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一项针对出生时体重1000克或以下婴儿的动脉导管极早期预防性结扎的随机对照试验。

A randomized, controlled trial of very early prophylactic ligation of the ductus arteriosus in babies who weighed 1000 g or less at birth.

作者信息

Cassady G, Crouse D T, Kirklin J W, Strange M J, Joiner C H, Godoy G, Odrezin G T, Cutter G R, Kirklin J K, Pacifico A D

机构信息

Department of Pediatrics, University of Alabama, Birmingham School of Medicine.

出版信息

N Engl J Med. 1989 Jun 8;320(23):1511-6. doi: 10.1056/NEJM198906083202302.

DOI:10.1056/NEJM198906083202302
PMID:2498657
Abstract

We speculated that prophylactic ligation of the ductus arteriosus would reduce mortality and morbidity in very-low-birth-weight infants. To test this hypothesis, we randomly assigned 84 babies who weighed 1000 g or less at birth and required supplemental oxygen either to receive standard treatment (n = 44) or to undergo prophylactic surgical ligation of the ductus arteriosus on the day of birth (n = 40). The ductus was ligated in babies in the control group only if the shunt was hemodynamically important. All the babies were followed for one year. The incidence of necrotizing enterocolitis was reduced in the group that underwent prophylactic ligation (3 of 40 [8 percent]) as compared with the control group (13 of 44 [30 percent]; P = 0.002). The frequency of death, bronchopulmonary dysplasia, retinopathy of prematurity, and intraventricular hemorrhage was similar in both groups. Because early enteral feeding may have increased the incidence of necrotizing enterocolitis, we analyzed separately the babies who were fed early. Among the infants who were fed within 14 days of birth, those who underwent prophylactic ligation had a lower incidence of necrotizing enterocolitis (1 of 11 [9 percent]) than those who did not (13 of 24 [54 percent]; P = 0.001). Within the control group, the infants who were fed within 14 days of birth and whose ductus was ligated for medical reasons within 5 days of birth had a lower incidence of necrotizing enterocolitis (2 of 10 [20 percent]) than those whose ductus was ligated later or not at all (11 of 14 [79 percent]; P = 0.004). We conclude that early surgical closure of the ductus arteriosus reduces the risk of necrotizing enterocolitis in infants of very low birth weight who require supplemental oxygen.

摘要

我们推测,预防性结扎动脉导管可降低极低出生体重儿的死亡率和发病率。为验证这一假设,我们将84名出生时体重1000克及以下且需要吸氧的婴儿随机分组,一组接受标准治疗(n = 44),另一组在出生当天接受动脉导管预防性手术结扎(n = 40)。仅当分流对血流动力学有重要影响时,才对对照组婴儿进行导管结扎。所有婴儿均随访一年。与对照组(44例中有13例[30%])相比,接受预防性结扎的组坏死性小肠结肠炎的发病率降低(40例中有3例[8%];P = 0.002)。两组的死亡、支气管肺发育不良、早产儿视网膜病变和脑室内出血的发生率相似。由于早期肠内喂养可能增加坏死性小肠结肠炎的发病率,我们单独分析了早期喂养的婴儿。在出生后14天内喂养的婴儿中,接受预防性结扎的婴儿坏死性小肠结肠炎的发病率(11例中有1例[9%])低于未接受结扎的婴儿(24例中有13例[54%];P = 0.001)。在对照组中,出生后14天内喂养且在出生后5天内因医学原因进行导管结扎的婴儿坏死性小肠结肠炎的发病率(10例中有2例[20%])低于导管结扎较晚或未结扎的婴儿(14例中有11例[79%];P = 0.004)。我们得出结论,对于需要吸氧的极低出生体重儿,早期手术闭合动脉导管可降低坏死性小肠结肠炎的风险。

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