吸入一氧化氮治疗足月或近足月儿低氧性呼吸衰竭的循证医学证据

Evidence of inhaled nitric oxide therapy for hypoxic respiratory failure in term and near-term infants

目的通过对吸入一氧化氮(iNO)治疗足月或近足月儿低氧性呼吸衰竭(HRF)的临床研究进行循证分析,综合评价iNO治疗足月或近足月儿HRF的临床效果,为临床应用提供指导。方法制定原始文献的纳入标准、排除标准及检索策略,检索PubMed、EMBASE、Ovid、Springer和中国期刊全文数据库等,获得iNO治疗足月或近足月儿HRF的临床文献。使用国际Cochrane中心推荐的方法进行文献质量评估后,采用Review Manager 4.2软件对满足纳入标准的有关iNO治疗足月或近足月儿HRF的随机对照试验(RCT)研究进行Meta分析。结果共检索出162篇文献,对符合标准的15篇RCT研究进行Meta分析,其中11篇为多中心研究,4篇为单中心研究。结果表明经过iNO的治疗,能够在30min到60min显著降低患儿的氧合指数(OI)(P<0.05)、升高动脉血氧分压(PaO2)(P<0.05),减少使用体外膜肺(P<0.05),长期神经系统的发育随访和对照组比较没有统计学差异(P>0.05);先天性膈疝患儿经过iNO的治疗不能改善患儿的氧合和减少死亡率(P>0.05)。结论经用Meta分析认为对于患有HRF的足月或近足月儿,除了先天性膈疝外,当OI>25或吸入FiO2达到100%,PaO2<13.3kPa时,可以进行iNO的治疗,但对患儿长期神经系统发育的影响还需要进行随访。

Objective To study the evidence-based therapy of inhaled nitric oxide （iNO）for hypoxic respiratory failure （HRF） in term and near-term infants by analyzing the literature systematically. Methods The literature related to the treatment of HRF with iNO was retrieved from the following： PubMed, EMBASE, OVID, Springer and Chinese Journals Full-Text Database （CNKI）. The relevant literature on randomized controlled trials （RCTs） that met the criteria was statistically analyzed by the software of Review Manager 4.2, as recommended by Cochrane Collaboration. Results A total of 162 articles were retrieved. Fifteen met the criteria and were selected for Meta analysis （4 single center and 11 muhicenter randomized trials）. Meta analysis showed that 30-60 minutes iNO therapy decreased the oxygenation index （P 〈0.05）, increased PaO2 significantly, and reduced need of extracorporeal membrane oxygenation （ECMO） （P 〈 0.05）. However, for the neonates with HRF caused by congenital diaphragmatic hernia, iNO therapy did not result in a significant reduction in the oxygenation index and death rate. There was no significant difference in the occurrence of neurodevelopmental sequelae between the iNO and control groups. Conclusions The currently published evidence from RCTs supports the use of iNO in term and near-term infants with HRF but except for the HRF infants caused by diaphragmatic hernia. The effect of iNO therapy on long-term neurodevelopment needs to be further studied.