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比较米索前列醇阴道负荷剂量与非负荷剂量方案在孕中期终止妊娠疗效的随机对照试验。

Randomized controlled trial comparing efficacy between a vaginal misoprostol loading and non-loading dose regimen for second-trimester pregnancy termination.

作者信息

Pongsatha Saipin, Tongsong Theera

机构信息

Department of Obstetrics and Gynecology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.

出版信息

J Obstet Gynaecol Res. 2014 Jan;40(1):155-60. doi: 10.1111/jog.12147. Epub 2013 Sep 5.

Abstract

AIM

The aim of this study was to compare the efficacy of vaginal misoprostol loading dose regimen with non-loading dose regimen for termination of second-trimester pregnancy with live fetuses.

MATERIAL AND METHODS

A randomized controlled trial was conducted on pregnant women with a live fetus at 14-28 weeks. The patients were randomly allocated to receive either the vaginal misoprostol loading dose regimen (600 mcg, then 400 mcg every 6 h) or the non-loading dose regimen (400 mcg every 6 h). Failure to abort within 48 h was considered to be a failure.

RESULTS

Of 157 recruited women, 77 were assigned to be in group 1 (loading group) and 80 were in group 2 (non-loading group). The median abortion time was not statistically different between the groups (14.08; 95% confidence interval: 12.45-17.77 h and 14.58; 95% confidence interval: 12.8-17.27 h, P > 0.05). The rates of abortion within 24 h and 48 h were also comparable between the groups. Fever and chills were more common in the loading group. No other serious complications, such as postpartum hemorrhage and uterine rupture, were found.

CONCLUSION

Vaginal misoprostol in the loading dose regimen had a similar efficacy to the non-loading dose regimen but was associated with more adverse maternal effects.

摘要

目的

本研究旨在比较阴道米索前列醇负荷剂量方案与非负荷剂量方案在终止中期妊娠活胎妊娠中的疗效。

材料与方法

对妊娠14 - 28周的活胎孕妇进行了一项随机对照试验。患者被随机分配接受阴道米索前列醇负荷剂量方案(600微克,然后每6小时400微克)或非负荷剂量方案(每6小时400微克)。48小时内未流产被视为失败。

结果

在157名招募的女性中,77名被分配到第1组(负荷组),80名在第2组(非负荷组)。两组之间的中位流产时间无统计学差异(14.08;95%置信区间:12.45 - 17.77小时和14.58;95%置信区间:12.8 - 17.27小时,P>0.05)。两组在24小时和48小时内的流产率也相当。负荷组发热和寒战更为常见。未发现其他严重并发症,如产后出血和子宫破裂。

结论

阴道米索前列醇负荷剂量方案与非负荷剂量方案疗效相似,但母体不良反应更多。

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