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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">10.30895/2312-7821-2019-7-2-72-83</article-id><article-id custom-type="elpub" pub-id-type="custom">safetyrisk-145</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>ОРИГИНАЛЬНЫЕ СТАТЬИ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>ORIGINAL ARTICLES</subject></subj-group></article-categories><title-group><article-title>Фторхинолоновые антибиотики: безопасность применения на примере ципрофлоксацина</article-title><trans-title-group xml:lang="en"><trans-title>Fluoroquinolone antibiotics: safety of use by the example of ciprofloxacin</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-2430-0107</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Молчан</surname><given-names>Н. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Molchan</surname><given-names>N. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Молчан Нина Валерьевна, кандидат фармацевтических наук </p></bio><bio xml:lang="en"><p>Nina V. Molchan, Candidate of Pharmaceutical Sciences</p><p> </p></bio><email xlink:type="simple">molchan@expmed.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/0000-0002-8606-1810</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Смирнова</surname><given-names>Ю. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Smirnova</surname><given-names>Yu. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Смирнова Юлия Анатольевна, кандидат фармацевтических наук научный редактор</p><p> </p></bio><bio xml:lang="en"><p>Yulia A. Smirnova,  Candidate of Pharmaceutical Sciences</p></bio><email xlink:type="simple">smirnovaja@expmed.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/0000-0002-9514-6322</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Вельц</surname><given-names>Н. Ю.</given-names></name><name name-style="western" xml:lang="en"><surname>Velts</surname><given-names>N. Yu.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Вельц Наталья Юрьевна,  кандидат биологических наук, доцент</p><p> </p></bio><bio xml:lang="en"><p>Natalia Y. Velts,  Candidate of Biological Sciences, Associate Professor</p><p> </p></bio><email xlink:type="simple">Velts@expmed.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/0000-0001-9662-3701</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Дармостукова</surname><given-names>М. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Darmostukova</surname><given-names>M. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Дармостукова Мария Андреевна  </p></bio><bio xml:lang="en"><p>Maria A. Darmostukova</p><p> </p></bio><email xlink:type="simple">Darmostukova@expmed.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/0000-0003-2665-796X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Казаков</surname><given-names>А. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Kazakov</surname><given-names>A. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Казаков Александр Сергеевич, кандидат медицинских наук </p></bio><bio xml:lang="en"><p>Alexander S. Kazakov, Candidate of Medical Sciences</p><p> </p></bio><email xlink:type="simple">KazakovAS@expmed.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>Поливанов</surname><given-names>В. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Polivanov</surname><given-names>V. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Поливанов Виталий Анатольевич</p><p>Scopus Author ID: https://www.scopus.com/authid/detail.uri?authorId=57193928059</p></bio><bio xml:lang="en"><p>Vitaly A. Polivanov</p><p> </p><p>Scopus Author ID: https://www.scopus.com/authid/detail.uri?authorId=57193928059</p></bio><email xlink:type="simple">polivanov123@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 бюджетное учреждение «Научный центр экспертизы средств медицинского применения»&#13;
Министерства здравоохранения Российской Федерации</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Scientific 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 «Информационно-методический центр по экспертизе, учету и анализу обращения средств медицинского применения» Росздравнадзора</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Information and Methodological Centre for Expert Evaluation, Recording and Analysis of Circulation of Medicinal Products</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2019</year></pub-date><pub-date pub-type="epub"><day>17</day><month>05</month><year>2019</year></pub-date><volume>7</volume><issue>2</issue><fpage>72</fpage><lpage>83</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Молчан Н.В., Смирнова Ю.А., Вельц Н.Ю., Дармостукова М.А., Казаков А.С., Поливанов В.А., 2019</copyright-statement><copyright-year>2019</copyright-year><copyright-holder xml:lang="ru">Молчан Н.В., Смирнова Ю.А., Вельц Н.Ю., Дармостукова М.А., Казаков А.С., Поливанов В.А.</copyright-holder><copyright-holder xml:lang="en">Molchan N.V., Smirnova Y.A., Velts N.Y., Darmostukova M.A., Kazakov A.S., Polivanov V.A.</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/145">https://www.risksafety.ru/jour/article/view/145</self-uri><abstract><p>В связи с повторяющимися сообщениями о побочных эффектах при  применении антибиотиков фторхинолоновой группы эти  препараты вновь  и вновь  становятся объектом пристального внимания специалистов фармаконадзора и  врачей. Цель  работы:  изучение частоты и характера нежелательных реакций, связанных с применением препарата ципрофлоксацин, на основе  анализа спонтанных сообщений, поступивших в российскую службу фармаконадзора. Материалы и методы: проведен ретроспективный анализ спонтанных сообщений о препарате ципрофлоксацин за период с 2008  по 2018  г. по базе данных «Фармаконадзор»  автоматизированной  информационной  системы Росздравнадзора.  Результаты: всего  было  зарегистрировано 3403  нежелательные реакции, возникшие у 2083  пациентов при  применении ципрофлоксацина. Чаще всего  развивались реакции со стороны кожи и подкожных тканей (37,3 %), общие расстройства и нарушения в месте введения (21,1 %), реакции со стороны желудочно-кишечного тракта (14,9 %). Более трети сообщений содержали информацию о серьезных нежелательных реакциях. Были выявлены непредвиденные реакции, не зафиксированные в инструкции по медицинскому применению ципрофлоксацина: брадикардия, предсердная аритмия, цианоз, повышение артериального давления. Выводы: антибиотики фторхинолонового ряда с доказанной эффективностью и многолетним опытом клинического применения продолжают оставаться препаратами, безопасность которых требует постоянного контроля. Результаты исследования подтвердили возможность выявления широкого спектра нежелательных реакций методом спонтанных сообщений. Регуляторным органам Российской Федерации целесообразно рекомендовать держателям  регистрационных  удостоверений внести в инструкцию по медицинскому применению ципрофлоксацина информацию о нежелательных реакциях, которые были  зарегистрированы в постмаркетинговый период.</p></abstract><trans-abstract xml:lang="en"><p>Due  to repeated reports of adverse effects with the  use  of fluoroquinolone antibiotics,  these drugs become  over  and  over  again the  object of the  close  attention of pharmacovigilance  specialists and  health care  specialists. The aim: to study the  frequency and  the  nature of adverse reactions associated with the  use  of ciprofloxacin, based  on the  analysis of the  spontaneous reports received by  the  Russian pharmacovigilance service. Materials and  Methods: A retrospective analysis of the  spontaneous reports of ciprofloxacin was conducted on the  data-base «Pharmacovigilance» of the  automated information system of Roszdravnadzor from 2008 to 2018. Results: 3403  adverse reactions that occurred in 2083  patients using ciprofloxacin were recorded. The  most frequently developed reactions were  from skin and  subcutaneous tissues (37.3 %), general disorders and  disorders at the  injection site (21.1 %), gastrointestinal tract reactions (14.9 %). More than a one third of the  reports contained information about serious adverse reactions. Unexpected reactions were identified as not  recorded in the  instructions for the medical use of ciprofloxacin: bradycardia, atrial arrhythmia, cyanosis, increased blood pressure. Conclusions: fluoroquinolone antibiotics with proven efficacy and years of experience in clinical use, continue to be drugs whose  safety requires constant monitoring. The  results of the  study confirmed the  possibility of detecting a wide  range of the  adverse reactions using the  method of spontaneous reports. Regulatory authorities of the  Russian Federation should recommend to registration certificate holders to include the  information of adverse reactions of ciprofloxacin that were registered in the  post-marketing period in the  instructions for medical use.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>ципрофлоксацин</kwd><kwd>фторхинолоновые антибиотики</kwd><kwd>нежелательные реакции</kwd><kwd>фармаконадзор</kwd><kwd>безопасность лекарств</kwd></kwd-group><kwd-group xml:lang="en"><kwd>ciprofloxacin</kwd><kwd>fluoroquinolone</kwd><kwd>adverse drug reactions</kwd><kwd>pharmacovigilance</kwd><kwd>drug safety</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Работа выполнена в рамках государственного задания ФГБУ  «НЦЭСМП» Минздрава России № 056-00154-19-00 на проведение прикладных научных исследований (номер государственного учета НИР AAAA-A18-118021590048-3)</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.  056-00154-19-00 and  was  supported by  the   Scientific  Centre for   Expert Evaluation of  Medicinal Products  (R&amp;D  public accounting No. AAAA-A18-118021590048-3)</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">Олефир ЮВ, Верлан НВ, Романов БК, Двойникова НА, Кочкина ЕО. 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