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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">vtio</journal-id><journal-title-group><journal-title xml:lang="ru">Вестник трансплантологии и искусственных органов</journal-title><trans-title-group xml:lang="en"><trans-title>Russian Journal of Transplantology and Artificial Organs</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">1995-1191</issn><publisher><publisher-name>Academician V.I.Shumakov National Medical Research Center of Transplantology and Artificial Organs", Ministry of Health of the Russian Federation</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.15825/1995-1191-2019-2-112-120</article-id><article-id custom-type="elpub" pub-id-type="custom">vtio-1027</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>РЕГЕНЕРАТИВНАЯ МЕДИЦИНА И КЛЕТОЧНЫЕ ТЕХНОЛОГИИ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>REGENERATIVE MEDICINE  AND CELL TECHNOLOGIES</subject></subj-group></article-categories><title-group><article-title>Оценка безопасности трансплантации аутологичных мононуклеаров костного мозга в комбинированном лечении ишемической болезни сердца результаты рандомизированного, слепого, плацебо контролируемого исследования (TAMIS)</article-title><trans-title-group xml:lang="en"><trans-title>Assessment of safety of additional transplantation of autologous bone marrow mononuclear cells in the combined treatment of coronary heart disease. Results from a randomized, blind, placebo-controlled trial (TAMIS)</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>Комок</surname><given-names>В. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Komok</surname><given-names>V. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Комок Владимир Владимирович</p><p>196084, Санкт-Петербург, ул. Смоленская, д. 1, кв. 38, Тел. (904) 632-19-00</p></bio><bio xml:lang="en"><p>Komok Vladimir Vladimirovich </p><p>1, 38, Smolenskaya str., St. Petersburg, 196084, Tel. (904) 632-19-00</p></bio><email xlink:type="simple">vladimir_komok@mail.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>Буненков</surname><given-names>Н. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Bunenkov</surname><given-names>N. S.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Белый</surname><given-names>С. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Beliy</surname><given-names>S. A.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Пизин</surname><given-names>В. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Pizin</surname><given-names>V. M.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Кондратьев</surname><given-names>В. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Kondratev</surname><given-names>V. M.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Дулаев</surname><given-names>А. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Dulaev</surname><given-names>А. V.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Лукашенко</surname><given-names>В. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Lukashenko</surname><given-names>V. I.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Кобак</surname><given-names>А. Е.</given-names></name><name name-style="western" xml:lang="en"><surname>Kobak</surname><given-names>A. E.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Максимова</surname><given-names>Т. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Maksimova</surname><given-names>T. S.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Сергиенко</surname><given-names>И. П.</given-names></name><name name-style="western" xml:lang="en"><surname>Sergienko</surname><given-names>I. P.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Парусова</surname><given-names>Е. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Parusova</surname><given-names>E. V.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Смирнова</surname><given-names>Л. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Smirnova</surname><given-names>L. A.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Бабенко</surname><given-names>Е. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Babenko</surname><given-names>E. V.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Афанасьев</surname><given-names>Б. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Afanasev</surname><given-names>B. V.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Немков</surname><given-names>А. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Nemkov</surname><given-names>A. S.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Хубулава</surname><given-names>Г. Г.</given-names></name><name name-style="western" xml:lang="en"><surname>Khubulava</surname><given-names>G. G.</given-names></name></name-alternatives><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>ФГБОУ ВО «Первый Санкт-Петербургский государственный медицинский университет имени академика И.П. Павлова» Минздрава России</institution><country>Россия</country></aff><aff xml:lang="en"><institution>I.P. Pavlov First Saint Petersburg State Medical University</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2019</year></pub-date><pub-date pub-type="epub"><day>11</day><month>07</month><year>2019</year></pub-date><volume>21</volume><issue>2</issue><fpage>112</fpage><lpage>120</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Комок В.В., Буненков Н.С., Белый С.А., Пизин В.М., Кондратьев В.М., Дулаев А.В., Лукашенко В.И., Кобак А.Е., Максимова Т.С., Сергиенко И.П., Парусова Е.В., Смирнова Л.А., Бабенко Е.В., Афанасьев Б.В., Немков А.С., Хубулава Г.Г., 2019</copyright-statement><copyright-year>2019</copyright-year><copyright-holder xml:lang="ru">Комок В.В., Буненков Н.С., Белый С.А., Пизин В.М., Кондратьев В.М., Дулаев А.В., Лукашенко В.И., Кобак А.Е., Максимова Т.С., Сергиенко И.П., Парусова Е.В., Смирнова Л.А., Бабенко Е.В., Афанасьев Б.В., Немков А.С., Хубулава Г.Г.</copyright-holder><copyright-holder xml:lang="en">Komok V.V., Bunenkov N.S., Beliy S.A., Pizin V.M., Kondratev V.M., Dulaev А.V., Lukashenko V.I., Kobak A.E., Maksimova T.S., Sergienko I.P., Parusova E.V., Smirnova L.A., Babenko E.V., Afanasev B.V., Nemkov A.S., Khubulava G.G.</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://journal.transpl.ru/vtio/article/view/1027">https://journal.transpl.ru/vtio/article/view/1027</self-uri><abstract><sec><title>Цель</title><p>Цель. Оценить безопасность трансплантации аутологичных мононуклеаров костного мозга при выполнении операции аортокоронарного шунтирования в комбинированном лечении ишемической болезни сердца у пациентов с коронарной и сердечной недостаточностью.</p></sec><sec><title>Материалы и методы</title><p>Материалы и методы. За период с 2013-го по 2016 г. в работу включено 117 пациентов, соответствующих установленным критериям. Рандомизация в группы наблюдения: группа 0 - группа контроля (операция аортокоронарного шунтирования (АКШ) и интрамиокардиальное введение 0,9% раствора NaCl), группа 1 - операция АКШ и интрамиокардиальное введение аутологичных мононуклеаров костного мозга (АМНКМ), группа 2 - операция АКШ, интрамиокардиальное и внутришунтовое введение АМНКМ. В указанных группах проведена оценка: клинических, лабораторных (КФК МВ, миоглобин, тропонин I, HCT, Hb, К+, АВС), инструментальных (нагрузочные тесты - ишемические изменения, жизнеугрожающие нарушения ритма, эхокардиография, 8реск1е traoking (оценка степени деформации миокарда) - наличие дополнительных зон гипо-, акинезии, коронарография) данных. Выполнен анализ частоты послеоперационных осложнений (гидроторакс, гидроперикард, нарушения ритма); длительности пребывания в реанимационном отделении, длительности пребывания в стационаре (койко-день) и другие показатели. Через 6 и 12 месяцев оценивали общую летальность, крупные кардиальные события - развитие острого инфаркта миокарда, желудочковые нарушения ритма, онкологическую настороженность. Номер в международном регистре клинических исследований ClinicalTrial. gov Identifier:NCT02059512.</p></sec><sec><title>Результаты</title><p>Результаты. Статистический анализ показал отсутствие статистически достоверных различий в группах наблюдения по сравниваемым критериям.</p></sec><sec><title>Заключение</title><p>Заключение. Трансплантация аутологичных мононуклеаров костного мозга при выполнении операции аортокоронарного шунтирования в комбинированном лечении ишемической болезни сердца является безопасным методом.</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>Aim</title><p>Aim: to assess the safety of transplantation of autologous bone marrow mononuclear cells when performing coronary artery bypass grafting in the combined treatment of ischemic heart disease in patients with coronary and heart failure.</p></sec><sec><title>Materials and methods</title><p>Materials and methods. During the period from 2013 to 2016 years 117 patients, who meet the established criteria, were included in the work. Randomization was performed in observation groups: group 0 -control group (coronary artery bypass grafting (CABG) and intramyocardial administration of a 0.9% NaCl solution), group 1 - CABG surgery and intramyocardial administration of autologous bone marrow mononuclear cells (ABMMS), group 2 - CABG surgery and intramyocardial and intragraft administration of ABMMS. Clinical, laboratory - CPK MB, myoglobin, troponin I, HCT, Hb, K +, ABC; instrumental (stress tests, echocardiography, speckle tracking, coronary angiography) data were evaluated in these groups. The analysis of the frequency of postoperative complications (hydrothorax, hydropericardium, rhythm disturbances) was performed; the length of stay in the intensive care unit, the length of stay in the hospital and other indicators. After 6 and 12 months, the overall mortality was assessed, major cardiac events - the development of acute myocardial infarction, ventricular arrhythmias, oncological alertness. Number in international register clinical trials Clinical Trial. gov Identifier: NCT02059512.</p></sec><sec><title>Results</title><p>Results. Statistical analysis showed no statistically significant differences in the observation groups for the compared criteria.</p></sec><sec><title>Conclusion</title><p>Conclusion. Transplantation of autologous bone marrow mononuclear cells during aorto-coronary bypass surgery in the combined treatment of coronary heart disease is a safe method.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>аортокоронарное шунтирование</kwd><kwd>аутологичные мононуклеары костного мозга</kwd><kwd>реперфузионное повреждение миокарда</kwd><kwd>ишемическая болезнь сердца</kwd><kwd>диастолическая дисфункция миокарда левого желудочка</kwd><kwd>сердечная недостаточность</kwd><kwd>клиническое исследование</kwd></kwd-group><kwd-group xml:lang="en"><kwd>coronary artery bypass grafting</kwd><kwd>autologous bone marrow mononuclear cells</kwd><kwd>reperfusion myocardial damage</kwd><kwd>ischemic heart disease</kwd><kwd>diastolic dysfunction of the left ventricular myocardium</kwd><kwd>heart failure</kwd><kwd>clinical study</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">Wahid FSA, Ismail NA, Wan Jamaludin WF, Muhamad NA, Mohamad Idris MA, Lai NM. 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