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Comparative Evaluation of the Safety and Efficacy of Recombinant Fviii in Severe Hemophilia a Patients Publisher



Abolghasemi H1 ; Panahi Y2 ; Ahmadinejad M3 ; Karimi M4 ; Eghbali A5 ; Mirbehbahani NB6 ; Dehdezi BK7 ; Badiee Z8 ; Hoorfar H9 ; Eshghi P1 ; Maghsoudi N10 ; Sahebkar A11, 12, 13 ; Gholamifesharaki M14
Authors
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Authors Affiliations
  1. 1. Pediatric Congenital Hematologic Disorders Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  2. 2. Pharmacotherapy Department, Faculty of Pharmacy, Baqiyatallah University of Medical Sciences, Tehran, Iran
  3. 3. High Institute of Research, Iranian Blood Transfusion Organization, Tehran, Iran
  4. 4. Hematology Research Centre, Shiraz University of Medical Sciences, Shiraz, Iran
  5. 5. Department of Pediatric Hematology-Oncology, Mofid Children's Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  6. 6. Golestan University of Medical Sciences, Gorgan, Iran
  7. 7. Department of Thalassemia and Hemoglobinopathy Research Center, Ahvaz Jundishapur University of Medical Science, Ahvaz, Iran
  8. 8. Doctor Sheikh Hospital, Mashhad University of Medical Sciences, Mashhad, Iran
  9. 9. Isfahan University of Medical Sciences, Isfahan, Iran
  10. 10. Neuroscience Research Center (NRC), Shahid Beheshti University of Medical Sciences, Tehran, Iran
  11. 11. Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran
  12. 12. Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, Mashhad, Iran
  13. 13. School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran
  14. 14. Department of Biostatistics, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran

Source: Journal of Pharmacopuncture Published:2018


Abstract

Objective: This study compared the safety and efficacy of Safacto® versus xyntha® in patients with severe hemophilia A. Methods: Thirty-three male patients with severe hemophilia A were randomly divided into two groups. Seventeen patients received Safacto® and 16 patients received Xyntha® for four consecutive times. The dosage of FVIII was 40-50 IU/kg for each injection. Plasma level of FVIII activity was evaluated before every injection, 15 minutes after the injection and one month after the start of the trial. The rate of factor VIII activity, pain and joint motion were also assessed before and after the treatment. Results: Plasma level of FVIII clotting activity in Safacto® and Xyntha® were 1.96±0.5 IU/dl and 1.63±0.5 IU/dl and increased to 88.84±25.2 IU/dl and 100.09±17.8 IU/dl, respectively (P < 0.001). Pain score and range of motion improvement were 9.3±0.9 and 8.7±0.1 in Safacto® (P=0.17); and 9.4±0.8 and 8.8±0.3 in Xyntha® (P=0.35), respectively. No allergic or other unfavorable reactions was observed with either of the preparations. Conclusion: This study showed that Safacto® has a favorable efficacy and safety profile. © 2018 Korean Pharmacopuncture Institute.
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