nidНефрология и диализNephrology and Dialysis1680-44222618-9801Российское диализное обществоnid-1014Research ArticleОРИГИНАЛЬНЫЕ СТАТЬИORIGINAL ARTICLESОценка эффективности и безопасности нового отечественного препарата эритропоэтина альфа (Обзор литературы и отчет открытого многоцентрового исследования)An evaluation of the efficacy and safety of the new domestically produced epoietin a produced in Russia (A review and report of an open multicenter study)ЗемченковА. Ю.ZemchenkovA. Yu.zemchenkov@nephro.ruГерасимчукР. П.GerasimchukR. P.noemail@neicon.ruКостылеваТ. Г.KostylevaT. G.noemail@neicon.ruНавасардянА. С.NavasardianA. S.noemail@neicon.ruХорошиловС. Е.HoroshilovS. E.noemail@neicon.ruСПб ГМА им. И.И. Мечникова, СПб ГУЗ «Городская Мариинская больница», ГУЗ «Самарская областная клиническая больница им. М.И. Калинина», Главный военный клинический госпиталь имени акад. Н.Н. БурденкоRussian Federation201017062025124287294Copyright © Земченков А.Ю., Герасимчук Р.П., Костылева Т.Г., Навасардян А.С., Хорошилов С.Е., 20252025Земченков А.Ю., Герасимчук Р.П., Костылева Т.Г., Навасардян А.С., Хорошилов С.Е.Zemchenkov A.Y., Gerasimchuk R.P., Kostyleva T.G., Navasardian A.S., Horoshilov S.E.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://journal.nephro.ru/jour/article/view/1014

Результаты наблюдательных исследований и клинических испытаний сформировали современные представления о целевых параметрах коррекции анемии при хронической болезни почек, хотя некоторые вопросы остались без определенного ответа и служат предметом оживленной дискуссии, представленной в кратком обзоре. Дополнительные вопросы вызывает расширяющийся спектр доступных эритропоэз-стимулирующих средств: все ли они эквивалентны в отношении требующейся дозы, клинической эффективности и возможных побочных эффектов. В настоящем исследовании представлен результат перевода 51 гемодиализного пациента с терапии традиционными оригинальными препаратами эритропоэтина альфа и бета на равные дозы Эральфона – новой лекарственной формы эритропоэтина альфа в предварительно заполненных шприцах, выпускаемых ЗАО Сотекс из фармсубстанции, производимой ФГУП «Гос. НИИ особо чистых биопрепаратов» ФМБА России (С.-Петербург). Эральфон вводился внутривенно после диализа. В результате перевода уровень гемоглобина не изменился: как в среднем по группе – от 117 ± 6 г/л (исходно) до 116 ± 6 г/л, так и в отношении динамики индивидуальных значений – среднее изменение составило –0,46 г/л (95% ДИ –1,79÷+0,84), р = 0,46. Исходная средняя недельная доза составила 5118 ± 2819 МЕ/нед. и не отличалась от конечной – 5034 ± 2719 МЕ/нед. (р > 0,5). Нежелательных явлений, связанных с применением препарата, индивидуальной непереносимости или реакций на внутривенное введение в коротком исследовании не зафиксировано. Ухудшения течения артериальной гипертензии не зафиксировано.

The results of observational studies and clinical trials have formed a contemporary view on the anemia correction targets in patients with chronic kidney disease. However some questions remain unsolved and are the subject of active discussion which are presented in a short review. Expansion of available drugs which stimulate erythropoiesis arise additional concern about their bioequivalence (dosing, clinical effect, adverse events). This study presents the results of transferring of 51 hemodialysis patients from treatment with original epoietin a and b to the treatment with the same doses of Eralfon – a new pharmaceutical dosage formulation of epoietin a in pre-filled syringes produced by ZAO Sotex out of pharmacological substance manufactured by the State Scientific Research Institute of Highly Pure Biopreparations (St.-Petersburg). Eralfon was injected intravenously. After changing the drugs the hemoglobin level in the whole group remained the same (117 ± 6 g/l vs 116 ± 6 g/l); individual changes were also not significantly different from zero: the mean hemoglobin level change was –0,46 g/l (95% CI –1,79÷+0,84), р = 0,46. The mean baseline weekly epoietin dose was 5118 ± 2819 IU/week and did not differ from mean final Eralfon dose 5034 ± 2719 IU/week (р > 0,5). There was neither adverse event related to investigated new drug nor individual intolerability or allergic reactions in a short-term study. The blood pressure level was also stable.

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The authors declare that there are no conflicts of interest present.