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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">10.30895/2312-7821-2023-11-3-336-347</article-id><article-id custom-type="elpub" pub-id-type="custom">safetyrisk-371</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>ОТ ИССЛЕДОВАНИЙ IN VITRO К КЛИНИЧЕСКИМ ИССЛЕДОВАНИЯМ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>FROM IN VITRO EXPERIMENTS TO CLINICAL STUDIES</subject></subj-group></article-categories><title-group><article-title>Устойчивость к антимикробным средствам — фактор риска системы биобезопасности</article-title><trans-title-group xml:lang="en"><trans-title>Antimicrobial Resistance: A Risk Factor for the Biosafety System</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-9162-3881</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Орехов</surname><given-names>С. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Orekhov</surname><given-names>S. N.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Орехов Сергей Николаевич - кандидат биологических наук, доцент.</p><p>Трубецкая ул., д. 8, стр. 2, Москва, 119991</p></bio><bio xml:lang="en"><p>Sergey N. Orekhov - Cand. Sci. (Biol.), Associate Professor.</p><p>8/2 Trubetskaya St., Moscow 119991</p></bio><email xlink:type="simple">sorekhov@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/0000-0001-8139-7932</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Мохов</surname><given-names>А. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Mokhov</surname><given-names>A. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Мохов Александр Анатольевич - доктор юридических наук, профессор.</p><p>Садовая-Кудринская ул., д. 9, Москва, 125993</p></bio><bio xml:lang="en"><p>Alexander A. Mokhov - Dr. Sci. (Jurid.), Professor.</p><p>9 Sadovaya-Kudrunskaya St., Moscow 125993</p></bio><email xlink:type="simple">med-farm-law@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/0000-0002-8631-0303</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Яворский</surname><given-names>А. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Yavorsky</surname><given-names>A. N.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Яворский Александр Николаевич - доктор медицинских наук, профессор.</p><p>Садовая-Кудринская ул., д. 9, Москва, 125993</p></bio><bio xml:lang="en"><p>Alexander N. Yavorsky - Dr. Sci. (Med.), Professor.</p><p>9 Sadovaya-Kudrunskaya St., Moscow 125993</p></bio><email xlink:type="simple">200-31-11@mail.ru</email><xref ref-type="aff" rid="aff-2"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>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>I.M. Sechenov First Moscow State Medical University (Sechenov University)</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное образовательное учреждение высшего образования «Московский государственный юридический университет имени О.Е. Кутафина (МГЮА)»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Kutafin Moscow State Law University (MSAL)</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2023</year></pub-date><pub-date pub-type="epub"><day>26</day><month>09</month><year>2023</year></pub-date><volume>11</volume><issue>3</issue><fpage>336</fpage><lpage>347</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Орехов С.Н., Мохов А.А., Яворский А.Н., 2023</copyright-statement><copyright-year>2023</copyright-year><copyright-holder xml:lang="ru">Орехов С.Н., Мохов А.А., Яворский А.Н.</copyright-holder><copyright-holder xml:lang="en">Orekhov S.N., Mokhov A.A., Yavorsky A.N.</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/371">https://www.risksafety.ru/jour/article/view/371</self-uri><abstract><sec><title>Актуальность</title><p>Актуальность. Устойчивость патогенных микроорганизмов к антимикробным средствам в последние годы стала глобальной проблемой, которая угрожает здоровью людей, животных и представляет риск для биобезопасности России.</p></sec><sec><title>Цель</title><p>Цель. Проанализировать распространенность устойчивости к антимикробным средствам, рассмотреть риски и негативные медицинские последствия этого биологического явления и представить направления оптимизации применения существующих и поиска новых антимикробных средств.</p></sec><sec><title>Обсуждение</title><p>Обсуждение. Возникновение устойчивости к антибиотикам у бактерий является естественным биологическим процессом. Селекция устойчивых микроорганизмов происходит постоянно при использовании всего спектра антимикробных средств в здравоохранении, сельском хозяйстве и других сферах. Контроль за этими процессами осуществляет Всемирная организация здравоохранения (ВОЗ) в рамках проекта «Глобальная система по надзору за устойчивостью к противомикробным препаратам (GLASS)». В России принята «Стратегия предупреждения распространения антимикробной резистентности в Российской Федерации на период до 2030 года» и создана нормативная правовая база, на основе которой действует государственная система профилактики развития и распространения микробной устойчивости. Для реализации стратегии предотвращения распространения устойчивости к антибиотикам проводятся организационные мероприятия и создаются инновационные лекарственные средства, действие которых основано на понимании молекулярных механизмов развития инфекции и микробной устойчивости. В обзоре рассмотрены основные подходы к дизайну некоторых поисковых исследований и оценке антимикробной активности полученных инновационных молекул. Быстрое развитие синтетической биологии повышает вероятность появления искусственно созданных патогенных биологических агентов, обладающих высокой вирулентностью и устойчивостью к антимикробным средствам, которые создают риски искусственных эпидемий.</p></sec><sec><title>Выводы</title><p>Выводы. Система предупреждения устойчивости к антимикробным средствам в нашей стране должна относиться к числу стратегически значимых медицинских технологий, которые обеспечивают биобезопасность государства и общества.</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>Scientific relevance</title><p>Scientific relevance. In recent years, antimicrobial resistance in pathogenic microorganisms has become a global problem that threatens the health of humans and animals and poses a risk to the biosafety of Russia.</p></sec><sec><title>Aim</title><p>Aim. The study aimed to analyse the prevalence of antimicrobial resistance, consider the risks and medical consequences of this biological phenomenon, and suggest ways to optimise the use of existing antimicrobial agents and search for new ones.</p></sec><sec><title>Discussion</title><p>Discussion. The emergence of antibiotic resistance in bacteria is a natural biological process; the selection of resistant microorganisms occurs constantly with the use of the entire spectrum of antimicrobial agents in healthcare, agriculture, and other fields. The World Health Organisation (WHO) monitors these processes using the Global Antimicrobial Resistance Surveillance System (GLASS). Russia has adopted the Strategy to prevent the spread of antimicrobial resistance in the Russian Federation to 2030. The country has established a regulatory framework that supports the operation of the national antimicrobial resistance prevention system. The strategy to prevent the spread of antimicrobial resistance is being implemented through making organisational arrangements and developing novel medicines with mechanisms of action based on an understanding of the molecular mechanisms of infection and resistance. This review considers the main approaches to designing exploratory studies and evaluating the antimicrobial activity of the innovative molecules obtained. The rapid development of synthetic biology increases the likelihood of creating synthetic biological pathogens with high virulence and resistance to antimicrobial agents, which might pose risks of artificial epidemics.</p></sec><sec><title>Conclusions</title><p>Conclusions. The antimicrobial resistance prevention system in Russia should be considered a strategically essential medical technology ensuring the biosafety of the country and the people.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>антимикробные средства</kwd><kwd>антимикробная резистентность</kwd><kwd>факторы риска</kwd><kwd>нормативноправовая база</kwd><kwd>организационные мероприятия</kwd><kwd>инновационные антибиотики</kwd><kwd>биобезопасность</kwd></kwd-group><kwd-group xml:lang="en"><kwd>antimicrobial agents</kwd><kwd>antimicrobial resistance</kwd><kwd>risk factors</kwd><kwd>legal and regulatory framework</kwd><kwd>innovative antibiotics</kwd><kwd>organisational arrangements</kwd><kwd>biosafety</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Работа выполнена в рамках программы Стратегического академического лидерства «Приоритет-2030»</funding-statement><funding-statement xml:lang="en">The study reported in this publication was carried out as part of the federal academic leadership programme Priority 2030.</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">Супотницкий МВ. 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