Dani Carlo, Lista Gianluca, Bianchi Silvia, Mosca Fabio, Schena Federico, Ramenghi Luca, Zecca Enrico, Vento Giovanni, Poggi Chiara, Leonardi Valentina, Minghetti Diego, Rosignoli Maria Teresa, Calisti Fabrizio, Comandini Alessandro, Cattaneo Agnese, Lipone Paola
Department of Neuroscience, Psychology, Drug Research and Child Health, Careggi University Hospital of Florence, Largo Brambilla 3, 50134, Florence, Italy.
Division of Neonatology, Careggi University Hospital of Florence, Largo Brambilla 3, 50134, Florence, Italy.
Eur J Pediatr. 2021 Mar;180(3):807-816. doi: 10.1007/s00431-020-03780-8. Epub 2020 Sep 4.
Our aim was to assess the efficacy and safety of intravenous (i.v.) paracetamol vs. i.v. ibuprofen for the treatment of hemodynamically significant patent ductus arteriosus (hsPDA) in preterm infants. This is a multicenter randomized controlled study. Infants with a gestational age of 25-31 weeks were randomized to receive i.v. paracetamol (15 mg/kg/6 h for 3 days) or i.v. ibuprofen (10-5-5 mg/kg/day). The primary outcome was the closure rate of hsPDA after the first treatment course with paracetamol or ibuprofen. Secondary outcomes included the constriction rate of hsPDA, the re-opening rate, and the need for surgical closure. Fifty-two and 49 infants received paracetamol or ibuprofen, respectively. Paracetamol was less effective in closing hsPDA than ibuprofen (52 vs. 78%; P = 0.026), but the constriction rate of the ductus was similar (81 vs. 90%; P = 0.202), as confirmed by logistic regression analysis. The re-opening rate, the need for surgical closure, and the occurrence of adverse effects were also similar.Conclusions: Intravenous paracetamol was less effective in closing hsPDA than ibuprofen, but due to a similar constriction effect, its use was associated with the same hsPDA outcome. These results can support the use of i.v. paracetamol as a first-choice drug for the treatment of hsPDA.Trial registration: Clinicaltrials.gov : NCT02422966, Date of registration: 04/09/2015; EudraCT no: 2013-003883-30. What is Known: • The successful closure of patent ductus arteriosus with oral paracetamol has been recently reported in several preterm infants, but only one randomized controlled study investigated the efficacy of intravenous paracetamol. What is New: • Intravenous paracetamol is less effective in closing hsPDA than ibuprofen, but have a similar constriction effect. • These results can support the use of i.v. paracetamol as a first-choice drug for the treatment of hsPDA.
我们的目的是评估静脉注射对乙酰氨基酚与静脉注射布洛芬治疗早产儿血流动力学显著的动脉导管未闭（hsPDA）的疗效和安全性。这是一项多中心随机对照研究。胎龄为25 - 31周的婴儿被随机分为接受静脉注射对乙酰氨基酚（15毫克/千克/6小时，共3天）或静脉注射布洛芬（10 - 5 - 5毫克/千克/天）。主要结局是在首次使用对乙酰氨基酚或布洛芬治疗疗程后hsPDA的闭合率。次要结局包括hsPDA的收缩率、再开放率以及手术闭合的必要性。分别有52名和49名婴儿接受了对乙酰氨基酚或布洛芬治疗。对乙酰氨基酚在闭合hsPDA方面比布洛芬效果差（52%对78%；P = 0.026），但动脉导管的收缩率相似（81%对90%；P = 0.202），逻辑回归分析证实了这一点。再开放率、手术闭合的必要性以及不良反应的发生率也相似。结论：静脉注射对乙酰氨基酚在闭合hsPDA方面比布洛芬效果差，但由于收缩作用相似，其使用与hsPDA的结局相同。这些结果可以支持将静脉注射对乙酰氨基酚作为治疗hsPDA的首选药物。试验注册：Clinicaltrials.gov：NCT02422966，注册日期：2015年9月4日；EudraCT编号：2013 - 003883 - 30。已知信息：• 最近有报道称，在几名早产儿中口服对乙酰氨基酚成功闭合了动脉导管未闭，但只有一项随机对照研究调查了静脉注射对乙酰氨基酚的疗效。新发现：• 静脉注射对乙酰氨基酚在闭合hsPDA方面比布洛芬效果差，但收缩作用相似。• 这些结果可以支持将静脉注射对乙酰氨基酚作为治疗hsPDA的首选药物。
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