早期口服布洛芬治疗极低出生体重儿动脉导管未闭的临床研究

Therapeutic effect of early administration of oral ibuprofen in very low birth weight infants with patent ductus arteriosus

目的探讨早期口服布洛芬治疗极低出生体重儿(VLBWI)动脉导管未闭(PDA)的临床效果和安全性。方法生后24 h内经床边心脏彩超确诊的有临床症状的VLBWI PDA 64例,随机分为治疗组和对照组,每组32例。治疗组生后24 h内口服布洛芬,首剂10 mg/kg,第2、3剂5 mg/kg,每剂间隔24 h。对照组给予安慰剂生理盐水1 mL/kg,第2、3剂0.5 mL/kg,每剂间隔24 h。观察两组患儿的治疗效果及不良反应。结果第1疗程结束后治疗组动脉导管关闭率为84%,明显高于对照组的41%,两组比较差异有统计学意义(P<0.01)。治疗组脑室周围白质软化和支气管肺发育不良的发生率明显低于对照组(P<0.05);机械通气时间和平均住院时间明显短于对照组(P<0.05)。两组脑室内出血、早期肺出血、坏死性小肠结肠炎的发生率等差异无统计学意义(P>0.05),且均未发现明显不良反应。结论早期口服布洛芬治疗VLBWI PDA可以减少部分近期并发症的发生率,缩短住院时间,且未发现明显不良反应。

Objective To study therapeutic effect and safety of early administration of oral ibuprofen in very low birth weight infants （VLBWIs） with patent ductus arteriosus （PDA）. Methods A total of 64 symptomatic VLBWIs （ within 24 hours after birth） with PDA confirmed by bedside Color Doppler ultrasound were randomly divided into two groups： treatment and control （n = 32 each）. The treatment group was orally administered ibuprofen within 24 hours after birth at 10 mg/kg, followed 24 hours later by a second dose of 5 mg/kg and 48 hours later by a third dose of 5 mg/kg. The control group was treated with placebo （normal saline） at 1 mL/kg, followed 24 hours later by a second dose of 0.5 rnIJkg and 48 hours later by a third dose of 0.5 mL/kg. The therapeutic efficacies and adverse effects in both groups were observed. Results The treatment group showed a significantly higher closure rate of ductus arterious than the control group after one course of treatment （84% vs 41% ;P 〈 0.01 ）. The incidence rates of periventricular leukomalacia and bronehopulmonary dysplasia were significantly lower in the treatment group than in the control group （ P 〈 0.05 ）. The duration of mechanical ventilation and mean hospitalization time were significantly shorter in the treatment group than in the control group （ P 〈 O. 05 ）. There were no significant differences in the incidence rates of intraventrieular hemorrhage, early pulmonary hemorrhage and necrotizing enterocolitis between the two groups （ P 〉 0.05 ）. No obvious adverse effects were observed in both groups. Conclusions Early administration of oral ibuprofen for treatment of PDA in VLBWIs can decrease the incidence rates of some early complications and shorten hospitalization time, but causes no significant adverse effects.