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吸入药用级一氧化氮治疗胎龄≥34 周常规治疗失败新生儿持续性 肺动脉高压的安全性和有效性评价:5 例前瞻性病例观察研究
庄佳璐,董楚晗,沈艳青,李志玲,贝斐
(上海交通大学医学院附属上海儿童医学中心,上海 200127)
摘要:
目的:评价吸入一氧化氮(iNO)在胎龄≥34 周、常规治疗失败的低氧性呼吸衰竭合并新生儿持续性肺动脉高压(PPHN) 患儿中的安全性和有效性。方法:前瞻性纳入我院新生儿重症监护室(NICU)2024 年3 月-2025 年2 月收治的PPHN 患儿。采 用药用级iNO(INOmax􀳏 )治疗,动态监测有效性指标[氧合指数(OI)和血管活性-正性肌力评分(VIS)]及安全性指标[高铁血 红蛋白(MetHb)和二氧化氮(NO2 )浓度]。结果:纳入5 例患儿,治疗后OI 快速改善,VIS 评分逐渐下降。MetHb 和NO2 浓度均 在安全范围,无严重不良事件,均治愈出院。结论:药用级iNO 可显著改善胎龄≥34 周常规治疗失败PPHN 患儿氧合功能,安 全性良好,为国内临床应用提供了初步实践证据,尚待多中心、大样本量研究进一步检验。
关键词:  新生儿  持续性肺动脉高压  吸入一氧化氮  氧合指数  安全性
DOI:doi:10.13407/j.cnki.jpp.1672-108X.2026.11.013
基金项目:基金项目:浦东新区卫生健康委员会卫生计生科研项目,编号PW2022D-09。
Evaluation on Safety and Efficacy of Inhaled Pharmaceutical-Grade Nitric Oxide in the Treatment ofPersistent Pulmonary Hypertension in Neonates with Gestational Age⩾34 Weeks: a Prospective Case Studyof 5 Cases
Zhuang Jialu, Dong Chuhan, Shen Yanqing, Li Zhiling, Bei Fei
(Shanghai Children’s Medical Center, Shanghai Jiao Tong University School of Medicine, Shanghai 200127, China)
Abstract:
Objective: To evaluate the efficacy and safety of inhaled nitric oxide (iNO) in children with gestational age ⩾34 weeks who developed persistent pulmonary hypertension of neonates (PPHN) with hypoxic respiratory failure refractory to conventional treatment. Methods: Children with PPHN admitted into the Neonatal Intensive Care Unit (NICU) of our hospital from Mar. 2024 to Feb. 2025 were prospectively enrolled. All patients received pharmaceutical-grade iNO (INOmax􀳏 ). Efficacy was assessed by dynamic monitoring of oxygenation index (OI) and vasoactive-inotropic score (VIS). Safety was evaluated by methemoglobin (MetHb) levels and nitrogen dioxide (NO2 ) concentrations. Results: Five neonates were included. After initiation of iNO therapy, the OI improved rapidly, and the VIS decreased progressively. MetHb and NO2 levels remained within safe ranges throughout treatment. No severe adverse events occurred, and all patients were cured and discharged. Conclusion: Pharmaceutical-grade iNO can significantly improve the oxygenation function of children (gestational age ⩾34 weeks) with PPHN with higher safety. These findings provide preliminary evidence for its clinical application in China, further verification is needed through multi-center large-sample studies.
Key words:  neonates  persistent pulmonary hypertension  inhaled nitric oxide  oxygenation index  safety

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