口服布洛芬和消炎痛关闭早产儿动脉导管未闭的疗效和安全性的比较

目的: 比较口服布洛芬悬液和消炎痛关闭早产儿动脉导管未闭 (PDA) 的治疗效果和安全性。方法: 30例胎龄 30~35周早产儿, 心脏彩超证实诊断为动脉导管未闭 (PDA), 随机分为布洛芬组 (n=15) 和消炎痛组 (n=15), 于生后 3d口服分 3次给药。布洛芬组首剂给予 10mg/kg, 于 24、48h后各给予 5mg/kg。消炎痛组 0 2mg(kg·次 ), 每间隔 12h1次。结果: 两组关闭率相似, 布洛芬组 12例导管关闭 (80% ), 消炎痛组 13例导管关闭 ( 87% ), 两组相比没有显著性差异 (P>0 .05)。布洛芬组 3例合并尿少, 消炎痛组 10例合并尿少, 两组相比有显著性差异 (P<0. 05), 消炎痛组 5例血肌酐增高, 6例血尿素氮增高, 布洛芬组无血肌酐增高, 1例血尿素氮增高, 两个项目均有显著性差异 (P<0. 05)。其他副作用无显著性差异,消炎痛组 2例大便潜血阳性, 1例血总胆红素轻度升高, 两组均无腹胀和坏死性小肠结肠炎发生。结论: 生后 3d口服布洛芬悬液治疗早产儿动脉导管未闭与口服消炎痛同样有效, 并能显著减少尿少和急性肾功能不全的发生。

The efficacy and safety of oral ibuprofen and indomethacin for the treatment of patent ductus arteriosus in premature infants

Objective:To compare the efficacy and safety of oral ibuprofen and indomethacin for the early treatment of patent ductus arteriosus in premature infants.Methods:30 cases of infants with gestational ages of 30～35 weeks and color doppler echocardiograhpically confirmed PDA, were randomly assigned into two groups to receive either oral ibuprofen suspension (a first dose of 10 mg per kilogram, followed at 24-hour intervals by two doses of 5 mg per kilogram each) or oral indomethacin (0.2 mg per kilogram of body weight, given at 12-hour intervals) starting on the third day of life.Results:The rate of ductul closure was similar with the two treatments: PDA closed in 12 of 15 patients from the ibuprofen group(80%),and in 13 of 15 from indomethacin group(87%).There was no significant difference between two groups(P>0.05). Oliguria occurred in 3 infants treated with ibuprofen and in 10 treated with indomethacin.5 cases of increase in serum creatinine and 6 cases of blood urea nitrogen in indomethacin group whereas 1 case of increase in serum creatinine and 0 case of blood urea nitrogen in ibuprofen group. There was significant difference about urinary output, serum creatinine and blood urea nitrogen between two groups(P<0.05)。 No significant differences with respect to other side effects or complications. There were 2 cases of occult bleeding in stool and 1 case of increased serum total bilirubin in indomethacin group. No abdominal distension and necrotizing enterocolitis.Conclusion:Oral ibuprofen therapy on the third day of life is as efficacious as indomethacin for the treatment of patent ductus arteriosus in premature infants and is significantly less likely to induce oliguria and renal failure.