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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">clinvest</journal-id><journal-title-group><journal-title xml:lang="ru">Качественная клиническая практика</journal-title><trans-title-group xml:lang="en"><trans-title>Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2588-0519</issn><issn pub-type="epub">2618-8473</issn><publisher><publisher-name>ООО «Издательство ОКИ</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.37489/2588-0519-2021-2-22-29</article-id><article-id custom-type="elpub" pub-id-type="custom">clinvest-573</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ФАРМАКОЭКОНОМИКА</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>PHARMACOECONOMICS</subject></subj-group></article-categories><title-group><article-title>Индивидуализированная профилактика гемофилии А как путь повышения эффективности терапии и оптимизации потребления препаратов на примере октокога альфа и руриоктакога альфа пэгола. Систематический обзор литературы</article-title><trans-title-group xml:lang="en"><trans-title>Individualized prophylactic treatment of patients with hemophilia A to improve effectiveness and optimize product consumption on the example of octocog alpha and rurioctocog alpha pegol. A systematic literature review</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-6803-4763</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Толкушин</surname><given-names>А. Г.</given-names></name><name name-style="western" xml:lang="en"><surname>Tolkushin</surname><given-names>A. G.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Толкушин Александр Геннадьевич, к. ф. н., ведущий специалист отдела оценки медицинских технологий. SPIN-код: 7706-3809</p><p>Москва</p></bio><bio xml:lang="en"><p>Tolkushin Alexander G., Cand. Sci. Pharm., leading specialist of the Medical Technology Assessment Department. SPIN code: 7706-3809</p><p>Moscow</p></bio><email xlink:type="simple">tolkushin@inbox.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-2437-298X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Холовня-Волоскова</surname><given-names>М. Э.</given-names></name><name name-style="western" xml:lang="en"><surname>Holownia-Voloskova</surname><given-names>M. E.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Холовня-Волоскова Мальвина Эва Альбертовна, заведующая отделом оценки медицинских технологий. SPIN-код: 6435-2624</p><p>Москва</p></bio><bio xml:lang="en"><p>Holownia-Voloskova Malwina Eva A., Head of the Medical Technology Assessment Department. SPIN code: 6435-26241</p><p>Moscow</p></bio><email xlink:type="simple">malwina.holownia@gmail.com</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-4083-8417</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Погудина</surname><given-names>Н. Л.</given-names></name><name name-style="western" xml:lang="en"><surname>Pogudina</surname><given-names>N. L.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Погудина Наталья Леонидовна, генеральный директор </p><p>Москва</p></bio><bio xml:lang="en"><p>Pogoudina Natalia L., CEO</p><p>Moscow</p></bio><email xlink:type="simple">ooonik77@bk.ru</email><xref ref-type="aff" rid="aff-3"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Государственное бюджетное учреждение города Москвы «Научно-исследовательский институт организации здравоохранения и медицинского менеджмента Департамента здравоохранения города Москвы»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>State Budgetary Institution «Research Institute for Healthcare Organization and Medical Management of Moscow Healthcare Department»</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Государственное бюджетное учреждение города Москвы «Научно-исследовательский институт организации&#13;
здравоохранения и медицинского менеджмента Департамента здравоохранения города Москвы»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>State Budgetary Institution «Research Institute for Healthcare Organization and Medical Management of Moscow Healthcare Department»</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>Независимая исследовательская компания «РАЗУМНЫЙ ВЫБОР»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>REASONABLE CHOICE, an independent research company</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2021</year></pub-date><pub-date pub-type="epub"><day>06</day><month>08</month><year>2021</year></pub-date><volume>0</volume><issue>2</issue><fpage>22</fpage><lpage>29</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Толкушин А.Г., Холовня-Волоскова М.Э., Погудина Н.Л., 2021</copyright-statement><copyright-year>2021</copyright-year><copyright-holder xml:lang="ru">Толкушин А.Г., Холовня-Волоскова М.Э., Погудина Н.Л.</copyright-holder><copyright-holder xml:lang="en">Tolkushin A.G., Holownia-Voloskova M.E., Pogudina N.L.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.clinvest.ru/jour/article/view/573">https://www.clinvest.ru/jour/article/view/573</self-uri><abstract><p>Цель: обобщение информации об эффективности и потреблении препаратов октоког альфа и руриоктоктог альфа пэгол при стандартной профилактической терапии и профилактической терапии с использованием индивидуализированного подхода у пациентов с гемофилией А на основании опубликованных международных данных. Материалы и методы: был проведён систематический поиск и обзор литературы. Из выявленных в ходе систематического поиска 25 источников было отобрано 7 релевантных источников, описывающих результаты сравнения терапии препаратами октоког альфа и руриоктоког альфа пэгол у взрослых и детей с тяжёлой и среднетяжёлой формами гемофилии А с использованием персонифицированной оценки фармакокинетической кривой на основе программного обеспечения myPKFiT и стандартным режимом дозирования. Проводили объединение и анализ данных об отдельных пациентах во вторично выделяемых подгруппах, в том числе по возрасту, наличию кровотечений, риску кровотечений, связанному с повседневной физической активностью пациентов. Результаты. В наблюдательных исследованиях пересмотр режима дозирования октокога альфа на основании персонифицированной оценки фармакокинетической кривой с использованием myPKFiT привёл к сокращению объёма потребления лекарственных препаратов и/или к повышению эффективности профилактики кровотечений у пациентов с тяжёлой гемофилией А — сокращению среднегодовой частоты кровотечений. В продлённом контролируемом клиническом исследовании применения myPKFiT при терапии руриоктокогом альфа пэгол по сравнению с отсутствием персонификации выявлена тенденция к снижению частоты кровотечений и увеличению среднегодового потребления лекарственного препарата. В исследованиях по оценке одномоментного среза применение myPKFiT приводило к пересмотру режима применения менее чем у четверти пациентов. Заключение. Использование дозирования лекарственных препаратов октоког альфа и руриоктоког альфа пэгол на основе персонифицированной оценки фармакокинетической кривой с применением фармакокинетической популяционной модели приводит к обоснованному корректированию дозы и улучшению исходов.</p></abstract><trans-abstract xml:lang="en"><p>Objective: to review the data on the efficacy and consumption of octocog alfa and rurioctoctog alfa pegol in standard prophylaxis and individualized prophylaxis in hemophilia A patients based on published international data. Material and methods: a systematic literature search and review were performed. Among 25 sources identified within the systematic search 7 relevant sources describing the comparison of treatment with octocog alfa and rurioctocog alfa pegol in adult and pediatric patients with severe and moderate hemophilia A based on personalized assessment of the pharmacokinetic curve using the interactive tool myPKFit versus the standard (non-personalized) dosage regimen were selected. Data on individual patients, as well as data from secondary subgroups defined by age, bleeding rate, risk of bleeding associated with the daily physical activity were combined and analyzed. Results. In observational studies, adjustments of the dose and administration of octocog alfa in patients with severe hemophilia based on personalized assessment of the pharmacokinetic curve using myPKFit resulted in the reduced consumption and/or increased efficacy of prophylaxis — a reduced annual bleeding rate. In an extended controlled study of rurioctocog alpha pegol a trend toward reduced bleeding rate and increased mean annual consumption of the drug was reported in patients who received myPKFit guided prophylaxis compared to a non-personalized treatment regimen. In the single-cut studies, myPKFiT use resulted in the regimen revisions in less than a quarter of patients. Summary. Personalized dosing for octocog alpha and rurioctocog alpha pegol based on pharmacokinetic curve built using pharmacokinetic population model enables reasonable dose adjustments and improves outcomes.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>гемофилия А</kwd><kwd>октоког альфа</kwd><kwd>руриоктоког альфа пэгол</kwd><kwd>кровотечения</kwd><kwd>потребление лекарственных препаратов</kwd></kwd-group><kwd-group xml:lang="en"><kwd>hemophilia A</kwd><kwd>octocog alpha</kwd><kwd>rurioctocog alpha pegol</kwd><kwd>hemorrhage</kwd><kwd>consumption of medicines</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Статья подготовлена по материалам систематического обзора литературы, проведенного при поддержке компанией Такеда.</funding-statement><funding-statement xml:lang="en">The article is based on the materials of a systematic review of the literature conducted with the support of the Takeda company.</funding-statement></funding-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Клинические рекомендации по диагностике и лечению гемофилии.Коллектив авторов под руководством академика В.Г. 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