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卡贝缩宫素与缩宫素预防剖宫产术后子宫收缩乏力的双盲对照研究

Double-blind comparison of carbetocin versus oxytocin in prevention of uterine atony after cesarean section.

作者信息

Dansereau J, Joshi A K, Helewa M E, Doran T A, Lange I R, Luther E R, Farine D, Schulz M L, Horbay G L, Griffin P, Wassenaar W

机构信息

British Columbia Women's Hospital, University of British Columbia, Vancouver, British Columbia.

出版信息

Am J Obstet Gynecol. 1999 Mar;180(3 Pt 1):670-6. doi: 10.1016/s0002-9378(99)70271-1.

DOI:10.1016/s0002-9378(99)70271-1
PMID:10076146
Abstract

OBJECTIVE

The goal of this study was to compare carbetocin, a long-acting oxytocin analog, with oxytocin in the prevention of uterine atony after cesarean section.

STUDY DESIGN

We enrolled 694 patients undergoing elective cesarean section in a Canadian multicenter, double-blind, randomized clinical trial. We compared the effect of a single 100 microg dose of carbetocin with that of a standard 8-hour infusion of oxytocin. The primary outcome was the proportion of patients requiring additional oxytocic intervention for uterine atony. A variable sample size, sequential design was used.

RESULTS

The overall oxytocic intervention rate was 7.4%. The odds of treatment failure requiring oxytocic intervention was 2.03 (95% confidence interval 1.1 to 2.8) times higher in the oxytocin group compared with the carbetocin group, respectively, 32 of 318 (10.1%) versus 15 of 317 (4.7%), P <.05.

CONCLUSIONS

Carbetocin, a new drug for the prevention of uterine atony, appears to be more effective than a continuous infusion of oxytocin and has a similar safety profile.

摘要

目的

本研究的目的是比较长效缩宫素类似物卡贝缩宫素与缩宫素在剖宫产术后预防子宫收缩乏力方面的效果。

研究设计

我们在一项加拿大多中心、双盲、随机临床试验中纳入了694例行择期剖宫产的患者。我们比较了单次100微克剂量的卡贝缩宫素与标准8小时输注缩宫素的效果。主要结局是因子宫收缩乏力需要额外使用宫缩剂干预的患者比例。采用了可变样本量的序贯设计。

结果

总的宫缩剂干预率为7.4%。与卡贝缩宫素组相比,缩宫素组因宫缩剂干预治疗失败的几率分别高2.03倍(95%置信区间1.1至2.8),缩宫素组318例中有32例(10.1%),卡贝缩宫素组317例中有15例(4.7%),P<0.05。

结论

卡贝缩宫素作为一种预防子宫收缩乏力的新药,似乎比持续输注缩宫素更有效,且安全性相似。

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