Repository of Research and Investigative Information

Repository of Research and Investigative Information

Baqiyatallah University of Medical Sciences

Comparative evaluation of the safety and efficacy of recombinant FVIII in severe hemophilia A patients

(2018) Comparative evaluation of the safety and efficacy of recombinant FVIII in severe hemophilia A patients. Journal of Pharmacopuncture. pp. 76-81. ISSN 2093-6966

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Abstract

Objective: This study compared the safety and efficacy of Safacto (R) versus xyntha (R) 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 (R) and 16 patients received Xyntha (R) 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 (R) and Xyntha (R) 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 (R) (P=0.17); and 9.4 +/- 0.8 and 8.8 +/- 0.3 in Xyntha (R) (P=0.35), respectively. No allergic or other unfavorable reactions was observed with either of the preparations. Conclusion: This study showed that Safacto (R) has a favorable efficacy and safety profile.

Item Type: Article
Keywords: Hemophilia A Recombinant Factor VIII Safacto Xyntha factor-viii products fc fusion protein cross-over trial inhibitor development pharmacokinetics children Integrative & Complementary Medicine
Divisions:
Page Range: pp. 76-81
Journal or Publication Title: Journal of Pharmacopuncture
Journal Index: ISI
Volume: 21
Number: 2
Identification Number: https://doi.org/10.3831/kpi.2018.21.009
ISSN: 2093-6966
Depositing User: مهندس مهدی شریفی
URI: http://eprints.bmsu.ac.ir/id/eprint/3766

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