safetyriskБезопасность и риск фармакотерапииSafety and Risk of Pharmacotherapy2312-78212619-1164Federal State Budgetary Institution ‘Scientific Centre for Expert Evaluation of Medicinal Products’ of the Ministry of Health of the Russian Federation (FSBI ‘SCEEMP’)10.30895/2312-7821-2022-10-1-19-33safetyrisk-277Research ArticleБЕЗОПАСНОСТЬ ФАРМАКОТЕРАПИИ ПРИ COVID-19SAFETY OF COVID-19 PHARMACOTHERAPYИвермектин: оценка эффективности и безопасности при COVID-19Ivermectin: Evaluation of Efficacy and Safety in COVID-19https://orcid.org/0000-0002-2888-5993ШубниковаЕ. В.ShubnikovaE. V.

Шубникова Елена Владимировна, канд. мед. наук

Петровский б-р, д. 8, стр. 2, Москва, 127051

Elena V. Shubnikova, Cand. Sci. (Med.)

8/2 Petrovsky Blvd, Moscow 127051

shubnikovaev@expmed.ruhttps://orcid.org/0000-0002-4094-8918СусековаН. А.SusekovaN. A.

Сусекова Наталья Андреевна

Петровский б-р, д. 8, стр. 2, Москва, 127051

Natalia A. Susekova

8/2 Petrovsky Blvd, Moscow 127051

Susekova@expmed.ruhttps://orcid.org/0000-0002-7597-2926БукатинаТ. М.BukatinaT. M.

Букатина Татьяна Михайловна, канд. мед. наук

Петровский б-р, д. 8, стр. 2, Москва, 127051

Tatyana M. Bukatina, Cand. Sci (Med.)

8/2 Petrovsky Blvd, Moscow 127051

Bukatina@expmed.ruhttps://orcid.org/0000-0002-9050-5947ГаленкоМ. С.GalenkoM. S.

Галенко Марта Сергеевна

Петровский б-р, д. 8, стр. 2, Москва, 127051Трубецкая ул., д. 8, cтр. 2, Москва, 119991

Marta S. Galenko

8/2 Petrovsky Blvd, Moscow 1270518/2 Trubetskaya St., Moscow 119991

galenkoms@expmed.ruhttps://orcid.org/0000-0001-6091-6449ДружининаА. А.DruzhininaA. A.

Дружинина Анна Александровна

Петровский б-р, д. 8, стр. 2, Москва, 127051

Anna A. Druzhinina

8/2 Petrovsky Blvd, Moscow 127051

DruzhininaAA@expmed.ruФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской ФедерацииРоссияScientific Centre for Expert Evaluation of Medicinal ProductsRussian FederationФедеральное государственное бюджетное учреждение «Научный центр экспертизы средств медицинского применения» Министерства здравоохранения Российской Федерации; Федеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет им. И.М. Сеченова» Министерства здравоохранения Российской Федерации (Сеченовский Университет)РоссияScientific Centre for Expert Evaluation of Medicinal Products; I.M. Sechenov First Moscow State Medical University (Sechenov University)Russian Federation2022010320221011933Copyright © Шубникова Е.В., Сусекова Н.А., Букатина Т.М., Галенко М.С., Дружинина А.А., 20222022Шубникова Е.В., Сусекова Н.А., Букатина Т.М., Галенко М.С., Дружинина А.А.Shubnikova E.V., Susekova N.A., Bukatina T.M., Galenko M.S., Druzhinina A.A.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.risksafety.ru/jour/article/view/277

Поиск эффективной и безопасной терапии COVID-19 проводится в том числе путем изучения эффективности препаратов, уже используемых для лечения различных заболеваний и обладающих потенциальной противовирусной активностью в отношении SARS-CoV-2. Актуальность представленного исследования определяется неоднозначными данными о не регламентированном инструкцией применении противопаразитарного препарата ивермектин для лечения пациентов с COVID-19. Цель работы — анализ эффективности и безопасности применения ивермектина при лечении COVID-19 по данным научной литературы. Ивермектин — противопаразитарный препарат из группы макроциклических лактонов, продуцируемых Streptomyces avermitilis, усиливает выработку тормозного нейромедиатора гамма-аминомасляной кислоты, что приводит к нарушению передачи нервных импульсов, параличу и гибели паразитов. Результаты доклинических исследований свидетельствуют об ингибирующей активности ивермектина в отношении ряда РНК- и ДНК-вирусов, включая SARS-CoV-2. Результаты клинических исследований неоднозначны: в ряде исследований показано положительное влияние ивермектина на состояние пациентов с COVID-19, тем не менее убедительные доказательства обоснованности и эффективности применения ивермектина для профилактики и лечения пациентов с COVID-19 в настоящее время отсутствуют. Профиль безопасности ивермектина относительно благоприятный. Необходимы крупные рандомизированные контролируемые исследования, результаты которых позволят в полной мере оценить целесообразность применения ивермектина при COVID-19.

The search for an effective and safe COVID-19 therapy involves, among other things, assessment of efficacy of medicines already used for the treatment of other diseases, and having potential antiviral activity against SARS-CoV-2. The relevance of the presented study stems from ambiguous data on the off-label use of the antiparasitic medicine ivermectin for the treatment of COVID-19 patients. The aim of the study was to analyse ivermectin efficacy and safety for COVID-19 treatment, as reflected in the scientific literature. Ivermectin, an antiparasitic medicine from the group of macrocyclic lactones produced by Streptomyces avermitilis, stimulates release of the inhibitory neurotransmitter gamma-aminobutyric acid, which leads to impaired transmission of nerve impulses, paralysis and death of parasites. The results of preclinical studies show ivermectin’s inhibitory activity against a number of RNA and DNA viruses, including SARS-CoV-2. The results of ivermectin clinical studies are ambiguous: a number of studies demonstrated a positive effect on the condition of COVID-19 patients, however, there is currently no convincing evidence of the validity and efficacy of ivermectin use for the prevention and treatment of COVID-19 patients. The safety profile of ivermectin is relatively favourable. Large randomised controlled trials are needed to fully assess the feasibility of using ivermectin in COVID-19.

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The authors declare that there are no conflicts of interest present.