Hsiao Hsiu-Feng, Yang Mei-Chin, Lai Mei-Yin, Chu Shih-Ming, Huang Hsuan-Rong, Chiang Ming-Chou, Fu Ren-Huei, Hsu Jen-Fu, Tsai Ming-Horng
Department of Respiratory Therapy, Chang Gung Memorial Hospital, Linkou, Taiwan.
Department of Respiratory Therapy, Chang Gung University, Taoyuan, Taiwan.
J Clin Med. 2019 Jul 27;8(8):1113. doi: 10.3390/jcm8081113.
The indication of inhaled nitric oxide (iNO) used in preterm infants has not been well defined. Neonates with refractory hypoxemia may benefit from the pulmonary vasodilatory effects of iNO. The aim of this study was to investigate the off-label use of iNO as a rescue therapy.
Between January 2010 and December 2017, all neonates who received iNO as a rescue therapy from a tertiary-level medical center were enrolled, and those who were not diagnosed with persistent pulmonary hypertension of newborn (PPHN) were defined as having received off-label use of iNO. The controls were 636 neonates with severe respiratory failure requiring high-frequency oscillatory ventilation but no iNO.
A total of 206 neonates who received iNO as a rescue therapy were identified, and 84 (40.8%) had off-label use. The median (interquartile) gestational age was 30.5 (26.3-37.0) weeks. Neonates receiving iNO had significantly more severe respiratory failure and a higher oxygenation index than the controls ( < 0.001). Respiratory distress syndrome and secondary pulmonary hypertension after severe bronchopulmonary dysplasia (BPD) were the most common causes of the off-label iNO prescription. Of the 84 neonates with off-label use of iNO, 53 (63.1%) had initial improvement in oxygenation, but 44 (52.4%) eventually died. The overall mortality rate was 41.7% (86/206). After multivariate logistic regression, extremely preterm (odds ratio [OR] 5.51; < 0.001), presence of pulmonary hemorrhage (OR 2.51; = 0.036) and severe hypotension (OR 2.78; = 0.008) were the independent risk factors for final mortality.
iNO is applicable to be an off-label rescue therapy for premature neonates with refractory hypoxemia due to severe pulmonary hypertension and bronchopulmonary dysplasia.
吸入一氧化氮（iNO）在早产儿中的应用指征尚未明确界定。患有难治性低氧血症的新生儿可能会从iNO的肺血管舒张作用中获益。本研究的目的是调查iNO作为一种挽救疗法的超说明书使用情况。
在2010年1月至2017年12月期间，纳入所有在一家三级医疗中心接受iNO作为挽救疗法的新生儿，未被诊断为新生儿持续性肺动脉高压（PPHN）的新生儿被定义为接受了iNO的超说明书使用。对照组为636例需要高频振荡通气但未使用iNO的严重呼吸衰竭新生儿。
共确定206例接受iNO作为挽救疗法的新生儿，其中84例（40.8%）存在超说明书使用情况。中位（四分位间距）胎龄为30.5（26.3 - 37.0）周。接受iNO治疗的新生儿比对照组有更严重的呼吸衰竭和更高的氧合指数（<0.001）。呼吸窘迫综合征和严重支气管肺发育不良（BPD）后的继发性肺动脉高压是iNO超说明书处方最常见的原因。在84例iNO超说明书使用的新生儿中，53例（63.1%）氧合最初有改善，但44例（52.4%）最终死亡。总体死亡率为41.7%（86/206）。多因素逻辑回归分析后，极早产儿（比值比[OR]5.51；<0.001）、存在肺出血（OR 2.51；=0.036）和严重低血压（OR 2.78；=0.008）是最终死亡的独立危险因素。
iNO适用于作为因严重肺动脉高压和支气管肺发育不良导致难治性低氧血症的早产儿的超说明书挽救疗法。
