Cherif Ahmed, Khrouf Naima, Jabnoun Sami, Mokrani Chahnez, Amara Moez Ben, Guellouze Nedia, Kacem Samia
Neonatal Intensive Care Unit, Neonatology and Maternity Center, Faculty of Medicine, Department of Neonatology, University of Tunis, 1007 Jebari, Tunis, Tunisia.
Pediatrics. 2008 Dec;122(6):e1256-61. doi: 10.1542/peds.2008-1780.
We conducted a prospective, randomized, single-masked pilot study with the principal aim of comparing efficacy and tolerance between oral and intravenous ibuprofen in early closure of patent ductus arteriosus in very low birth weight infants. The possibility of ductal closure with only 1 or 2 doses of treatment was a secondary objective.
Sixty-four very low birth weight patients with echocardiographically confirmed patent ductus arteriosus and respiratory distress were studied. The patients were randomly assigned to receive either oral (group O, n=32) or intravenous (group I, n=32) ibuprofen starting on the third day of life. After the first dose of treatment in both groups, echocardiographic evaluation was performed to determine the need for a second or third dose. The rate of ductal closure, adverse effects, complications, and the patient's clinical course were recorded.
In each group, 24 (75%) patients were born after 28 weeks' gestation. The rate of ductal closure tended to increase in group O (84.3% vs 62.5%). Closure of the ductus was obtained after 1 or 2 doses of treatment in 19 (70.3%) of 27 patients in group O and 14 (70%) of 20 patients in group I. The adverse effects were increased in group I (31.2% vs 9.3%). There were no significant differences with respect to complications during the stay. Adverse effects were significantly fewer when closure was achieved after an incomplete course of treatment (23.1% vs 76.9%).
In very low birth weight infants, the rate of early ductal closure with oral ibuprofen is at least as good as with the intravenous route. Ductal closure may be obtained with an incomplete course of ibuprofen. Oral ibuprofen is associated with fewer adverse effects. However, a larger sample is needed for more definitive conclusions.
我们开展了一项前瞻性、随机、单盲试点研究，主要目的是比较口服布洛芬与静脉注射布洛芬在极低出生体重儿动脉导管未闭早期闭合中的疗效和耐受性。仅用1或2剂治疗实现导管闭合的可能性是次要目标。
研究了64例经超声心动图证实动脉导管未闭且有呼吸窘迫的极低出生体重患者。这些患者在出生后第三天被随机分配接受口服（O组，n = 32）或静脉注射（I组，n = 32）布洛芬。两组在首次给药后，均进行超声心动图评估以确定是否需要第二剂或第三剂。记录导管闭合率、不良反应、并发症及患者的临床病程。
每组中，24例（75%）患者在妊娠28周后出生。O组导管闭合率有上升趋势（84.3%对62.5%）。O组27例患者中有19例（70.3%）在1或2剂治疗后实现导管闭合，I组20例患者中有14例（70%）实现导管闭合。I组不良反应增加（31.2%对9.3%）。住院期间并发症方面无显著差异。在未完成整个疗程即实现导管闭合时，不良反应明显较少（23.1%对76.9%）。
在极低出生体重儿中，口服布洛芬早期导管闭合率至少与静脉途径一样好。布洛芬疗程未完成时也可能实现导管闭合。口服布洛芬不良反应较少。然而，需要更大样本才能得出更确切结论。
