Цель. Изучить особенности постковидного астенического синдрома и оценить эффективность лекарственного средства на основе янтарнокислого комплекса с триметилгидразинием в его коррекции. Материалы и методы. В проспективное многоцентровое сравнительное рандомизированное двойное слепое плацебо-контролируемое исследование эффективности последовательной терапии препаратами БРЕЙНМАКС® включены 160 пациентов, перенесших коронавирусную инфекцию давностью 12–16 нед (но не более 12 мес). Исследование проводилось на территории 6 медицинских центров в разных регионах Российской Федерации. Проводили тестирование по шкалам: ВАШ для оценки головной боли, шкалы астении MFI-20, теста PSQI, шкалы оценки усталости FAS-10, шкалы оценки головокружения DHI, шкалы оценки когнитивных нарушений MoCA, шкалы уровня тревоги Бека, вычисление вегетативного индекса Кердо. Результаты. Показано значимое улучшение качества сна по опроснику PSQI в группе исследования: на 2,5 балла [-4; -1] (p<0,001); отмечено более выраженное статистически значимое снижение баллов по шкале MFI-20 на 19,5 балла [-27; -11] (p<0,001); значимое снижение баллов по шкале оценки усталости FAS-10 на 9 [-13,5; -4] баллов (p<0,001); по шкале оценки головокружения DHI снижение на 6 [-12; 0] баллов в группе препарата БРЕЙНМАКС® (p=0,001); помимо этого, применение препарата сопровождалось уменьшением балла по шкале тревоги и депрессии Бека на 5 [-11; -2] баллов (p<0,001). По данным множественной линейной регрессии продемонстрировано статистически значимое увеличение балла по шкале МоСА на 0,56 (p=0,02). Заключение. В проведенном исследовании убедительно показана эффективность терапии препаратом БРЕЙНМАКС® в отношении широкого спектра симптомов у пациентов с постковидным синдромом.
Aim. To study the features of post-COVID asthenic syndrome and evaluate the effectiveness of the drug containing the succinic acid complex with trimethylhydrazinium in its treatment. Materials and methods. A prospective, multicenter, comparative, randomized, double-blind, placebo-controlled study of the efficacy of sequential therapy with BRAINMAX® included 160 patients with a history of coronavirus infection within 12 to 16 weeks (not more than 12 months). The study was conducted at 6 healthcare centers in different regions of the Russian Federation. Testing was performed on the following scores: VAS for headache score, MFI-20 asthenia score, PSQI test, FAS-10 fatigue score, DHI dizziness score, MoCA cognitive impairment score, Beck anxiety score, vegetative index of Kerdo. Results. PSQI questionnaire showed significant improvement in sleep quality in the study group: by -2.5 points [-4; -1] (p<0.001); there was a more pronounced significant decrease in the MFI-20 score of -19.5 points [-27; -11] (p<0.001); a significant decrease in the FAS-10 fatigue score by -9 [-13.5; -4] points (p<0.001); DHI dizziness score showed a decrease by -6 [-12; 0] points in the BRAINMAX® group (p=0.001); the score of Beck anxiety and depression scale decreased by -5 [-11; -2] points (p<0.001). Multiple linear regression data showed a significant increase of 0.56 (p=0.02) in the MoCA score. Conclusion. Our study convincingly showed the effectiveness of therapy with BRAINMAX® in a wide range of symptoms in patients with the post-COVID syndrome.
1. Сайт Всемирной организации здравоохранения. Режим доступа: https://covid19.who.int/ Дата обращения: 20.01.2023 [World Health Organization website. Available at: https://covid19.who.int/ Accessed: 20.01.2023 (in Russian)].
2. Aiyegbusi OL, Hughes SE, Turner G, et al. Symptoms, complications and management of long COVID: a review. J R Soc Med. 2021;114(9):428-42. DOI:10.1177/01410768211032850
3. Танашян М.М., Кузнецова П.И., Раскуражев А.А. Неврологические аспекты COVID19. Анналы клинической и экспериментальной неврологии. 2020;14(2):62-9 [Tanashyan MM, Kuznetsova PI, Raskurazhev AA. Neurological aspects of COVID-19. Annals of Clinical and Experimental Neurology. 2020;14(2):62-9 (in Russian)]. DOI:10.25692/ACEN.2020.2.8
4. Раскуражев А.А., Кузнецова П.И., Коновалов Р.Н., Танашян М.М. Нарушения обоняния на фоне COVID-19: клинико-нейровизуализационный анализ. Нервные болезни. 2022;2:4-7 [Raskurazhev AA, Kuznetsova PI, Konovalov RN, Tanashyan MM. Olfactory Dysfunctions in COVID-19: Clinical and Neuroimaging Analysis. Neurological Diseases. 2022;2:4-7 (in Russian)]. DOI:10.24412/2226-0757-2022-12818
5. Olesen J, Gustavsson A, Svensson M, et al. The economic cost of brain disorders in Europe. Eur J Neurol. 2012;19(1):155-62. DOI:10.1111/j.1468-1331.2011.03590.x
6. Jacobson GP, Newman CW. The development of the dizziness handicap inventory. Arch Otolaryngol Head Neck Surg. 1990;116:424-7. DOI:10.1001/archotol.1990.01870040046011.
7. Ceban F, Ling S, Lui LMW, et al. Fatigue and cognitive impairment in Post-COVID-19 Syndrome: A systematic review and meta-analysis. Brain Behav Immun. 2022;101:93-135. DOI:10.1016/j.bbi.2021.12.020
8. Танашян М.М., Раскуражев А.А., Кузнецова П.И., и соавт. Перспективы и возможности терапии пациентов с астеническим синдромом после перенесенной новой коронавирусной инфекции COVID-19. Терапевтический архив. 2022;94(11):1285-93 [Tanashyan MM, Raskurazhev AA, Kuznetsova PI, at al. Prospects and possibilities for the treatment of patients with long COVID-19 syndrome. Terapevticheskii Arkhiv (Ter. Arkh.). 2022;94(11):1285-93 (in Russian)]. DOI:10.26442/00403660.2022.11.201981
9. Fietsam AC, Bryant AD, Rudroff T. Fatigue and perceived fatigability, not objective fatigability, are prevalent in people with post-COVID-19. Exp Brain Res. 2022:1-9. DOI:10.1007/s00221-022-06518-0
10. Tana C, Bentivegna E, Cho SJ, et al. Long COVID headache. J Headache Pain. 2022;23(1):93. DOI:10.1186/s10194-022-01450-8
11. Medic G, Wille M, Hemels ME. Short- and long-term health consequences of sleep disruption. Nat Sci Sleep. 2017;9:151-61. DOI:10.2147/NSS.S134864
12. Jahrami H, BaHammam AS, Bragazzi NL, et al. Sleep problems during the COVID-19 pandemic by population: a systematic review and meta-analysis. J Clin Sleep Med. 2021;17(2):299-313. DOI:10.5664/jcsm.8930
13. Viselli L, Salfi F, D'Atri A, et al. Sleep Quality, Insomnia Symptoms, and Depressive Symptomatology among Italian University Students before and during the Covid-19 Lockdown. Int J Environ Res Public Health. 2021;18(24):13346. DOI:10.3390/ijerph182413346
14. Hartung TJ, Neumann C, Bahmer T, et al. Fatigue and cognitive impairment after COVID-19: A prospective multicentre study. EClinicalMedicine. 2022;53:101651. DOI:10.1016/j.eclinm.2022.101651
15. Ludwig S, Schell A, Berkemann M, et al. Post-COVID-19 Impairment of the Senses of Smell, Taste, Hearing, and Balance. Viruses. 2022;14(5):849. DOI:10.3390/v14050849
16. COVID-19 Mental Disorders Collaborators. Global prevalence and burden of depressive and anxiety disorders in 204 countries and territories in 2020 due to the COVID-19 pandemic. Lancet. 2021;398(10312):1700-12. DOI:10.1016/S0140-6736(21)02143-7
________________________________________________
1. World Health Organization website. Available at: https://covid19.who.int/ Accessed: 20.01.2023 (in Russian).
2. Aiyegbusi OL, Hughes SE, Turner G, et al. Symptoms, complications and management of long COVID: a review. J R Soc Med. 2021;114(9):428-42. DOI:10.1177/01410768211032850
3. Tanashyan MM, Kuznetsova PI, Raskurazhev AA. Neurological aspects of COVID-19. Annals of Clinical and Experimental Neurology. 2020;14(2):62-9 (in Russian). DOI:10.25692/ACEN.2020.2.8
4. Raskurazhev AA, Kuznetsova PI, Konovalov RN, Tanashyan MM. Olfactory Dysfunctions in COVID-19: Clinical and Neuroimaging Analysis. Neurological Diseases. 2022;2:4-7 (in Russian). DOI:10.24412/2226-0757-2022-12818
5. Olesen J, Gustavsson A, Svensson M, et al. The economic cost of brain disorders in Europe. Eur J Neurol. 2012;19(1):155-62. DOI:10.1111/j.1468-1331.2011.03590.x
6. Jacobson GP, Newman CW. The development of the dizziness handicap inventory. Arch Otolaryngol Head Neck Surg. 1990;116:424-7. DOI:10.1001/archotol.1990.01870040046011.
7. Ceban F, Ling S, Lui LMW, et al. Fatigue and cognitive impairment in Post-COVID-19 Syndrome: A systematic review and meta-analysis. Brain Behav Immun. 2022;101:93-135. DOI:10.1016/j.bbi.2021.12.020
8. Tanashyan MM, Raskurazhev AA, Kuznetsova PI, at al. Prospects and possibilities for the treatment of patients with long COVID-19 syndrome. Terapevticheskii Arkhiv (Ter. Arkh.). 2022;94(11):1285-93 (in Russian). DOI:10.26442/00403660.2022.11.201981
9. Fietsam AC, Bryant AD, Rudroff T. Fatigue and perceived fatigability, not objective fatigability, are prevalent in people with post-COVID-19. Exp Brain Res. 2022:1-9. DOI:10.1007/s00221-022-06518-0
10. Tana C, Bentivegna E, Cho SJ, et al. Long COVID headache. J Headache Pain. 2022;23(1):93. DOI:10.1186/s10194-022-01450-8
11. Medic G, Wille M, Hemels ME. Short- and long-term health consequences of sleep disruption. Nat Sci Sleep. 2017;9:151-61. DOI:10.2147/NSS.S134864
12. Jahrami H, BaHammam AS, Bragazzi NL, et al. Sleep problems during the COVID-19 pandemic by population: a systematic review and meta-analysis. J Clin Sleep Med. 2021;17(2):299-313. DOI:10.5664/jcsm.8930
13. Viselli L, Salfi F, D'Atri A, et al. Sleep Quality, Insomnia Symptoms, and Depressive Symptomatology among Italian University Students before and during the Covid-19 Lockdown. Int J Environ Res Public Health. 2021;18(24):13346. DOI:10.3390/ijerph182413346
14. Hartung TJ, Neumann C, Bahmer T, et al. Fatigue and cognitive impairment after COVID-19: A prospective multicentre study. EClinicalMedicine. 2022;53:101651. DOI:10.1016/j.eclinm.2022.101651
15. Ludwig S, Schell A, Berkemann M, et al. Post-COVID-19 Impairment of the Senses of Smell, Taste, Hearing, and Balance. Viruses. 2022;14(5):849. DOI:10.3390/v14050849
16. COVID-19 Mental Disorders Collaborators. Global prevalence and burden of depressive and anxiety disorders in 204 countries and territories in 2020 due to the COVID-19 pandemic. Lancet. 2021;398(10312):1700-12. DOI:10.1016/S0140-6736(21)02143-7
1 ФГБНУ «Научный центр неврологии», Москва, Россия;
2 ФГБОУ ВО «Национальный исследовательский Мордовский государственный университет им. Н.П. Огарева», Саранск, Россия
*angioneurology0@gmail.com
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Marine M. Tanashyan1, Polina I. Kuznetsova*1, Anton A. Raskurazhev1, Kira Ia. Zaslavskaya2
1 Scientific Center of Neurology, Moscow, Russia;
2 Ogarev National Research Mordovian State University, Saransk, Russia
*angioneurology0@gmail.com