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The Effect of Pentoxifylline on the Prevention of ARDS in PICU Patients: A Randomized Double-Blind Clinical Trial

Document Type : review article

Authors

1 Department of Clinical pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.

2 Department of Surgery, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

3 Department of Pediatrics, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

4 Clinical Research Development Unit of Akbar Hospital, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.

5 Neonatal Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.

6 Pharmaceutical Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.

Abstract

Background: Inflammation has a remarkable role in Acute Respiratory Distress Syndrome (ARDS) pathophysiology. Pentoxifylline is a phosphodiesterase IV inhibitor with anti-inflammatory and anti-thrombotic properties, which has had positive results in rodents with ARDS. Due to the lack of human studies, we designed this clinical trial to evaluate the pentoxifylline effect on ARDS prevention in high-risk pediatric patients.
Methods: We included thirty-four children from Akbar hospital’s pediatric intensive care unit (PICU). These patients were highly susceptible to ARDS progression. Using a randomized, double-blind method, 17 patients received pentoxifylline tablets three times a day for a week, while others received placebo tablets at the same interval for seven days. Lung Injury Prediction Score (LIPS), vital signs, pulse oximetry, PaO2, pH, and PaCO2 were measured at baseline and every day for a week period. CRP was assessed at baseline, then on the third and seventh days. Finally, we imported all the data to SPSS software to compare the treatment and placebo groups.
Results: Each placebo and treatment group had seventeen patients who had no statistically significant difference in baseline demographic information or lab data. The variations in LIPS score (P=0.475), CRP (P=0.053), pH (P=0.199), PO2 (P=0.077), PCO2 (P=0.528), Heart rate (P=0.086), Respiratory rate (P=0.512), Diastolic blood pressure (P=0.572), Systolic blood pressure (P=0.517), and SPO2 (P=0.260) were compared between the two groups; and no significant difference was observed.
Conclusion: The results of this clinical trial suggest that pentoxifylline had no prophylactic effect on pediatric ARDS, but for confirmation, further clinical trials with different designs and larger sample sizes are required.

Keywords

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Journal of Pediatric Perspectives
Volume 12, Issue 1
January 2024
Pages 18517-18529
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