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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">medsovet</journal-id><journal-title-group><journal-title xml:lang="ru">Медицинский Совет</journal-title><trans-title-group xml:lang="en"><trans-title>Meditsinskiy sovet = Medical Council</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2079-701X</issn><issn pub-type="epub">2658-5790</issn><publisher><publisher-name>REMEDIUM GROUP Ltd.</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.21518/ms2023-321</article-id><article-id custom-type="elpub" pub-id-type="custom">medsovet-7886</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>ХРОНИЧЕСКИЕ ЗАБОЛЕВАНИЯ ЛЕГКИХ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>CHRONIC PULMONARY DISEASES</subject></subj-group></article-categories><title-group><article-title>Опыт применения омализумаба у пациентов с тяжелой бронхиальной астмой</article-title><trans-title-group xml:lang="en"><trans-title>Experience of using omalizumab in patients with severe bronchial asthma</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-6257-354X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Болотова</surname><given-names>Е. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Bolotova</surname><given-names>E. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Болотова Елена Валентиновна, доктор медицинских наук, профессор кафедры терапии №1 факультета повышения квалификации и последипломной подготовки специалистов</p><p>350063, Краснодар, ул. Митрофана Седина, д. 4</p></bio><bio xml:lang="en"><p>Elena V. Bolotova, Dr. Sci. (Med.), Professor of Department of Therapy No 1, Faculty of Advanced Training and Postgraduate Retraining of Specialists</p><p>4, Mitrofan Sedin St., Krasnodar, 350063</p></bio><email xlink:type="simple">bolotowa_e@mail.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/0000-0003-2601-7831</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Дудникова</surname><given-names>А. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Dudnikova</surname><given-names>A. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Дудникова Анна Валерьевна, кандидат медицинских наук, врач-терапевт высшей квалификационной категории консультативно-диагностического отделения клиники </p><p>350063, Краснодар, ул. Митрофана Седина, д. 4</p></bio><bio xml:lang="en"><p>Anna V. Dudnikova, Cand. Sci. (Med.), General Practitioner of the Highest Qualification Grade, Consultative and Diagnostic Department of the Clinic</p><p>4, Mitrofan Sedin St., Krasnodar, 350063</p></bio><email xlink:type="simple">avdudnikova@yandex.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Шульженко</surname><given-names>Л. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Shulzhenko</surname><given-names>L. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Шульженко Лариса Владимировна, доктор медицинских наук, заведующая кафедрой пульмонологии факультета повышения квалификации и последипломной подготовки специалистов, Кубанский государственный медицинский университет; заведующая пульмонологическим отделением, Научно-исследовательский институт – Краевая клиническая больница №1 имени С.В. Очаповского</p><p>350063, Краснодар, ул. Митрофана Седина, д. 4,</p><p>360086, Краснодар, ул. 1 Мая, д. 167</p></bio><bio xml:lang="en"><p>Larisa V. Shulzhenko, Dr. Sci. (Med.), Head of Department of Pulmonology, Faculty of Advanced Training and Postgraduate Retraining of Specialists, Kuban State Medical University; Head of Department of Pulmonology, Research Institute – Ochapovsky Regional Clinical Hospital No. 1</p><p>4, Mitrofan Sedin St., Krasnodar, 350063,</p><p>167, May 1st St., Krasnodar, 360086</p></bio><xref ref-type="aff" rid="aff-2"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Кубанский государственный медицинский университет</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Kuban State Medical University</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Кубанский государственный медицинский университет;&#13;
Научно-исследовательский институт – Краевая клиническая больница №1 имени С.В. Очаповского</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Kuban State Medical University;</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2023</year></pub-date><pub-date pub-type="epub"><day>16</day><month>11</month><year>2023</year></pub-date><volume>0</volume><issue>20</issue><fpage>45</fpage><lpage>51</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Болотова Е.В., Дудникова А.В., Шульженко Л.В., 2023</copyright-statement><copyright-year>2023</copyright-year><copyright-holder xml:lang="ru">Болотова Е.В., Дудникова А.В., Шульженко Л.В.</copyright-holder><copyright-holder xml:lang="en">Bolotova E.V., Dudnikova A.V., Shulzhenko L.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.med-sovet.pro/jour/article/view/7886">https://www.med-sovet.pro/jour/article/view/7886</self-uri><abstract><sec><title>Введение</title><p>Введение. Понимание сложной патофизиологии тяжелой бронхиальной астмы (ТБА) привело к разработке персонализированной стратегии лечения с использованием генно-инженерных препаратов, основанной не только на тяжести заболевания, но и на специфических характеристиках пациента и эндотипах бронхиальной астмы.</p></sec><sec><title>Цель</title><p>Цель. Оценить эффективность применения препарата омализумаб у пациентов с ТБА.</p></sec><sec><title>Материалы и методы</title><p>Материалы и методы. Проспективное наблюдательное исследование (срок 12 мес.) с участием 39 пациентов с ТБА (20 женщин и 19 мужчин, средний возраст 47,7 ± 14,2 года), проходивших лечение в Краевой клинической больнице №1 им. профессора С.В. Очаповского. Всем пациентам, включенным в исследование, был назначен препарат омализумаб.</p></sec><sec><title>Результаты</title><p>Результаты. Уже через 6 мес. наблюдения отмечалось улучшение контроля астмы в виде увеличения среднего количества баллов по опроснику АСТ: 15,9 (1,19) vs 10,7 (3,19); уменьшения удельного веса пациентов с результатом по шкале ACT ≤ 19 баллов на 15,6% (с 32 до 27 пациентов); уменьшения удельного веса пациентов с результатом по АСТ ≤ 15 баллов на 16%. В течение 12 мес. от начала лечения омализумабом было отмечено снижение обострений астмы независимо от исходного уровня IgE и эозинофилов, уменьшение количества дней нетрудоспособности на 68,9%, количества обращений за неотложной помощью на 50%, обращений за амбулаторной помощью к пульмонологу на 65,2%, количества госпитализаций на 63,6%, количества дней, проведенных в стационаре, на 49,2, зафиксировано достоверное снижение суточных доз ИГКС, пероральных ГКС, общего количества обострений, среднего балла по тесту АСТ у всех пациентов (р = 0,01).</p></sec><sec><title>Выводы</title><p>Выводы. Использование препарата омализумаб у пациентов с ТБА в сочетании с различным спектром сенсибилизации позволило вывести лечение таких пациентов на качественно новый уровень, обеспечивающий выраженный клинический эффект за счет минимизации симптомов, прекращения обострений, повышения качества жизни. Важным является хороший профиль безопасности и переносимости, а также удобный режим применения.</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>Introduction</title><p>Introduction. New insights into the complex pathophysiology of severe asthma (SA) have led to the development of personalized treatment strategies using genetically engineered drugs, which is based not only on disease severity, but also on specific patient characteristics and asthma endotypes.</p></sec><sec><title>Aim</title><p>Aim. Evaluation of the effectiveness of omalizumab in patients with severe bronchial asthma (SBA).</p></sec><sec><title>Materials and methods</title><p>Materials and methods. A prospective observational study (12 months) with the participation of 39 patients with TB (20 women and 19 men, average age 47.7 ± 14.2 years) who were treated at the Ochapovsky Regional Clinic Hospital of Krasnodar Region. All patients included in the study were prescribed the drug omalizumab.</p></sec><sec><title>Results</title><p>Results. After 6 months of follow-up, there was an improvement in asthma control in the form of an increase in the average number of points according to the ACT questionnaire: 15.9 (1.19) vs 10.7 (3.19); a decrease in the proportion of patients with an ACT score of ≤ 19 points by 15.6% (from 32 patients to 27), a decrease in the proportion of patients with the result of the ACT is less than 15 points by 16%. Within 12 months from the start of treatment with omalizumab, there was a decrease in asthma exacerbations regardless of the initial level of IgE and eosinophils, a decrease in the number of days of disability by 68.9%, the number of emergency calls by 50%, outpatient visits to a pulmonologist by 65.2%, the number of hospitalizations by 63.6%, the number of days spent in hospital – by 49.2, there was a significant decrease in daily doses of IGCS, oral GCS, the total number of exacerbations, the average score on the ACT test in all patients (p = 0.01).</p></sec><sec><title>Conclusions</title><p>Conclusions. Use of the drug omalizumab in patients with SBA, in combination with a different spectrum of sensitization, it was possible to bring the treatment of such patients to a qualitatively new level, providing a pronounced clinical effect by minimizing symptoms, stopping exacerbations, and improving the quality of life. It is important to have a good safety and portability profile, as well as a convenient application mode.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>тяжелая бронхиальная астма</kwd><kwd>моноклональные антитела</kwd><kwd>омализумаб</kwd><kwd>контроль астмы</kwd><kwd>аллергический ринит</kwd></kwd-group><kwd-group xml:lang="en"><kwd>severe bronchial asthma</kwd><kwd>monoclonal antibodies</kwd><kwd>omalizumab</kwd><kwd>asthma control</kwd><kwd>allergic rhinitis</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">Wang E, Wechsler ME, Tran TN, Heaney LG, Jones RC, Menzies-Gow AN et al. Characterization of Severe Asthma Worldwide: Data From the International Severe Asthma Registry. 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