Valerio Enrico, Valente Marta Rossella, Salvadori Sabrina, Frigo Anna Chiara, Baraldi Eugenio, Lago Paola
Neonatal Intensive Care Unit, Department of Woman and Child's Health, University of Padua, Medical School, Via Giustiniani, 3, 35128, Padova, Italy.
Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Medical School, Padova, Italy.
Eur J Pediatr. 2016 Jul;175(7):953-66. doi: 10.1007/s00431-016-2731-9. Epub 2016 May 5.
Increasing recent evidence favors paracetamol use for patent ductus arteriosus (PDA) closure in preterms. Our study aims were (1) to assess efficacy and safety of intravenous (i.v.) paracetamol for PDA closure in a 23-32-week preterm population, as "first-line" (when traditional ibuprofen treatment was contraindicated) or "rescue" treatment (after ibuprofen failed), and (2) to identify predictors of PDA closure. The cumulative efficacy of consecutive cycles of i.v. paracetamol on PDA closure was confirmed after both "first-line" and "rescue" treatment, the overall PDA closure rates being, respectively, 56.7 and 61.1 % (p = 0.7624) after two cycles and 63.3 and 77.8 % (p = 0.2959) after three cycles. No toxicity was apparent after either "first-line" or "rescue" i.v. paracetamol treatment. On multivariate analysis, gestational age (GA) emerged as an independent predictor of PDA closure in the "first-line" i.v. paracetamol treatment group, while clinical risk index for babies (CRIB) score (a patient risk index based on birth weight, GA at birth, sex, patient's temperature on admission, and maximum base excess in first 12 h of life) was an independent predictor of PDA closure failure in the "rescue" group.
I.V. paracetamol proved effective in our study population. Randomized control trials (RCTs) are warranted to further investigate the efficacy and safety of i.v. paracetamol for PDA closure in preterms.
• Oral paracetamol has been judged as effective as oral ibuprofen for PDA closure in the preterm. • To date, only a handful of non-randomized studies exist to support the effectiveness of i.v. paracetamol in PDA closure. What is New: • Our observations confirm the clinical efficacy of i.v. paracetamol for PDA closure in a very low birth weight (VLBW)/extremely low birth weight (ELBW) preterm population. • Gestational age and CRIB score emerge as independent predictors of PDA closure.
近期越来越多的证据支持使用对乙酰氨基酚来关闭早产儿的动脉导管未闭(PDA)。我们的研究目的是:(1)评估静脉注射对乙酰氨基酚在23 - 32周早产人群中关闭PDA的有效性和安全性,作为“一线”治疗(当传统布洛芬治疗禁忌时)或“挽救”治疗(布洛芬治疗失败后);(2)确定PDA关闭的预测因素。在“一线”和“挽救”治疗后,均证实了连续静脉注射对乙酰氨基酚周期对PDA关闭的累积有效性,两个周期后总体PDA关闭率分别为56.7%和61.1%(p = 0.7624),三个周期后分别为63.3%和77.8%(p = 0.2959)。在“一线”或“挽救”静脉注射对乙酰氨基酚治疗后均未发现明显毒性。多因素分析显示,在“一线”静脉注射对乙酰氨基酚治疗组中,胎龄(GA)是PDA关闭的独立预测因素,而婴儿临床风险指数(CRIB)评分(一种基于出生体重、出生时GA、性别、入院时患者体温以及出生后12小时内最大碱剩余的患者风险指数)是“挽救”组中PDA关闭失败的独立预测因素。
在我们的研究人群中,静脉注射对乙酰氨基酚被证明是有效的。有必要进行随机对照试验(RCT)以进一步研究静脉注射对乙酰氨基酚在早产儿中关闭PDA的有效性和安全性。
• 口服对乙酰氨基酚在关闭早产儿PDA方面被认为与口服布洛芬一样有效。• 迄今为止,仅有少数非随机研究支持静脉注射对乙酰氨基酚在关闭PDA方面的有效性。新发现:• 我们的观察结果证实了静脉注射对乙酰氨基酚在极低出生体重(VLBW)/超低出生体重(ELBW)早产人群中关闭PDA的临床有效性。• 胎龄和CRIB评分是PDA关闭的独立预测因素。