Abstract
The aim of this study was a retrospective analysis of the effectiveness of the domestic Factor VIII drug Octofactor for the prophylactic treatment of patients with hemophilia A living in the Amur Region. For the past 3 years, 10 hemophilia A patients over the age of 18 years have been receiving replacement therapy with this medication while other 10 hemophilia A patients of the same age have been receiving Factor VIII, a foreign drug. Each group included 6 patients with severe hemophilia A and 4 patients with moderate disease. This retrospective clinical study has been approved by the local Ethics Committee Amur State Medical Academy, Ministry of Healthcare of Russian Federation. All of the patients have signed voluntary informed consent for the use of their personal data in clinical studies and publications. Octofactor at a dose of 20–40 IU/kg body weight was administered every second or third day (2 to 3 times a week). Prevention has significantly reduced the need for hospitalization, improve performance. Patients with good adherence to treatment of spontaneous bleeding were not observed. Spontaneous bleeding of mild to moderate severity was diagnosed only in patients with low adherence to treatment, was stopped by administering the drug in therapeutic doses on an outpatient basis and did not require hospitalization. It was possible to achieve the desired indicators of clinical control – no more than 2 spontaneous hemarthrosis or other bleeding per year. Adverse reactions were not identified in patients treated with the drug Octofactor. With prophylactic treatment, it was possible to reduce the number of bleeding by 98%, both in patients using foreign commercial drugs of Factor VIII and in the treatment with Octofactor, compared with the period until 2005, when patients with hemophilia A received treatment on demand with cryoprecipitate and freshly frozen plasma. It is concluded that Octofactor preparation is not inferior to foreign Factor VIII concentrates in terms of efficiency and safety and can be effectively used for the prevention of bleeding in hemophilia A, including for individualized therapy
Highlights
Контактная информация: Войцеховский Валерий Владимирович, д-р мед. наук, доцент, заведующий кафедрой госпитальной терапии с курсом фармакологии ФГБОУ ВПО «Амурская ГМА» Минздрава России
The aim of this study was a retrospective analysis of the effectiveness of the domestic Factor VIII drug Octofactor for the prophylactic treatment of patients with hemophilia A living in the Amur Region
Each group included 6 patients with severe hemophilia A and 4 patients with moderate disease. This retrospective clinical study has been approved by the local Ethics Committee Amur State Medical Academy, Ministry of Healthcare of Russian Federation
Summary
Применение препарата Октофактор для профилактического лечения больных гемофилией А. Целью данного исследования явился ретроспективный анализ эффективности применения отечественного препарата фактора VIII Октофактор (мороктоког альфа) для профилактического лечения пациентов с гемофилией А, проживающих в Амурской области. При профилактическом лечении удалось добиться снижения числа кровотечений на 98% как у пациентов, применявших зарубежные коммерческие препараты фактора VIII, так и при лечении препаратом Октофактор по сравнению с периодом до 2005 г., когда больные гемофилией А получали лечение криопреципитатом и свежезамороженной плазмой «по требованию». Целью данного исследования явилось ретроспективное изучение эффективности и безопасности применения отечественного препарата Октофактор (мороктоког альфа, АО «ГЕНЕРИУМ») для профилактического лечения пациентов с гемофилией А, проживающих в Амурской области. 2. Получение данных об эффективности препарата Октофактор для остановки кровотечений, возникших на фоне профилактической терапии или при лечении «по требованию». 3. Получение данных о безопасности препарата Октофактор при профилактической терапии и/или лечении «по требованию»
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