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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">10.30895/2312-7821-2022-10-3-283-292</article-id><article-id custom-type="elpub" pub-id-type="custom">safetyrisk-281</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>БЕЗОПАСНОСТЬ ФАРМАКОТЕРАПИИ ПРИ COVID-19</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>SAFETY OF COVID-19 PHARMACOTHERAPY</subject></subj-group></article-categories><title-group><article-title>Подходы к оценке безопасности лекарственных средств во время пандемии COVID-19 на примере азитромицина</article-title><trans-title-group xml:lang="en"><trans-title>Approaches to Assessing the Safety of Medicines during the COVID-19 Pandemic Using the Example of Azithromycin</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-7704-9900</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Гомон</surname><given-names>Ю. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Gomon</surname><given-names>Yu. M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Гомон Юлия Михайловна, доктор медицинских наук</p><p>ул. Льва Толстого, д. 6–8, Санкт-Петербург, 197022, Российская Федерация,</p><p>Северный пр-т, д. 1, Санкт-Петербург, 194354, Российская Федерация</p></bio><bio xml:lang="en"><p>Yulia M. Gomon, Dr. Sci. (Med.).</p><p>6–8 Lev Tolstoy St., St. Petersburg 197022, Russian Federation</p><p>1 Severny Ave, St. Petersburg 194354, Russian Federation</p></bio><email xlink:type="simple">gomonmd@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/0000-0001-6284-7133</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Касимова</surname><given-names>А. Р.</given-names></name><name name-style="western" xml:lang="en"><surname>Kasimova</surname><given-names>A. R.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Касимова Алина Рашидовна, кандидат медицинских наук</p><p>ул. Льва Толстого, д. 6–8, Санкт-Петербург, 197022, Российская Федерация,</p><p>ул. Академика Байкова, д. 8, Санкт-Петербург, 195427, Российская Федерация</p></bio><bio xml:lang="en"><p>Alina R. Kasimova, Cand. Sci. (Med.)</p><p>6–8 Lev Tolstoy St., St. Petersburg 197022, Russian Federation,</p><p>8 Academician Baykov St., St. Petersburg 195427, Russian Federation</p></bio><email xlink:type="simple">kasi-alina@yandex.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/0000-0002-1919-2909</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Колбин</surname><given-names>А. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Kolbin</surname><given-names>A. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Колбин Алексей Сергеевич, доктор медицинских наук, профессор</p><p>ул. Льва Толстого, д. 6–8, Санкт-Петербург, 197022, Российская Федерация,</p><p>Университетская наб., д. 7–9, Санкт-Петербург, 199034, Российская Федерация</p></bio><bio xml:lang="en"><p>Alexey S. Kolbin, Dr. Sci. (Med.), Professor</p><p>6–8 Lev Tolstoy St., St. Petersburg 197022, Russian Federation,</p><p>7–9, Universitetskaya Emb., St. Petersburg 199034, Russian Federation</p></bio><email xlink:type="simple">alex.kolbin1971@gmail.com</email><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-1838-9961</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Стрижелецкий</surname><given-names>В. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Strizheletsky</surname><given-names>V. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Стрижелецкий Валерий Викторович, доктор медицинских наук, профессор</p><p>Северный пр-т, д. 1, Санкт-Петербург, 194354, Российская Федерация,</p><p>Университетская наб., д. 7–9, Санкт-Петербург, 199034, Российская Федерация</p></bio><bio xml:lang="en"><p>Valery V. Strizheletsky, Dr. Sci. (Med.), Professor</p><p>1 Severny Ave, St. Petersburg 194354, Russian Federation,</p><p>7–9, Universitetskaya Emb., St. Petersburg 199034, Russian Federation</p></bio><email xlink:type="simple">b4@zdrav.spb.ru</email><xref ref-type="aff" rid="aff-4"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-3040-4009</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Иванов</surname><given-names>И. Г.</given-names></name><name name-style="western" xml:lang="en"><surname>Ivanov</surname><given-names>I. G.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Иванов Игорь Григорьевич</p><p>Северный пр-т, д. 1, Санкт-Петербург, 194354, Российская Федерация,</p><p>Университетская наб., д. 7–9, Санкт-Петербург, 199034, Российская Федерация</p></bio><bio xml:lang="en"><p>Igor G. Ivanov</p><p>1 Severny Ave, St. Petersburg 194354, Russian Federation,</p><p>7–9, Universitetskaya Emb., St. Petersburg 199034, Russian Federation</p></bio><email xlink:type="simple">b4@zdrav.spb.ru</email><xref ref-type="aff" rid="aff-4"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-1915-2237</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Мазуренко</surname><given-names>С. O.</given-names></name><name name-style="western" xml:lang="en"><surname>Mazurenko</surname><given-names>S. O.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Мазуренко Сергей Oлегович, доктор медицинских наук, профессор</p><p>Северный пр-т, д. 1, Санкт-Петербург, 194354, Российская Федерация</p><p>Университетская наб., д. 7–9, Санкт-Петербург, 199034, Российская Федерация</p></bio><bio xml:lang="en"><p>Sergey O. Mazurenko, Dr. Sci. (Med.), Professor</p><p>1 Severny Ave, St. Petersburg 194354, Russian Federation</p><p>7–9, Universitetskaya Emb., St. Petersburg 199034, Russian Federation</p></bio><email xlink:type="simple">b4@zdrav.spb.ru</email><xref ref-type="aff" rid="aff-4"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное учреждение высшего образования «Первый Санкт-Петербургский государственный медицинский университет имени академика И.П. Павлова» Министерства здравоохранения Российской Федерации;&#13;
Государственное бюджетное учреждение здравоохранения «Больница Святого Великомученика Георгия»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Academician I.P. Pavlov First St. Petersburg State Medical University;&#13;
St. George City Hospital</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное учреждение высшего образования «Первый Санкт-Петербургский государственный медицинский университет имени академика И.П. Павлова» Министерства здравоохранения Российской Федерации;&#13;
Федеральное государственное бюджетное учреждение  «Национальный медицинский исследовательский центр травматологии и ортопедии им. Р.Р. Вредена» Министерства здравоохранения Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Academician I.P. Pavlov First St. Petersburg State Medical University;&#13;
R.R. Vreden National Medical Research Centre of Traumatology and Orthopaedics</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное учреждение высшего образования «Первый Санкт-Петербургский государственный медицинский университет имени академика И.П. Павлова» Министерства здравоохранения Российской Федерации;&#13;
Федеральное государственное бюджетное образовательное учреждение высшего образования «Санкт-Петербургский государственный университет»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Academician I.P. Pavlov First St. Petersburg State Medical University;&#13;
St. Petersburg State University</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-4"><aff xml:lang="ru"><institution>Государственное бюджетное учреждение здравоохранения «Больница Святого Великомученика Георгия»;&#13;
Федеральное государственное бюджетное образовательное учреждение высшего образования «Санкт-Петербургский государственный университет»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>St. George City Hospital;&#13;
St. Petersburg State University</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2022</year></pub-date><pub-date pub-type="epub"><day>05</day><month>10</month><year>2022</year></pub-date><volume>10</volume><issue>3</issue><fpage>283</fpage><lpage>292</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Гомон Ю.М., Касимова А.Р., Колбин А.С., Стрижелецкий В.В., Иванов И.Г., Мазуренко С.O., 2022</copyright-statement><copyright-year>2022</copyright-year><copyright-holder xml:lang="ru">Гомон Ю.М., Касимова А.Р., Колбин А.С., Стрижелецкий В.В., Иванов И.Г., Мазуренко С.O.</copyright-holder><copyright-holder xml:lang="en">Gomon Y.M., Kasimova A.R., Kolbin A.S., Strizheletsky V.V., Ivanov I.G., Mazurenko S.O.</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/281">https://www.risksafety.ru/jour/article/view/281</self-uri><abstract><p>Большинство лекарственных средств для терапии новой коронавирусной инфекции COVID-19 используется вне зарегистрированных показаний к применению либо на основании процедуры ускоренной регистрации, что требует особого внимания к оценке безопасности этих препаратов.Цель работы: обзор методологических подходов к сбору данных о безопасности лекарственных средств на примере применения азитромицина в режимах терапии COVID-19.Материалы и методы: в базах данных PubMed® (MEDLINE), Scopus, eLIBRARY, Киберленинка проведен поиск публикаций о применении азитромицина в комплексной терапии при COVID-19 в 2020–2021 гг. Поисковый запрос составляли из названия лекарственного средства или группового названия лекарственных средств и терминов, описывающих нежелательные реакции (НР) при лечении.Результаты: в анализ включены 7 публикаций результатов исследований, охватывающих опыт применения азитромицина в комплексной терапии COVID-19 более чем у 4000 пациентов. Выявлено, что у пациентов при терапии COVID-19 с использованием азитромицина наиболее часто (до 30% случаев назначения азитромицина) развивались нарушения со стороны сердечно-сосудистой системы. Информацию о НР в 3 включенных в анализ исследованиях получали методом спонтанных сообщений и путем активной регистрации на основании анализа данных лабораторных и инструментальных исследований при проведении клинических исследований, в 3 исследованиях — только методом спонтанных сообщений, в одном исследовании — путем анализа информации в базе данных НР.Выводы: в настоящее время метод спонтанных сообщений является основным для сбора информации о НР при применении лекарственных средств. Перспективным направлением совершенствования существующих подходов к сбору данных о безопасности лекарственных средств является получение сведений об индивидуальном опыте применения непосредственно от пациентов, в том числе анализ публикаций в социальных сетях.</p></abstract><trans-abstract xml:lang="en"><p>Most of the medicines used to treat the novel coronavirus infection (COVID-19) are either approved under an accelerated procedure or not approved for the indication. Consequently, their safety requires special attention.The aim of the study was to review methodological approaches to collecting data on the safety of medicines, using COVID-19 treatment regimens involving azithromycin as a case study.Materials and methods: PubMed® (MEDLINE), Scopus, eLIBRARY, and Cyberleninka databases were searched for publications on azithromycin as part of combination therapy for COVID-19 in 2020–2021. Search queries included names of the medicinal product or its pharmacotherapeutic group and words describing adverse drug reactions (ADRs) during treatment.Results: the analysis included 7 publications presenting the results of studies covering the use of azithromycin as part of COVID-19 combination therapy in more than 4000 patients. Most commonly, the patients receiving COVID-19 therapy including azithromycin developed cardiovascular ADRs (up to 30% of azithromycin prescription cases). In 3 of the analysed publications, safety information was collected through spontaneous reporting and active identification based on the findings of laboratory and instrumental investigations performed during the clinical studies; in other 3, only spontaneous reports were used; and in the last one, ADR database information was studied.Conclusion: currently, information on ADRs associated with the use of medicines is mainly gathered via spontaneous reporting. Direct sourcing of information on personal experiences with a certain product from patients, among other means through social media analysis, opens a promising direction towards the improvement of existing approaches to collecting safety data.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>фармаконадзор</kwd><kwd>нежелательные реакции</kwd><kwd>спонтанные сообщения</kwd><kwd>азитромицин</kwd><kwd>новая коронавирусная инфекция</kwd><kwd>COVID-19</kwd><kwd>база данных</kwd><kwd>социальные сети</kwd><kwd>сообщество пациентов</kwd></kwd-group><kwd-group xml:lang="en"><kwd>pharmacovigilance</kwd><kwd>adverse drug reactions</kwd><kwd>spontaneous reports</kwd><kwd>azithromycin</kwd><kwd>novel coronavirus infection</kwd><kwd>COVID-19</kwd><kwd>database</kwd><kwd>social networks</kwd><kwd>patient community</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Работа выполнена без спонсорской поддержки.</funding-statement><funding-statement xml:lang="en">The study was performed without external funding.</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">Мурашко МА, Пархоменко ДВ, Асецкая ИЛ, Косенко ВВ, Поливанов ВА, Глаголев СВ. 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