Comparative study of the efficacy and safety of paracetamol, ibuprofen, and indomethacin in closure of patent ductus arteriosus in preterm neonates

Comparative study of the efficacy and safety of paracetamol, ibuprofen, and indomethacin in closure of patent ductus arteriosus in preterm neonates
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DOI:
10.1007/s00431-016-2830-7
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发表时间:
2017-02-01
影响因子:
3.6
通讯作者:
Elgendy, Marwa
Elgendy, Marwa
中科院分区:
医学3区
文献类型:
--
作者:
El-Mashad, Abd El-Rahman;El-Mahdy, Heba;Elgendy, Marwa

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在这项前瞻性研究中,我们比较了吲哚美辛、布洛芬和扑热息痛在早产儿动脉导管未闭(PDA)封堵术中的疗效和副作用。我们的新生儿重症监护病房收治了300例患有血流动力学显著PDA(hs-PDA)的早产儿。他们被随机分为三组。I组(扑热息痛组)给予扑热息痛15 mg/kg/6 h静脉输注,连续3 d。组II(布洛芬组)接受10 mg/kg IV布洛芬输注,随后5 mg/kg/天,持续2天。吲哚美辛组(Ⅲ组)静脉滴注吲哚美辛0.2mg/kg/12h,共3次。除超声心动图检查外,还进行了实验室检查,如肾功能检查、肝功能检查、全血细胞计数和血气分析。所有研究均在治疗前和治疗后3天进行。所有组之间PDA闭合的有效性无显著差异(P = 0.868)。布洛芬组和吲哚美辛组的血肌酐和血尿素氮(BUN)均显著升高(P <0.001)。布洛芬组和吲哚美辛组血小板计数和尿量(UOP)均明显减少(P <0.001)。仅布洛芬组胆红素水平显著升高(P = 0.003)。各组间血红蛋白(HB)水平及肝酶活性无显著性差异(P> 0.05).结论:扑热息痛治疗早产儿PDA疗效与吲哚美辛、布洛芬相当,但对肾功能、血小板计数、胃肠道出血等不良反应较少。
In this prospective study, we compared the efficacy and side effects of indomethacin, ibuprofen, and paracetamol in patent ductus arteriosus (PDA) closure in preterm neonates. Three hundred preterm neonates with hemodynamically significant PDA (hs-PDA) admitted at our neonatal intensive care unit were enrolled in the study. They were randomized into three groups. Group I (paracetamol group) received 15 mg/kg/6 h IV paracetamol infusion for 3 days. Group II (ibuprofen group) received 10 mg/kg IV ibuprofen infusion followed by 5 mg/kg/day for 2 days. Group III (indomethacin group) received 0.2 mg/kg/12 h indomethacin IV infusion for three doses. Laboratory investigations such as renal function test, liver function test, complete blood count, and blood gases were conducted in addition to echocardiographic examinations. All investigations were done before and 3 days after treatment. There was no significant difference between all groups regarding efficacy of PDA closure (P = 0.868). There was a significant increase in serum creatinine levels and serum blood urea nitrogen (BUN) in the ibuprofen and indomethacin groups (P < 0.001). There was a significant reduction in platelet count and urine output (UOP) in both ibuprofen and indomethacin groups (P < 0.001). There was a significant increase in bilirubin levels in only the ibuprofen group (P = 0.003). No significant difference of hemoglobin (HB) level or liver enzymes in all groups (P > 0.05). Ventilatory settings improved significantly in patients with successful closure of PDA than those with failed PDA closure (P < 0.001).Conclusion: Paracetamol is as effective as indomethacin and ibuprofen in closure of PDA in preterm neonates and has less side effects mainly on renal function, platelet count, and GIT bleeding.