Regional Neonatal Center-Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla, New York 10595, USA.
Clin Ther. 2010 May;32(5):939-48. doi: 10.1016/j.clinthera.2010.04.023.
The use of inhaled nitric oxide (NO) has been studied for the treatment of hypoxic respiratory failure (HRF) in newborns who require mechanical ventilation. Although inhaled NO is typically used in patients with a greater severity of illness, the treatment response (eg, improvement in oxygenation) and the associated outcomes (eg, time on mechanical ventilation) may be affected by the timing of treatment and baseline severity of illness.
This analysis was conducted to assess the effects of inhaled NO on measures of oxygenation, efficacy of inhaled NO across a range of illness severity strata, and duration of mechanical ventilation.
This was a retrospective pooled analysis of 3 pivotal clinical trials comparing inhaled NO (starting dose, 20 ppm) with control (100% oxygen or nitrogen gas) in term and late preterm (gestational age > or = 34 weeks) infants with HRF who required mechanical ventilation. Data on partial pressure of arterial oxygen (PaO2), inspired oxygen concentration, and mean airway pressure at 0 and 30 minutes after administration of inhaled NO were extracted from the case-report forms from the 3 clinical trials and used to calculate the oxygenation index (OI). The change in PaO2 was assessed by baseline severity of illness, stratified based on the OI (< or = 15 = mild, >15 to < or = 25 = moderate, >25 to < or = 40 = severe, >40 = very severe). The duration of mechanical ventilation was compared between the inhaled NO and control groups.
Five hundred twenty-four patients were analyzed (260 inhaled NO, 264 control). The overall mean (SD) birth weight and gestational age of the patients were 3.4 (0.58) kg and 39.1 (1.96) weeks, respectively. After 30 minutes of treatment, there was a significant increase from baseline in PaO2 with inhaled NO compared with control (54.91 vs 14.15 mm Hg, respectively; P < 0.001). The increases from baseline in PaO2 at 30 minutes were statistically significant for inhaled NO compared with controls across all severity strata (mild: 62.39 vs -23.03 mm Hg, respectively [P = 0.003]; moderate: 52.93 vs 18.28 mm Hg [P = 0.004]; severe: 62.07 vs 13.95 mm Hg [P < 0.001]; very severe: 45.17 vs 18.66 mm Hg [P < 0.001]). On Kaplan-Meier analysis, the median duration of mechanical ventilation was 11 and 14 days in the inhaled NO and control groups, respectively (P = 0.003).
This pooled analysis of data from 3 clinical trials in term and late preterm infants with HRF requiring mechanical ventilation found that inhaled NO at a starting dose of 20 ppm was associated with improved oxygenation acutely and a reduced median duration of mechanical ventilation. The improvements were significant across all severity-of-illness strata.
吸入一氧化氮（NO）已被研究用于治疗需要机械通气的新生儿缺氧性呼吸衰竭（HRF）。尽管吸入 NO 通常用于病情较重的患者，但治疗反应（例如，氧合改善）和相关结局（例如，机械通气时间）可能会受到治疗时机和基线疾病严重程度的影响。
本分析旨在评估吸入 NO 对氧合指标的影响、不同疾病严重程度分层中吸入 NO 的疗效以及机械通气时间。
这是对 3 项比较吸入 NO（起始剂量为 20 ppm）与控制（100%氧气或氮气）治疗需要机械通气的足月和晚期早产儿（胎龄>或=34 周）HRF 的关键临床试验的回顾性汇总分析。从 3 项临床试验的病例报告表中提取动脉氧分压（PaO2）、吸入氧浓度和吸入 NO 后 0 和 30 分钟时的平均气道压数据，并用于计算氧合指数（OI）。通过疾病严重程度分层，根据 OI（<或=15=轻度、>15 至<或=25=中度、>25 至<或=40=重度、>40=极重度）评估 PaO2 的变化。比较吸入 NO 组和对照组之间的机械通气时间。
分析了 524 例患者（吸入 NO 组 260 例，对照组 264 例）。患者的总体平均（SD）出生体重和胎龄分别为 3.4（0.58）kg 和 39.1（1.96）周。与对照组相比，吸入 NO 治疗 30 分钟后 PaO2 从基线显著升高（分别为 54.91 和 14.15 mmHg；P<0.001）。与对照组相比，在所有严重程度分层中，吸入 NO 在 30 分钟时 PaO2 的升高均具有统计学意义（轻度：分别为 62.39 和-23.03 mmHg；P=0.003；中度：分别为 52.93 和 18.28 mmHg；P=0.004；重度：分别为 62.07 和 13.95 mmHg；P<0.001；极重度：分别为 45.17 和 18.66 mmHg；P<0.001）。在 Kaplan-Meier 分析中，吸入 NO 组和对照组的机械通气中位时间分别为 11 天和 14 天（P=0.003）。
本分析汇总了 3 项需要机械通气的足月和晚期早产儿 HRF 临床试验的数据，发现起始剂量为 20 ppm 的吸入 NO 可迅速改善氧合，并缩短机械通气的中位时间。在所有疾病严重程度分层中，这些改善均具有统计学意义。
