Low-dose nitric oxide therapy for persistent pulmonary hypertension of the newborn.
Low-dose nitric oxide therapy for persistent pulmonary hypertension of the newborn.
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DOI：
10.1056/nejm200002173420704
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发表时间：
2000-02-17
影响因子：
158.5
通讯作者：
Kinsella, JP
中科院分区：
文献类型：
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作者：
Clark, RH;Kueser, TJ;Kinsella, JP
背景：吸入一氧化氮改善了新生儿的气体交换，但小剂量吸入一氧化氮减少体外膜氧合需求的效果尚未确定。方法：我们进行了一项临床试验，以确定小剂量吸入一氧化氮是否会减少34周后出生、出生4天或以下、需要辅助呼吸机、氧合指数大于或等于25的低氧性呼吸衰竭的新生儿体外膜氧合的使用。接受一氧化氮治疗的新生儿最多接受20ppm的治疗24小时，然后是5ppm的治疗不超过96小时。研究的主要终点是体外膜肺氧合。结果：在入选的248名新生儿中，126名随机分配到一氧化氮组，122名分配给对照组。对照组采用体外膜肺氧合78例(%)，一氧化氮组48例(38%)(P=0.001)。两组的30天死亡率相似(对照组为8%，一氧化氮组为7%)。接受一氧化氮治疗的新生儿发生慢性肺部疾病的几率低于对照组(7%比20%，P=0.02)。结论：吸入一氧化氮降低了新生儿低氧性呼吸衰竭和肺动脉高压患儿体外膜肺氧合的需要量。(N Engl J Med 2000；342：469-74)(C)2000年，马萨诸塞州医学会。
Background: Inhaled nitric oxide improves gas exchange in neonates, but the efficacy of low-dose inhaled nitric oxide in reducing the need for extracorporeal membrane oxygenation has not been established.Methods: We conducted a clinical trial to determine whether low-dose inhaled nitric oxide would reduce the use of extracorporeal membrane oxygenation in neonates with pulmonary hypertension who were born after 34 weeks' gestation, were 4 days old or younger, required assisted ventilation, and had hypoxemic respiratory failure as defined by an oxygenation index of 25 or higher. The neonates who received nitric oxide were treated with 20 ppm for a maximum of 24 hours, followed by 5 ppm for no more than 96 hours. The primary end point of the study was the use of extracorporeal membrane oxygenation.Results: Of 248 neonates enrolled, 126 were randomly assigned to the nitric oxide group and 122 to the control group. Extracorporeal membrane oxygenation was used in 78 neonates in the control group (64 percent) and in 48 neonates in the nitric oxide group (38 percent) (P=0.001). The 30-day mortality rate in the two groups was similar (8 percent in the control group and 7 percent in the nitric oxide group). Chronic lung disease developed less often in neonates treated with nitric oxide than in those in the control group (7 percent vs. 20 percent, P=0.02). The efficacy of nitric oxide was independent of the base-line oxygenation index and the primary pulmonary diagnosis.Conclusions: Inhaled nitric oxide reduces the extent to which extracorporeal membrane oxygenation is needed in neonates with hypoxemic respiratory failure and pulmonary hypertension. (N Engl J Med 2000;342:469-74.) (C) 2000, Massachusetts Medical Society.