吸入一氧化氮用于足月及近足月低氧性呼吸衰竭婴儿。

Inhaled nitric oxide in full-term and nearly full-term infants with hypoxic respiratory failure.

机构信息

Department of Pediatrics, Yale University School of Medicine, New Haven, CT 06520-8064, USA.

出版信息

N Engl J Med. 1997 Feb 27;336(9):597-604. doi: 10.1056/NEJM199702273360901.

DOI:10.1056/NEJM199702273360901

PMID:9036320

Abstract

BACKGROUND

Neonates with pulmonary hypertension have been treated with inhaled nitric oxide because of studies suggesting that it is a selective pulmonary vasodilator. We conducted a randomized, multicenter, controlled trial to determine whether inhaled nitric oxide would reduce mortality or the initiation of extracorporeal membrane oxygenation in infants with hypoxic respiratory failure.

METHODS

Infants born after a gestation of > or =34 weeks who were 14 days old or less, had no structural heart disease, and required assisted ventilation and whose oxygenation index was 25 or higher on two measurements were eligible for the study. The infants were randomly assigned to receive nitric oxide at a concentration of 20 ppm or 100 percent oxygen (as a control). Infants whose partial pressure of arterial oxygen (PaO2) increased by 20 mm Hg or less after 30 minutes were studied for a response to 80-ppm nitric oxide or control gas.

RESULTS

The 121 infants in the control group and the 114 in the nitric oxide group had similar base-line clinical characteristics. Sixty-four percent of the control group and 46 percent of the nitric oxide group died within 120 days or were treated with extracorporeal membrane oxygenation (P=0.006). Seventeen percent of the control group and 14 percent of the nitric oxide group died (P not significant), but significantly fewer in the nitric oxide group received extracorporeal membrane oxygenation (39 percent vs. 54 percent, P=0.014). The nitric oxide group had significantly greater improvement in PaO2 (increase, 58.2+/-85.2 mm Hg, vs. 9.7+/-51.7 mm Hg in the controls; P<0.001) and in the oxygenation index (a decrease of 14.1+/-21.1, vs. an increase of 0.8+/-21.1 in the controls; P<0.001). The study gas was not discontinued in any infant because of toxicity.

CONCLUSIONS

Nitric oxide therapy reduced the use of extracorporeal membrane oxygenation, but had no apparent effect on mortality in critically ill infants with hypoxic respiratory failure.

摘要

背景

由于研究表明吸入一氧化氮是一种选择性肺血管扩张剂，患有肺动脉高压的新生儿一直采用吸入一氧化氮进行治疗。我们进行了一项随机、多中心、对照试验，以确定吸入一氧化氮是否会降低患有低氧性呼吸衰竭婴儿的死亡率或体外膜肺氧合的启用率。

方法

孕周≥34周、年龄在14天及以下、无结构性心脏病、需要辅助通气且两次测量时氧合指数为25或更高的婴儿符合研究条件。婴儿被随机分配接受浓度为20 ppm的一氧化氮或100%氧气（作为对照）。30分钟后动脉血氧分压（PaO2）升高20 mmHg或更低的婴儿，研究其对80 ppm一氧化氮或对照气体的反应。

结果

对照组的121名婴儿和一氧化氮组的114名婴儿具有相似的基线临床特征。对照组64%的婴儿和一氧化氮组46%的婴儿在120天内死亡或接受了体外膜肺氧合治疗（P = 0.006）。对照组17%的婴儿和一氧化氮组14%的婴儿死亡（P无统计学意义），但一氧化氮组接受体外膜肺氧合治疗的婴儿明显较少（39%对54%，P = 0.014）。一氧化氮组的PaO2改善明显更大（增加58.2±85.2 mmHg，而对照组为9.7±51.7 mmHg；P<0.001），氧合指数也明显改善（降低14.1±21.1，而对照组增加0.8±21.1；P<0.001）。没有任何婴儿因毒性而停止使用研究气体。