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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">10.37489/2588-0519-2024-1-45-55</article-id><article-id custom-type="edn" pub-id-type="custom">NFMUDT</article-id><article-id custom-type="elpub" pub-id-type="custom">clinvest-705</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>БЕЗОПАСНОСТЬ ЛЕКАРСТВ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>DRUG SAFETY</subject></subj-group></article-categories><title-group><article-title>Взаимосвязь уровня маркеров почечного повреждения с наличием кровотечений у пациентов с фибрилляцией предсердий и хронической болезнью почек, получающих ривароксабан</article-title><trans-title-group xml:lang="en"><trans-title>Relationship between renal damage marker levels and the presence of bleeding in patients with atrial fibrillation and chronic kidney disease receiving rivaroxaban</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-6823-6077</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Шаталова</surname><given-names>Н. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Shatalova</surname><given-names>N. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Шаталова Наталья Андреевна — ассистент, кафедра терапии и полиморбидной патологии имени академика М.С. Вовси.</p><p>Москва</p></bio><bio xml:lang="en"><p>Natalya A. Shatalova — Assistant of the Department of Therapy and Polymorbid Pathology named after Academician M.S. Vovsi.</p><p>Moscow</p></bio><email xlink:type="simple">natalia.sh2018@gmail.com</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-0795-8225</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Остроумова</surname><given-names>О. Д.</given-names></name><name name-style="western" xml:lang="en"><surname>Ostroumova</surname><given-names>O. D.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Остроумова Ольга Дмитриевна — д. м. н., профессор, зав. кафедрой терапии и полиморбидной патологии имени академика М.С. Вовси.</p><p>Москва</p></bio><bio xml:lang="en"><p>Olga D. Ostroumova — Dr. Sci. (Med.), Professor, Head of the Department of Therapy and Polymorbid Pathology named after academician M.S. Vovsi.</p><p>Moscow</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-3684-9992</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Короткова</surname><given-names>Т. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Korotkova</surname><given-names>T. N.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Короткова Татьяна Николаевна — к. м. н., заведующий лабораторией биохимии, иммунологии и аллергологии.</p><p>Москва</p></bio><bio xml:lang="en"><p>Tatiana N. Korotkova — PhD, Cand. Sci. (Med.), Head of the Laboratory of Clinical Biochemistry, Immunology and Allergology.</p><p>Moscow</p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-2529-9152</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Ворожко</surname><given-names>И. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Vorozhko</surname><given-names>I. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Ворожко Илья Викторович — к. м. н., с. н. с. лаборатории биохимии, иммунологии и аллергологии.</p><p>Москва</p></bio><bio xml:lang="en"><p>Ilya V. Vorozhko — PhD, Cand. Sci. (Med.), senior research fellow of the Laboratory of Clinical Biochemistry, Immunology and Allergology.</p><p>Moscow</p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-3349-0451</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Клычникова</surname><given-names>Е. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Klychnikova</surname><given-names>E. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Клычникова Елена Валерьевна — к. м. н., заведующая клинико-биохимической лабораторией экстренных методов исследования.</p><p>Москва</p></bio><bio xml:lang="en"><p>Elena V. Klychnikova — PhD, Cand. Sci. (Med.), Head of the Scientific Clinical and Biochemical Laboratory of Emergency Investigation Methods.</p><p>Moscow</p></bio><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-6573-4169</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Эбзеева</surname><given-names>Е. Ю.</given-names></name><name name-style="western" xml:lang="en"><surname>Ebzeeva</surname><given-names>E. Yu.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Эбзеева Елизавета Юрьевна — к. м. н., доцент кафедры терапии и полиморбидной патологии имени академика М.С. Вовси.</p><p>Москва</p></bio><bio xml:lang="en"><p>Elizaveta Yu. Ebzeeva — PhD, Cand. Sci. (Med.), Associate Professor of the Department of Therapy and Polymorbid Pathology named after Academician M. S. Vovsi RMA of Continuous Professional Education.</p><p>Moscow</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-9612-6705</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Годков</surname><given-names>М. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Godkov</surname><given-names>M. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Годков Михаил Андреевич — д. м. н., профессор, руководитель отдела лабораторной диагностики ГБУЗ «НИИСП имени Н.В. Склифосовского Департамента здравоохранения города Москвы»; зав. кафедрой клинической лабораторной диагностики ФГБОУ ДПО «РМАНПО» МЗ РФ.</p><p>Москва</p></bio><bio xml:lang="en"><p>Mikhail A. Godkov — Dr. Sci. (Med.), Professor, Head of the Department of Laboratory Diagnostics Sklifosovsky Research Institute for Emergency Medicine; Head of the Department of Clinical Laboratory Diagnostics, RMA of Continuous Professional Education.</p><p>Moscow</p></bio><xref ref-type="aff" rid="aff-4"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-9262-9233</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Стародубова</surname><given-names>А. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Starodubova</surname><given-names>A. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Стародубова Антонина Владимировна — д. м. н., зав. отделением сердечно-сосудистой патологии, заместитель директора по научной и лечебной работе ФГБУН «ФИЦПББП»; профессор кафедры факультетской терапии лечебного факультета ФГАОУ ВО «РНИМУ имени Н. И. Пирогова» Министерства здравоохранения РФ.</p><p>Москва</p></bio><bio xml:lang="en"><p>Antonina V. Starodubova — Dr. Sci. (Med.), Professor, Deputy Director for Scientific and Medical Work, Federal Research Centre of Nutrition and Biotechnology; Professor, Chair of Faculty Therapy, N.I. Pirogov RNRMU.</p><p>Moscow</p></bio><xref ref-type="aff" rid="aff-5"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-9307-4994</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Мирзаев</surname><given-names>К. Б.</given-names></name><name name-style="western" xml:lang="en"><surname>Mirzaev</surname><given-names>K. B.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Мирзаев Карин Бадавиевич — д. м. н., проректор по научной работе и инновациям, директор НИИ молекулярной и персонализированной медицины, профессор кафедры клинической фармакологии и терапии имени академика Б. Е. Вотчала ФГБОУ ДПО «РМАНПО» МЗ РФ.</p><p>Москва</p></bio><bio xml:lang="en"><p>Karin B. Mirzaev — Dr. Sci. (Med.), Vice-Rector for Research and Innovation, Director of RI of Molecular and Personalized Medicine, Professor of the Department of Clinical Pharmacology and Therapy named after Academician B. E. Votchala RMA of Continuous Professional Education.</p><p>Moscow</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-4496-3680</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Сычев</surname><given-names>Д. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Sychev</surname><given-names>D. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Сычев Дмитрий Алексеевич — д. м. н., профессор, академик РАН, зав. кафедрой клинической фармакологии и терапии имени академика Б. Е. Вотчала, ректор ФГБОУ ДПО «РМАНПО» МЗ РФ.</p><p>Москва</p></bio><bio xml:lang="en"><p>Dmitry A. Sychev — PhD, Dr. Sci (Med.), Professor, Academician RAS, Head. Department of Clinical Pharmacology and Therapy named after Academician B. E. Votchala, Rector of the RMA of Continuous Professional Education,</p><p>Moscow</p></bio><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» МЗ РФ</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Russian Medical Academy of Continuous Professional Education</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>ФГБУН «Федеральный исследовательский центр питания, биотехнологии и безопасности пищи»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Sklifosovsky Research Institute for Emergency Medicine</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>ГБУЗ «Научно-исследовательский институт скорой помощи имени Н.В. Склифосовского Департамента здравоохранения города Москвы»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Sklifosovsky Research Institute for Emergency Medicine</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-4"><aff xml:lang="ru"><institution>ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» МЗ РФ; ГБУЗ «Научно-исследовательский институт скорой помощи имени Н.В. Склифосовского Департамента здравоохранения города Москвы»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Russian Medical Academy of Continuous Professional Education; Sklifosovsky Research Institute for Emergency Medicine</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-5"><aff xml:lang="ru"><institution>ФГБУН «Федеральный исследовательский центр питания, биотехнологии и безопасности пищи»; ФГАОУ ВО «Российский национальный исследовательский медицинский университет имени Н.И. Пирогова» Министерства здравоохранения Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Sklifosovsky Research Institute for Emergency Medicine; N.I. Pirogov Russian National Research Medical University</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2024</year></pub-date><pub-date pub-type="epub"><day>19</day><month>04</month><year>2024</year></pub-date><volume>0</volume><issue>1</issue><fpage>45</fpage><lpage>55</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Шаталова Н.А., Остроумова О.Д., Короткова Т.Н., Ворожко И.В., Клычникова Е.В., Эбзеева Е.Ю., Годков М.А., Стародубова А.В., Мирзаев К.Б., Сычев Д.А., 2024</copyright-statement><copyright-year>2024</copyright-year><copyright-holder xml:lang="ru">Шаталова Н.А., Остроумова О.Д., Короткова Т.Н., Ворожко И.В., Клычникова Е.В., Эбзеева Е.Ю., Годков М.А., Стародубова А.В., Мирзаев К.Б., Сычев Д.А.</copyright-holder><copyright-holder xml:lang="en">Shatalova N.A., Ostroumova O.D., Korotkova T.N., Vorozhko I.V., Klychnikova E.V., Ebzeeva E.Y., Godkov M.A., Starodubova A.V., Mirzaev K.B., Sychev D.A.</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/705">https://www.clinvest.ru/jour/article/view/705</self-uri><abstract><sec><title>Актуальность</title><p>Актуальность. Хроническая болезнь почек (ХБП) часто является сопутствующей патологией у пациентов с фибрилляцией предсердий (ФП). Учитывая повышенный риск кровотечений у пациентов с ФП и ХБП при приёме антикоагулянтной терапии, требуется разработать новые методы прогнозирования риска развития кровотечений при назначении антикоагулянтов у данной категории пациентов.</p></sec><sec><title>Цель</title><p>Цель. Оценка возможной взаимосвязи между наличием кровотечений у пациентов с ФП и ХБП С3–4 стадий, получающих ривароксабан, с уровнем маркеров почечного повреждения в моче.</p></sec><sec><title>Методы</title><p>Методы. В исследование включено 133 пациента с ФП и ХБП С3а-С4 в возрасте от 52 до 97 лет (медиана возраста 82 [74;86] лет); всем пациентам выполнены ретроспективная оценка наличия кровотечений, анализ экскреции маркеров почечного повреждения (альбумин; нефрин; липокалин, ассоциированный с желатиназой нейтрофилов (neutrophil gelatinase-associated lipocalin; NGAL); молекула первого типа почечного повреждения (kidney injury molecule-1; KIM-1)) с мочой. Дополнительно выполнен анализ уровня маркеров почечного повреждения в моче у 45 здоровых добровольцев.</p></sec><sec><title>Результаты</title><p>Результаты. Уровни NGAL и KIM-1 в моче у пациентов с ФП и ХБП с наличием кровотечений в анамнезе (5,5 [3,81;23,83] нг/мл и 0,68 [0,27;1,10] нг/мл, соответственно) были статистически значимо выше по сравнению с пациентами без кровотечений (4,19 [2,22;15,53] нг/мл, р=0,039, и 0,38 [0,13;0,66] нг/мл, р=0,019, соответственно) и здоровыми людьми (2,6 [1,9;4,3] нг/мл, p&lt;0,001, и 0,21 [0,10;0,69], р=0,003, соответственно).</p></sec><sec><title>Заключение</title><p>Заключение. У пациентов с ФП и ХБП С3а-С4, получающих ривароксабан, с наличием кровотечений в анамнезе отмечается более высокий уровень экскреции KIM-1 и NGAL с мочой.</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>Relevance</title><p>Relevance. Chronic kidney disease (CKD) is often concomitant pathology in patients with atrial fibrillation (AF). Because of the increased risk of bleeding in patients with AF and CKD while taking anticoagulant therapy, it is necessary to assess new methods for predicting the risk of bleeding when prescribing anticoagulants in this category of patients.</p></sec><sec><title>Objective</title><p>Objective. To evaluate the possible relationship between the presence of bleeding in patients with AF and CKD C3–4 receiving rivaroxaban and the level of renal damage markers in urine.</p></sec><sec><title>Methods</title><p>Methods. One hundred and thirty-three patients with AF and CKD C3a-C4 aged 52 to 97 years (median age 82 [74;86] years) were included in the study. All patients were assessed for bleeding and excretion of markers of renal damage (albumin; nephrin; neutrophil gelatinase-associated lipocalin (NGAL), and kidney injury molecule-1 (KIM-1)) in with urine have been identified. In addition, the levels of kidney injury markers in the urine of 45 healthy volunteers were analyzed.</p></sec><sec><title>Results</title><p>Results. Urinary NGAL and KIM-1 levels in patients with AF and CKD with a history of bleeding (5.5 [3.81;23.83] ng/ml and 0.68 [0.27;1.10] ng/ml, respectively) were significantly higher than those in patients without bleeding (4.19 [2.22; 15.53] ng/ml, p=0.039, and 0.38 [0.13;0.66] ng/ml, p=0.019, respectively) and healthy subjects (2.6 [1.9;4.3] ng/ml, p&lt;0.001, and 0.21 [0.10;0.69], p=0.003, respectively).</p></sec><sec><title>Conclusion</title><p>Conclusion. Patients with AF and CKD C3a — C4 on rivaroxaban treatment with a history of bleeding have higher urinary excretion of KIM-1 and NGAL.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>фибрилляция предсердий</kwd><kwd>хроническая болезнь почек</kwd><kwd>кровотечение</kwd><kwd>ривароксабан</kwd><kwd>нефрин</kwd><kwd>липокалин</kwd><kwd>ассоциированный с желатиназой нейтрофилов</kwd><kwd>молекула первого типа почечного повреждения</kwd></kwd-group><kwd-group xml:lang="en"><kwd>atrial fibrillation</kwd><kwd>chronic kidney disease</kwd><kwd>bleeding</kwd><kwd>rivaroxaban</kwd><kwd>nephrin</kwd><kwd>neutrophil gelatinase-associated lipocalin</kwd><kwd>kidney injury molecule-1</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Работа поддержана грантом РНФ № 22–15–00251 «Персонализированное применение прямых оральных антикоагулянтов на основе фармакогеномного подхода»</funding-statement><funding-statement xml:lang="en">The work was supported by the Russian Science Foundation grant No. 22–15–00251 “Personalized use of direct oral anticoagulants based on a pharmacogenomic approach.”</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">Hindricks G, Potpara T, Dagres N, et al. 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