Meena Vasudha, Meena Durga Shankar, Rathore Pradeep Singh, Chaudhary Sandeep, Soni Jai Prakash
Department of Paediatric Medicine, Division of Paediatric Cardiology, Dr. S. N. Medical College, MDM Hospital for Mother and Child, Jodhpur, Rajasthan, India.
Department of Medicine, AIIMS, Jodhpur, Rajasthan, India.
Ann Pediatr Cardiol. 2020 Apr-Jun;13(2):130-135. doi: 10.4103/apc.APC_115_19. Epub 2020 Feb 14.
In this prospective study, we compared the efficacy and safety of ibuprofen, indomethacin, and paracetamol in the closure of patent ductus arteriosus (PDA) in preterm neonates.
This randomized prospective study was conducted in the Division of Pediatric Cardiology, M. D. M and Umaid Hospital, Jodhpur. A total of 105 preterm neonates with gestational age <37 weeks and hemodynamically significant PDA (hs-PDA) diagnosed clinically and confirmed by echocardiography were enrolled. All neonates were randomly assigned in a ratio of 1:1:1 to oral indomethacin (Group A, 3 doses at an interval of 12 h with a starting dose of 0.2 mg/kg), oral ibuprofen (Group B, 10 mg/kg ibuprofen followed by 5 mg/kg/day for 2 days), or IV paracetamol (Group C, 15 mg/kg every 6 hourly for 3 consecutive days). After the completion of the first course, neonates were assessed clinically as well as by echocardiography to confirm PDA closure. If PDA remained open, the second course of the same drug was given and repeat assessment was done within 24 h of the last dose. In addition to an echocardiographic examination, complete blood counts, renal and liver function tests were performed.
Our study shows that there was no significant difference observed in PDA closure among all the three treatment groups after the completion of two courses of treatment. The cumulative rate of PDA closure was 68% in the indomethacin group, 77.14% in the ibuprofen group, and 71.43% in the paracetamol group ( = 0.716). There were no significant changes found in Hb, platelet, blood urea nitrogen (BUN), creatinine, and liver enzymes after treatment in the paracetamol group ( > 0.05). BUN and serum creatinine levels were significantly increased after treatment in indomethacin and ibuprofen groups ( < 0.0001 and < 0.05, respectively).
Our study shows that IV paracetamol is as effective as indomethacin and ibuprofen in promoting the closure of hs-PDA in premature infants with a better safety profile.
在这项前瞻性研究中，我们比较了布洛芬、吲哚美辛和对乙酰氨基酚在早产儿动脉导管未闭（PDA）闭合中的疗效和安全性。
这项随机前瞻性研究在焦特布尔的M.D.M和乌迈德医院儿科心脏病学部进行。总共纳入了105例孕周<37周、临床上诊断为血流动力学显著的动脉导管未闭（hs-PDA）且经超声心动图确认的早产儿。所有新生儿按1:1:1的比例随机分配至口服吲哚美辛组（A组，间隔12小时给药3剂，起始剂量为0.2mg/kg）、口服布洛芬组（B组，先给予10mg/kg布洛芬，随后2天给予5mg/kg/天）或静脉注射对乙酰氨基酚组（C组，连续3天每6小时给予15mg/kg）。在完成第一个疗程后，对新生儿进行临床评估以及超声心动图检查以确认动脉导管未闭闭合情况。如果动脉导管未闭仍开放，则给予相同药物的第二个疗程，并在最后一剂给药后24小时内进行重复评估。除超声心动图检查外，还进行了全血细胞计数、肾功能和肝功能检查。
我们的研究表明，在完成两个疗程的治疗后，所有三个治疗组在动脉导管未闭闭合方面未观察到显著差异。吲哚美辛组动脉导管未闭闭合的累积率为68%，布洛芬组为77.14%，对乙酰氨基酚组为71.43%（P = 0.716）。对乙酰氨基酚组治疗后血红蛋白、血小板、血尿素氮（BUN）、肌酐和肝酶无显著变化（P>0.05）。吲哚美辛组和布洛芬组治疗后BUN和血清肌酐水平显著升高（分别为P<0.0001和P<0.05）。
我们的研究表明，静脉注射对乙酰氨基酚在促进早产儿hs-PDA闭合方面与吲哚美辛和布洛芬一样有效，且安全性更好。
