预防性易布洛芬与非常早产婴儿的安慰剂:一个随机的,双盲的,安慰剂控制的试验
V Gournay1, J C Roze, A Kuster
1Service de Réanimation Pédiatrique et Néonatale, Hôpital de la Mère et de l'Enfant, Centre Hospitalier Universitaire (CHU) de Nantes, Quai Moncousu, 44000 Nantes, France. veronique.gournay@chu-nantes.fr
Lancet (London, England)
|November 30, 2004
概括
在早产婴儿的预防性布洛芬减少了专利导管动脉动脉的手术,但没有改善生存率. 由于不良事件,不建议在预防性治疗上使用早期治愈性易布洛芬.
科学领域:
- 新生儿科学 新生儿科学
- 儿童心脏病学 儿童心脏病学
- 药理学 药理学是指药理学的学科.
背景情况:
- 专利动脉管 (PDA) 是早产婴儿的常见并发症,通常需要干预.
- 预防性印梅他辛对PDA的疗效尚不确定;布洛芬提供了一个潜在的更安全的替代品,对 perfusion 有较少的不良影响.
- 在非常早产的婴儿中,比较PDA的预防性与治疗性易布罗芬至关重要.
研究的目的:
- 为了比较预防性布洛芬与安慰剂在非常早产婴儿中的有效性和安全性.
- 评估预防性布洛芬对PDA手术干预的需要的影响.
- 评估预防性布洛芬对死亡率和其他疾病的影响.
主要方法:
- 一项随机对照试验,涉及28周孕期以下的婴儿.
- 婴儿在出生后6小时内接受了三剂易布洛芬或安慰剂.
- 症状性PDA在必要时用治疗性易布洛芬,印米他或手术治疗;主要终点是手术绑定.
主要成果:
- 该研究因预防组的肺高血压而提前停止.
- 预防性易布洛芬显著降低了手术绑架的需要 (0%对9%,p=0.03).
- 虽然心室内出血率下降了 (11%对23%,p=0.10),但生存率没有改善,呼吸,脏和消化系统不良事件增加.
结论:
- 预防性布洛芬有效地减少了早产婴儿PDA的手术干预.
- 然而,它并不能改善存活率或降低整体发病率,并带有不良事件的风险.
- 在这种人群中,不建议使用早期治愈性易布洛芬,而不是预防性治疗.
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