吸入的氧化用于预防早产儿的支气管肺功能障碍症 (EUNO):一项随机对照试验
Jean-Christophe Mercier1, Helmut Hummler, Xavier Durrmeyer
1Assistance Publique-Hôpitaux de Paris, Université Paris-7 Denis Diderot, Hôpital Robert Debré, Paris, France. jean-christophe.mercier@rdb.aphp.fr
Lancet (London, England)
|July 27, 2010
概括
早期低剂量吸入的氧化并没有改善早产婴儿轻度呼吸衰竭的结果. 这项研究发现,与安慰剂相比,在接受吸入氧化的婴儿中,没有支气管肺功能障碍的生存率没有显著差异.
科学领域:
- 新生儿医学 新生儿医学
- 儿科呼吸系统医学 儿科呼吸系统医学
- 临床试验 临床试验
背景情况:
- 吸入的氧化 (iNO) 在动物模型中显示出改善肺部发育的前景.
- 它在患有支气管肺功能障碍 (BPD) 风险的早产婴儿中的有效性仍然存在争议.
- 这项研究调查了iNO在轻度呼吸衰竭的早产婴儿中降低BPD的潜力.
研究的目的:
- 为了测试早期,低度的吸入氧化是否会减少支气管肺功能失调的发生率.
- 评估iNO对早产婴儿没有BPD的生存的影响.
- 评估iNO对该人群的整体存活率和脑损伤的影响.
主要方法:
- 800名早产婴儿 (怀孕24-28周) 被随机分配给iNO (5ppm) 或安慰剂.
- 在双盲多中心试验中,治疗持续时间从7天到21天不等.
- 主要结局是36周月经后没有BPD的生存.
主要成果:
- 在iNO和安慰剂组之间没有显著的生存差异,没有BPD (65%vs66%).
- 在月经后36周的总生存时间没有显著差异 (86%vs90%).
- 在BPD的发病率上没有显著的差异 (24%对27%).
结论:
- 早期,低剂量吸入的氧化并没有改善非常早产婴儿在没有BPD的情况下的生存率.
- 在这种情况下,使用iNO的预防策略被发现没有成功.
- 可能需要进一步的研究来探索BPD预防的替代或精细的治疗方法.
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