Ghanem Sabry, Mostafa Mansour, Shafee Mohamed
Department of Pediatrics, Alazhar University, Cairo, Egypt.
J Saudi Heart Assoc. 2010 Jan;22(1):7-12. doi: 10.1016/j.jsha.2010.03.002. Epub 2010 Mar 10.
Patent ductus arteriosus (PDA), a common finding among premature infants, is conventionally treated by intravenous indomethacin. Intravenous ibuprofen was recently shown to be as effective and to have fewer adverse reactions in preterm infants. If equally effective, then oral ibuprofen for PDA closure would have several important advantages over the intravenous route. This study was designed to determine whether oral ibuprofen treatment is efficacious and safe in closure of a PDA in premature infants.
Thirty-three premature group I (study group) were treated with ibuprofen 10 mg/kg administered through a feeding tube. Thirty-three premature group II (control group) receive placebo the two imaging procedures were again performed 24 h after each ibuprofen dose. When the PDA was still hemodynamically significant, as demonstrated by echocardiography, and there was no evidence of deterioration in brain ultrasonography, a second dose of ibuprofen 5 mg/kg (placebo for control) was administered. A third equivalent dose was given after another 24 h if necessary. Cranial ultrasound was repeated 1 week after the last ibuprofen dose and again before discharge from the ward. Hematochemical analysis was preformed daily in the unit during the first days of life.
In the study group the rate of PDA closure was 93.9% (31 of 33 cases) while in the control group the rate of PDA closure was 30.3% (10 of 33 cases) with significant difference in between. There was no reopening of the ductus after closure had been achieved. No infant required surgical ligation of the ductus in study group while in the control group 24.2% (8 of 33 cases) were required surgical ligation (Table 2). Twenty-one newborns were treated with 1 dose of ibuprofen, 9 were treated with 2 doses, and the remaining 3 were treated with 3 doses.
Oral ibuprofen is an effective and safe alternative to intravenous ibuprofen for PDA closure in premature infants.
动脉导管未闭(PDA)在早产儿中较为常见,传统上采用静脉注射吲哚美辛进行治疗。最近研究表明,静脉注射布洛芬对早产儿同样有效且不良反应更少。如果效果相同,那么口服布洛芬治疗PDA闭合相较于静脉途径具有几个重要优势。本研究旨在确定口服布洛芬治疗早产儿PDA闭合是否有效且安全。
33例早产I组(研究组)通过喂食管给予10mg/kg布洛芬治疗。33例早产II组(对照组)接受安慰剂治疗。每次布洛芬给药24小时后再次进行两项影像学检查。当超声心动图显示PDA仍具有血流动力学意义,且脑超声检查无恶化迹象时,给予第二剂5mg/kg布洛芬(对照组给予安慰剂)。如有必要,24小时后再给予第三剂等量药物。在最后一剂布洛芬给药1周后及出院前再次进行颅脑超声检查。在出生后的头几天,每天在病房进行血液化学分析。
研究组PDA闭合率为93.9%(33例中的31例),而对照组PDA闭合率为30.3%(33例中的10例),两者之间存在显著差异。导管闭合后未再重新开放。研究组无婴儿需要进行动脉导管手术结扎,而对照组有24.2%(33例中的8例)需要进行手术结扎(表2)。21例新生儿接受1剂布洛芬治疗,9例接受2剂治疗,其余3例接受3剂治疗。
口服布洛芬是早产儿PDA闭合时静脉注射布洛芬的一种有效且安全的替代方法。