Thornton Steven, Goodwin Thomas M, Greisen Gorm, Hedegaard Morten, Arce Joan-Carles
Warwick Medical School, University of Warwick, Coventry, England, United Kingdom.
Am J Obstet Gynecol. 2009 Jun;200(6):627.e1-10. doi: 10.1016/j.ajog.2009.01.015.
The objective of the study was to compare barusiban with placebo in threatened preterm labor.
This was a randomized, double-blind, placebo-controlled, multicenter study. One hundred sixty-three women at 34-35 weeks plus 6 days, and with 6 or more contractions of 30 seconds duration during 30 minutes, cervical length 15 mm or less, and cervical dilatation > 1 and < 4 cm were randomized to a single intravenous bolus of barusiban (0.3, 1, 3, or 10 mg) or placebo. The primary endpoint was percentage of women who did not deliver within 48 hours.
None of the barusiban doses reduced the number of uterine contractions compared with placebo. There was no significant difference in the percentage of women who did not deliver within 48 hours (72% placebo and 65-88% barusiban groups; P = .21-.84). Barusiban was not associated with an adverse safety profile in the woman, fetus, neonate, or infant.
An intravenous bolus of barusiban was no more effective than placebo in stopping preterm labor in pregnant women at late gestational age.
本研究的目的是比较巴曲酶与安慰剂在先兆早产中的疗效。
这是一项随机、双盲、安慰剂对照、多中心研究。163名孕34 - 35周加6天的女性，在30分钟内有6次或更多持续30秒的宫缩，宫颈长度15毫米或更短，宫颈扩张>1厘米且<4厘米，被随机分为单次静脉推注巴曲酶（0.3、1、3或10毫克）或安慰剂组。主要终点是48小时内未分娩的女性百分比。
与安慰剂相比，巴曲酶的任何剂量均未减少子宫收缩次数。48小时内未分娩的女性百分比无显著差异（安慰剂组为72%，巴曲酶组为65 - 88%；P = 0.21 - 0.84）。巴曲酶在女性、胎儿、新生儿或婴儿中未显示出不良安全性。
静脉推注巴曲酶在阻止晚期妊娠孕妇早产方面并不比安慰剂更有效。
