Safety and efficacy of ibuprofen versus indomethacin in preterm infants treated for patent ductus arteriosus: a randomised controlled trial
Safety and efficacy of ibuprofen versus indomethacin in preterm infants treated for patent ductus arteriosus: a randomised controlled trial
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DOI：
10.1007/s00431-002-0915-y
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发表时间：
2002-04-01
影响因子：
3.6
通讯作者：
Saia, OS
中科院分区：
文献类型：
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作者：
Lago, P;Bettiol, T;Saia, OS
吲哚美辛（INDO）和最近的布洛芬（IBU）已被用于治疗早产儿血流动力学上显著的动脉导管未闭（PDA）。两者都是环加氧酶阻滞剂，但似乎对局部循环有不同的影响。在一项前瞻性、随机对照研究中，我们比较了INDO和IBU在PDA早期非侵入性治疗中的疗效和安全性。采用多普勒超声心动图对232例伴有呼吸窘迫综合征的早产儿（胎龄23-34周）进行了研究，其中175例在出生后48-72小时有持续的、血流动力学显著的PDA。他们随机接受三次静脉注射剂量的INDO （0.2 mg/kg，间隔12小时）或IBU（第一次10mg /kg剂量，随后两次5mg /kg剂量，间隔24小时），记录导管关闭率、额外治疗需求、副作用和临床病程。两组药物治疗效果相似（INDO组为56/81,69%；IBU组为69/94,73%）。接受INDO治疗的患者血清肌酐显著升高（89+/-24 vs 82+/-20 mmol/l， P=0.03），钠排泄量下降趋势接近显著（3+/-3 vs 4+/-2%， P= 0.08）；此外。12/81（15%）的INDO患者和1/94（1%）的IBU患者出现少尿(
Indomethacin (INDO) and, more recently, ibuprofen (IBU) have been used to treat haemodynamically significant patent ductus arteriosus (PDA) in preterm infants. Both are cyclo-oxygenase blockers, but seem to have a different influence on regional circulation. In a prospective, randomised, controlled study, we compared INDO and IBU with regard to efficacy and safety for the early non-invasive treatment of PDA. Doppler echocardiography was used to study 232 preterm infants (gestational age 23-34 weeks) with respiratory distress syndrome of whom 175 had persistent, haemodynamically significant PDA at 48-72 h of life. They were randomised to receive three intravenous doses of either INDO (0.2 mg/kg, at 12 h intervals) or IBU (a first 10 mg/kg dose followed by two doses of 5 mg/kg at 24 h intervals), recording rate of ductal closure, need for additional treatment, side-effects and clinical course. The efficacy of the pharmacological treatment was similar in the two groups (56/81, 69% INDO; 69/94, 73% IBU). Patients treated with INDO showed a significant increase in serum creatinine (89+/-24 versus 82+/-20 mmol/l, P=0.03) and a near-significant tendency for a lower fractional excretion of sodium (3+/-3 versus 4+/-2%, P = 0.08); moreover. 12/81 (15%) INDO patients versus 1/94 (1%) IBU patients became oliguric (