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The pharmacological treatment of patent ductus arteriosus in premature infants with respiratory distress syndrome: oral ibuprofen vs. indomethacin

Korean Journal of Pediatrics 2008;51(9):956-963.
Published online September 15, 2008.
The pharmacological treatment of patent ductus arteriosus in premature infants with respiratory distress syndrome: oral ibuprofen vs. indomethacin
Soo Jin Lee, Ji Young Kim, Eun Ae Park, Sejung Sohn
Department of Pediatrics, Ewha Womans University, School of Medicine, Seoul, Korea
호흡곤란 증후군 미숙아에서 동맥관 개존증의 약물 치료 : 경구용 ibuprofen과 indomethacin의 비교
이수진, 김지영, 박은애, 손세정
이화여자대학교 의학전문대학원 소아과학교실
Correspondence: 
Eun Ae Park, Email: pea8639@ewha.ac.kr
Abstract
Purpose
: Indomethacin is widely used for the prophylaxis and treatment of patent ductus arteriosus (PDA); however, it is associated with side effects such as renal failure, intraventricular hemorrhage, and gastrointestinal bleeding. Intravenous ibuprofen has been shown to be as effective as indomethacin in prompting PDA closure. If treatment with oral ibuprofen is as effective as indomethacin, it would have the advantages of greater availability, simpler administration, and lower cost. We conducted this study to compare the efficacy and side effects of indomethacin with those of oral ibuprofen, vis-à-vis on the pharmacological closure of PDA.
Methods
: As a randomized double-blind study, 34 preterm infants with respiratory distress syndrome and hemodynamically significant PDA were treated with either intravenous indomethacin or oral ibuprofen. Echocardiography was performed by one cardiologist who was blind to the treatment that any given infant received. The rate of ductal closure, the need for additional drug treatment or surgical ligation, clinical outcome, and the side effects of drug treatment were compared.
Results
: Ductal closure occurred in 16 of 18 patients (88.9%) from the indomethacin group and in 14 of 16 patients (87.5%) from the ibuprofen group (P>0.05). Three patients in the indomethacin group and four in the ibuprofen group required a second drug treatment (P>0.05). Three patients (i.e., one patient in the indomethacin group and two in the ibuprofen group) underwent surgical ligation (P>0.05). Between the two groups, there was no significant difference vis-à-vis in side effects or clinical outcome.
Conclusion
: Compared to indomethacin, oral ibuprofen has the advantages of simpler administration and lower cost, while being as effective; in addition, there are no differences between the two drug treatments with regards to side effects or clinical outcomes. Therefore, the widespread use of oral ibuprofen should be considered in treating PDA in preterm infants.
Key Words: Ibuprofen, Indomethacin, Patent ductus arteriosus, Respiratory distress syndrome


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