Husslein P, Roura L C, Dudenhausen J, Helmer H, Frydman R, Rizzo N, Schneider D
Department of Obstetrics and Gynaecology, University of Vienna, General Hospital, Vienna, Austria.
BJOG. 2006 Dec;113 Suppl 3:105-10. doi: 10.1111/j.1471-0528.2006.01134.x.
To evaluate the efficacy and safety of early administration compared with standard administration of atosiban, when predefined eligibility criteria were met.
A prospective, open-label, randomised clinical trial. Women were randomised to receive atosiban either immediately (early) or when specified criteria, in terms of duration/frequency of uterine contraction or status of cervical dilation/effacement, were fulfilled (standard).
Carried out at 105 centres in six European countries.
Pregnant women admitted to hospital in threatened preterm labour between 24 and 34 weeks of gestation, comprising a subgroup of women enrolled in the Tractocile Efficacy Assessment Survey in Europe (TREASURE) clinical experience review.
Efficacy was defined as the successful delay of delivery with no alternative tocolytic agent for 48 hours.
More women in the early group remained undelivered at 48 hours with no alternative tocolytic agent compared with those who received atosiban when specified criteria were fulfilled (88.9 versus 76.1%; P = 0.03). Safety was comparable between the groups. There were no statistical differences in maternal, fetal or neonatal adverse events between the early and standard atosiban arms.
The use of atosiban was effective for the delay of preterm labour and presented no safety concerns irrespective of the time it was administered.
在满足预先设定的入选标准时，评估阿托西班早期给药与标准给药相比的疗效和安全性。
一项前瞻性、开放标签、随机临床试验。将女性随机分为两组，一组立即（早期）接受阿托西班治疗，另一组在子宫收缩持续时间/频率或宫颈扩张/消退状态等特定标准满足时（标准组）接受阿托西班治疗。
在六个欧洲国家的105个中心开展。
妊娠24至34周因先兆早产入院的孕妇，包括欧洲宫缩抑制剂疗效评估调查（TREASURE）临床经验回顾中纳入的一组女性。
疗效定义为成功延迟分娩48小时且无需使用其他宫缩抑制剂。
与在满足特定标准时接受阿托西班治疗的女性相比，早期组在48小时时更多女性未分娩且无需使用其他宫缩抑制剂（88.9%对76.1%；P = 0.03）。两组安全性相当。早期和标准阿托西班治疗组在母体、胎儿或新生儿不良事件方面无统计学差异。
阿托西班用于延迟早产有效，且无论给药时间如何均无安全问题。
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