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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">10.30895/2312-7821-2021-9-3-128-135</article-id><article-id custom-type="elpub" pub-id-type="custom">safetyrisk-224</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>Факторы риска и некоторые особенности нежелательных реакций при применении бета-лактамных антибиотиков у пациентов пожилого и старческого возраста</article-title><trans-title-group xml:lang="en"><trans-title>Risk Factors and Characteristics of Adverse Reactions Associated with the Use of Beta-Lactam Antibiotics in Older Patients</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-6389-2099</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></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></bio><email xlink:type="simple">sokova904@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/0000-0002-1441-3418</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Архипов</surname><given-names>В. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Arkhipov</surname><given-names>V. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Архипов Владимир Владимирович, д-р мед. наук, доцент</p><p>Петровский б-р, д. 8, стр. 2, Москва, 127051, Российская Федерация</p></bio><bio xml:lang="en"><p>Vladimir V. Arkhipov, Dr. Sci. (Med.), Associate Professor</p><p>8/2 Petrovsky Blvd, Moscow 127051, Russian Federation</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/0000-0003-0123-3044</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Демидова</surname><given-names>О. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Demidova</surname><given-names>O. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Демидова Ольга Александровна, канд. фарм. наук</p><p>Петровский б-р, д. 8, стр. 2, Москва, 127051, Российская Федерация</p></bio><bio xml:lang="en"><p>Olga A. Demidova, Cand. Sci. (Pharm.)</p><p>8/2 Petrovsky Blvd, Moscow 127051, Russian Federation</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/0000-0002-3733-6822</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><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-3855-5899</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><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-9198-8661</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Журавлева</surname><given-names>М. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Zhuravleva</surname><given-names>M. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Журавлева Марина Владимировна, д-р мед. наук, профессор</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>Marina V. Zhuravleva, Dr. Sci. (Med.), Professor</p><p>8/2 Petrovsky Blvd, Moscow 127051, Russian Federation</p><p>8/2 Trubetskaya St., Moscow 119991, Russian Federation</p></bio><xref ref-type="aff" rid="aff-2"/></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>Scientifc 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 университет им. И. М.Сеченова» Министерства здравоохранения Российской Федерации (Сеченовский Университет)</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Scientifc 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><pub-date pub-type="collection"><year>2021</year></pub-date><pub-date pub-type="epub"><day>24</day><month>08</month><year>2021</year></pub-date><volume>9</volume><issue>3</issue><fpage>128</fpage><lpage>135</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Сокова Е.А., Архипов В.В., Демидова О.А., Мазеркина И.А., Александрова Т.В., Журавлева М.В., 2021</copyright-statement><copyright-year>2021</copyright-year><copyright-holder xml:lang="ru">Сокова Е.А., Архипов В.В., Демидова О.А., Мазеркина И.А., Александрова Т.В., Журавлева М.В.</copyright-holder><copyright-holder xml:lang="en">Sokova E.A., Arkhipov V.V., Demidova O.A., Mazerkina I.A., Alexandrova T.V., Zhuravleva M.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/224">https://www.risksafety.ru/jour/article/view/224</self-uri><abstract><p>Частота развития нежелательных реакций (НР) у пациентов пожилого и старческого возраста, по данным литературы, составляет около 11%. Антибиотики занимают третье место (19,5%) среди лекарственных препаратов по частоте развития НР у гериатрических пациентов. Бета-лактамные антибиотики являются препаратами выбора при проведении эмпирической терапии в амбулаторных и стационарных условиях у пациентов пожилого и старческого возраста при внебольничной пневмонии, смертность от которой у этой категории пациентов составляет 85% смертности от этого заболевания в целом. Цель работы: анализ научной информации о факторах риска и некоторых особенностях НР при применении бета-лактамных антибиотиков у пациентов пожилого и старческого возраста. Особенности НР, возникающие при применении бета-лактамных антибиотиков у этой категории пациентов, обусловлены наличием возрастных изменений фармакокинетики и фармакодинамики, а также полиморбидности и полипрагмазии. Анализ научной литературы показал, что количество фармакоэпидемиологических исследований НР в этой популяции ограничено, а их данные разнородны. Частота возникновения, причины и клинические проявления НР у гериатрических пациентов разнообразны и заметно отличаются от таковых у более молодых людей. Среди наиболее часто применяемых бета-лактамных антибиотиков цефтриаксон и цефаклор показали достоверно меньший риск развития НР у пожилых, чем у молодых людей. В то же время для цефтриаксона была продемонстрирована относительно более высокая частота возникновения серьезных НР у пожилых людей, чем у более молодых пациентов, тогда как уровень серьезных НР при применении цефаклора был более низкий. На сегодня вероятность развития нефротоксических, нейротоксических и гепатотоксических эффектов, связанных с применением бета-лактамных антимикробных препаратов, становится все более очевидной, но остается недооцененной в клинической гериатрической практике. Мониторинг безопасности, проведение терапевтического лекарственного мониторинга с учетом факторов риска развития НР у пациентов пожилого и старческого возраста, а также включение пациентов старших возрастных групп в клинические исследования антибактериальных препаратов будут способствовать повышению эффективности и безопасности антибиотикотерапии.</p></abstract><trans-abstract xml:lang="en"><p>The frequency of adverse drug reactions (ADRs) in older patients is approximately 11.0%, according to scientific literature. Antibiotics are the third largest group (19.5%) of medicinal products in terms of ADR frequency in geriatric patients. Beta-lactam antibiotics are the empiric treatment of choice for older outpatients and inpatients with community-acquired pneumonia. The mortality in this group of patients accounts for 85% of the overall mortality from community-acquired pneumonia. The aim of the study was to analyse scientific data on risk factors and characteristics of adverse drug reactions associated with the use of beta-lactam antibiotics in older patients. Specificity of ADRs to beta-lactam antibiotics in this group of patients is due to age-related changes in pharmacokinetics and pharmacodynamics as well as polymorbidity and polypharmacy. The analysis of scientific literature demonstrated that there have not been so many pharmacoepidemiological studies in this group of patients, and their results have been inconsistent. The frequency, causes, and clinical manifestations of ADRs in geriatric patients are diverse and differ considerably from those in younger patients. Of the most widely used antibiotics, ceftriaxone and cefaclor exhibited a statistically lower risk of ADRs in older patients than in younger patients. At the same time, ceftriaxone was associated with a relatively higher frequency of serious ADRs in older patients as compared to younger patients, whereas the frequency of serious ADRs was lower with cefaclor. The likelihood of nephrotoxic, neurotoxic, and hepatotoxic ADRs associated with the use of beta-lactam antibiotics is becoming more and more obvious but it is still underestimated in clinical and geriatric practice. Safety monitoring, therapeutic drug monitoring with due consideration of ADR risk factors in older patients, and inclusion of older patients in clinical trials of antimicrobial drugs, would improve efficacy and safety of antibiotic treatment.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>бета-лактамные антибиотики</kwd><kwd>лекарственная безопасность</kwd><kwd>пожилой возраст</kwd><kwd>старческий возраст</kwd><kwd>нежелательная реакция</kwd><kwd>факторы риска</kwd><kwd>лекарственное средство</kwd><kwd>фармакодинамика</kwd><kwd>фармакокинетика</kwd><kwd>полиморбидность</kwd><kwd>полипрагмазия</kwd></kwd-group><kwd-group xml:lang="en"><kwd>beta-lactam antibiotics</kwd><kwd>drug safety</kwd><kwd>elderly age</kwd><kwd>old age</kwd><kwd>adverse drug reactions</kwd><kwd>risk factors</kwd><kwd>medicinal product</kwd><kwd>pharmacodynamics</kwd><kwd>pharmacokinetics</kwd><kwd>polymorbidity</kwd><kwd>polypharmacy</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 121022000154-2).</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. 121021800098-4)</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">Silva C, Ramalho C, Luz I, Monteiro J, Fresco P. 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