A Randomized, Double-Blind, Placebo-Controlled Trial on Intravenous Ibuprofen L-Lysine for the Early Closure of Nonsymptomatic Patent Ductus Arteriosus within 72 Hours of Birth in Extremely Low-Birth-Weight Infants
A Randomized, Double-Blind, Placebo-Controlled Trial on Intravenous Ibuprofen L-Lysine for the Early Closure of Nonsymptomatic Patent Ductus Arteriosus within 72 Hours of Birth in Extremely Low-Birth-Weight Infants
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DOI：
10.1055/s-0028-1103515
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发表时间：
2009-03-01
影响因子：
2
通讯作者：
Darko, Laszlo
中科院分区：
文献类型：
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作者：
Aranda, Jacob V.;Clyman, Ronald;Darko, Laszlo
进行了一项多中心、双盲、随机、安慰剂对照试验，旨在评估静脉注射（IV）布洛芬（L-赖氨酸）对于极低出生体重（ELBW）婴儿出生后 72 小时内无症状动脉导管未闭（PDA）早期闭合的有效性和安全性，并通过超声心动图证明导管分流。 11 个研究中心招募了 136 名无症状早期 PDA 婴儿（胎龄 < 30 周；体重 500 至 1000 克），接受为期 3 天的疗程（10 毫克/公斤、5 毫克/公斤和 5 毫克/公斤）静脉注射布洛芬 (n = 68) 或安慰剂 (n = 68)。在研究第 1 天和第 14 天进行心脏超声心动图检查，并进行抢救。对婴儿进行随访至受孕后 36 周。布洛芬和安慰剂之间的患者人口统计学平均值（标准差）相似：出生体重：798.5 克（128.7）对比 797.3 克（132.8）；胎龄：26.1 周 (1.3) 对比 26.2 周 (1.4)；首次剂量年龄：1.5 天 (0.7)。主要终点（受试者在研究第 14 天获救、死亡或退出）的意向治疗分析，布洛芬组为 21/68 (30.9%)，安慰剂组为 36/68 (52.9%) (p = 0.005)。死亡、脑室内出血、坏死性小肠结肠炎、每日液体摄入量/排出量、肝功能、支气管肺发育不良和早产儿视网膜病变没有差异。注意到布洛芬有减少脑室周围白质软化的趋势。静脉注射布洛芬在早产儿 PDA 早期闭合中有效且安全。
A multicenter, double-blind, randomized, placebo-controlled trial was conducted to evaluate the efficacy and safety of intravenous (IV) ibuprofen (L-lysine) for the early closure of nonsymptomatic patent ductus arteriosus (PDA) within 72 hours of birth in extremely low-birth-weight (ELBW) infants with evidence of ductal shunting by echocardiogram. Eleven sites enrolled 136 infants with nonsymptomatic early PDA (gestational age < 30 weeks; body weight 500 to 1000 g) to receive a 3-day course (10 mg/kg, 5 mg/kg, and 5 mg/kg) of IV ibuprofen (n = 68) or placebo (n = 68). Cardiac echocardiogram was performed on study days 1 and 14, and with rescue. Infants were followed to 36 weeks postconceptional age. Patient demographics, mean (standard deviation), were similar between ibuprofen and placebo: birth weight: 798.5 g (128.7) versus 797.3 g (132.8); gestational age: 26.1 weeks (1.3) versus 26.2 weeks (1.4); and age at first dose: 1.5 days (0.7). The intent-to-treat analysis of the primary endpoint, subjects rescued, died, or dropped through study day 14, was 21/68 (30.9%) with ibuprofen and 36/68 (52.9%) for placebo (p = 0.005). Death, intraventricular hemorrhage, necrotizing enterocolitis, daily fluid intake/output, liver function, bronchopulmonary dysplasia, and retinopathy of prematurity did not differ. A trend toward decreased periventricular leukomalacia by ibuprofen was noted. IV ibuprofen was effective and safe in the early closure of PDA in preterm neonates.