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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">10.30895/2312-7821-2025-13-3-290-299</article-id><article-id custom-type="elpub" pub-id-type="custom">safetyrisk-518</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>ГЛАВНАЯ ТЕМА: БЕЗОПАСНОСТЬ ПАЦИЕНТА: КАК ДОКЛИНИЧЕСКИЕ ДАННЫЕ И ПОСТРЕГИСТРАЦИОННЫЙ ФАРМАКОНАДЗОР ФОРМИРУЮТ СОВРЕМЕННЫЙ ЛАНДШАФТ ФАРМАКОТЕРАПИИ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>MAIN TOPIC: PATIENT SAFETY: THE WAY PRECLINICAL DATA AND POST-AUTHORISATION PHARMACOVIGILANCE SHAPE MODERN PHARMACOTHERAPEUTIC LANDSCAPE</subject></subj-group></article-categories><title-group><article-title>Терапевтический потенциал мио-инозитола при недостаточности мужской репродуктивной функции: коррекция параметров сперматогенеза и окислительного стресса (обзор)</article-title><trans-title-group xml:lang="en"><trans-title>Therapeutic Potential of Myo-Inositol in Male Infertility: Correction of Spermatogenesis Parameters and Oxidative Stress (Review)</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-9416-8135</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Гюлахмедова</surname><given-names>С. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Giulakhmedova</surname><given-names>S. M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Гюлахмедова Сафия Мирзабеговна</p><p>Петровский б-р, д. 8, стр. 2, Москва, 127051</p></bio><bio xml:lang="en"><p>Safiya M. Giulakhmedova</p><p>8/2 Petrovsky Blvd, Moscow 127051</p></bio><email xlink:type="simple">giulakhmedovasm@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/0000-0001-6091-6449</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Дружинина</surname><given-names>А. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Druzhinina</surname><given-names>A. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Дружинина Анна Александровна</p><p>Петровский б-р, д. 8, стр. 2, Москва, 127051</p></bio><bio xml:lang="en"><p>Anna A. Druzhinina</p><p>8/2 Petrovsky Blvd, Moscow 127051</p></bio><email xlink:type="simple">druzhininaaa@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/0000-0003-0770-8020</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Аляутдина</surname><given-names>О. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Alyautdina</surname><given-names>O. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Аляутдина Ольга Сергеевна, д-р мед. наук, профессор</p><p>Трубецкая ул., д. 8, cтр. 2, Москва, 119991</p></bio><bio xml:lang="en"><p>Olga S. Alyautdina, Dr. Sci. (Med.), Professor</p><p>8/2 Trubetskaya St., Moscow 119991</p></bio><email xlink:type="simple">olasa@list.ru</email><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0009-0007-0566-7700</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Елисеева</surname><given-names>Е. М.</given-names></name><name name-style="western" xml:lang="en"><surname>Eliseeva</surname><given-names>E. M.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Екатерина Максимовна Елисеева</p><p>Петровский б-р, д. 8, стр. 2, Москва, 127051</p></bio><bio xml:lang="en"><p>Ekaterina M. Eliseeva</p><p>8/2 Petrovsky Blvd, Moscow 127051</p></bio><email xlink:type="simple">eliseevaem@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/0009-0000-8907-1873</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Чистохина</surname><given-names>А. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Chistokhina</surname><given-names>A. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Чистохина Анна Андреевна</p><p>Петровский б-р, д. 8, стр. 2, Москва, 127051</p></bio><bio xml:lang="en"><p>Anna A. Chistokhina</p><p>8/2 Petrovsky Blvd, Moscow 127051, Russian Federation</p></bio><email xlink:type="simple">chistokhina@expmed.ru</email><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» 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 автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет им. И.М. Сеченова» Министерства здравоохранения Российской Федерации (Сеченовский Университет)</institution><country>Россия</country></aff><aff xml:lang="en"><institution>I.M. Sechenov First Moscow State Medical University (Sechenov University)</institution><country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2025</year></pub-date><pub-date pub-type="epub"><day>29</day><month>09</month><year>2025</year></pub-date><volume>13</volume><issue>3</issue><fpage>290</fpage><lpage>299</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Гюлахмедова С.М., Дружинина А.А., Аляутдина О.С., Елисеева Е.М., Чистохина А.А., 2025</copyright-statement><copyright-year>2025</copyright-year><copyright-holder xml:lang="ru">Гюлахмедова С.М., Дружинина А.А., Аляутдина О.С., Елисеева Е.М., Чистохина А.А.</copyright-holder><copyright-holder xml:lang="en">Giulakhmedova S.M., Druzhinina A.A., Alyautdina O.S., Eliseeva E.M., Chistokhina 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.risksafety.ru/jour/article/view/518">https://www.risksafety.ru/jour/article/view/518</self-uri><abstract><p>ВВЕДЕНИЕ. Мужское бесплодие, в частности недостаточность мужской репродуктивной функции, часто связано с окислительным стрессом. Мио-инозитол, обладающий антиоксидантными свойствами, играет важную роль в различных биохимических и клеточных процессах, происходящих в сперматозоидах, в том числе положительно влияет на функцию митохондрий и подвижность сперматозоидов. Это создает предпосылки для его применения в комплексном лечении недостаточности мужской репродуктивной функции различного генеза, включая олигоастенотератозооспермию, астенозооспермию, а также при вспомогательных репродуктивных технологиях.ЦЕЛЬ. Оценка возможности и эффективности применения инозитола для восстановления сперматогенеза у мужчин при нарушениях репродуктивной функции, вызванных окислительным стрессом.ОБСУЖДЕНИЕ. Окислительный стресс вызывает нарушение клеточной мембраны сперматозоидов, дисфункцию митохондрий и повреждение ДНК. Показано, что мио-инозитол оказывает положительное воздействие на сперматогенез за счет антиоксидантных свойств и активизации митохондриального метаболизма. Он способствует увеличению производства АТФ, снижает уровень маркеров окислительного повреждения, уменьшает фрагментацию ДНК и улучшает морфологию сперматозоидов. Мио-инозитол также повышает уровень тестостерона в клетках, увеличивает подвижность сперматозоидов за счет оптимизации взаимодействия актин–глобулин и модулирует содержание внутриклеточного кальция, необходимого для окислительного метаболизма и синтеза АТФ. По данным клинических исследований, мио-инозитол увеличивает общую подвижность сперматозоидов на 20–30%, долю прогрессивно-подвижных сперматозоидов до 40%, повышает частоту оплодотворений на 10–15% и снижает фрагментацию ДНК на 3–5%. Применение мио-инозитола при криоконсервации спермы уменьшает уровень активных форм кислорода, апоптоз, фрагментацию ДНК сперматозоидов, поддерживает митохондриальный мембранный потенциал и повышает эффективность окислительного фосфорилирования.ВЫВОДЫ. Мио-инозитол является перспективным соединением для терапии недостаточности мужской репродуктивной функции, включая олигоастенотератозооспермию, астенозооспермию, а также для подготовки спермы к использованию при вспомогательных репродуктивных технологиях. Благодаря антиоксидантным свойствам мио-инозитол может быть рекомендован в случае, когда предполагается или лабораторно подтверждается окислительное повреждение спермы. Однако для подтверждения положительного влияния мио-инозитола на репродуктивную функцию у мужчин необходимы дальнейшие масштабные контролируемые исследования.</p></abstract><trans-abstract xml:lang="en"><p>INTRODUCTION. Male infertility, in particular reproductive system deficiency, is often associated with oxidative stress. Myo-inositol antioxidant properties are essential for various biochemical and cellular processes in spermatozoa; for example, they contribute to mitochondrial function and sperm motility. This creates an opportunity to use inositol in the complex infertility treatment of various aetiology, including oligoasthenoteratozoospermia, asthenozoospermia, and in assisted reproductive technologies.AIM. This study aimed to evaluate the possibility and effectiveness of using inositol for spermatogenesis restoration in male reproductive dysfunction caused by oxidative stress.DISCUSSION. Oxidative stress damages sperm cell membrane, causes mitochondrial dysfunction, and affects DNA. Studies show that myo-inositol positively impacts spermatogenesis due to its antioxidant properties and activation of mitochondrial metabolism. It promotes ATP production, reduces oxidative damage markers, decreases DNA fragmentation and improves sperm morphology. Moreover, myo-inositol increases cellular testosterone, optimises actin — globulin binding, thus enhancing sperm motility, and modulates intracellular calcium concentrations necessary for oxidative metabolism and ATP synthesis. Clinical studies have shown that inositol increases overall sperm motility by 20–30%; progressive motility — up to 40%; fertilisation rate — by 10–15%, and reduces DNA fragmentation by 3–5%. Myo-inositol used for sperm cryopreservation reduces reactive oxygen and apoptosis, maintains mitochondrial membrane potential, and increases oxidative phosphorylation efficiency by 6–15%.CONCLUSIONS. Myo-inositol is a promising therapeutic compound for treating male infertility of various aetiology, including oligoasthenoteratozoospermia, asthenozoospermia, and for preparing sperm in assisted reproductive technologies. Also, due to its antioxidant properties, myo-inositol can be recommended in suspected or confirmed oxidative damage to sperm. However, large controlled trials are needed to confirm positive effect of myo-inositol on male reproductive function.</p></trans-abstract><kwd-group xml:lang="ru"><kwd>инозитол</kwd><kwd>мио-инозитол</kwd><kwd>сперматогенез</kwd><kwd>сперма</kwd><kwd>олигозооспермия</kwd><kwd>астенозооспермия</kwd><kwd>тератозооспермия</kwd><kwd>фертильность</kwd><kwd>мужское бесплодие</kwd><kwd>окислительный стресс</kwd><kwd>фрагментация ДНК</kwd><kwd>вспомогательные репродуктивные технологии</kwd><kwd>подвижность сперматозоидов</kwd></kwd-group><kwd-group xml:lang="en"><kwd>inositol</kwd><kwd>myo-inositol</kwd><kwd>spermatogenesis</kwd><kwd>sperm</kwd><kwd>oligozoospermia</kwd><kwd>asthenozoospermia</kwd><kwd>teratozoospermia</kwd><kwd>fertility</kwd><kwd>male infertility</kwd><kwd>oxidative stress</kwd><kwd>DNA fragmentation</kwd><kwd>assisted reproductive technologies</kwd><kwd>sperm motility</kwd></kwd-group><funding-group><funding-statement xml:lang="ru">Работа выполнена в рамках государственного задания ФГБУ «НЦЭСМП» Минздрава России № 056-00001- 25-00 на проведение прикладных научных исследований (номер государственного учета НИР 124022300127-0).</funding-statement><funding-statement xml:lang="en">This study was conducted by the Scientific Centre for Expert Evaluation of Medicinal Products as part of the applied research funded under State Assignment No. № 056-00001-25-00 (R&amp;D Registry No. 124022300127-0)</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">Андреева МВ, Хаят СШ, Сорокина ТМ и др. 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PMID: 28724183</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>
