Field D, Elbourne D, Truesdale A, Grieve R, Hardy P, Fenton A C, Subhedar N, Ahluwalia J, Halliday H L, Stocks J, Tomlin K, Normand C
Department of Health Science, Leicester Royal Infirmary, PO Box 65, Leicester LE2 7LX, United Kingdom.
Pediatrics. 2005 Apr;115(4):926-36. doi: 10.1542/peds.2004-1209.
Although inhaled nitric oxide (iNO) may be a promising treatment for newborn infants with severe respiratory failure, the results from 3 previous small trials were inconclusive.
Infants of <34 weeks' gestation, <28 days old, and with severe respiratory failure requiring ventilatory support were randomized to receive or not receive iNO. The study was not blinded.
Recruited were 108 infants (55 allocated to receive iNO and 53 not allocated to receive iNO) from 15 neonatal units in the United Kingdom and Republic of Ireland. Fifty-nine percent (64 of 108) died, and 84% of the survivors (37 of 44) had signs of some impairment or disability, 9 (20%) of them classified as severely disabled. There was no evidence of an effect of iNO on the primary outcomes: death or severe disability at 1 year corrected age (relative risk [RR]: 0.99; 95% confidence interval [CI]: 0.76 to 1.29); death or supplemental oxygen on expected date of delivery (RR: 0.84; 95% CI: 0.68 to 1.02); or death or supplemental oxygen at 36 weeks' postmenstrual age (RR: 0.98; 95% CI: 0.87 to 1.12). There was a trend for infants allocated to the iNO group to spend more time on the ventilator (log rank: 3.6), on supplemental oxygen (log rank: 1.4), and in hospital (log rank: 3.5) than those allocated to receive no iNO. This pattern predominantly reflected the infants who died. Mean total costs at 1 year corrected age were significantly higher in the iNO group, partly because of the costs of the gas but mainly because of the difference in initial hospitalization costs.
Evidence of prolongation of intensive care and increased costs of such care, without clear beneficial effects, implies that iNO cannot be recommended for preterm infants with severe hypoxic respiratory failure.
尽管吸入一氧化氮（iNO）可能是治疗患有严重呼吸衰竭的新生儿的一种有前景的方法，但之前3项小型试验的结果尚无定论。
将胎龄小于34周、年龄小于28天且患有严重呼吸衰竭需要通气支持的婴儿随机分为接受或不接受iNO治疗组。该研究未设盲。
从英国和爱尔兰共和国的15个新生儿病房招募了108名婴儿（55名被分配接受iNO治疗，53名未被分配接受iNO治疗）。59%（108名中的64名）死亡，84%的幸存者（44名中的37名）有某种损伤或残疾迹象，其中9名（20%）被归类为严重残疾。没有证据表明iNO对主要结局有影响：矫正年龄1岁时的死亡或严重残疾（相对风险[RR]：0.99；95%置信区间[CI]：0.76至1.29）；预计分娩日期时的死亡或补充氧气（RR：0.84；95%CI：0.68至1.02）；或月经龄36周时的死亡或补充氧气（RR：0.98；95%CI：0.87至1.12）。与未接受iNO治疗的婴儿相比，被分配到iNO治疗组的婴儿在呼吸机上的时间（对数秩检验：3.6）、接受补充氧气的时间（对数秩检验：1.4）和住院时间（对数秩检验：3.5）有延长的趋势。这种模式主要反映了死亡的婴儿。矫正年龄1岁时iNO治疗组的平均总费用显著更高，部分原因是气体费用，但主要是因为初始住院费用的差异。
重症监护延长且此类护理成本增加但无明显有益效果的证据表明，对于患有严重缺氧性呼吸衰竭的早产儿，不推荐使用iNO。
