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<article 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" xmlns:ali="http://www.niso.org/schemas/ali/1.0/" article-type="research-article" dtd-version="1.2" xml:lang="en"><front><journal-meta><journal-id journal-id-type="publisher-id">Russian Journal of Allergy</journal-id><journal-title-group><journal-title xml:lang="en">Russian Journal of Allergy</journal-title><trans-title-group xml:lang="ru"><trans-title>Российский Аллергологический Журнал</trans-title></trans-title-group></journal-title-group><issn publication-format="print">1810-8830</issn><issn publication-format="electronic">2686-682X</issn><publisher><publisher-name xml:lang="en">Publishing House ABV Press</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="publisher-id">1395</article-id><article-id pub-id-type="doi">10.36691/RJA1395</article-id><article-categories><subj-group subj-group-type="toc-heading" xml:lang="en"><subject>Help to the practitioner</subject></subj-group><subj-group subj-group-type="toc-heading" xml:lang="ru"><subject>В помощь практикующему врачу</subject></subj-group><subj-group subj-group-type="article-type"><subject>Research Article</subject></subj-group></article-categories><title-group><article-title xml:lang="en">Efficacy and safety of the antileukotriene drugs: relevant data. RAACI experts conclusion</article-title><trans-title-group xml:lang="ru"><trans-title>Безопасность и эффективность антилейкотриеновых препаратов: актуальные данные. Заключение экспертов РААКИ</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-3556-969X</contrib-id><name-alternatives><name xml:lang="en"><surname>Il`ina</surname><given-names>Natalya I.</given-names></name><name xml:lang="ru"><surname>Ильина</surname><given-names>Наталья Ивановна</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>head physician, NRC Institute of Immunology FMBA of Russia, MD, PhD, DSc, professor</p></bio><bio xml:lang="ru"><p>главный врач, ФГБУ «ГНЦ Институт иммунологии» ФМБА России, доктор мед. наук, профессор</p></bio><email>instimmun@yandex.ru</email><xref ref-type="aff" rid="aff1"/></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-3250-0694</contrib-id><name-alternatives><name xml:lang="en"><surname>Kurbacheva</surname><given-names>Oksana M.</given-names></name><name xml:lang="ru"><surname>Курбачёва</surname><given-names>Оксана Михайловна</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>head of the Department of Bronchial Asthma, NRC Institute of Immunology FMBA of Russia, MD, PhD, DSc, professor</p></bio><bio xml:lang="ru"><p>зав. отделением бронхиальной астмы ФГБУ «ГНЦ Институт иммунологии» ФМБА России, д.м.н., профессор</p></bio><email>kurbacheva@gmail.com</email><xref ref-type="aff" rid="aff1"/></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-3162-2510</contrib-id><name-alternatives><name xml:lang="en"><surname>Nenasheva</surname><given-names>Natalya M.</given-names></name><name xml:lang="ru"><surname>Ненашева</surname><given-names>Наталья Михайловна</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>head of the Chair of Clinical Allergology, Russian Medical Academy of Continuous Professional Education of Ministry of Health of the Russian Federation, MD, PhD, DSc, professor</p></bio><bio xml:lang="ru"><p>зав. кафедрой клинической аллергологии ФГБОУ ДПО «Российская медицинская академия непрерывного профессионального образования» Минздрава России, д.м.н., профессор</p></bio><email>1444031@gmail.com</email><xref ref-type="aff" rid="aff2"/></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-7691-4584</contrib-id><name-alternatives><name xml:lang="en"><surname>Astafieva</surname><given-names>Natalya G.</given-names></name><name xml:lang="ru"><surname>Астафьева</surname><given-names>Наталья Григорьевна</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>head of the Chair of Clinical Immunology and Allergology, FSBE Institution of Higher Education «Saratov State Medical University named after V. I. Razumovsky» of Ministry of Health of the Russian Federation, MD, PhD, DSc, professor</p></bio><bio xml:lang="ru"><p>зав. кафедрой клинической иммунологии и аллергологии ФГБОУ ВО «Саратовский государственный медицинский университет им. В.И. Разумовского» Минздрава России, д.м.н., профессор</p></bio><email>astang@mail.ru</email><xref ref-type="aff" rid="aff3"/></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-2485-2243</contrib-id><name-alternatives><name xml:lang="en"><surname>Beltyukov</surname><given-names>Evgenij K.</given-names></name><name xml:lang="ru"><surname>Бельтюков</surname><given-names>Евгений Кронидович</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>professor of the Department of Faculty Therapy, Endocrinology, Allergology and Immunology, FSBE Institution of Higher Education «Ural State Medical University» of Ministry of Health of the Russian Federation, chief freelance specialist allergist-immunologist of Ministry of Health of the Sverdlovsk Region and the Ural Federal District, MD, PhD, DSc, professor</p></bio><bio xml:lang="ru"><p>профессор кафедры факультетской терапии, эндокринологии, аллергологии и иммунологии ФГБОУ ВО «Уральский государственный медицинский университет» Минздрава России, главный внештатный специалист аллерголог-иммунолог МЗ Свердловской области и Уральского ФО, д.м.н., профессор</p></bio><email>asthma@mail.ru</email><xref ref-type="aff" rid="aff4"/></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-8982-5292</contrib-id><name-alternatives><name xml:lang="en"><surname>Demko</surname><given-names>Irina V.</given-names></name><name xml:lang="ru"><surname>Демко</surname><given-names>Ирина Владимировна</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>professor of the Department of Internal Diseases, «Professor V.F. Voino-Yasenetsky Krasnoyarsk State Medical University» of Ministry of Health of the Russian Federation, chief physician-pulmonologist of the Siberian Federal District, chief allergist of the Siberian Federal District, chief pulmonologist and allergist of Ministry of Health of the Krasnoyarsk Region, MD, PhD, DSc, professor</p></bio><bio xml:lang="ru"><p>зав. кафедрой внутренних болезней ГБОУ ВПО «Красноярский государственный медицинский университет им. профессора В.Ф. Войно-Ясенецкого» Минздрава России, главный терапевт-пульмонолог Сибирского ФО, главный аллерголог Сибирского ФО, главный пульмонолог и аллерголог МЗ Красноярского края, д.м.н., профессор</p></bio><email>demko64@mail.ru</email><xref ref-type="aff" rid="aff5"/></contrib><contrib contrib-type="author"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-3960-830X</contrib-id><name-alternatives><name xml:lang="en"><surname>Zhestkov</surname><given-names>Aleksandr V.</given-names></name><name xml:lang="ru"><surname>Жестков</surname><given-names>Александр Викторович</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>head of the Chair of General and Clinical Microbiology, Immunology and Allergology, FSBE Institution of Higher Education «Samara State Medical University» of Ministry of Health of the Russian Federation, chief freelance specialist in allergology and immunology of Ministry of Health of the Samara Region; chief pulmonologist of the Volga Federal District, MD, PhD, DSc, professor</p></bio><bio xml:lang="ru"><p>зав. кафедрой общей и клинической микробиологии, иммунологии и аллергологии ФГБОУ ВО «Самарский государственный медицинский университет» Минздрава России, главный внештатный специалист по аллергологии и иммунологии МЗ Самарской области, главный пульмонолог Приволжского ФО, д.м.н., профессор</p></bio><email>avzhestkov2015@yandex.ru</email><xref ref-type="aff" rid="aff6"/></contrib><contrib contrib-type="author"><name-alternatives><name xml:lang="en"><surname>Osipova</surname><given-names>Galina L.</given-names></name><name xml:lang="ru"><surname>Осипова</surname><given-names>Галина Леонидовна</given-names></name></name-alternatives><address><country country="RU">Russian Federation</country></address><bio xml:lang="en"><p>head of the Clinical Research Department, Pulmonology Research Institute under FMBA of Russia, MD, PhD, DSc</p></bio><bio xml:lang="ru"><p>зав. отделом клинических исследований ФГБУ «НИИ пульмонологии» ФМБА России, д.м.н.</p></bio><email>osipovagl@mail.ru</email><xref ref-type="aff" rid="aff7"/></contrib></contrib-group><aff-alternatives id="aff1"><aff><institution xml:lang="en">NRC Institute of Immunology FMBA of Russia</institution></aff><aff><institution xml:lang="ru">ГНЦ «Институт иммунологии ФМБА России»</institution></aff></aff-alternatives><aff-alternatives id="aff2"><aff><institution xml:lang="en">Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of Russian Federation</institution></aff><aff><institution xml:lang="ru">Российская медицинская академия непрерывного профессионального образования Минздрава России</institution></aff></aff-alternatives><aff-alternatives id="aff3"><aff><institution xml:lang="en">Saratov State Medical University named after V.I. Razumovsky</institution></aff><aff><institution xml:lang="ru">Саратовский государственный медицинский университет им. В.И. Разумовского Минздрава России</institution></aff></aff-alternatives><aff-alternatives id="aff4"><aff><institution xml:lang="en">Ural State Medical University</institution></aff><aff><institution xml:lang="ru">Уральский государственный медицинский университет Минздрава России</institution></aff></aff-alternatives><aff-alternatives id="aff5"><aff><institution xml:lang="en">Professor V.F. Voino-Yasenetsky Krasnoyarsk State Medical University</institution></aff><aff><institution xml:lang="ru">Красноярский государственный медицинский университет им. профессора В.Ф. Войно-Ясенецкого Минздрава России</institution></aff></aff-alternatives><aff-alternatives id="aff6"><aff><institution xml:lang="en">Samara State Medical University</institution></aff><aff><institution xml:lang="ru">Самарский государственный медицинский университет Минздрава России</institution></aff></aff-alternatives><aff-alternatives id="aff7"><aff><institution xml:lang="en">Pulmonology Research Institute FMBA of Russia</institution></aff><aff><institution xml:lang="ru">НИИ пульмонологии ФМБА России</institution></aff></aff-alternatives><pub-date date-type="pub" iso-8601-date="2020-10-29" publication-format="electronic"><day>29</day><month>10</month><year>2020</year></pub-date><volume>17</volume><issue>3</issue><issue-title xml:lang="en"/><issue-title xml:lang="ru"/><fpage>121</fpage><lpage>129</lpage><history><date date-type="received" iso-8601-date="2020-09-09"><day>09</day><month>09</month><year>2020</year></date><date date-type="accepted" iso-8601-date="2020-09-11"><day>11</day><month>09</month><year>2020</year></date></history><permissions><copyright-statement xml:lang="en">Copyright ©; 2020, Pharmarus Print Media</copyright-statement><copyright-statement xml:lang="ru">Copyright ©; 2020, Фармарус Принт Медиа</copyright-statement><copyright-year>2020</copyright-year><copyright-holder xml:lang="en">Pharmarus Print Media</copyright-holder><copyright-holder xml:lang="ru">Фармарус Принт Медиа</copyright-holder><ali:free_to_read xmlns:ali="http://www.niso.org/schemas/ali/1.0/" start_date="2022-10-29"/></permissions><self-uri xlink:href="https://rusalljournal.ru/raj/article/view/1395">https://rusalljournal.ru/raj/article/view/1395</self-uri><abstract xml:lang="en"><p>In many countries of the world and in Russia, in particular, the pharmacological use of antagonists of cysteinyl receptors LT1 (CysLTR) is a long­-proven and well­-proven pharmacotherapy of bronchial asthma (BA) and allergic rhinitis (AR) in adults and children.</p> <p>Among antileukotriene drugs the most commonly used medication for the treatment of these diseases is the original montelukast, which is considered a safe drug associated with the appearance of only a few adverse reactions, usually not differing in type and frequency from those that occur with placebo. Currently, there are a large number of generics of montelukast, therefore, practitioners have many questions regarding the benefits and risks of montelukast therapy for patients with BA and AR.</p> <p>In 2020 FDA (Food and Drug Administration USA) analyzed the risk of adverse events during Montelukast treatment and indicated them on the packaging of the drug (original montelukast and its generics). This contributed to the creation of an expert commission to study this issue and form an expert opinion, which is demonstrated in our publication.</p></abstract><trans-abstract xml:lang="ru"><p>Во многих странах мира и в России, в частности, фармакологическое использование антагонистов цистеиниловых ЛТ<sub>1</sub>-рецепторов (цис-ЛТ<sub>1</sub>-рецепторов) является давно одобренной и хорошо зарекомендовавшей себя фармакотерапией бронхиальной астмы (БА) и аллергического ринита (АР) у взрослых и детей.</p> <p>Среди антилейкотриеновых препаратов чаще всего применяют оригинальный монтелукаст, который считается безопасным лекарственным препаратом, связанным с появлением лишь нескольких побочных реакций, обычно по виду и частоте не отличающихся от реакций, возникающих на плацебо. В настоящее время существует большое количество генериков монтелукаста, поэтому у практикующих врачей возникает много вопросов относительно пользы и риска терапии монтелукастом пациентов с БА и АР.</p> <p>После детального анализа информации по риску развития нежелательных явлений на фоне приема монтелукаста FDA (Управление по надзору за качеством пищевых продуктов и медикаментов США) в 2020 г. внесло коррекцию в виде письменного упоминания о них на каждой упаковке этого лекарственного препарата (оригинальный монтелукаст и его генерики). Это способствовало созданию экспертной комиссии для изучения данного вопроса и формированию экспертного заключения, что демонстрируется в нашей публикации.</p></trans-abstract><kwd-group xml:lang="en"><kwd>leukotriene</kwd><kwd>LТ</kwd><kwd>cysteinyl leukotrienes (CysLTR)</kwd><kwd>antileukotriene drugs</kwd><kwd>montelukast</kwd><kwd>allergic rhinitis</kwd><kwd>АR</kwd><kwd>bronchial asthma</kwd><kwd>BA</kwd><kwd>phenotypes BA</kwd></kwd-group><kwd-group xml:lang="ru"><kwd>лейкотриены</kwd><kwd>цистеиниловые лейкотриены</kwd><kwd>антилейкотриеновые препараты</kwd><kwd>монтелукаст</kwd><kwd>аллергический ринит</kwd><kwd>бронхиальная астма</kwd><kwd>фенотипы бронхиальной астмы</kwd></kwd-group><funding-group/></article-meta></front><body></body><back><ref-list><ref id="B1"><label>1.</label><citation-alternatives><mixed-citation xml:lang="en">Miligkos M, Bannuru RR, Alkofide H, Kher SR, Schmid CH, Balk EM. 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