Email this article Experience in personifying the standard treatment of patients with hemophilia A: results of a multicenter Russian open-labeled prospective study evaluating the use of haemoctin
- Authors: Zozulya N.I.1, Plyushch O.P.1, Zozulya NI2, Plyushch OP2
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Affiliations:
- Учреждение Российской академии медицинских наук Гематологический научный центр РАМН
- Hematology Research Center, Russian Academy of Medical Sciences
- Issue: Vol 82, No 4 (2010)
- Pages: 56-61
- Section: Editorial
- URL: https://journal-vniispk.ru/0040-3660/article/view/30603
- ID: 30603
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Abstract
Aim. To evaluate the clinical efficiency, tolerability, safety, and immunogenicity of replacement therapy with haemoctin SDH (Biotest Pharma GmbH, Germany) in pretreated patients with hemophilia A (HA).
Subjects and methods. The pretreated patients (n = 140) with varying GA from 12 regions of the Russian Federation received haemoctin replacement therapy (for prophylaxis and if needed) during a year. The levels of coagulation factor VIII, its inhibitor, HIV-1/HIV-2, the markers of hepatic and renal diseases, clinical blood test were determined and a virological study was made thrice during this period at an interval of 6 months. The therapy was considered to be effective if the pain syndrome regressed within 24 hours after the last administration of the drug and/or bleeding stopped. The results of a one-year follow-up of 106 patients receiving haemoctin monotherapy were analyzed.
Results. The history data suggest that there are problems in the diagnosis of hereditary coagulopathies (the mean age of diagnosis verification of 3.5 years; no family history data in 67% of cases), there is a need for the guaranteed provision of patients with adequate quantities of the drug due to the fact that a third of patients had life-threatening bleedings/hemorrhages and that the patients (46%) need additional examination and treatment for comorbidity according to the standards of therapy.
Compliance of haemoctin doses and regimens with their timely individual correction ensures a 3-fold reduction on average in the incidence of the hemorrhagic syndrome, an increase in quality of life, and a decrease in the frequency of analgesic use (from 21% to 0). Treatment is satisfactorily tolerated. There is evidence for the safety and low immunogenicity of the drug.
Conclusion. To enhance the efficiency of therapeutic-and-prophylactic care to patients with GA and to optimize their quality of life, a personification approach to treatment is recommended, by individually choosing drugs, their doses and regimens.
Subjects and methods. The pretreated patients (n = 140) with varying GA from 12 regions of the Russian Federation received haemoctin replacement therapy (for prophylaxis and if needed) during a year. The levels of coagulation factor VIII, its inhibitor, HIV-1/HIV-2, the markers of hepatic and renal diseases, clinical blood test were determined and a virological study was made thrice during this period at an interval of 6 months. The therapy was considered to be effective if the pain syndrome regressed within 24 hours after the last administration of the drug and/or bleeding stopped. The results of a one-year follow-up of 106 patients receiving haemoctin monotherapy were analyzed.
Results. The history data suggest that there are problems in the diagnosis of hereditary coagulopathies (the mean age of diagnosis verification of 3.5 years; no family history data in 67% of cases), there is a need for the guaranteed provision of patients with adequate quantities of the drug due to the fact that a third of patients had life-threatening bleedings/hemorrhages and that the patients (46%) need additional examination and treatment for comorbidity according to the standards of therapy.
Compliance of haemoctin doses and regimens with their timely individual correction ensures a 3-fold reduction on average in the incidence of the hemorrhagic syndrome, an increase in quality of life, and a decrease in the frequency of analgesic use (from 21% to 0). Treatment is satisfactorily tolerated. There is evidence for the safety and low immunogenicity of the drug.
Conclusion. To enhance the efficiency of therapeutic-and-prophylactic care to patients with GA and to optimize their quality of life, a personification approach to treatment is recommended, by individually choosing drugs, their doses and regimens.
About the authors
Nadezhda Ivanovna Zozulya
Учреждение Российской академии медицинских наук Гематологический научный центр РАМН
Email: zozulya@blood.ru
отд. гемофилии и других коагулопатий, врач-гематолог, канд. мед. наук, тел.: 8-495-612-49-60; Учреждение Российской академии медицинских наук Гематологический научный центр РАМН
Ol'ga Pavlovna Plyushch
Учреждение Российской академии медицинских наук Гематологический научный центр РАМНотд. гемофилии и других коагулопатий, гл. науч. сотр., д-р мед. наук., проф; Учреждение Российской академии медицинских наук Гематологический научный центр РАМН
N I Zozulya
Hematology Research Center, Russian Academy of Medical SciencesHematology Research Center, Russian Academy of Medical Sciences
O P Plyushch
Hematology Research Center, Russian Academy of Medical SciencesHematology Research Center, Russian Academy of Medical Sciences
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