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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">tumors</journal-id><journal-title-group><journal-title xml:lang="ru">Malignant tumours</journal-title><trans-title-group xml:lang="en"><trans-title>Malignant tumours</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2224-5057</issn><issn pub-type="epub">2587-6813</issn><publisher><publisher-name>Rosoncoweb</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.18027/2224-5057-2020-10-1-5-20</article-id><article-id custom-type="elpub" pub-id-type="custom">tumors-715</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 ИССЛЕДОВАНИЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>ORIGINAL REPORTS</subject></subj-group></article-categories><title-group><article-title>Результаты применения иммунотерапевтических препаратов при немелкоклеточном раке легкого в реальной клинической практике</article-title><trans-title-group xml:lang="en"><trans-title>Real world efficacy of immunotherapy in nonsmall cell lung cancer</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Моисеенко</surname><given-names>Ф. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Moiseenko</surname><given-names>F. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Федор В. Моисеенко, д. м. н., заведующий отделением химиотерапии ГБУЗ «Санкт-Петербургский клинический научнопрактический центр специализированных видов медицинской помощи (онкологический)», научный сотрудник научного отдела инновационных методов терапевтической онкологии и реабилитации ФГБУ «НМИЦ онкологии им. Н. Н. Петрова» Минздрава России, профессор кафедры онкологии ФГБОУ ВО «Северо-Западный государственный медицинский университет имени И. И. Мечникова» Минздрава России</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Fyodor V. Moiseenko, MD, PhD, DSc, Head of Chemotherapy Department, Saint Petersburg Clinical Research and Practice Centre for Specialized Care (Oncological), Senior Research Fellow Department of Innovative Methods of Therapeutic Oncology and Rehabilitation, N. N. Petrov Research Institute of Oncology, Professor Department of Oncology, North‑Western State Medical University named after I. I Mechnikov</p><p>Saint Petersburg</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Волков</surname><given-names>Н. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Volkov</surname><given-names>N. M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Никита М. Волков, к. м. н., начальник отделений химиотерапевтического и радиотерапевтического профиля</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Nikita M. Volkov, MD, PhD, Head of Chemotherapy and Radiotherapy Departments Unit</p><p>Saint Petersburg</p></bio><email xlink:type="simple">volkovnm@gmail.com</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Абдулоева</surname><given-names>Н. Х.</given-names></name><name name-style="western" xml:lang="en"><surname>Abduloeva</surname><given-names>N. H.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Нуринисо Х. Абдулоева, к. м. н., заведующая амбулаторно-консультативным отделением</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Nuriniso H. Abduloeva, MD, PhD, Head of Ambulatory Department</p><p>Saint Petersburg</p></bio><email xlink:type="simple">Abduloeva-n@mail.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Левченко</surname><given-names>Н. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Levchenko</surname><given-names>N. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Наталья В. Левченко, к. м. н., заведующая дневным стационаром</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Natalya V. Levchenko, MD, PhD, Head of Chemotherapy Department</p><p>Saint Petersburg</p></bio><email xlink:type="simple">Levch.nv@gmail.com</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Чубенко</surname><given-names>В. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Chubenko</surname><given-names>V. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Вячеслав А. Чубенко, к. м. н., заведующий отделением химиотерапии</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Vyacheslav A. Chubenko, MD, PhD, Head of the Department of Chemotherapy</p><p>Saint Petersburg</p></bio><email xlink:type="simple">vchubenko@me.com</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Жабина</surname><given-names>А. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Zhabina</surname><given-names>A. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Альбина С. Жабина, к. м. н., врач отделения химиотерапии</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Albina S. Zhabina, MD, PhD, oncologist, Department of Chemotherapy</p><p>Saint Petersburg</p></bio><email xlink:type="simple">albina_zhabina@indox.ru</email><xref ref-type="aff" rid="aff-3"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Чернобривцева</surname><given-names>В. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Chernobrivceva</surname><given-names>V. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Вера В. Чернобривцева, к. м. н., заведующая диагностическим отделением</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Vera V. Chernobrivceva, MD, PhD, Head of the Department of Diagnostics</p><p>Saint Petersburg</p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Шугинова</surname><given-names>Т. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Shuginova</surname><given-names>T. N.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Татьяна Н. Шугинова, заведующая отделением функциональной диагностики</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Tatyana N. Shuginova, Head of the Department of Functional Diagnostics</p><p>Saint Petersburg</p></bio><email xlink:type="simple">shuginova@mail.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Шелехова</surname><given-names>К. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Shelekhova</surname><given-names>K. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Ксения В. Шелехова, д. м. н., заведующая паталогоанатомическим отделением</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Ksenia V. Shelekhova, MD, PhD, DSc, Head of the Department of Pathology</p><p>Saint Petersburg</p></bio><email xlink:type="simple">kshelekhova@mail.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Хенштейн</surname><given-names>В. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Kheinshtein</surname><given-names>V. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Валерия А. Хейнштейн, врач паталогоанатомического отделения</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Valeriya A. Kheinshtein, pathologist, Department of Pathomorphology</p><p>Saint Petersburg</p></bio><email xlink:type="simple">v.a.heinstein@gmail.com</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Степанова</surname><given-names>М. Л.</given-names></name><name name-style="western" xml:lang="en"><surname>Stepanova</surname><given-names>M. L.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Мария Л. Степанова, научный сотрудник научного отдела</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Maria L. Stepanova, stuff scientist</p><p>Saint Petersburg</p></bio><email xlink:type="simple">stepanovamary1992@gmail.com</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Крамчанинов</surname><given-names>М. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Kramchaninov</surname><given-names>M. M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Михаил М. Крамчанинов, врач отделения химиотерапии</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Mikhail M. Kramchaninov, oncologist, Department of Chemotherapy</p><p>Saint Petersburg</p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Белухин</surname><given-names>С. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Belukhin</surname><given-names>S. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Сергей А. Белухин, врач отделения химиотерапии</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Sergey A. Belukhin, oncologist, Department of Chemotherapy</p><p>Saint Petersburg</p></bio><email xlink:type="simple">counterfeitomgg@gmail.com</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Хабичева</surname><given-names>А. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Khabitcheva</surname><given-names>A. M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Асият М. Хабичева, врач отделения химиотерапии</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Asiyat M. Khabitcheva, oncologist, Department of Chemotherapy</p><p>Saint Petersburg</p></bio><email xlink:type="simple">Khabicheva.asya@yandex.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Артемьева</surname><given-names>Е. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Artemieva</surname><given-names>E. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Елизавета В. Артемьева, врач отделения химиотерапии</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Elizaveta V. Artemieva, oncologist, Department of Chemotherapy</p><p>Saint Petersburg</p></bio><email xlink:type="simple">Mukhina_ev@mail.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Носова</surname><given-names>М. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Nosova</surname><given-names>M. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Маргарита В. Носова, ординатор кафедры онкологии</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Margarita V. Nosova, resident Department of Oncology</p><p>Saint Petersburg</p></bio><email xlink:type="simple">nosovamargarita13@gmail.com</email><xref ref-type="aff" rid="aff-4"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Тулейко</surname><given-names>В. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Tuleyko</surname><given-names>V. M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Вероника М. Тулейко, ординатор кафедры онкологии</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Veronika M. Tuleyko,, resident Department of Oncology</p><p>Saint Petersburg</p></bio><email xlink:type="simple">veronikatuleiko@gmail.com</email><xref ref-type="aff" rid="aff-4"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Моисеенко</surname><given-names>В. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Moiseyenko</surname><given-names>V. M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Владимир М. Моисеенко, д. м. н., профессор, директор</p><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Vladimir M. Moiseyenko, MD, PhD, DSc, Prof., Director</p><p>Saint Petersburg</p></bio><email xlink:type="simple">moiseyenkov@gmail.com</email><xref ref-type="aff" rid="aff-2"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ГБУЗ «Санкт-Петербургский клинический научно-практический центр специализированных видов медицинской помощи (онкологический)»; ФГБУ «НМИЦ онкологии им. Н. Н. Петрова» Минздрава России; ФГБОУ ВО «Северо-Западный государственный медицинский университет имени И. И. Мечникова» Минздрава России</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Saint Petersburg Clinical Research and Practice Centre for Specialized Care (Oncological); N. N. Petrov Research Institute of Oncology; North-Western State Medical University named after I. I Mechnikov</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>ГБУЗ «Санкт-Петербургский клинический научно-практический центр специализированных видов медицинской помощи (онкологический)»</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Saint Petersburg Clinical Research and Practice Centre for Specialized Care (Oncological)</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>ГБУЗ «Санкт-Петербургский клинический научно-практический центр специализированных видов медицинской помощи (онкологический)»; ФГБУ «НМИЦ онкологии им. Н. Н. Петрова» Минздрава России</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Saint Petersburg Clinical Research and Practice Centre for Specialized Care (Oncological); N. N. Petrov Research Institute of Oncology</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-4"><aff xml:lang="ru"><institution>ФГБОУ ВПО «Санкт-Петербургский государственный педиатрический медицинский университет» Минздрава России</institution><country>Россия</country></aff><aff xml:lang="en"><institution>St. Petersburg State Pediatric Medical University</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2020</year></pub-date><pub-date pub-type="epub"><day>16</day><month>10</month><year>2020</year></pub-date><volume>10</volume><issue>1</issue><elocation-id>5 ‑20</elocation-id><permissions><copyright-statement>Copyright &amp;#x00A9; Моисеенко Ф.В., Волков Н.М., Абдулоева Н.Х., Левченко Н.В., Чубенко В.А., Жабина А.С., Чернобривцева В.В., Шугинова Т.Н., Шелехова К.В., Хенштейн В.А., Степанова М.Л., Крамчанинов М.М., Белухин С.А., Хабичева А.М., Артемьева Е.В., Носова М.В., Тулейко В.М., Моисеенко В.М., 2020</copyright-statement><copyright-year>2020</copyright-year><copyright-holder xml:lang="ru">Моисеенко Ф.В., Волков Н.М., Абдулоева Н.Х., Левченко Н.В., Чубенко В.А., Жабина А.С., Чернобривцева В.В., Шугинова Т.Н., Шелехова К.В., Хенштейн В.А., Степанова М.Л., Крамчанинов М.М., Белухин С.А., Хабичева А.М., Артемьева Е.В., Носова М.В., Тулейко В.М., Моисеенко В.М.</copyright-holder><copyright-holder xml:lang="en">Moiseenko F.V., Volkov N.M., Abduloeva N.H., Levchenko N.V., Chubenko V.A., Zhabina A.S., Chernobrivceva V.V., Shuginova T.N., Shelekhova K.V., Kheinshtein V.A., Stepanova M.L., Kramchaninov M.M., Belukhin S.A., Khabitcheva A.M., Artemieva E.V., Nosova M.V., Tuleyko V.M., Moiseyenko V.M.</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.malignanttumors.org/jour/article/view/715">https://www.malignanttumors.org/jour/article/view/715</self-uri><abstract><p>Совершенствование лекарственной терапии злокачественных опухолей позволяет существенно увеличить продолжительность жизни пациентов, но неминуемо ведет на ранних этапах внедрения к повышению затрат на лекарственное обеспечение. Ни одна из стран мира на настоящий момент не может позволить себе полное обеспечение новейшими лекарственными препаратами всех больных. Двукратное увеличение расходов на лекарственное лечение на территории РФ в течение 2019 года позволило обеспечить современными препаратами 70 % нуждавшихся пациентов немелколеточным раком легкого (НМРЛ).</p><sec><title>Цель</title><p>Цель. Оценить клиническую эффективность различных методов лекарственной терапии рака легкого в реальной клинической практике.</p></sec><sec><title>Материалы и методы</title><p>Материалы и методы. В анализ включались пациенты с гистологически верифицированным неоперабельным НМРЛ, получавшие первую или вторую линию терапии в 2018–2019 гг. В исследование были включены 287 пациентов с НМРЛ: 230 больных для оценки эффективности первой линии, 100 — второй. Были оценены: время без прогрессирования, общая выживаемость, частота объективных ответов.</p></sec><sec><title>Результаты</title><p>Результаты. Применение ингибиторов контрольных точек в любом из зарегистрированных вариантов (первая линия при PD-L1 &gt; 1 %, химиоиммунотерапия независимо от статуса PD-L1, вторая линия независимо от статуса PD-L1) позволяет снизить одногодичную летальность с 61 % до 33 %, однако приводит к достоверному увеличению затрат на лекарственное обеспечение (р&lt; 0,000). Кроме того, использование ингибиторов контрольных точек в монорежиме у больных с высоким уровнем экспрессии PD-L1 или в комбинации с цитостатическими препаратами позволяло увеличить частоту объективных ответов (10 % и 21 % для монотерапии и платиновых дуплетов против 33,2 % для химиоиммунотерапии), медиану времени без прогрессирования (4,1 и 6,2 месяца для монотерапии и платиновых дуплетов против 6,5 месяцев для химиоиммунотерапии, тогда как медиана для монотерапии ингибиторами контрольных точек не достигнута).</p></sec><sec><title>Выводы</title><p>Выводы. Более чем 2-кратное повышение финансирования лекарственного лечения позволило обеспечить современными препаратами всех нуждавшихся пациентов НМРЛ. Подобные меры позволили достоверно увеличить продолжительность жизни больных НМРЛ. Тем не менее, рациональное использование подобных ресурсов требует выработки жестких критериев для того или иного дорогостоящего метода лечения.</p></sec></abstract><trans-abstract xml:lang="en"><p>The evolution of drug therapy in solid tumors primarily leads to the increase in cancer specific survival, but inevitably raises financial burden. So far, none of the countries can venture total reimbursement with all necessary contemporary drugs for all patients. Doubling of expenses for cancer drug therapy in Russia in 2019 allowed oncologists using the most expensive treatments in more than 70 % of patients.</p><sec><title>Purpose</title><p>Purpose: To evaluate efficacy of various treatment types of non‑small cell lung cancer in real clinical setting.</p></sec><sec><title>Material and methods</title><p>Material and methods. We included patients with histologically verified metastatic non‑small cell lung cancer without activating mutations treated with first or second line therapy in 2018 – 2019. In total 287 patients were included: 230 — for the first line efficacy analysis, 100 — for the second. Time to disease progression, overall survival and objective response rate were evaluated.</p></sec><sec><title>Results</title><p>Results. The use of checkpoint inhibitors in accordance with all actual recommendations (first line pembrolizumab monotherapy in PD-L1 &gt; 50 %, chemoimmunotherapy in first line or monotherapy in the second line irrespectively to PD-L1 status) decreased one‑year mortality from 61 % in 2018 to 33 % in 2019, but significantly increased financial cost (p &lt; 0.000). Moreover, checkpoint inhibitors in combination with chemotherapy irrespectively of PD-L1 expression increased response rate (from 10 % and 21 % for monotherapy and platinum doublet, respectively, to 33,2 % for chemoimmunotherapy). PD‑1 inhibitors as monotherapy increased median time to disease progression (4,1 and 6,2 months for monotherapy with chemotherapy and platinum doublet, respectively, to 6,5 months and not achieved for chemoimmunotherapy and monotherapy with checkpoint inhibitors).</p></sec><sec><title>Conclusion</title><p>Conclusion. More than doubling of financial costs spent for non‑small cell lung cancer treatment allowed access to contemporary treatment for all patients. Such unprecedented measures significantly improved efficacy, including double decrease of one‑year mortality. Nevertheless, rational design of regional clinical guidelines interpretation is of great importance in accurate and effective use of the healthcare budget.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>немелкоклеточный рак легкого</kwd><kwd>иммунотерапия</kwd><kwd>финансирование</kwd><kwd>лекарственная терапия</kwd></kwd-group><kwd-group xml:lang="en"><kwd>non‑small cell lung cancer</kwd><kwd>immunotherapy</kwd><kwd>financing</kwd><kwd>drug therapy</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">Под ред. А. Д. Каприна, В. В. Старинского, Г. В. 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