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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">clinvest</journal-id><journal-title-group><journal-title xml:lang="ru">Качественная клиническая практика</journal-title><trans-title-group xml:lang="en"><trans-title>Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2588-0519</issn><issn pub-type="epub">2618-8473</issn><publisher><publisher-name>ООО «Издательство ОКИ</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.24411/2588-0519-2018-10049</article-id><article-id custom-type="elpub" pub-id-type="custom">clinvest-415</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>ФАРМАКОЭКОНОМИКА</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>PHARMACOECONOMICS</subject></subj-group></article-categories><title-group><article-title>Социально-экономическое бремя хронической мигрени в России</article-title><trans-title-group xml:lang="en"><trans-title>Socio-economic burden of chronic migraine in Russia</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-1919-2909</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. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Колбин Алексей Сергеевич, профессор, заведующий кафедрой клинической фармакологии и доказательной медицины, ФГБОУ ВО ПСПбГМУ им. И.П. Павлова Минздрава России; профессор кафедры фармакологии медицинского факультета Санкт-Петербургского государственного университета</p><p>Санкт-Петербург </p><p>SPIN-код: 7966-0845</p></bio><bio xml:lang="en"><p>Kolbin Alexey, MD, Professor, Head of the Department of Clinical Pharmacology and Evidence-Based Medicine, FSBEI HE I.P. Pavlov SPbSMU MOH Russia; professor of the Department of Pharmacology, Medical Faculty, St. Petersburg State University</p><p>Saint-Petersburg</p><p>SPIN-code: 7966-0845</p></bio><email xlink:type="simple">alex.kolbin@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/0000-0003-4204-2279</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Наприенко</surname><given-names>М. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Naprienko</surname><given-names>M. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Наприенко Маргарита Валентиновна, профессор</p><p>Москва</p><p>SPIN-код: 9109-8980</p></bio><bio xml:lang="en"><p>Naprienko Margarita, Professor</p><p>Moscow</p><p>SPIN-code: 9109-8980 </p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-6219-3384</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Артеменко</surname><given-names>А. Р.</given-names></name><name name-style="western" xml:lang="en"><surname>Artemenko</surname><given-names>A. R.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Артеменко Ада Равильевна, ведущий научный сотрудник</p><p>Москва</p><p>SPIN-код: 7962-7886</p><p> </p></bio><bio xml:lang="en"><p>Arepeva Maria, leading researcher</p><p>Moscow</p><p>SPIN-code: 7962-7886 </p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-5132-2873</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Вилюм</surname><given-names>И. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Vilyum</surname><given-names>I. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Вилюм Ирина Александровна, начальник отдела по обеспечению ЛС и ИМН, Клиника высоких медицинских технологий</p><p>Санкт-Петербург </p><p>SPIN-код: 7168-6396  </p></bio><bio xml:lang="en"><p>Vilyum Irina, head of medical ensuring department Clinic of high medical technologies</p><p>Saint-Petersburg</p><p>SPIN-code: 7168-6396 </p></bio><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-9600-5540</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Латышева</surname><given-names>Н. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Latysheva</surname><given-names>N. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Латышева Нина Владимировна, доцент кафедры нервных болезней Института профессионального образования</p><p>Москва</p></bio><bio xml:lang="en"><p>Latysheva Nina associate professor, Department of Neurology, Institute for Professional Education</p><p>Moscow</p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-9468-0953</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Проскурин</surname><given-names>М. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Proskurin</surname><given-names>M. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Проскурин Максим Александрович, ассистент кафедры математического моделирования энергетических систем, факультет прикладной математики-процессов управления</p><p>Санкт-Петербург </p><p>SPIN-код: 7406-2352</p></bio><bio xml:lang="en"><p>Proskurin Maksim, assistant of the Department of mathematical modeling of energy systems, faculty of applied mathematics and control processes</p><p>Saint-Petersburg</p><p>SPIN-code: 7406-2352 </p></bio><xref ref-type="aff" rid="aff-4"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-2143-0440</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Балыкина</surname><given-names>Ю. Е.</given-names></name><name name-style="western" xml:lang="en"><surname>Balykina</surname><given-names>Yu. Ye.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Балыкина Юлия Ефимовна, кандидат физико-математических наук, кафедра процессов управления, факультет прикладной математики</p><p>Санкт-Петербург </p><p>SPIN-код: 1886-5256 </p></bio><bio xml:lang="en"><p>Balykina Yulia, Candidate of Physico-mathematical sciences, Department of control processes, faculty of applied mathematics</p><p>Saint-Petersburg</p><p>SPIN-code: 1886-5256 </p></bio><xref ref-type="aff" rid="aff-4"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФГБОУ ВО «Первый Санкт-Петербургский государственный медицинский университет им. академика И.П. Павлова»;&#13;
Федеральное государственное бюджетное образовательное учреждение высшего образования «Санкт-Петербургский государственный университет»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>FSBEI HE I.P. Pavlov SPbSMU MOH Russia;&#13;
Federal State Budgetary Educational Institution of Higher Education «Saint-Petersburg State University»</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>ФГАОУ ВО Первый МГМУ имени И.М. Сеченова Минздрава России (Сеченовский Университет)</institution><country>Россия</country></aff><aff xml:lang="en"><institution>FSAEI HE I.M. Sechenov First MSMU MOH Russia (Sechenovskiy University)</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>ФГБОУ ВО «Первый Санкт-Петербургский государственный медицинский университет им. академика И.П. Павлова»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>FSBEI HE I.P. Pavlov SPbSMU MOH Russia</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-4"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное образовательное учреждение высшего образования «Санкт-Петербургский государственный университет»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Federal State Budgetary Educational Institution of Higher Education «Saint-Petersburg State University»</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2018</year></pub-date><pub-date pub-type="epub"><day>16</day><month>01</month><year>2019</year></pub-date><volume>0</volume><issue>3</issue><fpage>26</fpage><lpage>44</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Колбин А.С., Наприенко М.В., Артеменко А.Р., Вилюм И.А., Латышева Н.В., Проскурин М.А., Балыкина Ю.Е., 2019</copyright-statement><copyright-year>2019</copyright-year><copyright-holder xml:lang="ru">Колбин А.С., Наприенко М.В., Артеменко А.Р., Вилюм И.А., Латышева Н.В., Проскурин М.А., Балыкина Ю.Е.</copyright-holder><copyright-holder xml:lang="en">Kolbin A.A., Naprienko M.V., Artemenko A.R., Vilyum I.A., Latysheva N.V., Proskurin M.A., Balykina Y.Y.</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.clinvest.ru/jour/article/view/415">https://www.clinvest.ru/jour/article/view/415</self-uri><abstract><sec><title>Введение</title><p>Введение. Результаты и клинических, и эпидемиологических исследований демонстрируют высокий уровень нетрудоспособности, ассоциированный с головной болью, сниженную социально-экономическую активность, низкий уровень качества жизни, большее число коморбидных заболеваний и психических расстройств у пациентов с хронической мигренью (ХМ) по сравнению с теми, кто страдает эпизодической первичной головной болью.</p></sec><sec><title>Цели</title><p>Цели. Целью настоящего исследования была сравнительная оценка стоимости болезни и клинико-экономических последствий применения различных терапевтических подходов для профилактического лечения ХМ с позиции общества в целом в условиях РФ.</p></sec><sec><title>Методы</title><p>Методы. Использовали следующие виды фармакоэкономических анализов: анализ стоимости болезни, анализ «влияния на бюджет». Модели на основе данных литературы (Сценарий № 1) и на основе мнения экспертов (Сценарий № 2) были построены параллельно с последующей интерпретацией и обсуждением полученных результатов. Учитывали прямые и непрямые затраты. В качестве критериев эффективности принимали клинические исходы применения рассматриваемых терапевтических опций — изменение частоты использования мигрень-ассоциированной медицинской помощи (МАМП): неотложной медицинской помощи и стационарного лечения.</p></sec><sec><title>Результаты</title><p>Результаты. ХМ — заболевание, отличающееся значительным социально-экономическим бременем: на целевую популяцию в 1 470 840 пациентов при текущем распределении применяемых терапевтических подходов может достигать до 402 569 527 778 руб. при клинико-экономическом моделировании на основе данных литературы и 444 918 119 377 руб. при клинико-экономическом моделировании на основе результатов опроса мнения экспертов. Непрямые затраты являются весомой долей социально-экономической стоимости ХМ и оцениваются от 61 995 589 503 руб. до 88 794 056 961 руб. Применение различных терапевтических подходов в терапии ХМ могут сократить стоимость рассматриваемого заболевания на целевую популяцию. Стоимость ведения одного пациента в год лекарственным препаратом Ботокс® (141 820 руб.) оказалась до 40 % ниже стоимости профилактического лечения пациента с ХМ пероральными лекарственными препаратами (202 894 руб.), до 192 % — ниже стоимости ведения пациентов без профилактического лечения (414 305 руб.). Применение лекарственного препарата Ботокс характеризуется значительно меньшими непрямыми затратами в сравнении с иными терапевтическими подходами в ведении пациентов с ХМ.</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>Introduction</title><p>Introduction. Results of both clinical and epidemiological studies demonstrate a high frequency of work incapacity associated with headache, reduced socio-economic activity, low quality of life, greater number of comorbid diseases and mental disorders in patients with chronic migraine (CM) compared to those who suﬀer from episodic primary headache.</p></sec><sec><title>Objectives</title><p>Objectives. Te objective of the study was comparative assessment of the disease cost and clinical and economic consequences of using various therapeutic approaches for preventive treatment of CM from the societal perspective in the Russian Federation.</p></sec><sec><title>Methods</title><p>Methods. Te following types of pharmacoeconomic analyses were used: disease cost analysis, budget eﬀect analysis. Models based on literature data (Scenario No. 1) and based on expert opinion (Scenario No. 2) were constructed in parallel with subsequent interpretation and discussion of the results obtained. Direct and indirect costs were considered. Efcacy criteria were clinical outcomes of the use of therapeutic options in question — change in the frequency of use of migraine-associated aid: change in the frequency of use of emergency medical care; change in the frequency of inpatient treatment.</p></sec><sec><title>Results</title><p>Results. CM is a disease associated with a signifcant socio-economic burden: the cost of managing a target population of 1 470 840 patients with current distribution of therapeutic approaches can reach up to 402 569 527 778 RUB with clinical and economic modeling based on literature data, and 444 918 119 377 RUB with clinical and economic modeling based on expert opinion surveys. Indirect costs constitute a signifcant proportion of the socio-economic cost of CM, estimated at 61 995 589 503 RUB to 88 794 056 961 RUB. Te use of various therapeutic approaches for treating CM can reduce the cost of the disease for the target population. Te cost of managing one patient with Botox® per year (141 820 RUB) was up to 40 % lower than the cost of preventive treatment of a patient with CM with oral medications (202 894 RUB), up to 192 % lower than the cost of managing patients without preventive treatment (414 305 RUB). Te use of Botox is associated with signifcantly smaller indirect costs in comparison with the use of other therapeutic approaches in managing patients with CM.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>мигрень</kwd><kwd>хроническая мигрень</kwd><kwd>профилактика мигрени</kwd><kwd>пероральные препараты для профилактики мигрени</kwd><kwd>использование ресурсов здравоохранения</kwd><kwd>Ботокс</kwd><kwd>исследования стоимости болезни</kwd><kwd>экономическое влияние болезни</kwd><kwd>анализ влияния на бюджет</kwd></kwd-group><kwd-group xml:lang="en"><kwd>migraine</kwd><kwd>chronic migraine</kwd><kwd>migraine preventive treatments</kwd><kwd>oral drugs for migraine preventive treatments</kwd><kwd>healthcare resources utilization</kwd><kwd>Botox</kwd><kwd>cost-of-illness studies</kwd><kwd>economic impact of disease</kwd><kwd>budget impact analysis</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Исследование выполнено при финансовой поддержке «Аллерган Фармасьютикэлз Айэрлэнд»</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">Adams AM, Serrano D, Buse DC, et al. 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