Changes in oxygenation with inhaled nitric oxide in severe bronchopulmonary dysplasia

Changes in oxygenation with inhaled nitric oxide in severe bronchopulmonary dysplasia
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DOI:
10.1542/peds.103.3.610
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发表时间:
1999-03-01
期刊:
影响因子:
8
通讯作者:
Ballard, RA
Ballard, RA
中科院分区:
医学2区
文献类型:
--
作者:
Banks, BA;Seri, I;Ballard, RA

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背景。严重支气管肺发育不良(BPD)具有很高的死亡率和发病率,被认为是未成熟肺受到机械性、炎症性和氧化性损伤的结果,包括肺动脉高压的发展和血管重构。进行了一项II期试点研究,以确定吸入一氧化氮(iNO)对严重BPD患者氧合的影响。这是一项开放标记的非对照试验,旨在评估安全性并为未来的随机对照试验确定合适的剂量。如果婴儿大于或等于4周龄,呼吸机依赖,平均气道压力大于或等于10 cm H2O, FIO2大于或等于0.45,则符合入组条件。研究中,婴儿接受20 ppm的iNO治疗72小时,FIO2调节至维持血氧饱和度为0.92%。72小时后FIO2降低大于或等于15%的婴儿接受低剂量iNO延长治疗,在耐受情况下每3天断奶20%。16名1至7个月的早产儿(孕23-29周)被纳入研究。16例婴儿中有11例在注射1小时后出现显著的Fao升高(变化中位数为24 mm Hg,变化范围为-15 ~ 59 mm Hg
Background. Severe bronchopulmonary dysplasia (BPD), which is associated with high mortality and morbidity, is thought to be the result of mechanical, inflammatory, and oxidant injury to the immature lung, and includes the development of pulmonary hypertension with vascular remodeling.Methods. A phase II pilot study was conducted to determine the effect of inhaled nitric oxide (iNO) on oxygenation in severe BPD. This was an open-labeled, noncontrolled trial to evaluate safety and determine appropriate dosing for a future randomized controlled trial. Infants were eligible for enrollment if they were greater than or equal to 4 weeks of age and ventilator dependent with a mean airway pressure of greater than or equal to 10 cm H2O and an FIO2 of greater than or equal to 0.45. Study infants received iNO (20 ppm) for 72 hours, and FIO2 was adjusted to maintain oxygen saturations of >92%. Infants who had a greater than or equal to 15% reduction in FIO2 after 72 hours received prolonged treatment with low-dose iNO, weaning by 20% every 3 days as tolerated.Findings. Sixteen preterm infants (23-29 weeks of gestation), age 1 to 7 months, were enrolled. Eleven of 16 infants had a significant increase in Fao, after 1 hour of iNO (median change, 24 mm Hg; range, -15 to 59 mm Hg; P