Human Recombinant DNA–Derived Antihemophilic Factor (Factor VIII) in the Treatment of Hemophilia A
| Autor: | Richard S. Schwartz, Charles F. Abildgaard, Louis M. Aledort, Steven Arkin, Arthur L. Bloom, Hans H. Brackmann, Doreen B. Brettler, Hiromu Fukui, Margaret W. Hilgartner, Martin J. Inwood, Carol K. Kasper, Peter B.A. Kernoff, Peter H. Levine, Jeanne M. Lusher, Pier M. Mannucci, Inge Scharrer, Mary A. MacKenzie, Nazreen Pancham, Harng S. Kuo, Randy U. Allred |
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| Rok vydání: | 1990 |
| Předmět: |
medicine.medical_specialty
business.industry General Medicine Surgical procedures Recombinant factor viii Gastroenterology law.invention Clinical trial Pharmacokinetics In vivo law hemic and lymphatic diseases Internal medicine Hemostasis Immunology medicine Recombinant DNA Antihemophilic factor business |
| Zdroj: | New England Journal of Medicine. 323:1800-1805 |
| ISSN: | 1533-4406 0028-4793 |
| DOI: | 10.1056/nejm199012273232604 |
| Popis: | Background. Current treatment of hemophilia A, a hereditary disorder affecting approximately 1 in 10,000 males, relies on plasma-derived factor VIII concentrates. We tested the safety and efficacy of a recombinant factor VIII preparation for the treatment of this disorder. Methods. We conducted the investigation in three stages: comparing the pharmacokinetics of plasma-derived and recombinant factor VIII, assessing the efficacy of recombinant factor VIII for home therapy, and assessing its efficacy for major surgical procedures and hemorrhage. A total of 107 subjects with hemophilia, 20 of whom had not been treated previously, enrolled in the investigation. Results. The in vivo recovery and elimination half-lives of recombinant factor VIII equaled or exceeded those of plasma-derived factor VIII. Seventy-six subjects participated in a home-treatment program, using recombinant factor VIII for 69 to 807 days (median, 618); home diaries of 56 subjects treated for 5 months were analyzed. Of 540 bleedi... |
| Databáze: | OpenAIRE |
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