Stewart Dan L, Vogel Paul A, Jarrett Brant, Potenziano Jim
Department of Pediatrics, University of Louisville School of Medicine, Louisville, KY, USA -
Medical Affairs and Research and Development, Mallinckrodt Pharmaceuticals, Hampton, NJ, USA.
Minerva Pediatr. 2018 Feb;70(1):51-58. doi: 10.23736/S0026-4946.17.04944-1. Epub 2017 May 4.
To assess the role of inhaled nitric oxide (iNO) in reducing the need for oxygen therapy, decreasing time on mechanical ventilatory support, and attenuating probability of hypoxic respiratory failure severity progression, we reviewed published reports of phase III iNO studies in neonates with hypoxic respiratory failure and pulmonary hypertension, as well as a novel post-hoc analysis of data from the Clinical Inhaled Nitric Oxide Research Group Initiative (CINRGI) study population not been previously reported. The post-hoc analysis of the CINRGI study showed that iNO shortens the duration of oxygen therapy versus placebo (17 vs. 34 days; P<0.05); the CINRGI retrospective analysis by Konduri et al. showed earlier administration of iNO (oxygenation index [OI] 15-25) yielded a 48% relative reduction vs. placebo in number of patients who progressed to OI≥30 (16.7% vs. 32.2%; P=0.002). Golombek and Young's pooled analysis of phase III studies showed a rapid improvement in oxygenation after initiation of iNO therapy versus controls in each study, and a significant reduction in median ventilation duration (11 vs. 14 days; P=0.003). A study by Gonzalez et al. revealed that earlier iNO administration in infants with mild to moderate hypoxic respiratory failure (OI 10-30) resulted in a decreased duration of oxygen therapy versus placebo (11.5 vs. 18.0 days; P<0.03) and reduced the probability of developing severe hypoxic respiratory failure.
为评估吸入一氧化氮（iNO）在减少氧疗需求、缩短机械通气支持时间以及降低低氧性呼吸衰竭严重程度进展概率方面的作用，我们回顾了已发表的关于iNO治疗新生儿低氧性呼吸衰竭和肺动脉高压的III期研究报告，以及一项此前未报道过的对临床吸入一氧化氮研究组倡议（CINRGI）研究人群数据的新的事后分析。CINRGI研究的事后分析表明，与安慰剂相比，iNO可缩短氧疗持续时间（17天对34天；P<0.05）；Konduri等人对CINRGI的回顾性分析显示，更早给予iNO（氧合指数[OI]为15 - 25）的患者进展至OI≥30的人数与安慰剂相比相对减少了48%（16.7%对32.2%；P = 0.002）。Golombek和Young对III期研究的汇总分析表明，在每项研究中，iNO治疗开始后与对照组相比氧合迅速改善，且中位通气持续时间显著缩短（11天对14天；P = 0.003）。Gonzalez等人的一项研究表明，在轻度至中度低氧性呼吸衰竭（OI为10 - 30）的婴儿中更早给予iNO，与安慰剂相比可缩短氧疗持续时间（11.5天对18.0天；P<0.03），并降低发生严重低氧性呼吸衰竭的概率。
