Neonatal Intensive Care Unit, John Hunter Children's Hospital, Lookout Road, New Lambton, Australia.
Arch Dis Child Fetal Neonatal Ed. 2011 Jan;96(1):F45-52. doi: 10.1136/adc.2009.168682. Epub 2010 Sep 27.
To evaluate the effects of indomethacin or ibuprofen compared with placebo on closure, morbidity and mortality in preterm infants <37 weeks' gestation with echocardiographically and/or clinically important patent ductus arteriosus (PDA) at >24 h of life.
MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, CINAHL, Cochrane Library, clinicaltrials.gov, controlled-trials.com, American Pediatric and European Paediatric Research Societies and Effective Care of the Newborn Infant.
Systematic review with network meta-analysis of randomised studies comparing intravenous indomethacin, ibuprofen or placebo for PDA in preterm infants at >24 h of life.
Ten trials compared intravenous indomethacin versus intravenous ibuprofen, nine intravenous indomethacin versus placebo and one intravenous ibuprofen versus placebo. Both intravenous indomethacin (pooled RR 2.39 (95% CI 2.05 to 2.78)) and intravenous ibuprofen (RR 2.40 (95% CI 2.03 to 2.84)) closed a PDA more effectively than placebo. Intravenous ibuprofen was associated with approximately 30% greater risk of chronic lung disease than intravenous indomethacin (RR 1.28 (95% CI 1.03 to 1.60)) or placebo (RR 1.29 (95% CI 0.99 to 1.70)). Differences in risk or benefit were not significant between any combination of intravenous indomethacin, intravenous ibuprofen or placebo groups for intraventricular haemorrhage, necrotising enterocolitis and death. Reporting on neurological outcomes was insufficient for pooling.
Intravenous indomethacin or ibuprofen administered to preterm infants for PDA at >24 h of life promoted ductal closure, but other short-term benefits were not seen. Treatment with intravenous ibuprofen may increase the risk of chronic lung disease. Good-quality evidence of treatment effect on morbidity, mortality and improved neurodevelopment is urgently needed.
评估吲哚美辛或布洛芬与安慰剂相比，对 24 小时后有超声心动图和/或临床重要的动脉导管未闭（PDA）且胎龄<37 周的早产儿的闭合率、发病率和死亡率的影响。
MEDLINE、EMBASE、Cochrane 对照试验中心注册库、CINAHL、Cochrane 图书馆、clinicaltrials.gov、controlled-trials.com、美国儿科协会和欧洲儿科研究协会以及新生儿有效护理。
对比较 24 小时后有超声心动图和/或临床重要的动脉导管未闭且胎龄<37 周的早产儿使用静脉内吲哚美辛、布洛芬或安慰剂治疗 PDA 的随机研究进行系统评价和网络荟萃分析。
10 项试验比较了静脉内吲哚美辛与静脉内布洛芬，9 项试验比较了静脉内吲哚美辛与安慰剂，1 项试验比较了静脉内布洛芬与安慰剂。静脉内吲哚美辛（汇总 RR 2.39（95%CI 2.05 至 2.78））和静脉内布洛芬（RR 2.40（95%CI 2.03 至 2.84））都比安慰剂更有效地关闭 PDA。与静脉内吲哚美辛（RR 1.28（95%CI 1.03 至 1.60））或安慰剂（RR 1.29（95%CI 0.99 至 1.70））相比，静脉内布洛芬与慢性肺部疾病的风险增加约 30%相关。在颅内出血、坏死性小肠结肠炎和死亡方面，任何静脉内吲哚美辛、静脉内布洛芬或安慰剂组之间的风险或获益差异均无统计学意义。由于报告的神经结局数据不足，无法进行汇总。
在 24 小时后有 PDA 的早产儿中使用静脉内吲哚美辛或布洛芬可促进导管闭合，但未见其他短期益处。静脉内使用布洛芬可能会增加慢性肺部疾病的风险。迫切需要高质量的证据来证明治疗对发病率、死亡率和神经发育改善的影响。
