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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">safetyrisk</journal-id><journal-title-group><journal-title xml:lang="ru">Безопасность и риск фармакотерапии</journal-title><trans-title-group xml:lang="en"><trans-title>Safety and Risk of Pharmacotherapy</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2312-7821</issn><issn pub-type="epub">2619-1164</issn><publisher><publisher-name>Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.30895/2312-7821-2021-9-4-173-184</article-id><article-id custom-type="elpub" pub-id-type="custom">safetyrisk-238</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>ОБЗОРЫ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>REVIEWS</subject></subj-group></article-categories><title-group><article-title>Биомаркеры нефротоксичности: роль и значимость в диагностике лекарственного повреждения почек</article-title><trans-title-group xml:lang="en"><trans-title>Nephrotoxicity Biomarkers: Role and Significance in the Diagnosis of Drug-Induced Kidney Injury</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-1009-9609</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Муслимова</surname><given-names>О. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Muslimova</surname><given-names>O. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Муслимова Ольга Валерьевна, канд. мед. наук</p><p>Петровский б-р, д. 8, стр. 2, Москва, 127051, Российская Федерация</p></bio><bio xml:lang="en"><p>Olga V. Muslimova, Cand. Sci. (Med.)</p><p>8/2 Petrovsky Blvd, Moscow 127051, Russian Federation</p></bio><email xlink:type="simple">muslimova@expmed.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/0000-0002-6150-5796</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Евтеев</surname><given-names>В. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Evteev</surname><given-names>V. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Евтеев Владимир Александрович</p><p>Петровский б-р, д. 8, стр. 2, Москва, 127051, Российская Федерация</p></bio><bio xml:lang="en"><p>Vladimir A. Evteev</p><p>8/2 Petrovsky Blvd, Moscow 127051, Russian Federation</p></bio><email xlink:type="simple">Evteev@expmed.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/0000-0002-3733-6822</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Мазеркина</surname><given-names>И. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Mazerkina</surname><given-names>I. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Мазеркина Ирина Анатольевна, канд. мед. наук</p><p>Петровский б-р, д. 8, стр. 2, Москва, 127051, Российская Федерация</p></bio><bio xml:lang="en"><p>Irina A. Mazerkina, Cand. Sci. (Med.)</p><p>8/2 Petrovsky Blvd, Moscow 127051, Russian Federation</p></bio><email xlink:type="simple">Mazerkina@expmed.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/0000-0002-6389-2099</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Сокова</surname><given-names>Е. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Sokova</surname><given-names>E. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Сокова Елена Андреевна, канд. мед. наук, доцент</p><p>Петровский б-р, д. 8, стр. 2, Москва, 127051, Российская Федерация;</p><p>Трубецкая ул., д. 8, стр. 2, Москва, 119991, Российская Федерация</p></bio><bio xml:lang="en"><p>Elena A. Sokova, Cand. Sci. (Med.), Associate Professor</p><p>8/2 Petrovsky Blvd, Moscow 127051, Russian Federation;</p><p>8/2 Trubetskaya St., Moscow 119991, Russian Federation</p></bio><email xlink:type="simple">sokova@expmed.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-7024-5546</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Прокофьев</surname><given-names>А. Б.</given-names></name><name name-style="western" xml:lang="en"><surname>Prokofiev</surname><given-names>A. B.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Прокофьев Алексей Борисович, д-р мед. наук, профессор</p><p>Петровский б-р, д. 8, стр. 2, Москва, 127051, Российская Федерация</p></bio><bio xml:lang="en"><p>Alexey B. Prokofiev, Dr. Sci. (Med.), Professor</p><p>8/2 Petrovsky Blvd, Moscow 127051, Russian Federation</p></bio><email xlink:type="simple">prokofiev@expmed.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/0000-0003-4856-9346</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Шапченко</surname><given-names>А. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Shapchenko</surname><given-names>A. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Шапченко Анна Валерьевна, канд. мед. наук, доцент</p><p>ул. Делегатская, д. 20, стр. 1, Москва, 127473, Российская Федерация</p></bio><bio xml:lang="en"><p>Anna V. Shapchenko, Cand. Sci. (Med.), Associate Professor</p><p>20/1 Delegatskaya St., Moscow 127473, Russian Federation</p></bio><email xlink:type="simple">msmsu@msmsu.ru</email><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-3855-5899</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Александрова</surname><given-names>Т. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Alexandrova</surname><given-names>T. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Александрова Татьяна Владимировна, канд. мед. наук</p><p>Петровский б-р, д. 8, стр. 2, Москва, 127051, Российская Федерация</p></bio><bio xml:lang="en"><p>Tatiana V. Alexandrova, Cand. Sci. (Med.)</p><p>8/2 Petrovsky Blvd, Moscow 127051, Russian Federation</p></bio><email xlink:type="simple">aleksandrova@expmed.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Scientific Centre for Expert Evaluation of Medicinal Products</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации; Федеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет им. И. М. Сеченова» Министерства здравоохранения Российской Федерации (Сеченовский Университет)</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Scientific Centre for Expert Evaluation of Medicinal Products; I. M. Sechenov First Moscow State Medical University (Sechenov University)</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное образовательное учреждение высшего образования «Московский государственный медико-стоматологический университет имени А. И. Евдокимова» Министерства здравоохранения Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>A. I. Yevdokimov Moscow State University of Medicine and Dentistry</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2021</year></pub-date><pub-date pub-type="epub"><day>21</day><month>10</month><year>2021</year></pub-date><volume>9</volume><issue>4</issue><fpage>173</fpage><lpage>184</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Муслимова О.В., Евтеев В.А., Мазеркина И.А., Сокова Е.А., Прокофьев А.Б., Шапченко А.В., Александрова Т.В., 2021</copyright-statement><copyright-year>2021</copyright-year><copyright-holder xml:lang="ru">Муслимова О.В., Евтеев В.А., Мазеркина И.А., Сокова Е.А., Прокофьев А.Б., Шапченко А.В., Александрова Т.В.</copyright-holder><copyright-holder xml:lang="en">Muslimova O.V., Evteev V.A., Mazerkina I.A., Sokova E.A., Prokofiev A.B., Shapchenko A.V., Alexandrova T.V.</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.risksafety.ru/jour/article/view/238">https://www.risksafety.ru/jour/article/view/238</self-uri><abstract><p>Лекарственное поражение почек составляет от 8 до 60% эпизодов острого повреждения почек (ОПП) среди госпитализированных пациентов. Как можно более раннее распознавание этого состояния и своевременное принятие мер по коррекции лечения могут уменьшить количество выявленных случаев почечного повреждения и летальных исходов. Цель работы: анализ данных научной литературы о биомаркерах, используемых при проведении диагностики лекарственного поражения почек. Выявлено, что такие маркеры повреждения почек, как уровень сывороточного креатинина, объем выделяемой мочи, концентрация азота мочевины, экскреция натрия, микроскопия мочевого осадка, ограничены в применении в связи с тем, что они не отражают в полном объеме динамику и степень повреждения почек и не позволяют диагностировать развитие ОПП на ранних этапах. Установлено, что наи более перспективными биомаркерами являются в первую очередь KIM-1, L-FABP, NAG, NGAL, цистатин С, кластерин, β2-микроглобулин, МСР-1, IGFBP7 и TIMP-2. Однако определение концентрации новых биомаркеров в моче или в крови для диагностики ОПП может носить лишь рекомендательный характер, так как клинических и доклинических исследований по установлению валидности такого рода тестов проведено недостаточно. До настоящего времени не разработаны точные алгоритмы оценки рисков развития, диагностики, мониторинга течения и терапии ОПП, основанные на определении наличия и уровней данных маркеров в моче и/или в сыворотке крови. Таким образом, необходимо продолжать исследования различных биомаркеров ОПП и совершенствовать экспериментальные модели (как in vivo, так и in vitro), в том числе для изучения потенциальных нефротоксических свойств уже известных и разрабатываемых лекарственных средств.</p></abstract><trans-abstract xml:lang="en"><p>Drug-induced kidney injury (DIKI) accounts for 8 to 60% of episodes of acute kidney injury (AKI) among hospital patients. Early DIKI detection and timely adjustment of therapy will help reduce the kidney injury incidence and mortality. The aim of the study was to analyse scientific literature on the biomarkers used in DIKI diagnosis. The study revealed that the use of such kidney damage markers as serum creatinine, urinary output, urea nitrogen, sodium excretion, urinary sediment microscopy is limited because they do not give a full picture of the kidney injury degree and progression and do not allow for early AKI diagnosis. It was demonstrated that some of the most promising biomarkers are KIM-1, L-FABP, NAG, NGAL, cystatin C, clusterin, β2-microglobulin, МСР-1, IGFBP7, and TIMP-2. However, recommendations for determination of these biomarkers’ urine or blood concentrations for AKI diagnosis are somewhat preliminary, because there have been insufficient clinical and preclinical studies to establish validity of such tests. No precise algorithms based on determination of the biomarkers levels in urea and/or blood serum have been developed for AKI risk assessment, diagnosis, monitoring, and treatment. Thus, further research is necessary to investigate different AKI biomarkers and improve experimental models (both in vivo and in vitro), which will support assessment of potential nephrotoxic properties of existing and new medicinal products.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>биомаркеры</kwd><kwd>лекарственная нефротоксичность</kwd><kwd>острое повреждение почек</kwd><kwd>NAG</kwd><kwd>L-FABP</kwd><kwd>KIM-1</kwd><kwd>NGAL</kwd><kwd>β2-микроглобулин</kwd><kwd>МСР-1</kwd><kwd>цистатин С</kwd><kwd>IGFBP7</kwd><kwd>TIMP-2</kwd></kwd-group><kwd-group xml:lang="en"><kwd>biomarkers</kwd><kwd>drug nephrotoxicity</kwd><kwd>acute kidney injury</kwd><kwd>NAG</kwd><kwd>L-FABP</kwd><kwd>KIM-1</kwd><kwd>NGAL</kwd><kwd>β2-microglobulin</kwd><kwd>MCP-1</kwd><kwd>cystatin C</kwd><kwd>IGFBP7</kwd><kwd>TIMP-2</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Работа выполнена в рамках государственного задания ФГБУ «НЦЭСМП» Минздрава России № 056-00005-21-00 на проведение прикладных научных исследований (номер государственного учета НИР 121022400082-4).</funding-statement><funding-statement xml:lang="en">The study reported in this publication was carried out as part of a publicly funded research project No. 056-00005-21-00 and was supported by the Scientific Centre for Expert Evaluation of Medicinal Products (R&amp;D public accounting No. 121022400082-4).</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">Mody H, Ramakrishnan V, Chaar M, Lezeau J, Rump A, Taha K, et al. 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