المؤلفون: Alexandra Taube A., Alexandr Kazakov S., Marya Darmostukova A., Natalya Velts Yu., Elena Shubnikova V., Renad Alyautdin N., Александра Таубэ Альбертовна, Александр Казаков Сергеевич, Мария Дармостукова Андреевна, Наталия Вельц Юрьевна, Елена Шубникова Владимировна, Ренад Аляутдин Николаевич

المصدر: Safety and Risk of Pharmacotherapy; Том 8, № 3 (2020); 160-162 ; Безопасность и риск фармакотерапии; Том 8, № 3 (2020); 160-162 ; 2619-1164 ; 2312-7821 ; 10.30895/2312-7821-2020-8-3

مصطلحات موضوعية: remdesivir, tocilizumab, COVID-19, adverse drug reactions, safety profile, ремдесивир, тоцилизумаб, нежелательные реакции, профиль безопасности

وصف الملف: application/pdf

Relation: https://www.risksafety.ru/jour/article/view/197/287; Guaraldi G, Meschiari M, Cozzi-Lepri A, Milic J, Tonelli R, Menozzi M, et al. Tocilizumab in patients with severe COVID-19: a retrospective cohort study. Lancet Rheumatol. 2020;2(8):e474–e484. https://doi.org/10.1016/S2665-9913(20)30173-9; Favalli EG, Caporali R. GM-CSF in the treatment of COVID-19: a new conductor in the pathogenesis of cytokine storm? Lancet Rheumatol. 2020;2(8):e448–e449. https://doi.org/10.1016/S2665-9913(20)30185-5; Fu B, Xu X, Wei H. Why tocilizumab could be an effective treatment for severe COVID-19? J Transl Med. 2020;18(1):164. https://doi.org/10.1186/s12967-020-02339-3; Singh AK, Singh A, Singh R, Misra A. Remdesivir in COVID-19: a critical review of pharmacology, pre-clinical and clinical studies. Diabetes Metab Syndr. 2020;14(4):641–8. https://doi.org/10.1016/j.dsx.2020.05.018; Sheahan TP, Sims AC, Leist SR, Schäfer A, Won J, Brown AJ, et al. Comparative therapeutic efficacy of remdesivir and combination lopinavir, ritonavir, and interferon beta against MERS-CoV. Nat Commun. 2020;11(1):222. https://doi.org/10.1038/s41467-019-13940-6; Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, et al. Remdesivir for the treatment of Covid-19 – preliminary report. N Engl J Med. 2020;383:10.1056/NEJMc2022236#sa5. https://doi.org/10.1056/NEJMc2022236; Wang Y, Zhang D, Du G, Du R, Zhao J, Jin Y, at al. Remdesivir in adults with severe COVID-19: a randomised, double-blind, placebo-controlled, multicentre trial. Lancet. 2020;395(10236):1569–78. https://doi.org/10.1016/S0140-6736(20)31022-9; Agostini ML, Andres EL, Sims AC, Graham RL, Sheahan TP, Lu X, et al. Coronavirus susceptibility to the antiviral remdesivir (GS-5734) is mediated by the viral polymerase and the proofreading exoribonuclease. mBio. 2018;9(2):e00221-18. https://doi.org/10.1128/mBio.00221-18; Pardo J, Shukla AM, Chamarthi G, Gupte A. The journey of remdesivir: from Ebola to COVID-19. Drugs Context. 2020;9:2020-4-14. https://doi.org/10.7573/dic.2020-4-14; Bimonte S, Crispo A, Amore A, Celentano E, Cuomo A, Cascella M. Potential antiviral drugs for SARS-Cov-2 treatment: preclinical findings and ongoing clinical research. In Vivo. 2020;34(3 Suppl):1597–1602. https://doi.org/10.21873/invivo.11949; Xu X, Han M, Li T, Sun W, Wang D, Fu B, et al. Effective treatment of severe COVID-19 patients with tocilizumab. Proc Natl Acad Sci USA. 2020;117(20):10970–5. https://doi.org/10.1073/pnas.2005615117; Zhang C, Wu Z, Li JW, Zhao H, Wang GQ. Cytokine release syndrome in severe COVID-19: interleukin-6 receptor antagonist tocilizumab may be the key to reduce mortality. Int J Antimicrob Agents. 2020;55(5):105954. https://doi.org/10.1016/j.ijantimicag.2020.105954; Zhou F, Yu T, Du R, Fan G, Liu Y, Liu Z, et al. Clinical course and risk factors for mortality of adult in patients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020;395(10229):1054–62. https://doi.org/10.1016/S0140-6736(20)30566-3; https://www.risksafety.ru/jour/article/view/197

الاتاحة: https://www.risksafety.ru/jour/article/view/197
https://doi.org/10.30895/2312-7821-2020-8-3-160-162

المؤلفون: R. Alyautdin N., B. Romanov K., A. Yavorsky N., N. Bunyatyan D., V. Merkulov A., A. Mironov N., Ренад Аляутдин Николаевич, Борис Романов Константинович, Александр Яворский Николаевич, Наталья Бунятян Дмитриевна, Вадим Меркулов Анатольевич, Александр Миронов Николаевич

المصدر: Safety and Risk of Pharmacotherapy; № 1 (2015); 7-12 ; Безопасность и риск фармакотерапии; № 1 (2015); 7-12 ; 2619-1164 ; 2312-7821 ; undefined

مصطلحات موضوعية: средства передовой терапии, нежелательные реакции, факторы риска, advanced therapy, medicinal products, adverse reactions, risk factors

وصف الملف: application/pdf

Relation: https://www.risksafety.ru/jour/article/view/3/4; Procedural advice on the provision of scientific recommendation on classification of advanced therapy medicinal products in accordance with article 17 of regulation (EC) no 1394/2007. 2013. EMA.; Reflection paper on classification of advanced therapy medicinal products. 2012. EMA.; http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000266.jsp&mid=WC0b01ac05800292a4.; http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/03/WC500139748.pdf.; http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=Oj:L:2009:194:0007:0 010:EN:PDF.; http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/06/WC500169466.pdf.; Lentz T., Gray S., Samulski R. Viral Vectors for Gene Delivery to the Central Nervous System. Neurobiol Dis. 2012; 48(2): 179-188.; Torrecilla J., Rodriguez-Gascуn A., Soling M.A. Lipid Nanoparticles as Carriers for RNAi against Viral Infections: Current Status and Future Perspectives. BioMed Research International. 2014, Article ID 161794, 17 p.; https://www.risksafety.ru/jour/article/view/3; undefined

الاتاحة: https://www.risksafety.ru/jour/article/view/3

المؤلفون: R. Alyautdin N., B. Romanov K., V. Merkulov A., Ренад Аляутдин Николаевич, Борис Романов Константинович, Вадим Меркулов Анатольевич

المصدر: Safety and Risk of Pharmacotherapy; № 3 (2015); 22-29 ; Безопасность и риск фармакотерапии; № 3 (2015); 22-29 ; 2619-1164 ; 2312-7821 ; undefined

مصطلحات موضوعية: нанотехнологии, фуллерены, РЭС, печень, токсичность, nanotechnology, fullerene, RES, liver, toxicity

وصف الملف: application/pdf

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Acute and subacute toxicity study of water soluble polyalkylsulfonated C60 in rats. Toxicol Pathol 1998; 26:143-151.; Yamashita K., Yoshioka Y., Pan H. Biochemical and hematologic effects of polyvinylpyrrolidone-wrapped fullerene C60 after oral administration. Pharmazie 2013; 68(1):54-7.; Folkmann J.K., Risom L., Jacobsen N.R., Wallin H. Oxidatively damaged DNA in rats exposed by oral gavage to C60 fullerenes and single-walled carbon nanotubes. Environ Health Perspec 2009; 117:703-708.; Gharbi N., Pressac M., Hadchouel M. (2005) [60] Fullerene is a powerful antioxidant in vivo with no acute or subacute toxicity. Nano Lett 2005; 5:2578-85.; Zogovic N.S., Nikolic N.S., Vranjes-Djuric S.D. et al. Opposite effects on nanocrystalline fullerene (C60) on tumor cell growth in vitro and in vivo and a possible role of immunosuppression in the cancerpromoting activity of C60. Biomaterials 2009; 30:6940-6946.; Chien C.T., Lee P.H., Chen C.F., Ma M.C. 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Distribution and biomarkers of carbon-14-labeled fullerene C60 ([14 C(U)]C60 ) in female rats and mice for up to 30 days after intravenous exposure. J Appl Toxicol 2015. Doi:10.1002/jat.3110.; Snyder R.W., Fennell T.R., Wingard C.J. Distribution and biomarker of carbon-14 labeled fullerene C60 ([14 C(U)]C60 ) in pregnant and lactating rats and their offspring after maternal intravenous exposure. J Appl Toxicol 2015 doi:10.1002/jat.3177.; Nikolicr N., Vranjes-Ethuricr S., Jankovicr. Preparation and biodistribution of radiolabeled fullerene C60 nanocrystals. Nanotechnology 2009; 20:385102.; Li Z., Pan L.L., Zhang F.L. Preparation and characterization of fullerene (C60) amino acid nanoparticles for liver cancer cell treatment. J Nanosci Nanotechnol 2014 Jun;14(6):4513-8.; Shamenkov D.A., Petrov V.E., Alyautdin R.N. Effects of apolipoproteins on dalargin transport across the blood-brain barrier. 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الاتاحة: https://www.risksafety.ru/jour/article/view/18