<?xml version="1.0" encoding="UTF-8"?>
<!DOCTYPE article PUBLIC "-//NLM//DTD JATS (Z39.96) Journal Publishing DTD v1.3 20210610//EN" "JATS-journalpublishing1-3.dtd">
<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">r-n-j</journal-id><journal-title-group><journal-title xml:lang="ru">Российский неврологический журнал</journal-title><trans-title-group xml:lang="en"><trans-title>Russian neurological journal</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2658-7947</issn><issn pub-type="epub">2686-7192</issn><publisher><publisher-name>МИА</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.30629/2658-7947-2024-29-1-25-35</article-id><article-id custom-type="elpub" pub-id-type="custom">r-n-j-521</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>ИССЛЕДОВАНИЯ И КЛИНИЧЕСКИЕ НАБЛЮДЕНИЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>CLINICAL RESEARCHES AND CASE REPORTS</subject></subj-group></article-categories><title-group><article-title>Качество жизни больных рассеянным склерозом после высокодозной иммуносупрессивной терапии с аутологичной трансплантацией гемопоэтических стволовых клеток</article-title><trans-title-group xml:lang="en"><trans-title>Quality of life of patients with multiple sclerosis after high-dose immunosuppressive therapy with autologous hematopoietic stem cell transplantation</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-8699-2482</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Полушин</surname><given-names>А. Ю.</given-names></name><name name-style="western" xml:lang="en"><surname>Polushin</surname><given-names>A. Yu.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Saint Petersburg</p></bio><email xlink:type="simple">alexpolushin@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/0000-0003-1647-1213</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Лопатина</surname><given-names>Е. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Lopatina</surname><given-names>E. I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Saint Petersburg</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-0015-4777</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Цынченко</surname><given-names>А. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Tsynchenko</surname><given-names>A. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Saint Petersburg</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-3881-4486</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Залялов</surname><given-names>Ю. Р.</given-names></name><name name-style="western" xml:lang="en"><surname>Zalyalov</surname><given-names>Yu.  R.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Saint Petersburg</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-1955-1032</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Скиба</surname><given-names>Я. Б.</given-names></name><name name-style="western" xml:lang="en"><surname>Skiba</surname><given-names>I. B.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Saint Petersburg</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0005-7117-0087</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Шегурова</surname><given-names>А. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Shegurova</surname><given-names>A.  V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Saint Petersburg</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-6715-8203</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Тотолян</surname><given-names>Н. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Totolyan</surname><given-names>N. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Санкт-Петербург</p></bio><bio xml:lang="en"><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>Кулагин</surname><given-names>А. Д.</given-names></name><name name-style="western" xml:lang="en"><surname>Kulagin</surname><given-names>A. D.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Saint Petersburg</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-9431-5286</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Ионова</surname><given-names>Т. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Ionova</surname><given-names>T. I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Saint Petersburg</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/0000-0002-8279-8129</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Никитина</surname><given-names>Т. П.</given-names></name><name name-style="western" xml:lang="en"><surname>Nikitina</surname><given-names>T. P.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Saint Petersburg</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/0000-0003-3329-2743</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Порфирьева</surname><given-names>Н. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Porfirieva</surname><given-names>N. M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Saint Petersburg</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/0000-0002-5884-3110</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Скоромец</surname><given-names>А. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Skoromets</surname><given-names>A. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Санкт-Петербург</p></bio><bio xml:lang="en"><p>Saint Petersburg</p></bio><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Первый Санкт-Петербургский государственный медицинский университет имени академика И.П. Павлова</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Pavlov University</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Клиника высоких медицинских технологий им. Н.И. Пирогова СПбГУ</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Saint Petersburg State University Hospital</institution><country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-3"><aff xml:lang="ru"><institution>Межнациональный центр исследования качества жизни</institution><country>Россия</country></aff><aff xml:lang="en"><institution>Multinational Center for Quality of Life Research</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2024</year></pub-date><pub-date pub-type="epub"><day>12</day><month>03</month><year>2024</year></pub-date><volume>29</volume><issue>1</issue><fpage>25</fpage><lpage>35</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Полушин А.Ю., Лопатина Е.И., Цынченко А.А., Залялов Ю.Р., Скиба Я.Б., Шегурова А.В., Тотолян Н.А., Кулагин А.Д., Ионова Т.И., Никитина Т.П., Порфирьева Н.М., Скоромец А.А., 2024</copyright-statement><copyright-year>2024</copyright-year><copyright-holder xml:lang="ru">Полушин А.Ю., Лопатина Е.И., Цынченко А.А., Залялов Ю.Р., Скиба Я.Б., Шегурова А.В., Тотолян Н.А., Кулагин А.Д., Ионова Т.И., Никитина Т.П., Порфирьева Н.М., Скоромец А.А.</copyright-holder><copyright-holder xml:lang="en">Polushin A.Y., Lopatina E.I., Tsynchenko A.A., Zalyalov Y.R., Skiba I.B., Shegurova A.V., Totolyan N.A., Kulagin A.D., Ionova T.I., Nikitina T.P., Porfirieva N.M., Skoromets A.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.r-n-j.com/jour/article/view/521">https://www.r-n-j.com/jour/article/view/521</self-uri><abstract><sec><title>Введение</title><p>Введение. Рассеянный склероз (РС) — хроническое аутоиммунное и нейродегенеративное заболевание центральной нервной системы (ЦНС). Высокодозная иммуносупрессивная терапия с аутологичной трансплантацией гемопоэтических стволовых клеток (ВИСТ-АТГСК) — наиболее эффективный метод лечения РС, оказывающий положительное влияние на качество жизни пациентов и торможение прогрессирования инвалидизации.</p><p>Цель исследования — проанализировать динамику качества жизни у пациентов с РС, участвовавших в программе клинической апробации ВИСТ-АТГСК в группах с разной клинической эффективностью метода.</p></sec><sec><title>Материал и методы</title><p>Материал и методы. В одноцентровое наблюдательное исследование включены пациенты с РС (n = 21, средний возраст 35,5 ± 6,2 (28–50) года; мужчины/женщины — 11/10; ремиттирующий РС (РРС) n = 16, вторично-прогрессирующий (ВПРС) n = 4, первично-прогрессирующий (ППРС) n = 1), которым проводили ВИСТ-АТГСК в соответствии с протоколом клинической апробации (режим кондиционирования циклофосфамид-ритуксимаб). Оценку качества жизни (SF-36, FAMS, CSP-MS42, HADS) и степени инвалидизации у всех пациентов проводили до и через 12 мес. после ВИСТ-АТГСК.</p></sec><sec><title>Результаты</title><p>Результаты. Через 12 мес. после ВИСТ-АТГСК более чем у 50% пациентов наблюдали клинически значимое улучшение качества жизни по шкалам жизнеспособности и социального функционирования опросника SF36, а также по шкалам общего благополучия и дополнительных проблем опросника FAMS. У 57% пациентов имелось значимое улучшение по общему баллу FAMS. По данным опросника CSP-MS42 выявлено уменьшение слабости (p &lt; 0,05), чувства постоянной усталости и быстрой утомляемости при нагрузках. После трансплантации установили незначительное уменьшение тревоги (p = 0,91) и значимое уменьшение депрессии (p = 0,011).</p></sec><sec><title>Заключение</title><p>Заключение. При анализе в группах пациентов с разной клинической эффективностью ВИСТ-АТГСК установлена ожидаемая динамика: у пациентов с клиническим улучшением имело место улучшение качества жизни по большинству показателей; у пациентов со стабилизацией большинство показателей качества жизни были сходными до и после ВИСТ-АТГСК; при клиническом ухудшении после ВИСТ-АТГСК показатели качества жизни ухудшались. Эти данные указывают на целесообразность дальнейшей оптимизации критериев отбора пациентов и различных этапов процедуры ВИСТ-АТГСК с целью получения оптимальных клинических результатов и, соответственно, улучшения качества жизни пациентов.</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>Introduction</title><p>Introduction. Multiple sclerosis (MS) is a chronic autoimmune and neurodegenerative disease of the central nervous system (CNS). High-dose immunosuppressive therapy with autologous hematopoietic stem cell transplantation (HDIT–AHSCT) is the most eff ective method of treating MS, which has a positive eff ect on the quality of life of patients and inhibition of the progression of disability.</p><p>The aim of the study was to analyze the dynamics of quality of life in patients with MS who underwent the HDIT– AHSCT method in groups with diff erent clinical effi  cacy of this method.</p></sec><sec><title>Material and methods</title><p>Material and methods. The single-center observational study included patients with MS (n = 21, mean age 35.5 ± 6.2 (28–50) years; men/women — 11/10; remitting MS (RMS) n = 16, secondary-progressive (SPMS) n = 4, primaryprogressive (PPMS) n = 1), after HDIT–AHSCT (cyclophosphamide-rituximab conditioning regimen). Assessment of the quality of life (SF-36, FAMS, CSP-MS42, HADS) and the degree of disability in all patients was carried out before and 12 months after HDIT–AHSCT.</p></sec><sec><title>Results</title><p>Results. 12 months after HDIT–AHSCT, more than 50% of patients showed signifi cant improvement in quality of life according to the scales of viability and social functioning of the SF-36 questionnaire, as well as according to the scales of general well-being and additional problems of the FAMS questionnaire. 57% of patients had a signifi cant improvement in the overall FAMS score. According to the CSP-MS42 questionnaire, a decrease in weakness (p &lt; 0.05), feelings of constant fatigue and rapid fatigue during exercise was revealed. After transplantation, there was a slight decrease in anxiety (p = 0.91) and a signifi cant decrease in depression (p = 0.011).</p></sec><sec><title>Conclusion</title><p>Conclusion. The expected dynamics was established: in patients with clinical improvement, there was an improvement in the quality of life for most indicators; in patients with stabilization, most quality of life indicators were similar before and after HDIT–AHSCT; with clinical deterioration after HDIT–AHSCT, quality of life parameters worsened. These data indicate the expediency of further optimization of patient selection criteria and various stages of the HDIT–AHSCT in order to obtain optimal clinical results and, accordingly, improve the quality of life of patients.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>высокодозная иммуносупрессивная терапия</kwd><kwd>рассеянный склероз</kwd><kwd>гемопоэтические стволовые клетки</kwd><kwd>трансплантация</kwd><kwd>качество жизни</kwd><kwd>апробация</kwd></kwd-group><kwd-group xml:lang="en"><kwd>high-dose immunosuppressive therapy</kwd><kwd>multiple sclerosis</kwd><kwd>hematopoietic stem cells</kwd><kwd>transplantation</kwd><kwd>quality of life</kwd><kwd>clinical approbation</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">Fassas A., Anagnostopoulos A., Kazis A., Kapinas K., Sakellari I., Kimiskidis V. et al. Peripheral blood stem cell transplantation in the treatment of progressive multiple sclerosis: fi rst results of a pilot study. Bone Marrow Transplant. 1997;20(8):631–8. doi: 10.1038/sj.bmt.1700944 PMID: 9383225</mixed-citation><mixed-citation xml:lang="en">Fassas A., Anagnostopoulos A., Kazis A., Kapinas K., Sakellari I., Kimiskidis V. et al. Peripheral blood stem cell transplantation in the treatment of progressive multiple sclerosis: fi rst results of a pilot study. Bone Marrow Transplant. 1997;20(8):631–8. doi: 10.1038/sj.bmt.1700944 PMID: 9383225</mixed-citation></citation-alternatives></ref><ref id="cit2"><label>2</label><citation-alternatives><mixed-citation xml:lang="ru">Полушин А.Ю., Залялов Ю.Р., Тотолян Н.А., Кулагин А.Д., Скоромец А.А. Высокодозная иммуносупрессивная терапия с аутологичной транлантацией гемопоэтических стволовых клеток при рассеянном склерозе: современный взгляд на метод (обзор литературы). Ученые записки СПбГМУ им. акад. И.П. Павлова. 2021;28(4):9–21. doi: 10.24884/16074181-2021-28-4-9-21.</mixed-citation><mixed-citation xml:lang="en">Polushin A.Yu., Zalyalov Yu.R., Totolyan N.A., Kulagin A.D., Skoromets A.A. Highdose immunosuppressive therapy with autologous hematopoietic stem cell transplantation in multiple sclerosis: a modern view of the method (review of literature). The Scientifi c Notes of Pavlov University. 2021;28(4):9–21. (In Russ.)]. doi: 10.24884/16074181-2021-28-4-9-21.</mixed-citation></citation-alternatives></ref><ref id="cit3"><label>3</label><citation-alternatives><mixed-citation xml:lang="ru">Giedraitiene N., Gasciauskaite G., Kaubrys G. Impact of autologous HSCT on the quality of life and fatigue in patients with relapsing multiple sclerosis. Sci Rep. 2022;12(1):15404. doi: 10.1038/s41598-022-19748-7 PMID: 36100664; PMCID: PMC9470541.</mixed-citation><mixed-citation xml:lang="en">Giedraitiene N., Gasciauskaite G., Kaubrys G. Impact of autologous HSCT on the quality of life and fatigue in patients with relapsing multiple sclerosis. Sci Rep. 2022;12(1):15404. doi: 10.1038/s41598-022-19748-7 PMID: 36100664; PMCID: PMC9470541.</mixed-citation></citation-alternatives></ref><ref id="cit4"><label>4</label><citation-alternatives><mixed-citation xml:lang="ru">Roberts F., Hobbs H., Jessop H., Bozzolini C., Burman J., Greco R. et al. Rehabilitation Before and After Autologous Haematopoietic Stem Cell Transplantation (AHSCT) for Patients With Multiple Sclerosis (MS): Consensus Guidelines and Recommendations for Best Clinical Practice on Behalf of the Autoimmune Diseases Working Party, Nurses Group, and Patient Advocacy Committee of the European Society for Blood and Marrow Transplantation (EBMT). Front Neurol. 2020;11:556141. doi: 10.3389/fneur.2020.556141 PMID: 33362684; PMCID: PMC7759663.</mixed-citation><mixed-citation xml:lang="en">Roberts F., Hobbs H., Jessop H., Bozzolini C., Burman J., Greco R. et al. Rehabilitation Before and After Autologous Haematopoietic Stem Cell Transplantation (AHSCT) for Patients With Multiple Sclerosis (MS): Consensus Guidelines and Recommendations for Best Clinical Practice on Behalf of the Autoimmune Diseases Working Party, Nurses Group, and Patient Advocacy Committee of the European Society for Blood and Marrow Transplantation (EBMT). Front Neurol. 2020;11:556141. doi: 10.3389/fneur.2020.556141 PMID: 33362684; PMCID: PMC7759663.</mixed-citation></citation-alternatives></ref><ref id="cit5"><label>5</label><citation-alternatives><mixed-citation xml:lang="ru">Шевченко Ю.Л., Кузнецов А.Н., Ионова Т.И., Мельниченко В.Я., Федоренко Д.А., Курбатова К.А. и др. Мониторинг параметров качества жизни у больных рассеянным склерозом при проведении высокодозной иммуносупрессивной терапии с трансплантацией кроветворных стволовых клеток. Вестник Национального медико-хирургического Центра им. Н.И. Пирогова. 2012;7(3):7–10.</mixed-citation><mixed-citation xml:lang="en">Shevchenko Y.L., Kuznetsov A.N., Ionova T.I., Melnichenko V.Y., Fedorenko D.A., Kurbatova K.A. et al. Quality of life monitoring in multiple sclerosis patients undergoing high dose immunosuppressive therapy with autologous hematopoietic stem cell transplantation. Vestnik Nacionalnogo medico-hirurgicheskogo Centra N.I. Pirogova. 2012;7(3):7–10. (In Russ.)].</mixed-citation></citation-alternatives></ref><ref id="cit6"><label>6</label><citation-alternatives><mixed-citation xml:lang="ru">Приказ Министерства здравоохранения РФ от 10 июля 2015 г. № 433н. «Об утверждении Положения об организации клинической апробации методов профилактики, диагностики, лечения и реабилитации и оказания медицинской помощи в рамках клинической апробации методов профилактики, диагностики, лечения и реабилитации (в том числе порядка направления пациентов для оказания такой медицинской помощи), типовой формы протокола клинической апробации методов профилактики, диагностики, лечения и реабилитации». https://static-0.minzdrav.gov.ru/system/attachments/attaches/000/028/360/original/Приказ_№433н_от_10_июля_2015_г..pdf?1447421228</mixed-citation><mixed-citation xml:lang="en">Order of the Ministry of Health of the Russian Federation No. 433n. July 10, 2015. “On approval of the Regulations on the organization of clinical testing of methods of prevention, diagnosis, treatment and rehabilitation and medical care within the framework of clinical testing of methods of prevention, diagnosis, treatment and rehabilitation (including the procedure for referral of patients for such medical care), the standard form of the protocol of clinical testing of methods of prevention, diagnosis, treatment and rehabilitation”. (in Russ.)]. https://static-0.minzdrav.gov.ru/system/attachments/attaches/000/028/360/original/Приказ_№433н_от_10_июля_2015_г..pdf?1447421228</mixed-citation></citation-alternatives></ref><ref id="cit7"><label>7</label><citation-alternatives><mixed-citation xml:lang="ru">Приказ Министерства здравоохранения РФ от 21 июля 2015 г. № 474н. «О порядке дачи информированного добровольного согласия на оказание медицинской помощи в рамках клинической апробации методов профилактики, диагностики, лечения и реабилитации, формах информированного добровольного согласия на оказание медицинской помощи в рамках клинической апробации методов профилактики, диагностики, лечения и реабилитации и отказа от медицинской помощи в рамках клинической апробации методов профилактики, диагностики, лечения и реабилитации». https://static-0.minzdrav.gov.ru/system/attachments/attaches/000/028/351/original/Приказ_№474н_от21июля_2015_г..pdf?1447419558</mixed-citation><mixed-citation xml:lang="en">Order of the Ministry of Health of the Russian Federation No. 474n July 21, 2015. “On the procedure for giving informed voluntary consent to the provision of medical care within the framework of clinical testing of methods of prevention, diagnosis, treatment and rehabilitation, forms of informed voluntary consent to the provision of medical care within the framework of clinical testing of methods of prevention, diagnosis, treatment and rehabilitation and refusal of medical care within the framework of clinical testing of methods of prevention, diagnosis, treatment and rehabilitation”. (in Russ.)]. https://static-0.minzdrav.gov.ru/system/attachments/attaches/000/028/351/original/Приказ_№474н_от21июля_2015_г..pdf?1447419558</mixed-citation></citation-alternatives></ref><ref id="cit8"><label>8</label><citation-alternatives><mixed-citation xml:lang="ru">Полушин А.Ю., Залялов Ю.Р., Гавриленко А.Н., Цынченко А.А., Лопатина Е.И., Скиба Я.Б. и др. Высокодозная иммуносупрессивная терапия с аутологичной трансплантацией гемопоэтических стволовых клеток при рассеянном склерозе: предварительные клинические результаты апробации метода. Российский неврологический журнал. 2022;27(5):25– 35. https://doi.org/10.30629/26587947-2022-27-5-25-35</mixed-citation><mixed-citation xml:lang="en">Polushin A.Yu., Zalyalov Yu.R., Gavrilenko A.N., Tsynchenko A.A., Lopatina E.I., Skiba I.B. et al. High-dose immunosuppressive therapy with autologous hematopoietic stem cell transplantation in multiple sclerosis: preliminary clinical results of approbation of the method. Russian neurological journal. 2022;27(5):25–35. (In Russ.)]. https://doi.org/10.30629/26587947-2022-27-5-25-35</mixed-citation></citation-alternatives></ref><ref id="cit9"><label>9</label><citation-alternatives><mixed-citation xml:lang="ru">World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191–4. doi: 10.1001/jama.2013.281053 PMID: 24141714.</mixed-citation><mixed-citation xml:lang="en">World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191–4. doi: 10.1001/jama.2013.281053 PMID: 24141714.</mixed-citation></citation-alternatives></ref><ref id="cit10"><label>10</label><citation-alternatives><mixed-citation xml:lang="ru">Krokavcova M., van Dijk J.P., Nagyova I., Rosenberger J., Gavelova M., Gdovinova Z. et al. Perceived health status as measured by the SF-36 in patients with multiple sclerosis: a review. Scand J Caring Sci. 2009;23(3):529–38. doi: 10.1111/j.1471-6712.2008.00633х</mixed-citation><mixed-citation xml:lang="en">Krokavcova M., van Dijk J.P., Nagyova I., Rosenberger J., Gavelova M., Gdovinova Z. et al. Perceived health status as measured by the SF-36 in patients with multiple sclerosis: a review. Scand J Caring Sci. 2009;23(3):529–38. doi: 10.1111/j.1471-6712.2008.00633х</mixed-citation></citation-alternatives></ref><ref id="cit11"><label>11</label><citation-alternatives><mixed-citation xml:lang="ru">Hays R.D., Sherbourne C.D., Mazel R.M. User’s Manual for Medical Outcomes Study (MOS) Core measures of health-related quality of life. RAND Corporation, 1995; MR-162-RC (available at www.rand.org).</mixed-citation><mixed-citation xml:lang="en">Hays R.D., Sherbourne C.D., Mazel R.M. User’s Manual for Medical Outcomes Study (MOS) Core measures of health-related quality of life. RAND Corporation, 1995; MR-162-RC (available at www.rand.org).</mixed-citation></citation-alternatives></ref><ref id="cit12"><label>12</label><citation-alternatives><mixed-citation xml:lang="ru">Hays R.D., Morales L.S. The RAND-36 measure of healthrelated quality of life. Ann Med. 2001;33(5):350–7. doi: 10.3109/07853890109002089 PMID: 11491194.</mixed-citation><mixed-citation xml:lang="en">Hays R.D., Morales L.S. The RAND-36 measure of healthrelated quality of life. Ann Med. 2001;33(5):350–7. doi: 10.3109/07853890109002089 PMID: 11491194.</mixed-citation></citation-alternatives></ref><ref id="cit13"><label>13</label><citation-alternatives><mixed-citation xml:lang="ru">Cella D.F., Dineen K., Arnason B., Reder A., Webster K.A., Karabatsos G. et al. Validation of the functional assessment of multiple sclerosis quality of life instrument. Neurology. 1996;47(1):129–39. doi: 10.1212/wnl.47.1.129 PMID: 8710066.</mixed-citation><mixed-citation xml:lang="en">Cella D.F., Dineen K., Arnason B., Reder A., Webster K.A., Karabatsos G. et al. Validation of the functional assessment of multiple sclerosis quality of life instrument. Neurology. 1996;47(1):129–39. doi: 10.1212/wnl.47.1.129 PMID: 8710066.</mixed-citation></citation-alternatives></ref><ref id="cit14"><label>14</label><citation-alternatives><mixed-citation xml:lang="ru">Новик А.А., Ионова Т.И. Руководство по исследованию качества жизни в медицине. Под ред. акад. РАМН Ю.Л. Шевченко. М.: Изд-во Национального медико-хирургического центра им. Н.И. Пирогова, 2021.</mixed-citation><mixed-citation xml:lang="en">Novik A.A., Ionova T.I. Guidelines for Quality of Life Research in Medicine. Shevchenko Yu.L., editor. 4th ed., rev. and ad. М.: Pirogov National Medical and Surgical Centre Publ; 2021. (In Russ.)].</mixed-citation></citation-alternatives></ref><ref id="cit15"><label>15</label><citation-alternatives><mixed-citation xml:lang="ru">Zigmond A.S., Snaith R.P. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–70. doi: 10.1111/j.1600-0447.1983.tb09716.x</mixed-citation><mixed-citation xml:lang="en">Zigmond A.S., Snaith R.P. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983;67:361–70. doi: 10.1111/j.1600-0447.1983.tb09716.x</mixed-citation></citation-alternatives></ref><ref id="cit16"><label>16</label><citation-alternatives><mixed-citation xml:lang="ru">https://cr.minzdrav.gov.ru/recomend/739_1.</mixed-citation><mixed-citation xml:lang="en">https://cr.minzdrav.gov.ru/recomend/739_1.</mixed-citation></citation-alternatives></ref><ref id="cit17"><label>17</label><citation-alternatives><mixed-citation xml:lang="ru">www.neurostatus.net</mixed-citation><mixed-citation xml:lang="en">www.neurostatus.net</mixed-citation></citation-alternatives></ref><ref id="cit18"><label>18</label><citation-alternatives><mixed-citation xml:lang="ru">Lakens D. Calculating and reporting eff ect sizes to facilitate cumulative science: a practical primer fort-tests and ANOVAs. Front. Psychol. 2013;4. https://doi.org/10.3389/fpsyg.2013.00863</mixed-citation><mixed-citation xml:lang="en">Lakens D. Calculating and reporting eff ect sizes to facilitate cumulative science: a practical primer fort-tests and ANOVAs. Front. Psychol. 2013;4. https://doi.org/10.3389/fpsyg.2013.00863</mixed-citation></citation-alternatives></ref><ref id="cit19"><label>19</label><citation-alternatives><mixed-citation xml:lang="ru">Thompson A.J., Banwell B.L., Barkhof F., Carroll W.M., Coetzee T., Comi G., et al. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018;17(2):162–173. doi: 10.1016/S1474-4422(17)30470-2 Epub 2017 Dec 21. PMID: 29275977.</mixed-citation><mixed-citation xml:lang="en">Thompson A.J., Banwell B.L., Barkhof F., Carroll W.M., Coetzee T., Comi G., et al. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018;17(2):162–173. doi: 10.1016/S1474-4422(17)30470-2 Epub 2017 Dec 21. PMID: 29275977.</mixed-citation></citation-alternatives></ref><ref id="cit20"><label>20</label><citation-alternatives><mixed-citation xml:lang="ru">Laureys G., Willekens B., Vanopdenbosch L., Deryck O., Selleslag D., D’Haeseleer M. et al. A Belgian consensus protocol for autologous hematopoietic stem cell transplantation in multiple sclerosis. Acta Neurol Belg. 2018;118(2):161–168. doi: 10.1007/s13760-018-0905-0 Epub 2018 Mar 13. PMID: 29536270.</mixed-citation><mixed-citation xml:lang="en">Laureys G., Willekens B., Vanopdenbosch L., Deryck O., Selleslag D., D’Haeseleer M. et al. A Belgian consensus protocol for autologous hematopoietic stem cell transplantation in multiple sclerosis. Acta Neurol Belg. 2018;118(2):161–168. doi: 10.1007/s13760-018-0905-0 Epub 2018 Mar 13. PMID: 29536270.</mixed-citation></citation-alternatives></ref><ref id="cit21"><label>21</label><citation-alternatives><mixed-citation xml:lang="ru">Burman J., Tolf A., Hоgglund H., Askmark H. Autologous haematopoietic stem cell transplantation for neurological diseases. J Neurol Neurosurg Psychiatry. 2018;89(2):147–155. doi: 10.1136/jnnp-2017-316271</mixed-citation><mixed-citation xml:lang="en">Burman J., Tolf A., Hоgglund H., Askmark H. Autologous haematopoietic stem cell transplantation for neurological diseases. J Neurol Neurosurg Psychiatry. 2018;89(2):147–155. doi: 10.1136/jnnp-2017-316271</mixed-citation></citation-alternatives></ref><ref id="cit22"><label>22</label><citation-alternatives><mixed-citation xml:lang="ru">Сизикова С.А., Лисуков И.А., Кулагин А.Д., Крючкова И.В., Гилевич А.В., Черных Е.Р. и др. Высокодозная иммуносупрессивная терапия с аутологичной трансплантацией стволовых кроветворных клеток при аутоиммунных заболеваниях. Терапевтический архив. 2002;74(7):22–26.</mixed-citation><mixed-citation xml:lang="en">Sizikova S.A., Lisukov I.A., Kulagin A.D., Kryuchkova I.V., Gilevich A.V., Chernykh E.R. et al. High-dose immunosuppressive therapy with autologous hematopoietic stem cell transplantation in autoimmune diseases. Therapeutic Archive. 2002;74(7):22–26. (In Russ.)].</mixed-citation></citation-alternatives></ref><ref id="cit23"><label>23</label><citation-alternatives><mixed-citation xml:lang="ru">Шевченко Ю.Л., Новик А.А., Кузнецов А.Н., Афанасьев Б.В., Лисуков И.А., Козлов В.А. и др. Аутологичная трансплантация кроветворных стволовых клеток при рассеянном склерозе: результаты исследования Российской кооперативной группы клеточной терапии. Неврологический журнал. 2008;13(2):11–18.</mixed-citation><mixed-citation xml:lang="en">Shevchenko Y.L., Novik A.A., Kuznetsov A.N., Afanasyev B.V., Lisukov I.A., Kozlov V.A. et al. Autologous transplantation of hematopoietic stem cells in multiple sclerosis: results of a study of the Russian cooperative cell therapy group. Neurological Journal. 2008;13(2):11–18. (In Russ.)].</mixed-citation></citation-alternatives></ref><ref id="cit24"><label>24</label><citation-alternatives><mixed-citation xml:lang="ru">Burt R.K., Balabanov R., Burman J., Sharrack B., Snowden J.A., Oliveira M.C. et al. Eff ect of Nonmyeloablative Hematopoietic Stem Cell Transplantation vs Continued Disease-Modifying Therapy on Disease Progression in Patients With Relapsing-Remitting Multiple Sclerosis: A Randomized Clinical Trial. JAMA. 2019;321(2):165–174. https://doi.org/10.1001/jama.2018.18743</mixed-citation><mixed-citation xml:lang="en">Burt R.K., Balabanov R., Burman J., Sharrack B., Snowden J.A., Oliveira M.C. et al. Eff ect of Nonmyeloablative Hematopoietic Stem Cell Transplantation vs Continued Disease-Modifying Therapy on Disease Progression in Patients With Relapsing-Remitting Multiple Sclerosis: A Randomized Clinical Trial. JAMA. 2019;321(2):165–174. https://doi.org/10.1001/jama.2018.18743</mixed-citation></citation-alternatives></ref><ref id="cit25"><label>25</label><citation-alternatives><mixed-citation xml:lang="ru">Riise T., Mohr D.C., Munger K.L., Rich-Edwards J.W., Kawachi I., Ascherio A. Stress and the risk of multiple sclerosis. Neurology. 2011;76(22):1866–71. doi: 10.1212/WNL.0b013e31821d74c5</mixed-citation><mixed-citation xml:lang="en">Riise T., Mohr D.C., Munger K.L., Rich-Edwards J.W., Kawachi I., Ascherio A. Stress and the risk of multiple sclerosis. Neurology. 2011;76(22):1866–71. doi: 10.1212/WNL.0b013e31821d74c5</mixed-citation></citation-alternatives></ref><ref id="cit26"><label>26</label><citation-alternatives><mixed-citation xml:lang="ru">Boff a G., Signori A., Massacesi L., Mariottini A., Sbragia E., Cottone S. et al.; Italian BMT-MS Study Group and the Italian MS Register. Hematopoietic Stem Cell Transplantation in People with Active Secondary Progressive Multiple Sclerosis. Neurology. 2023;100(11):e1109–e1122. doi: 10.1212/WNL.0000000000206750</mixed-citation><mixed-citation xml:lang="en">Boff a G., Signori A., Massacesi L., Mariottini A., Sbragia E., Cottone S. et al.; Italian BMT-MS Study Group and the Italian MS Register. Hematopoietic Stem Cell Transplantation in People with Active Secondary Progressive Multiple Sclerosis. Neurology. 2023;100(11):e1109–e1122. doi: 10.1212/WNL.0000000000206750</mixed-citation></citation-alternatives></ref><ref id="cit27"><label>27</label><citation-alternatives><mixed-citation xml:lang="ru">Mariottini A., De Matteis E., Cencioni M.T., Muraro P.A. Haematopoietic Stem Cell Transplantation for the Treatment of Multiple Sclerosis: Recent Advances. Curr Neurol Neurosci Rep. 2023;23(9):507–520. doi: 10.1007/s11910-023-01290-2</mixed-citation><mixed-citation xml:lang="en">Mariottini A., De Matteis E., Cencioni M.T., Muraro P.A. Haematopoietic Stem Cell Transplantation for the Treatment of Multiple Sclerosis: Recent Advances. Curr Neurol Neurosci Rep. 2023;23(9):507–520. doi: 10.1007/s11910-023-01290-2</mixed-citation></citation-alternatives></ref></ref-list><fn-group><fn fn-type="conflict"><p>The authors declare that there are no conflicts of interest present.</p></fn></fn-group></back></article>
