Suzuki Satoshi, Togari Hajime, Potenziano Jim L, Schreiber Michael D
Department of Neonatology, Nagoya City West Medical Center, Nagoya, Japan.
Mallinckrodt Pharmaceuticals, Hampton, NJ, USA.
J Perinat Med. 2018 Aug 28;46(6):657-663. doi: 10.1515/jpm-2017-0040.
To analyze data from a registry of Japanese neonates with hypoxic respiratory failure associated with pulmonary hypertension (PH) to compare the effectiveness of inhaled nitric oxide (iNO) in neonates born <34 weeks vs. ≥34 weeks gestational age (GA).
iNO was administered according to approved Japanese product labeling. Study data were collected before iNO administration and at predefined intervals until discontinuation.
A total of 1,114 neonates were included (n=431, <34 weeks GA; n=675, ≥34 weeks GA; n=8, missing age data). Mean decrease from baseline oxygenation index (OI) was similar in both age groups. OI reduction was more pronounced in the <34 weeks subgroups with baseline OI ≥25. Survival rates were similar in the <34 weeks GA and ≥34 weeks GA groups stratified by baseline OI (OI<15, 89% vs. 93%; 15≤OI<25, 85% vs. 91%; 25≤OI≤40, 73% vs. 79%; OI>40, 64% vs. 66%).
iNO improved oxygenation in preterm neonates as effectively as in late preterm and term neonates, without negative impact on survival. If clinically significant PH is present, as measured by pulse oximetry or echocardiography, a therapeutic trial of iNO might be indicated for preterm neonates.
分析日本患有与肺动脉高压(PH)相关的低氧性呼吸衰竭的新生儿登记数据,以比较吸入一氧化氮(iNO)对孕周<34周与≥34周的新生儿的疗效。
iNO根据日本批准的产品标签给药。研究数据在iNO给药前及预定的间隔时间收集,直至停药。
共纳入1114例新生儿(孕周<34周者431例;孕周≥34周者675例;8例年龄数据缺失)。两个年龄组从基线氧合指数(OI)的平均下降相似。在基线OI≥25的<34周亚组中,OI降低更为明显。根据基线OI分层,孕周< 34周组和孕周≥34周组的生存率相似(OI<15,89%对93%;15≤OI<25,85%对91%;25≤OI≤40,73%对79%;OI>40,64%对66%)。
iNO改善早产新生儿氧合的效果与晚期早产和足月新生儿相同,且对生存率无负面影响。如果通过脉搏血氧饱和度测定或超声心动图测量存在临床上显著的PH,iNO治疗试验可能适用于早产新生儿。