analgesia than in group I (48 versus 60%, P < 0.001) although the number requesting opiate was similar in each group (6.9 versus 5.2%, P > 0.4). The incidence of nausea and vomiting after misoprostol (47.8 and 21.9% respectively) was higher (P < 0.001) than after gemeprost (33.9 and 12% respectively).(ABSTRACT TRUNCATED AT 250 WORDS)

摘要

米非司酮(600毫克)联合前列腺素已被证明是妊娠前9周人工流产时一种安全、可接受的负压吸宫替代方法。然而,不同前列腺素与米非司酮联合使用的疗效和副作用尚未在随机试验中进行评估。在本研究中,800名妊娠龄≤闭经63天且寻求人工流产的妇女被随机分组,在口服200毫克米非司酮约48小时后,一组经阴道 pessary给予0.5毫克吉美前列素(I组),另一组口服600微克米索前列醇(II组)。副作用和完全流产数量用作疗效指标。I组(96.7%;95%置信区间[CI]94.9 - 98.5%,n = 391)和II组(94.6%;95%CI 92.3 - 96.9,n = 386)的完全流产率无显著差异。其余23名妇女的结局无法确切评估。然而,接受米索前列醇的妇女中持续妊娠的情况显著多于接受吉美前列素的妇女(9例对1例,P < 0.01),且这10名妇女中有8例妊娠龄>49天。II组需要镇痛的妇女少于I组(48%对60%,P < 0.001),尽管每组中请求使用阿片类药物的人数相似(6.9%对5.2%,P > 0.4)。米索前列醇后恶心和呕吐的发生率(分别为47.8%和21.9%)高于吉美前列素后(分别为33.9%和12%)(P < 0.001)。(摘要截短于250字)

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