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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">10.30895/2312-7821-2025-478</article-id><article-id custom-type="elpub" pub-id-type="custom">safetyrisk-478</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>ГЛАВНАЯ ТЕМА: БЕЗОПАСНОСТЬ ПАЦИЕНТА: КАК ДОКЛИНИЧЕСКИЕ ДАННЫЕ И ПОСТРЕГИСТРАЦИОННЫЙ ФАРМАКОНАДЗОР ФОРМИРУЮТ СОВРЕМЕННЫЙ ЛАНДШАФТ ФАРМАКОТЕРАПИИ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>MAIN TOPIC: PATIENT SAFETY: THE WAY PRECLINICAL DATA AND POST-AUTHORISATION PHARMACOVIGILANCE SHAPE MODERN PHARMACOTHERAPEUTIC LANDSCAPE</subject></subj-group></article-categories><title-group><article-title>Циркулирующие микроРНК — перспективные биомаркеры для оценки риска развития антипсихотик-индуцированного метаболического синдрома (обзор): часть 1</article-title><trans-title-group xml:lang="en"><trans-title>Circulating MicroRNAs Are Promising Biomarkers for Assessing the Risk of Antipsychotic-Induced Metabolic Syndrome (Review): Part 1</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-2840-837X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Шнайдер</surname><given-names>Н. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Shnayder</surname><given-names>N. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Шнайдер Наталья Алексеевна, д-р мед. наук, профессор</p><p>ул. Бехтерева, д. 3, Санкт-Петербург, 192019; ул. Партизана Железняка, д. 1, г. Красноярск, 660022</p></bio><bio xml:lang="en"><p>Natalia А. Shnayder, Dr. Sci. (Med.), Professor</p><p>3 Bekhterev St., St Petersburg 192019; 1 Partisan Zheleznyak St., Krasnoyarsk 660022</p></bio><email xlink:type="simple">NASchnaider@yandex.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/0000-0003-1874-9434</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Насырова</surname><given-names>Р. Ф.</given-names></name><name name-style="western" xml:lang="en"><surname>Nasyrova</surname><given-names>R. F.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Насырова Регина Фаритовна, д-р мед. наук</p><p>ул. Бехтерева, д. 3, Санкт-Петербург, 192019; пр. Ленина, д. 92, г. Тула, 300012</p></bio><bio xml:lang="en"><p>Regina F. Nasyrova, Dr. Sci. (Med.)</p><p>3 Bekhterev St., St Petersburg 192019; 92 Lenin Ave, Tula 300012</p></bio><email xlink:type="simple">regina_nmrcpn@mail.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/0009-0005-5895-1778</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Пекарец</surname><given-names>Н. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Pekarets</surname><given-names>N. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Пекарец Николай Александрович</p><p>ул. Бехтерева, д. 3, Санкт-Петербург, 192019</p></bio><bio xml:lang="en"><p>Nikolai A. Pekarets</p><p>3 Bekhterev St., St Petersburg 192019</p></bio><email xlink:type="simple">pekaretsnick@mail.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/0000-0001-8279-4198</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Гречкина</surname><given-names>В. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Grechkina</surname><given-names>V. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Гречкина Виолетта Владимировна</p><p>ул. Бехтерева, д. 3, Санкт-Петербург, 192019</p></bio><bio xml:lang="en"><p>Violetta V. Grechkina</p><p>3 Bekhterev St., St Petersburg 192019</p></bio><email xlink:type="simple">grechkina.vv@mail.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/0000-0002-8493-0058</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Петрова</surname><given-names>М. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Petrova</surname><given-names>M. M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Петрова Марина Михайловна, д-р мед. наук, профессор</p><p>ул. Партизана Железняка, д. 1, г. Красноярск, 660022</p></bio><bio xml:lang="en"><p>Marina M. Petrova, Dr. Sci. (Med.), Professor</p><p>1 Partisan Zheleznyak St., Krasnoyarsk 660022</p></bio><email xlink:type="simple">stk99@yandex.ru</email><xref ref-type="aff" rid="aff-4"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Институт персонализированной психиатрии и неврологии,&#13;
Национальный медицинский исследовательский центр психиатрии и неврологии имени В.М. Бехтерева ; Центр коллективного пользования «Молекулярные и клеточные технологии», Красноярский государственный медицинский университет имени профессора В.Ф. Войно-Ясенецкого</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Institute of Personalized Psychiatry and Neurology, V.M. Bekhterev National Medical Research Center for Psychiatry and Neurology ; Shared Core Facilities “Molecular and Cell Technologies”, Prof. V.F. Voino-Yasenetsky Krasnoyarsk State Medical University</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Институт персонализированной психиатрии и неврологии, Национальный медицинский исследовательский центр психиатрии и неврологии имени В.М. Бехтерева ; Федеральное государственное бюджетное образовательное учреждение высшего образования «Тульский государственный университет»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Institute of Personalized Psychiatry and Neurology, V.M. Bekhterev National Medical Research Center for Psychiatry and Neurology ; Tula State University</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>Институт персонализированной психиатрии и неврологии, Национальный медицинский исследовательский центр психиатрии и неврологии имени В.М. Бехтерева</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Institute of Personalized Psychiatry and Neurology, V.M. Bekhterev National Medical Research Center for Psychiatry and Neurology</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-4"><aff xml:lang="ru"><institution>Центр коллективного пользования «Молекулярные и клеточные технологии», Красноярский государственный медицинский университет имени профессора В.Ф. Войно-Ясенецкого</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Shared Core Facilities “Molecular and Cell Technologies”, Prof. V.F. Voino-Yasenetsky Krasnoyarsk State Medical University</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2025</year></pub-date><pub-date pub-type="epub"><day>29</day><month>09</month><year>2025</year></pub-date><volume>13</volume><issue>3</issue><fpage>344</fpage><lpage>356</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Шнайдер Н.А., Насырова Р.Ф., Пекарец Н.А., Гречкина В.В., Петрова М.М., 2025</copyright-statement><copyright-year>2025</copyright-year><copyright-holder xml:lang="ru">Шнайдер Н.А., Насырова Р.Ф., Пекарец Н.А., Гречкина В.В., Петрова М.М.</copyright-holder><copyright-holder xml:lang="en">Shnayder N.A., Nasyrova R.F., Pekarets N.A., Grechkina V.V., Petrova M.M.</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/478">https://www.risksafety.ru/jour/article/view/478</self-uri><abstract><p>ВВЕДЕНИЕ. Антипсихотик-индуцированный метаболический синдром (АИМетС) является распространенной нежелательной реакцией при фармакотерапии психических расстройств и болезней зависимости. Однако чувствительность и специфичность известных биохимических биомаркеров в крови могут быть недостаточными для оценки безопасности психофармакотерапии и риска развития АИМетС в связи с индивидуальными различиями метаболизма антипсихотиков у пациентов c расстройствами шизофренического спектра. Циркулирующие микроРНК в крови рассматриваются как новые перспективные эпигенетические биомаркеры АИМетС.ЦЕЛЬ. Оценить возможность использования циркулирующих микроРНК как эпигенетических биомаркеров для прогнозирования и ранней диагностики АИМетС.ОБСУЖДЕНИЕ. Проведен анализ результатов фундаментальных и клинических исследований роли циркулирующих микроРНК, влияющих на основные звенья патогенеза и прогрессирования АИМетС, опубликованных в период 2012–2024 гг. Представлены новые международные подходы к использованию основных и дополнительных клинических и биохимических биомаркеров АИМетС, показаны преимущества использования микроРНК в качестве эпигенетических биомаркеров АИМетС. Приведены обобщенные данные о роли микроРНК в механизмах развития АИМетС, включая окислительный стресс, системное воспаление, дифференцировку адипоцитов, метаболизм липидов и глюкозы, регуляцию аппетита, изменение экспрессии нейропептида Y, чувствительности к лептину, экспрессии орексина, уровней тестостерона, тиреоидных гормонов и паратиреоидного гормона.ВЫВОДЫ. Выявление изменений уровня экспрессии циркулирующих микроРНК в доступных образцах (кровь, слюна, моча) перспективно как одна из альтернативных методологий прогнозирования и диагностики АИМетС. Во второй части обзора будет рассмотрена роль циркулирующих микроРНК как эпигенетических биомаркеров развития основных проявлений МетС, АИМетС, а также распределение сигнатур микроРНК в зависимости от риска развития АИМетС.</p></abstract><trans-abstract xml:lang="en"><p>INTRODUCTION. Antipsychotic-induced metabolic syndrome (AIMetS) is a common adverse reaction to the pharmacotherapy of psychiatric and addiction disorders. However, interindividual variability in the metabolism of antipsychotics may limit the sensitivity and specificity of known blood-based biochemical biomarkers of AIMetS for assessing the safety of psychopharmacotherapy and the risk of AIMetS in patients with schizophrenia spectrum disorders. In recent years, circulating microRNAs have been considered as new and promising epigenetic biomarkers of AIMetS. AIM. This study aimed to evaluate the potential of circulating microRNAs as epigenetic biomarkers for the prediction and early diagnosis of AIMetS.DISCUSSION. The authors analysed the results of academic and clinical research published from 2012 to 2024 with a focus on the role of circulating microRNAs involved in the key AIMetS pathogenesis and progression pathways. This review presents novel international approaches to using primary and additional clinical and biochemical biomarkers of AIMetS and demonstrates the advantages of microRNAs as epigenetic biomarkers of AIMetS. The article summarises data on the roles of microRNAs in the mechanisms of AIMetS development (oxidative stress, systemic inflammation, adipocyte differentiation, lipid and glucose metabolism, appetite regulation, and changes in neuropeptide Y and orexin expression, leptin sensitivity, and testosterone, thyroid and parathyroid hormone levels).CONCLUSIONS. Detecting changes in the expression of circulating microRNAs in easily accessible samples (blood, saliva, urine, etc.) is a promising alternative method for predicting and diagnosing AIMetS. The second part of this review will explore the role of circulating microRNAs as epigenetic biomarkers for developing the main manifestations of MetS and AIMetS and will classify microRNA signatures according to the risk of developing AIMetS.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>антипсихотики</kwd><kwd>антипсихотик-индуцированный метаболический синдром</kwd><kwd>метаболический синдром</kwd><kwd>ранняя диагностика</kwd><kwd>циркулирующие микроРНК</kwd><kwd>нежелательная реакция</kwd><kwd>эпигенетический биомаркер</kwd><kwd>персонализированная оценка риска</kwd><kwd>психические расстройства</kwd></kwd-group><kwd-group xml:lang="en"><kwd>antipsychotics</kwd><kwd>antipsychotic-induced metabolic syndrome</kwd><kwd>metabolic syndrome</kwd><kwd>early diagnosis</kwd><kwd>circulating microRNAs</kwd><kwd>adverse drug reaction</kwd><kwd>epigenetic biomarker</kwd><kwd>personalised risk assessment</kwd><kwd>mental disorders</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Pillinger T, McCutcheon RA, Vano L, Mizuno Y, Arumuham A, Hindley G, et al. 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