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

被引:3
|
作者
Abolghasemi, Hassan [1 ]
Panahi, Yunes [2 ]
Ahmadinejad, Minoo. [3 ]
Toogeh, Gholamreza
Karimi, Mehran [4 ]
Eghbali, Aziz [5 ]
Mirbehbahani, Nargess Bigom [6 ]
Dehdezi, Bighan Keikhaei [7 ,8 ]
Badiee, Zahra [9 ]
Hoorfar, Hamid [10 ]
Eshghi, Peyman [1 ]
Maghsoudi, Nader [11 ]
Sahebkar, Amirhossein [12 ,13 ,14 ]
Gholami-Fesharaki, Mohammad [15 ]
机构
[1] Shahid Beheshti Univ Med Sci, Pediat Congenital Hematol Disorders Res Ctr, Tehran, Iran
[2] Baqiyatallah Univ Med Sci, Dept Pharmacotherapy, Fac Pharm, Tehran, Iran
[3] Iranian Blood Transfus Org, High Inst Res, Tehran, Iran
[4] Shiraz Univ Med Sci, Hematol Res Ctr, Shiraz, Iran
[5] Shahid Beheshti Univ Med Sci, Mofid Childrens Hosp, Dept Pediat Hematol Oncol, Tehran, Iran
[6] Golestan Univ Med Sci, Gorgan, Iran
[7] Ahvaz Jundishapur Univ Med Sci, Dept Thalassemia, Ahvaz, Iran
[8] Ahvaz Jundishapur Univ Med Sci, Hemoglobinopathy Res Ctr, Ahvaz, Iran
[9] Mashhad Univ Med Sci, Doctor Sheikh Hosp, Mashhad, Iran
[10] Isfahan Univ Med Sci, Esfahan, Iran
[11] Shahid Beheshti Univ Med Sci, NRC, Tehran, Iran
[12] Mashhad Univ Med Sci, Pharmaceut Technol Inst, Biotechnol Res Ctr, Mashhad, Iran
[13] Mashhad Univ Med Sci, Neurogen Inflammat Res Ctr, Mashhad, Iran
[14] Mashhad Univ Med Sci, Sch Pharm, Mashhad, Iran
[15] Tarbiat Modares Univ, Dept Biostat, Fac Med Sci, Tehran, Iran
关键词
Hemophilia A; Recombinant Factor VIII; Safacto; Xyntha;
D O I
10.3831/KPI.2018.21.009
中图分类号
R [医药、卫生];
学科分类号
10 ;
摘要
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.
引用
收藏
页码:76 / 81
页数:6
相关论文
共 50 条
  • [41] SAFETY AND EFFICACY OF RECOMBINANT FACTOR IX FUSION PROTEIN IN PEDIATRIC PATIENTS WITH HEMOPHILIA B
    Chambost, Herve
    Drelich, Douglass
    Seifert, Wilfried
    Castaman, Giancarlo
    PEDIATRIC BLOOD & CANCER, 2023, 70 : S175 - S175
  • [42] Safety and efficacy of recombinant factor VIII for the treatment of previously treated patients with hemophilia A in China
    Yang, R.
    Zhao, Y.
    Sun, J.
    Wu, J.
    Wang, X.
    Yu, M.
    JOURNAL OF THROMBOSIS AND HAEMOSTASIS, 2009, 7 : 507 - 507
  • [43] RECOMBINANT-FVIII (KOGENATE) TREATMENT OF PREVIOUSLY UNTREATED PATIENTS (PUPS) WITH HEMOPHILIA-A - UPDATE OF SAFETY, EFFICACY, AND INHIBITOR DEVELOPMENT AFTER 5 STUDY YEARS
    LUSHER, J
    ARKIN, S
    ABILDGAARD, CF
    HURST, D
    THROMBOSIS AND HAEMOSTASIS, 1995, 73 (06) : 1012 - 1012
  • [44] Evaluation of Safety and Efficacy of Emicizumab Prophylaxis in Egyptian Pediatric Patients with Hemophilia A
    Hassan, Tamer
    Zakaria, Marwa
    Fathy, Manar
    Farag, Ahmed
    Abdelhady, Eman
    Gameil, Dalia
    Abu Hashem, Mustafa
    TURKISH JOURNAL OF HEMATOLOGY, 2024, 41 (04) : 256 - 263
  • [45] COMPARATIVE MEASUREMENTS OF FVIII INHIBITORS IN HEMOPHILIA A PATIENTS BY ELISA AND BETHESDA ASSAY
    Kim, S. Y.
    Lee, W. I.
    Kang, S. Y.
    HAEMATOLOGICA-THE HEMATOLOGY JOURNAL, 2008, 93 : 396 - 396
  • [46] Efficacy of a new recombinant FVIII (N8) in a tail bleeding model in hemophilia a mice
    Elm, T.
    Kjalke, M.
    Pelzer, H.
    Tranholm, M.
    JOURNAL OF THROMBOSIS AND HAEMOSTASIS, 2009, 7 : 1131 - 1131
  • [47] Efficacy of OBI-1, a recombinant porcine sequence FVIII product, in animal models of hemophilia A
    Schiviz, Alexandra
    Piskernik, Christina
    Leidenmuehler, Peter
    Muchitsch, Eva-Maria
    Hoellriegl, Werner
    HAEMOPHILIA, 2014, 20 : 2 - 2
  • [48] First report on the safety and efficacy of an extended half-life glycoPEGylated recombinant FVIII for major surgery in severe haemophilia A
    Hampton, K.
    Chowdary, P.
    Dunkley, S.
    Ehrenforth, S.
    Jacobsen, L.
    Neff, A.
    Santagostino, E.
    Sathar, J.
    Takedani, H.
    Takemoto, C. M.
    Negrier, C.
    HAEMOPHILIA, 2017, 23 (05) : 689 - 696
  • [49] An evaluation of the safety and efficacy of turoctocog alfa for hemophilia A
    Boban, Ana
    Hermans, Cedric
    EXPERT REVIEW OF HEMATOLOGY, 2020, 13 (04) : 303 - 311
  • [50] CLINICAL EFFICACY AND SAFETY OF INTERVENTIONS FOR ADULT PATIENTS WITH MODERATELY SEVERE TO SEVERE HEMOPHILIA B: A SYSTEMATIC REVIEW
    Thakkar, S.
    Cappelleri, J.
    Merla, V
    Wilcox, L.
    Chhabra, A.
    Jin, H.
    Lindsley, K.
    Uyei, J.
    VALUE IN HEALTH, 2023, 26 (12) : S35 - S35