The Comparison of Desfonak with Desferal in Patients with Beta Thalassemia Major: A Randomized Crossover Clinical Trial

Authors

1 Assistant Professor of Pediatrics Hematology and Oncology, Department of Pediatrics, School of Medicine, Dr. Kermanshahi Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran.

2 Pediatrician, Department of Pediatrics, School of Medicine, Dr. Kermanshahi Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran.

3 Associate Professor of Pediatrics Hematology and Oncology, Department of Pediatrics, School of Medicine, Dr. Kermanshahi Hospital, Kermanshah University of Medical Sciences, Kermanshah, Iran.

4 Professor of Biostatistics, Social Development and Health Promotion Research Center, Kermanshah University of Medical Sciences, Kermanshah, Iran.

Abstract

Background
Beta thalassemia (β-thalassemia) is one of the most common genetic disorders that reduces the amount of specific chain production in hemoglobin. The aim of this study was to compare the efficacy and safety of Desfonak with Desferal in patients with β-thalassemia major in Iran. 
Materials and Methods
The study was a two-treatment and two-period crossover Randomizedclinical trialdesign that was carried out on 100 thalassemic patients referred to Mohammad Kermanshahi hospital of Kermanshah city, Iran in 2018-19. Eligible patients were divided into two groups using a random number table (Group A, n=50; Group B, n=50). The group A received Desferal then Desfonak vs. (30 mg/kg in 8 h and 6 days in a week). The group B received Desfonak then Desferal. The data collection tool was a checklist, including variables of age, sex, AST, ALT, ferritin, urea, creatinine and different complications of gastrointestinal, articular, skin, respiratory system and hearing problems. The data were analyzed by STATA software (version 14.0).
Results
The results of the study showed that there are no significant statistical differences between Desferal and Desfonakin terms of different complications of GI, articular, skin, respiratory and hearing systems (P>0.05). Also, the results showed that there was no significant statistical difference between Desferal and Desfonak in terms of variables of AST, ALT, ferritin, urea and creatinine at two time periods (P>0.05).
Conclusion
The results of this study highlighted that Desfonak and Desferal have similar efficacy and safety in patients with thalassemia major.

Keywords