Kuch Bradley A, Saville Alvin L, Sanchez De Toledo Joan, Venkataraman Shekhar T
Department of Respiratory Care Services
Transport Team, Children's Hospital of Pittsburgh of University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
Respir Care. 2017 Jun;62(6):678-698. doi: 10.4187/respcare.05360.
Inhaled nitric oxide (INO) is only FDA-cleared for neonates (> 34 weeks gestation) with hypoxic respiratory failure-associated pulmonary hypertension. Off-label use of INO is common in the pediatric population despite a lack of evidence regarding survival benefit, questioning whether the therapy should be considered outside the neonatal period. A lack of definitive evidence combined with increasing health-care costs has led to the use of less costly inhaled prostacyclin as an alternative to INO, presenting unique patient safety concerns. We evaluate the current evidence and patient safety considerations regarding inhaled pulmonary vasodilators in the pediatric population.
吸入一氧化氮(INO)仅被美国食品药品监督管理局(FDA)批准用于患有与低氧性呼吸衰竭相关的肺动脉高压的新生儿(胎龄>34周)。尽管缺乏关于生存获益的证据,但INO在儿科人群中的超说明书使用很常见,这引发了对于该疗法在新生儿期以外是否应被考虑使用的质疑。缺乏确凿证据以及医疗成本不断增加,导致使用成本较低的吸入性前列环素作为INO的替代药物,这带来了独特的患者安全问题。我们评估了儿科人群中吸入性肺血管扩张剂的现有证据和患者安全考量因素。