| Autor: |
White, GC, Courter, S, Bray, GL, Lee, M, Gomperts, ED, White, G, Cooper, H, Haire, W, Brettler, D, Kisker, T, Hoots, K, Shapiro, A, Halie, MR, Mannucci, PM, Scharrer, [No Value], Brackmann, HH, Gordon, EM, Goldsmith, J, Hilgartner, M, Gill, J, Laurian, Y, Larrieu, Y, Kessler, C, Pai, MKR, Lusher, JM, Neufeld, E, Ewenstein, B, Schulman, S, Morfini, M, Addiego, JE, Vermylen, JG, Krill, CE, Ingerslev, J |
| Přispěvatelé: |
Faculteit Medische Wetenschappen/UMCG |
| Jazyk: |
angličtina |
| Rok vydání: |
1997 |
| Předmět: |
|
| Zdroj: |
Thrombosis and Haemostasis, 77(4), 660-667. GEORG THIEME VERLAG KG |
| ISSN: |
0340-6245 |
| Popis: |
A prospective, open-label multicenter investigation has been conducted to compare pharmacokinetic parameters of recombinant DNA-derived FVIII (rFVIII) and plasma-derived FVIII concentrate (pdFVIII) and to assess safety and efficacy of long-term home-treatment with rFVIII for subjects with hemophilia A. Following comparative in vivo pharmacokinetic studies, 69 patients with severe (n = 67) or moderate (n = 2) hemophilia A commenced a program of home treatment using rFVIII exclusively for prophylaxis and treatment of all bleeding episodes for a period of 1.0 to 5.7 gears (median 3.7 years). The mean in vivo half-lives of rFVIII and pdFVIII were both 14.7 h. In vivo incremental recoveries at baseline were 2.40%/IU/kg and 2.47%/IU/kg, respectively (p = 0.59). The response to home treatment with rFVIII was categorized as good or excellent in 3,195 (91.2%) of 3,481 evaluated bleeding episodes. Thirteen patients received rFVIII for prophylaxis for twenty-four surgical procedures, In all cases, hemostasis was excellent. Adverse reactions were observed in only 13 of 13,591 (0.096%) infusions of rFVIII; none was serious. No patient developed an inhibitor to r FVIII. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
|
