Comparison of efficacy of paracetamol and ibuprofen for treatment of hemodynamically significant patent ductus arteriosus in preterm infants

Swathi R, Maulik Shah, Agnes Puthussery
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Abstract

Background: Indomethacin and ibuprofen (IBU) have been approved for the pharmacological closure of hemodynamically significant patent ductus arteriosus (hsPDA) in preterm infants. Recent works have demonstrated that paracetamol (PCM) can also be used but more research is required regarding efficacy and safety. Objectives: The objective is to compare the efficacy and safety of PCM and IBU for the treatment of hsPDA in preterm infants. Methodology: An observational study was designed with ethical clearance and parental consent. Patients were evaluated for hsPDA by clinical and 2 D echo findings. After inclusion and exclusion criteria, consecutive 100 patients were assigned between PCM and IBU and were given a 3-day course. After echocardiographic and clinical evaluation, if required, a second course with same drug was given. The outcome measures were the rate of ductal closure, the safety of drugs, and adverse events. Results: The PCM group had a closure rate of 76.25% and the IBU group had 75%. IBU had a significantly higher rate of closure in the first course (45% vs. 16.25%). The mean closure time observed was 4.54 days and 4 days for PCM and IBU, respectively. PCM gave a higher closure rate in the low-birth-weight group and where platelet counts were below normal. Regarding the safety aspect also no significant difference between groups was observed. Conclusion: PCM can be advised as a first-line treatment for hsPDA cases in preterm infants and is a better choice in cases of comorbidities and patients with low platelet count.
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对乙酰氨基酚与布洛芬治疗早产儿血流动力学意义显著的动脉导管未闭的疗效比较
背景:吲哚美辛和布洛芬(IBU)已被批准用于早产儿血流动力学显著性动脉导管未闭(hsPDA)的药理学封闭。最近的研究表明,扑热息痛(PCM)也可以使用,但还需要更多的研究来确定其有效性和安全性。目的:目的是比较PCM和IBU治疗早产儿hsPDA的疗效和安全性。方法:一项观察性研究是在伦理许可和家长同意的情况下设计的。通过临床和二维超声检查评估患者是否患有hsPDA。按照纳入和排除标准,连续100例患者被分配到PCM和IBU之间,并给予3天疗程。在超声心动图和临床评估后,如果需要,给予相同药物的第二个疗程。结局指标为导管闭合率、药物安全性和不良事件。结果:PCM组闭合率为76.25%,IBU组闭合率为75%。IBU在第一个疗程的愈合率明显更高(45% vs. 16.25%)。PCM和IBU的平均封闭时间分别为4.54天和4天。在低出生体重组和血小板计数低于正常的组中,PCM的闭合率更高。在安全性方面,两组之间也没有观察到显著差异。结论:PCM可作为早产儿hsPDA的一线治疗方案,对于合并症和血小板计数低的患者是较好的选择。
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