Prophylactic indomethacin therapy in the first twenty-four hours of life for the prevention of patent ductus arteriosus in preterm infants treated prophylactically with surfactant in the delivery room
Prophylactic indomethacin therapy in the first twenty-four hours of life for the prevention of patent ductus arteriosus in preterm infants treated prophylactically with surfactant in the delivery room
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DOI：
10.1016/s0022-3476(96)80127-2
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发表时间：
1996-05-01
影响因子：
5.1
通讯作者：
Payne, NR
中科院分区：
文献类型：
--
作者：
Couser, RJ;Ferrara, TB;Payne, NR
目的：确定出生后24小时内开始小剂量吲哚美辛治疗是否能减少在产房接受预防性表面活性物质治疗的早产儿的导管分流。设计：90名出生体重在600到1250克之间的早产儿进入前瞻性随机对照试验，接受吲哚美辛0.1 mg/kg/剂量，或安慰剂少于24小时，每24小时重复一次，共6次。分别于治疗前第1天、治疗后第7天、24小时进行超声心动图检查。结果：43例接受消炎痛治疗的婴儿(出生体重915+/-209 g；胎龄26.4+/-1.6周；25名男婴)和47名安慰剂(出生体重879±/-202 gm；胎龄26.4+/-1.8周；22名男婴)(P=无意义)。在90名婴儿中，77名(86%)在治疗前第一天超声心动图显示动脉导管未闭；在消炎痛治疗组中，84%的PDA是中等或大型的，相比之下，安慰剂组的这一比例为93%。在接受吲哚美辛治疗的40名婴儿中，有9名(21%)是研究剂量的无反应者，而在接受安慰剂治疗的47名婴儿中，有22名(47%)无反应(p<；0.018)，两组在任何长期结果变量上都没有显著差异，包括脑室出血、氧疗时间、气管插管、在新生儿重症监护病房停留的时间、恢复出生体重或达到全部热量摄入的时间、支气管肺发育不良的发生率和存活率。在少尿、血肌酐升高、血小板减少、肺出血和坏死性肠结肠炎的发生率方面没有显著差异。结论：低出生体重儿在产房接受预防性表面活性物质治疗的前24小时开始预防性使用小剂量吲哚美辛，可减少动脉导管水平从左向右分流的发生率。
Objective: To determine whether a course of low-dose indomethacin therapy, when initiated within 24 hours of birth, would decrease ductal shunting in premature infants who received prophylactic surfactant in the delivery room.Design: Ninety infants, with birth weights of 600 to 1250 gm, were entered into a prospective, randomized, controlled trial to receive either indomethacin, 0.1 mg/kg per dose, or placebo less than 24 hours and again every 24 hours for six doses. Echocardiography was performed on day 1 before treatment and on day 7, 24 hours after treatment. A hemodynamically significant patent ductus arteriosus (PDA) was confirmed with an out-of-study echocardiogram, and the nonresponders were treated with standard indomethacin or ligation.Results: Forty-three infants received indomethacin (birth weight, 915 +/- 209 gm; gestational age, 26.4 +/- 1.6 weeks; 25 boys), and 47 received placebo (birth weight, 879 +/- 202 gm; gestational age, 26.4 +/- 1.8 weeks; 22 boys) (p = not significant), Of 90 infants, 77 (86%) had a PDA by echocardiogram on the first day of life before study treatment; 84% of these PDAs were moderate or large in size in the indomethacin-treated group compared with 93% in the placebo group. Nine of forty indomethacin-treated infants (21%) were study-dose nonresponders compared with 22 (47%) of 47 placebo-treated infants (p < 0.018), There were no significant differences between both groups in any of the long-term outcome variables, including intraventricular hemorrhage, duration of oxygen therapy, endotracheal intubation, duration of stay in neonatal intensive care unit, time to regain birth weight or reach full caloric intake, incidence of bronchopulmonary dysplasia, and survival. No significant differences were noted in the incidence of oliguria, elevated plasma creatinine concentration, thrombocytopenia, pulmonary hemorrhage, or necrotizing enterocolitis.Conclusion: The prophylactic use of low doses of indomethacin, when initiated in the first 24 hours of life in low birth weight infants who receive prophylactic surfactant in the delivery room, decreases the incidence of left-to-right shunting at the level of the ductus arteriosus.