早期使用联合外源性表面活性剂和吸入一氧化氮可降低新生儿持续性肺动脉高压的治疗失败率：一项随机对照试验。

Early use of combined exogenous surfactant and inhaled nitric oxide reduces treatment failure in persistent pulmonary hypertension of the newborn: a randomized controlled trial.

机构信息

Department of Neonatology, Division of Pediatrics, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.

Hospital Guillermo Grant Benavente and Department of Pediatrics, Faculty of Medicine, Universidad de Concepción, Concepción, Chile.

出版信息

J Perinatol. 2021 Jan;41(1):32-38. doi: 10.1038/s41372-020-00777-x. Epub 2020 Aug 13.

DOI:10.1038/s41372-020-00777-x

PMID:32792635

Abstract

OBJECTIVE

To evaluate whether combined surfactant with inhaled nitric oxide (iNO) use will prevent newborns with hypoxemic respiratory failure (HRF) from developing an Oxygenation Index (OI) > 40.

METHODS

100 term newborns with acute HRF (OI ≥ 20) were randomized to: Surfactant+iNO: received iNO plus up to two doses of surfactant or iNO-Controls: received iNO+placebo. Main outcome was the development of severe HRF (OI > 40) despite iNO use.

RESULTS

Baseline mean ± SD OI was 37.4 ± 14 for the Surfactant+iNO group and 38.2 ± 16 for the controls. Infants receiving surfactant+iNO improved their oxygenation faster, resulting in lower OI at 24 h: 12.9 ± 9 vs 18.7 ± 11 of controls, p < 0.05; and a lower proportion developing OI > 40: 24%(12/50) vs 50%(25/50) of controls, p < 0.02. Fewer infants receiving surfactant+iNO presented the combined outcome of death or ECMO: 16%(8/50) compared to 36%(18/50) of controls, p < 0.05.

CONCLUSIONS

Early use of combined surfactant+iNO improves oxygenation preventing the progression to severe HRF. This may reduce mortality and ECMO need.

TRIAL REGISTRATION NUMBER

ISRCTN13727958.

摘要

目的

评估联合使用表面活性剂和吸入一氧化氮（iNO）是否能预防患有低氧性呼吸衰竭（HRF）的新生儿发生氧合指数（OI）>40。

方法

100 例患有急性 HRF（OI≥20）的足月新生儿被随机分为：表面活性剂+iNO 组：接受 iNO 加至多两剂表面活性剂或 iNO-对照组：接受 iNO 加安慰剂。主要结局是尽管使用了 iNO，但仍发展为严重 HRF（OI>40）。

结果

表面活性剂+iNO 组的基线平均±SD OI 为 37.4±14，对照组为 38.2±16。接受表面活性剂+iNO 的婴儿更快地改善了氧合作用，导致 24 小时时 OI 更低：12.9±9 与对照组的 18.7±11 相比，p<0.05；并且发展为 OI>40 的比例更低：24%（12/50）与对照组的 50%（25/50）相比，p<0.02。接受表面活性剂+iNO 的婴儿中，死亡或 ECMO 的联合结局更少：16%（8/50）与对照组的 36%（18/50）相比，p<0.05。