Evaluation of therapeutic equivalence of amorolfine hydrochloride-containing drugs: results of an open-label randomized multicenter study ; Оценка терапевтической эквивалентности препаратов, содержащих аморолфин гидрохлорид: результаты открытого рандомизированного многоцентрового исследования

Authors: Samtsov A.V., Araviyskaya E.A., Kotrechova L.P.

Contributors: The study was conducted with the financial support of Glenmark Pharmaceuticals Limited, Mumbai, India, representative of the sponsor in the Russian Federation — Glenmark Impex LLC, Moscow, Russia., Исследование проведено при финансовой поддержке компании «Гленмарк Фармасьютикалз Лимитед» (Glenmark Pharmaceuticals Limited), Мумбаи, Индия, представитель спонсора в Российской Федерации — ООО «Гленмарк Импэкс», Москва, Россия.

Source: Vestnik dermatologii i venerologii; Vol 101, No 1 (2025); 98-108 ; Вестник дерматологии и венерологии; Vol 101, No 1 (2025); 98-108 ; 2313-6294 ; 0042-4609 ; 10.25208/vdv.1011

Subject Terms: tinea pedis, amorolfine, skin cream, clinical trial, микоз стоп, аморолфин, крем, клиническое исследование

File Description: application/pdf

Relation: https://vestnikdv.ru/jour/article/view/16845/pdf_1; https://vestnikdv.ru/jour/article/view/16845/pdf; https://vestnikdv.ru/jour/article/downloadSuppFile/16845/158988; https://vestnikdv.ru/jour/article/downloadSuppFile/16845/158989; https://vestnikdv.ru/jour/article/downloadSuppFile/16845/158990; https://vestnikdv.ru/jour/article/downloadSuppFile/16845/158991; https://vestnikdv.ru/jour/article/downloadSuppFile/16845/159232; https://vestnikdv.ru/jour/article/downloadSuppFile/16845/159233; https://vestnikdv.ru/jour/article/view/16845

Availability: https://vestnikdv.ru/jour/article/view/16845
https://doi.org/10.25208/vdv16845

Safety of the New Russian Anti-smallpox Medicinal Product NIOCH-14: Open, Randomised Phase I Clinical Trial Results ; Безопасность нового российского противооспенного препарата ­НИОХ-14: открытое рандомизированное клиническое исследование I фазы

Authors: L. N. Shishkina, M. P. Bogryantseva, N. I. Bormotov, S. V. Usova, M. O. Skarnovich, O. Yu. Mazurkov, E. S. Bashkina, N. S. Kutserubova, S. G. Udalyeva, A. A. Sergeev, A. P. Agafonov, Л. Н. Шишкина, М. П. Богрянцева, Н. И. Бормотов, С. В. Усова, М. О. Скарнович, О. Ю. Мазурков, Е. С. Башкина, Н. С. Куцерубова, С. Г. Удальева, А. А. Сергеев, А. П. Агафонов

Contributors: This study was conducted by the State Research Center of Virology and Biotechnology ‘Vector’ as part of the applied research funded under State Assignment No. SA-42/24, Работа выполнена в рамках Государственного задания № ГЗ-42/24 ФБУН ГНЦ ВБ «Вектор» Роспотребнадзора

Source: Safety and Risk of Pharmacotherapy; Том 13, № 1 (2025); 20-30 ; Безопасность и риск фармакотерапии; Том 13, № 1 (2025); 20-30 ; 2619-1164 ; 2312-7821 ; 10.30895/2312-7821-2025-13-1

Subject Terms: клиническое исследование, NIOCH-14, orthopoxviruses, mpox, monkeypox, smallpox, safety, tolerability, clinical trial, НИОХ-14, ортопоксвирусы, оспа обезьян, натуральная оспа, безопасность, переносимость

File Description: application/pdf

Relation: https://www.risksafety.ru/jour/article/view/467/1353; https://www.risksafety.ru/jour/article/downloadSuppFile/467/601; https://www.risksafety.ru/jour/article/downloadSuppFile/467/607; https://www.risksafety.ru/jour/article/downloadSuppFile/467/609; https://www.risksafety.ru/jour/article/downloadSuppFile/467/615; https://www.risksafety.ru/jour/article/downloadSuppFile/467/616; Ефременко ДВ. Биологическая безопасность массовых мероприятий: особенности лабораторной диагностики. Журнал микробиологии, эпидемиологии и иммунобиологии. 2018;(1):45–52. https://doi.org/10.36233/0372-9311-2018-1-45-52; Аюбова ЛР, Найдина КА, Стасенков АВ, Сапронов ГИ. Биотерроризм как угроза человечеству: прошлое и настоящее. Молодежный инновационный вестник. 2019;8(2):326–7.; Álvarez Argüelles ME, Martínez ZP, Alba SR, González Alba JM, Fernandez-Verdugo AM, González IC, et al. Detecting, quantifying, and isolating monkeypox virus in suspected cases, Spain. Emerg Infect Dis. 2023;29(7):1465–9. https://doi.org/10.3201/eid2907.221229; Brosius I, Van Dijck C, Coppens J, Vandenhove L, Bangwen E, Vanroye F, et al. Presymptomatic viral shedding in high-risk mpox contacts: A prospective cohort study. J Med Virol. 2023;95(5):e28769. https://doi.org/10.1002/jmv.28769; Yuan S, Jiang SC, Zhang ZW, Fu YF, Yang XY, Li ZL, Hu J. How and when does monkeypox (mpox) transmit: Implications for prevention and treatments. Front Pharmacol. 2023;5(13):1109928. https://doi.org/10.3389/fphar.2022.1109928; Шишкина ЛН, Сергеев АН, Агафонов АП, ­Сергеев АА, Кабанов АС, Булычев ЛЕ и др. Лечебно-профилактическое средство против вируса натуральной оспы и способы его получения и применения. Патент Российской Федерации № 2543338; 2015.; Mazurkov OYu, Kabanov AS, Shishkina LN, Sergeev AА, Skarnovich MO, Bormotov NI, et al. The new effective chemically synthesized anti-smallpox compound NIOCH-14. J Gen Virol. 2016;97(5):1229–39. https://doi.org/10.1099/jgv.0.000422; Мазурков ОЮ, Шишкина ЛН, Бормотов НИ, Скарнович МО, Серова ОА, Мазуркова НА и др. Оценка абсолютной биодоступности химической субстанции противооспенного препарата ­НИОХ-14 в экспериментах на мышах. Бюллетень экспериментальной биологии и медицины. 2020;170(8):173–7.; Shukla AK, Misra S. Tecovirimat: A comprehensive review of novel drug for monkeypox disease. Int J Curr Pharm Research. 2023;15(5):45–9. https://doi.org/10.22159/ijcpr.2023v15i5.3066; Imran M, Alshammari MK, Arora MK, Dubey AK, Das SS, Kamal M, et al. Oral brincidofovir therapy for monkeypox outbreak: A focused review on the therapeutic potential, clinical studies, patent literature, and prospects. Biomedicines. 2023;11(2):278. https://doi.org/10.3390/biomedicines11020278; Мазурков ОЮ, Шишкина ЛН, Бормотов НИ, Скарнович МО, Серова ОА, Мазуркова НА, и др. Фармакокинетические показатели субстанции ­НИОХ-14 — нового противооспенного фармакологического вещества. Экспериментальная и клиническая фармакология. 2021;84(5):22–6. https://doi.org/10.30906/0869-2092-2021-84-5-22-26; Shishkina LN, Mazurkov OYu, Bormotov NI, Skarnovich MO, Serova OA, Mazurkova NA, et al. Safety and pharmacokinetics of the substance of the anti-smallpox drug NIOCH-14 after oral administration to laboratory animals. Viruses. 2023;­15(1):205. https://doi.org/10.3390/v15010205; Шишкина ЛН, Шеремет ОП, Мадонов ПГ, Корчажникова НП, Бормотов НИ, Скарнович МО, и др. Пероральная лекарственная форма препарата в капсулах для лечения и профилактики заболеваний, вызываемых ортопоксвирусами. Патент Российской Федерации № 2716709; 2020.; Chinsangaram J, Honeychurch KM, Tyavanagimatt SR, Leeds JM, Bolken TC, Jones KF, et al. Safety and pharmacokinetics of the anti-orthopoxvirus compound ST-246 following a single daily oral dose for 14 days in human volunteers. Antimicrob Agents Chemother. 2012;56(9):4900–5. https://doi:10.1128/AAC.00904-12; https://www.risksafety.ru/jour/article/view/467

Availability: https://www.risksafety.ru/jour/article/view/467
https://doi.org/10.30895/2312-7821-2025-467

Safety, reactogenicity, and immunogenicity of a viral vector vaccine against influenza A: Phase I open clinical trial ; Безопасность, реактогенность и иммуногенность векторной вакцины против гриппа А: открытое клиническое исследование I фазы

Authors: M. M. Shmarov, S. V. Alekseeva, N. A. Dovzhenko, A. S. Bandelyuk, I. B. Esmagambetov, D. N. Shcherbinin, L. V. Verkhovskaya, S. V. Volchihina, Ya. V. Simakova, V. F. Babira, D. Y. Logunov, A. L. Gintsburg, М. М. Шмаров, С. В. Алексеева, Н. А. Довженко, А. С. Банделюк, И. Б. Есмагамбетов, Д. Н. Щербинин, Л. В. Верховская, С. В. Волчихина, Я. В. Симакова, В. Ф. Бабира, Д. Ю. Логунов, А. Л. Гинцбург

Contributors: This clinical trial was funded under the State Assignment “Development of a broad-spectrum vaccine against influenza A based on recombinant viral vectors” (R&D Registry No. АААА-А17-117030110102-3), Государственное задание «Разработка вакцины широкого спектра действия против вирусов гриппа А на основе рекомбинантных вирусных векторов», номер госрегистрации АААА-А17-117030110102-3

Source: Biological Products. Prevention, Diagnosis, Treatment; Том 25, № 1 (2025); 7-21 ; БИОпрепараты. Профилактика, диагностика, лечение; Том 25, № 1 (2025); 7-21 ; 2619-1156 ; 2221-996X ; 10.30895/2221-996X-2025-25-1

Subject Terms: нежелательные реакции, universal influenza vaccine, viral vector vaccine against influenza A, intranasal vaccine, clinical trial, safety, reactogenicity, immunogenicity, adverse events, adverse drug reactions, универсальная противогриппозная вакцина, векторная вакцина против гриппа А, интраназальная вакцина, клиническое исследование, безопасность, реактогенность, иммуногенность, нежелательные явления

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Эпидемиология и вакцинопрофилактика. 2019;18(5):109–20. https://doi.org/10.31631/2073-3046-2019-18-5-109-120; Chen R, Holmes EC. Avian influenza virus exhibits rapid evolutionary dynamics. Mol Biol Evol. 2006;23(12):2336–41. https://doi.org/10.1093/molbev/msl102; Thompson AJ, Paulson JC. Adaptation of influenza viruses to human airway receptors. J Biol Chem. 2021;296:100017. https://doi.org/10.1074/jbc.rev120.013309; Krammer F, Smith GJD, Fouchier RAM, Peiris M, Kedzierska K, Doherty PC, et al. Influenza. Nat Rev Dis Primers. 2018;4(1):3. https://doi.org/10.1038/s41572-018-0002-y; Koutsakos M, Kedzierska K, Subbarao K. Immune responses to avian influenza viruses. J Immunol. 2019;202(2):382–91. https://doi.org/10.4049/jimmunol.1801070; Halder N, Kelso JK, Milne GJ. A model-based economic analysis of pre-pandemic influenza vaccination cost-effectiveness. BMC Infect Dis. 2014;14:266. https://doi.org/10.1186/1471-2334-14-266; Ostrowsky J, Arpey M, Moore K, Osterholm M, Friede M, Gordon J. Tracking progress in universal influenza vaccine development. Curr Opin Virol. 2020;40:28–36. https://doi.org/10.1016/j.coviro.2020.02.003; Logunov DY, Dolzhikova IV, Shcheblyakov DV, Tukhvatulin AI, Zubkova OV, Dzharullaeva AS, et al. Safety and efficacy of an rAd26 and rAd5 vector-based heterologous prime-boost COVID-19 vaccine: An interim analysis of a randomised controlled phase 3 trial in Russia. Lancet. 2021;397(10275):671–81. https://doi.org/10.1016/s0140-6736(21)00234-8; Zhang C, Zhou D. Adenoviral vector-based strategies against infectious disease and cancer. Hum Vaccin Immunother. 2016;12(8):2064–74. https://doi.org/10.1080/21645515.2016.1165908; Lenaerts L, De Clercq E, Naesens L. Clinical features and treatment of adenovirus infections. Rev Med Virol. 2008;18(6):357–74. https://doi.org/10.1002/rmv.589; Крюкова НО, Ракунова ЕБ, Костинов МП, Баранова ИА, Свитич ОА. Секреторный иммуноглобулин А респираторной системы и COVID-19. Пульмонология. 2021;31(6):792–8. https://doi.org/10.18093/0869-0189-2021-31-6-792-798; Зайнутдинов СС, Сиволобова ГФ, Локтев ВБ, Кочнева ГВ. Мукозальный иммунитет и вакцины против вирусных инфекций. Вопросы вирусологии. 2021;66(6):399–408. https://doi.org/10.36233/0507-4088-82; Alu A, Chen L, Lei H, Wei Y, Tian X, Wei X. Intranasal COVID-19 vaccines: From bench to bed. EBioMedicine. 2022;76:103841. https://doi.org/10.1016/j.ebiom.2022.103841; Седова ЕС, Верховская ЛВ, Артемова ЭА, Щербинин ДН, Лысенко АА, Руднева ИА и др. Защита мышей от заражения вирусом гриппа птиц субтипа H7 с помощью иммунизации рекомбинантным аденовирусом, кодирующим консервативные антигены вируса гриппа А. БИОпрепараты. Профилактика, диагностика, лечение. 2020;20(1):60–7. https://doi.org/10.30895/2221-996X-2020-20-1-60-67; Tutykhina I, Esmagambetov I, Bagaev A, Pichugin A, Lysenko A, Shcherbinin D, et al. Vaccination potential of B and T epitope-enriched NP and M2 against influenza A viruses from different clades and hosts. PLoS One. 2018;13(1): e0191574. https://doi.org/10.1371/journal.pone.0191574; Smirnov YA, Lipatov AS, Van Beek R, Gitelman AK, Osterhaus AD, Claas EC. Characterization of adaptation of an avian influenza A (H5N2) virus to a mammalian host. Acta Virol. 2000;44(1):1–8. PMID: 10989685; Черенова ЛВ, Каштиго ТВ, Саядян ХС, Шмаров ММ. Разработка вакцин на основе аденовирусных векторов: обзор зарубежных клинических исследований (часть 1). Медицинская иммунология 2017;19(2):111–26. https://doi.org/10.15789/1563-0625-2017-2-111-126; Черенова ЛВ, Каштиго ТВ, Саядян ХС, Шмаров ММ. Разработка вакцин на основе аденовирусных векторов: обзор зарубежных клинических исследований (часть 2). Медицинская иммунология. 2017;19(4):329–58. https://doi.org/10.15789/1563-0625-2017-4-329-358; Dolzhikova IV, Zubkova OV, Tukhvatulin AI, Dzharullaeva AS, Tukhvatulina NM, Shcheblyakov DV, et al. Safety and immunogenicity of GamEvac-Combi, a heterologous VSV- and Ad5-vectored Ebola vaccine: An open phase I/II trial in healthy adults in Russia. Hum Vaccin Immunother. 2017;13(3):613–20. https://doi.org/10.1080/21645515.2016.1238535; Tasker S, O’Rourke AW, Suyundikov A, Booth P-GJ, Bart St, Krishnan V, et al. Safety and immunogenicity of a novel intranasal influenza vaccine (NasoVAX): A phase 2 randomized, controlled trial. Vaccines. 2021;9(3):224. https://doi.org/10.3390/vaccines9030224; Зуев ЕВ, Евдокимова ОЛ, Маркова ОА, Короткевич ИА, Григорьева ТВ, Хамитов РА. Сравнительная оценка безопасности интраназальной и внутримышечной иммунизации вакцинами для профилактики коронавирусной инфекции на основе аденовирусов Ad26 и Ad5. БИОпрепараты. Профилактика, диагностика, лечение. 2023;23(3):275–89. https://doi.org/10.30895/2221-996X-2023-23-431; Krammer F, Weir JP, Engelhardt O, Katz JM, Cox RJ. 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Availability: https://www.biopreparations.ru/jour/article/view/606
https://doi.org/10.30895/2221-996X-2025-25-1-7-21

Planning a Clinical Trial Programme for Medicinal Products for Chronic Constipation: An Analysis of the European Medicines Agency Guideline ; Программа клинических исследований лекарственных препаратов для лечения хронического запора: анализ Руководства Европейского агентства по лекарственным средствам

Authors: I. A. Proskurina, T. E. Gorskaya, R. S. Ilin, D. V. Goryachev, И. А. Проскурина, Т. Е. Горская, Р. С. Ильин, Д. В. Горячев

Contributors: 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&D Registry No. 124022300127-0)., 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).

Source: Regulatory Research and Medicine Evaluation; Online First ; Регуляторные исследования и экспертиза лекарственных средств; Online First ; 3034-3453 ; 3034-3062

Subject Terms: слабительные средства, clinical trial, medicinal product, efficacy, safety, guidelines, European Medicines Agency, EMA, laxatives, клиническое исследование, лекарственный препарат, эффективность, безопасность, руководство, Европейское агентство по лекарственным средствам, ЕМА

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Availability: https://www.vedomostincesmp.ru/jour/article/view/734
https://doi.org/10.30895/1991-2919-2025-734

ВЛИЯНИЕ СОКА ФИОЛЕТОВОГО КАРТОФЕЛЯ НА КЛИНИЧЕСКИЙ СТАТУС И ГЕМАТОЛОГИЧЕСКИЕ ПОКАЗАТЕЛИ КРЫС

Subject Terms: крысы, сок фиолетового картофеля, клиническое исследование, гематологические показатели

ВЛИЯНИЕ СОКА ФИОЛЕТОВОГО КАРТОФЕЛЯ НА КЛИНИЧЕСКИЙ СТАТУС И ГЕМАТОЛОГИЧЕСКИЕ ПОКАЗАТЕЛИ КРЫС

Subject Terms: крысы, сок фиолетового картофеля, клиническое исследование, гематологические показатели

Specifics of motivation of volunteers participating in in a clinical trial of the COVID-19 vaccine

Authors: Y. D. Belousova, V. V. Rafalsky, E. D. Kislova

Source: Качественная клиническая практика, Vol 0, Iss 4, Pp 4-12 (2023)

Subject Terms: RS1-441, мотивация участия в клиническом исследовании, Pharmacy and materia medica, covid-19, социологическое исследование, коронавирусная инфекция, Medical technology, клиническое исследование, вакцина, R855-855.5, 16. Peace & justice, 3. Good health

Access URL: https://doaj.org/article/2d4f6c5ce2c243afb2befc1a8f8738a3

Applying real-world data to support regulatory decision — making in the United States

Authors: M. A. Borzova, А. S. Kolbin

Source: Качественная клиническая практика, Vol 0, Iss 1, Pp 64-69 (2021)

Subject Terms: RS1-441, Pharmacy and materia medica, пострегистрационное клиническое исследование, Medical technology, неинтервенционное клиническое исследование, R855-855.5, 16. Peace & justice, исследования реальной клинической практики

Access URL: https://www.clinvest.ru/jour/article/download/564/576
https://doaj.org/article/d5f912bd0a444185b7fa63216b1b68a4
https://www.clinvest.ru/jour/article/view/564/576
https://www.clinvest.ru/jour/article/download/564/576
https://cyberleninka.ru/article/n/primenenie-dannyh-realnoy-klinicheskoy-praktiki-dlya-podderzhki-prinyatiya-regulyatornyh-resheniy-v-ssha

Legal aspects of conducting real-world studies

Authors: V. V. Sikachev, V. V. Gorin, A. S. Kolbin, D. Yu. Belousov

Source: Качественная клиническая практика, Vol 0, Iss 5, Pp 64-69 (2021)

Subject Terms: RS1-441, 2. Zero hunger, Pharmacy and materia medica, пострегистрационное клиническое исследование, Medical technology, неинтервенционное клиническое исследование, R855-855.5, 16. Peace & justice, исследования реальной клинической практики

Access URL: https://www.clinvest.ru/jour/article/download/552/560
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https://www.clinvest.ru/jour/article/download/552/560
https://cyberleninka.ru/article/n/pravovye-aspekty-provedeniya-issledovaniy-realnoy-klinicheskoy-praktiki

Алфлутоп® в практике врача (обзор литературы)

Authors: Khassenova, G.P.

Source: INTERNATIONAL NEUROLOGICAL JOURNAL; № 6.92 (2017); 84-92
МЕЖДУНАРОДНЫЙ НЕВРОЛОГИЧЕСКИЙ ЖУРНАЛ; № 6.92 (2017); 84-92
МІЖНАРОДНИЙ НЕВРОЛОГІЧНИЙ ЖУРНАЛ; № 6.92 (2017); 84-92

Subject Terms: 03 medical and health sciences, 0302 clinical medicine, clinical research, Alflutop®, osteoarthrosis, coхar­throsis, pain syndrome, клінічне дослідження, Алфлутоп®, остеоартроз, коксартроз, больовий синдром, клиническое исследование, болевой синдром, 3. Good health

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Access URL: http://inj.zaslavsky.com.ua/article/download/111592/140660
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http://inj.zaslavsky.com.ua/article/view/111592

Hydrogen therapy from the initiation to its practical applications ; Терапия водородом: от идеи до практического применения

Authors: Sh. Ohta, Ш. Ота

Contributors: This study was not sponsored, Спонсорская поддержка отсутствовала

Source: PULMONOLOGIYA; Том 34, № 5 (2024); 624-633 ; Пульмонология; Том 34, № 5 (2024); 624-633 ; 2541-9617 ; 0869-0189

Subject Terms: передача сигнала, Alzheimer’s disease, cancer, cardiac arrest, clinical trial, heme, hydrogen medicine, lipid peroxide, metabolic syndrome, multiple functions, oxidation, porphyrin, signal transduction, quarity-of-life, болезнь Альцгеймера, рак, остановка сердца, клиническое исследование, гем, водородная медицина, перекисное окисление липидов, метаболический синдром, множественные функции, окисление, порфирин

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Molecular hydrogen as a preventive and therapeutic medical gas: initiation, development and potential of hydrogen medicine. Pharmacol. Ther. 2014; 144 (1): 1–11. DOI:10.1016/j.pharmthera.2014.04.006.; Li L., Lou W., Kong L., Shen W. Hydrogen commonly applicable from medicine to agriculture: from molecular mechanisms to the field. Curr. Pharm. Des. 2021; 27 (5): 747–759. DOI:10.2174/1381612826666201207220051.; Sano M., Ichihara G., Katsumata Y. et al. Pharmacokinetics of a single inhalation of hydrogen gas in pigs. PLoS One. 2020; 15 96): e0234626. DOI:10.1371/journal.pone.0234626.; Ichihara G., Katsumata Y., Moriyama H. et al. Pharmacokinetics of hydrogen after ingesting a hydrogen-rich solution: a study in pigs. Heliyon. 2021; 7 (11): e08359. DOI:10.1016/j.heliyon.2021.e08359.; Li J., Wang C., Zhang J.H. et al. Hydrogen-rich saline improves memory function in a rat model of amyloid-beta-induced Alzheimer's disease by reduction of oxidative stress. Brain Res. 2010; 1328: 152–161. 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Fe-porphyrin: a redox-related biosensor of hydrogen molecule. Nano Research. 2023; 16 (2): 2020–2025. DOI:10.1007/s12274-022-4860-y.; Sun X., Ohta S., Zhang J.H. Discovery of a hydrogen molecular target. Med. Gas Res. 2023; 13 (2): 41–42. DOI:10.4103/2045-9912.356472.; Ohta S. Molecular hydrogen may activate the transcription factor Nrf2 to alleviate oxidative stress through the hydrogen-targeted porphyrin. Aging Pathobiol. Ther. 2023; 5 (1): 25–32. DOI:10.31491/APT.2023.03.104.; Zhou Y., Wu H., Zhao M. et al. The Bach family of transcription factors: a comprehensive review. Clin. Rev. Allergy Immunol. 2016; 50 (3): 345–356. DOI:10.1007/s12016-016-8538-7.; Igarashi K., Kurosaki T., Roychoudhuri R. BACH transcription factors in innate and adaptive immunity. Nat. Rev. Immunol. 2017; 17 (7): 437–450. DOI:10.1038/nri.2017.26.; Song Q., Mao X., Jing M. et al. Pathophysiological role of BACH transcription factors in digestive system diseases. Front. Physiol. 2023; 14: 1121353. DOI:10.3389/fphys.2023.1121353.; Dixon S.J., Pratt D.A. Ferroptosis: A flexible constellation of related biochemical mechanisms. Mol. Cell. 2023; 83 (7): 1030–1042. DOI:10.1016/j.molcel.2023.03.005.; Iuchi K., Nishimaki K., Kamimura N., Ohta S. Molecular hydrogen suppresses free-radical-induced cell death by mitigating fatty acid peroxidation and mitochondrial dysfunction. Can. J. Physiol. Pharmacol. 2019; 97 (10): 999–1005. DOI:10.1139/cjpp-2018-0741.; Kamimura N., Ichimiya H., Iuchi K., Ohta S. Molecular hydrogen stimulates the gene expression of transcriptional coactivator PGC-1α to enhance fatty acid metabolism. NPJ. Aging. Mech. Dis. 2016; 2: 16008. DOI:10.1038/npjamd.2016.8.; Luchi K., Imoto A., Kamimura N. et al. Molecular hydrogen regulates gene expression by modifying the free radical chain reaction-dependent generation of oxidized phospholipid mediators. Sci. Rep. 2016; 6: 18971. DOI:10.1038/srep18971.; Matsumoto A., Yamafuji M., Tachibana T. et al. Oral 'hydrogen water' induces neuroprotective ghrelin secretion in mice. Sci. Rep. 2013; 3: 3273. DOI:10.1038/srep03273.; Kamimura N., Nishimaki K., Ohsawa I., Ohta S. Molecular hydrogen improves obesity and diabetes by inducing hepatic FGF21 and stimulating energy metabolism in db/db mice. Obesity (Silver Spring). 2011; 19 (7): 1396–1403. DOI:10.1038/oby.2011.6.; Nicolson G.L., de Mattos G.F., Settineri R. et al. Clinical effects of hydrogen administration: from animal and human diseases to exercise medicine. Int. J. Clin. Med. 2016; 7 (1): 32–76. DOI:10.4236/ijcm.2016.71005.; Johnsen H.M., Hiorth M., Klaveness J. Molecular hydrogen therapy-a review on clinical studies and outcomes. Molecules. 2023; 28 (23): 7785. DOI:10.3390/molecules28237785.; Mizuno K., Sasaki A.T., Ebisu K. et al. Hydrogen-rich water for improvements of mood, anxiety, and autonomic nerve function in daily life. Med. Gas Res. 2018; 7 (4): 247–255. DOI:10.4103/2045-9912.222448.; Mikami T., Tano K., Lee H. et al. Drinking hydrogen water enhances endurance and relieves psychometric fatigue: a randomized, double-blind, placebo-controlled study. Can. J. Physiol. Pharmacol. 2019; 97 (9): 857–862. DOI:10.1139/cjpp-2019-0059.; Botek M., Krejci J., McKune A.J., Sladeckova B. Hydrogen-rich water supplementation and up-hill running performance: effect of athlete performance level. Int. J. Sports Physiol. Perform. 2020; 15 (8): 1193–1196. DOI:10.1123/ijspp.2019-0507.; Ostojic S.M. Hydrogen gas as an exotic performance-enhancing agent: challenges and opportunities. Curr. Pharm. Des. 2021; 27 (5): 723–730. DOI:10.2174/1381612826666200922155242.; Botek M., Krejci J., McKune A. et al. Hydrogen rich water consumption positively affects muscle performance, lactate response, and alleviates delayed onset of muscle soreness after resistance training. J. Strength Cond. Res. 2022; 36 (10): 2792–2799. DOI:10.1519/jsc.0000000000003979.; Zhou K., Liu M., Wang Y. et al. Effects of molecular hydrogen supplementation on fatigue and aerobic capacity in healthy adults: a systematic review and meta-analysis. Front. Nutr. 2023; 10: 1094767. DOI:10.3389/fnut.2023.1094767.; Liu H., Kang X., Ren P. et al. Hydrogen gas ameliorates acute alcoholic liver injury via anti-inflammatory and antioxidant effects and regulation of intestinal microbiota. Int. Immunopharmacol. 2023; 120: 110252. DOI:10.1016/j.intimp.2023.110252.; Lv X., Lu Y., Ding G. et al. Hydrogen intake relieves alcohol consumption and hangover symptoms in healthy adults: a randomized and placebo-controlled crossover study. Am. J. Clin. Nutr. 2022; 116 (5): 1208–1218. DOI:10.1093/ajcn/nqac261.; Hu A., Yamaguchi T., Tabuchi M. et al. A pilot study to evaluate the potential therapeutic effect of hydrogen-water bathing on atopic dermatitis in humans. Adv. Integr. Med. 2024; 11 (1): 2–9. DOI:10.1016/j.aimed.2023.10.003.; Bajgai J., Lee K.J., Rahman M.H. et al. Role of molecular hydrogen in skin diseases and its impact in beauty. Curr. Pharm. Des. 2021; 27 (5): 737–746. DOI:10.2174/1381612826666200925124235.; Dhillon G., Buddhavarapu V., Grewal H. et al. Hydrogen water: extra healthy or a hoax? – A systematic review. In. J. Mol. Sci. 2024; 25 (2): 973. DOI:10.3390/ijms25020973.; Ono H., Nishijima Y., Ohta S. et al. Hydrogen gas inhalation treatment in acute cerebral infarction: a randomized controlled clinical study on safety and neuroprotection. J. Stroke Cerebrovasc. Dis. 2017; 26 (11): 2587–2594. DOI:10.1016/j.jstrokecerebrovasdis.2017.06.012.; Hayashida K., Sano M., Kamimura N. et al. Hydrogen inhalation during normoxic resuscitation improves neurological outcome in a rat model of cardiac arrest independently of targeted temperature management. Circulation. 2014; 130 (24): 2173–2180. DOI:10.1161/circulationaha.114.011848.; Tamura T., Suzuki M., Homma K. et al. Efficacy of inhaled hydrogen on neurological outcome following brain ischaemia during post-cardiac arrest care (HYBRID II): a multi-centre, randomised, double-blind, placebo-controlled trial. EClinicalMedicine. 2023; 58: 101907. DOI:10.1016/j.eclinm.2023.101907.; Qin S. Role of Hydrogen in atherosclerotic disease: from bench to Bedside. Curr. Pharm. Des. 2021; 27 (5): 713–722. DOI:10.2174/1381612826666201124112152.; Ohsawa I., Nishimaki K., Yamagata K. et al. Consumption of hydrogen water prevents atherosclerosis in apolipoprotein E knockout mice. Biochem. Biophys. Res. Commun. 2008; 377 (4): 1195–1198. DOI:10.1016/j.bbrc.2008.10.156.; Todorovic N., Fernández-Landa J., Santibañez A. et al. The effects of hydrogen-rich water on blood lipid profiles in clinical populations: a systematic review and meta-analysis. Pharmaceuticals (Basel). 2023; 16 (2): 142. DOI:10.3390/ph16020142.; Nagata K., Nakashima-Kamimura N., Mikami T. et al. Consumption of molecular hydrogen prevents the stress-induced impairments in hippocampus-dependent learning tasks during chronic physical restraint in mice. Neuropsychopharmacology. 2009; 34 (2): 501–508. DOI:10.1038/npp.2008.95.; Nishimaki K., Asada T., Ohsawa I. et al. Effects of molecular hydrogen assessed by an animal model and a randomized clinical study on mild cognitive impairment. Curr. Alzheimer Res. 2018; 15 (5): 482–492. DOI:10.2174/1567205014666171106145017.; Kueper J.K., Speechley M., Montero-Odasso M. The Alzheimer's disease assessment scale-cognitive subscale (ADAS-Cog): modifications and responsiveness in pre-dementia populations. A narrative review. J. Alzheimers Dis. 2018; 63 (2): 423–444. DOI:10.3233/jad-170991.; Ayyubova G. APOE4 is a risk factor and potential therapeutic target for Alzheimer's disease. CNS Neurol. Disord. Drug Targets. 2024; 23 (3): 342–352. DOI:10.2174/1871527322666230303114425.; Alm K.H., Bakker A. Relationships between diffusion tensor imaging and cerebrospinal fluid metrics in early stages of the Alzheimer's disease continuum. J. Alzheimers Dis. 2019; 70 (4): 965–981. DOI:10.3233/jad-181210.; Ono H., Nishijima Y., Ohta S. Therapeutic inhalation of hydrogen gas for Alzheimer's disease patients and subsequent long-term follow-up as a disease-modifying treatment: An open label pilot study. Pharmaceuticals (Basel). 2023; 16 (3): 434. DOI:10.3390/ph16030434.; Ono H., Nishijima Y., Sakamoto M. et al. Long-term inhalation of hydrogen gas for patients with advanced Alzheimer's disease: a case report showing improvement in fecal Incontinence. Med. Res. Arch. 2022; 10 (7). DOI:10.18103/mra.v10i7.2951.; Rahman M.H., Bajgai J., Sharma S. et al. Effects of hydrogen gas inhalation on community-dwelling adults of various ages: a single-arm, open-label, prospective clinical trial. Antioxidants (Basel). 2023; 12 (6): 1241. DOI:10.3390/antiox12061241.; Dan Z., Li H., Xie J. Efficacy of donepezil plus hydrogen-oxygen mixture inhalation for treatment of patients with Alzheimer disease: a retrospective study. Medicine (Baltimore). 2023; 102 (30): e34382. DOI:10.1097/md.0000000000034382.; He J., Liu F., Xu T. et al. The role of hydrogen therapy in Alzheimer's disease management: Insights into mechanisms, administration routes, and future challenges. Biomed. Pharmacother. 2023; 168: 115807. DOI:10.1016/j.biopha.2023.115807.; Nakashima-Kamimura N., Mori T., Ohsawa I. et al. Molecular hydrogen alleviates nephrotoxicity induced by an anti-cancer drug cisplatin without compromising anti-tumor activity in mice. Cancer Chemother. Pharmacol. 2009; 64 (4): 753–761. DOI:10.1007/s00280-008-0924-2.; Kang K.M., Kang Y.N., Choi I.B. et al. Effects of drinking hydrogen-rich water on the quality of life of patients treated with radiotherapy for liver tumors. Med. Gas Res. 2011; 1 (1): 11. DOI:10.1186/2045-9912-1-11.; Akagi J., Baba H. Hydrogen gas restores exhausted CD8+ T cells in patients with advanced colorectal cancer to improve prognosis. Oncol. Rep. 2019; 41 (1): 301–311. DOI:10.3892/or.2018.6841.; Akagi J., Baba H. Hydrogen gas activates coenzyme Q10 to restore exhausted CD8(+) T cells, especially PD-1(+)Tim3(+)terminal CD8(+) T cells, leading to better nivolumab outcomes in patients with lung cancer. Oncol. Lett. 2020; 20 (5): 258. DOI:10.3892/ol.2020.12121.; Mohd Noor M.N.Z., Alauddin A.S., Wong Y.H. et al. A systematic review of molecular hydrogen therapy in cancer management. Asian Pac. J. Cancer Prev. 2023; 24 (1): 37–47. DOI:10.31557/apjcp.2023.24.1.37.; https://journal.pulmonology.ru/pulm/article/view/4512

Availability: https://journal.pulmonology.ru/pulm/article/view/4512
https://doi.org/10.18093/0869-0189-2024-34-5-615-623

Programme for Studying Medicinal Products for Generalised Anxiety Disorder: Analysis of the European Medicines Agency Guideline ; Программа изучения лекарственных препаратов для лечения генерализованного тревожного расстройства: анализ Рекомендаций Европейского агентства по лекарственным средствам

Authors: A. P. Solovyova, I. M. Surmilo, А. П. Соловьева, И. М. Сурмило

Contributors: The study reported in this publication was carried out as part of publicly funded research project No. 056-00026-24-00 and was supported by the Scientific Centre for Expert Evaluation of Medicinal Products (R&D reporting No. 124022300127-0)., Работа выполнена в рамках государственного задания ФГБУ «НЦЭСМП» Минздрава России № 056-00026-24-00 на проведение прикладных научных исследований (номер государственного учета НИР 124022300127-0).

Source: Regulatory Research and Medicine Evaluation; Том 14, № 3 (2024); 351-361 ; Регуляторные исследования и экспертиза лекарственных средств; Том 14, № 3 (2024); 351-361 ; 3034-3453 ; 3034-3062 ; 10.30895/1991-2919-2024-14-3

Subject Terms: руководство ЕМA, clinical trial, study design, co-morbidity, mental health issues, Hamilton Anxiety Rating Scale, Clinical Global Impression Scale, Sheehan Disability Scale, clinical trial planning, EMA guidelines, клиническое исследование, дизайн исследования, коморбидность, психические расстройства, шкала тревоги Гамильтона, шкала общего клинического впечатления, шкала инвалидности Шихана, планирование клинического исследования

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Relation: https://www.vedomostincesmp.ru/jour/article/view/606/1464; https://www.vedomostincesmp.ru/jour/article/view/606/1393; https://www.vedomostincesmp.ru/jour/article/downloadSuppFile/606/617; Залуцкая НМ. Генерализованное тревожное расстройство: современные теоретические модели и подходы к диагностике и терапии. Часть 1. Обозрение психиатрии и медицинской психологии им. В.М. Бехтерева. 2014;(3):80–9. EDN: TBZSND; Караваева ТА, Коцюбинский АП. Холистическая диагностика пограничных психических расстройств. СПб.: Спецлит; 2017. EDN: VTIXZS; Bandelow B, Michaelis S. Epidemiology of anxiety disorders in the 21st century. Dialogues Clin Neurosci. 2015;17(3):327–35. https://doi.org/10.31887/DCNS.2015.17.3/bbandelow; Lijster JM, Dierckx B, Utens EM, Verhulst FC, Zieldorff C, Dieleman GC, Legerstee JS. The age of onset of anxiety disorders. Can J Psychiatry. 2017;62(4):37–46. https://doi.org/10.1177/0706743716640757; Weisberg RB. Overview of generalized anxiety disorder: epidemiology, presentation, and course. J Clin Psychiatry. 2009;70 Suppl 2:4–9. PMID: 19371500; Stein DJ, Scott KM, de Jonge P, Kessler RC. Epidemiology of anxiety disorders: from surveys to nosology and back. Dialogues Clin Neurosci. 2017;19(2):127–36. https://doi.org/10.31887/FDCNS.2017.19.2/dstein; Мартынихин ИА. Гендерные различия эпидемиологии и патогенеза депрессивных и тревожных расстройств в контексте их влияния на эффективность терапии сертралином (Золофтом). Психиатрия и психофармакотерапия. 2019;21(3):52–8. EDN: XBOAQX; Залуцкая НМ. Генерализованное тревожное расстройство: современные теоретические модели и подходы к диагностике и к терапии. Часть 2. Обозрение психиатрии и медицинской психологии им. В.М. Бехтерева. 2014;(4):129–34. EDN: TQUTSH; Maron E, Nutt D. Biological markers of generalized anxiety disorder. Dialogues Clin Neurosci. 2017;19(2):147–58. https://doi.org/10.31887/dcns.2017.19.2/dnutt; Бобров АЕ, Файзрахманова ЕВ. Клинические, личностные и когнитивно-стилевые особенности больных с тревожными расстройствами. Российский психиатрический журнал. 2017;(5):50–8. EDN: ZOGABN; Bandelow B. Current and novel psychopharmacological drugs for anxiety disorders. Adv Exp Med Biol. 2020;1191:347–65. https://doi.org/10.1007/978-981-32-9705-0_19; Cuijpers Р, Sijbrandij M, Koole SL, Andersson G, Beekman AT, Reynolds CF. The efficacy of psychotherapy and pharmacotherapy in treating depressive and anxiety disorders: a meta-analysis of direct comparisons. World Psychiatry. 2013;12(2):137–48. https://doi.org/10.1002/wps.20038; Erickson SR, Guthrie S, Vanetten-Lee M, Himle J, Hoffman J, Santos SF, et al. Severity of anxiety and work-related outcomes of patients with anxiety disorders. Depress Anxiety. 2009;26(12):1165–71. https://doi.org/10.1002/da.20624; Nepon J, Belik SL, Bolton J, Sareen J. The relationship between anxiety disorders and suicide attempts: findings from the National Epidemiologic Survey on Alcohol and Related Conditions. Depress Anxiety. 2010;27(9):791–8. https://doi.org/10.1002/da.20674; Cougle JR, Keough ME, Riccardi CJ, Sachs-Ericsson N. Anxiety disorders and suicidality in the National Comorbidity Survey-Replication. J Psychiatr Res. 2009;43(9):825–9. https://doi.org/10.1016/j.jpsychires.2008.12.004; Pfeiffer PN, Ganoczy D, Ilgen M, Zivin K, Valenstein M. Comorbid anxiety as a suicide risk factor among depressed veterans. Depress Anxiety. 2009;26(8):752–7. https://doi.org/10.1002/da.20583; Hofmeijer-Sevink MK, Batelaan NM, van Megen HJ, Penninx BW, Cath DC, van den Hout MA, van Balkom A. Clinical relevance of comorbidity in anxiety disorders: a report from the Netherlands Study of Depression and Anxiety (NESDA). J Affect Disord. 2012;137(1–3):106–12. https://doi.org/10.1016/j.jad.2011.12.008; Mackenzie CS, Reynolds K, Cairney J, Streiner DL, Sareen J. Disorder-specific mental health service use for mood and anxiety disorders: associations with age, sex, and psychiatric comorbidity. Depress Anxiety. 2012;29(3):234–42. https://doi.org/10.1002/da.20911; https://www.vedomostincesmp.ru/jour/article/view/606

Availability: https://www.vedomostincesmp.ru/jour/article/view/606
https://doi.org/10.30895/1991-2919-2024-14-3-351-361

POSTOPERATIVE COURSE OF PERITONITIS: THE ROLE OF CYTOKINE IMBALANCE

Authors: Chagina, Yevgeniya, Khanina, Elena, Buraya, Varvara, Ivanova, Anna

Subject Terms: перитонит, inflammation, цитокины, pathogenesis, патогенез, клиническое исследование, clinical study, peritonitis, воспаление, cytokines, 3. Good health

Dose-Dependent Efficacy of the Vitex Agnus Castus Extract ZE 440 in Patients Suffering from Premenstrual Syndrome

Source: Репродуктивное здоровье. Восточная Европа. :387-399

Subject Terms: фитотерапия, dose-response, 03 medical and health sciences, Vitex agnus castus, 0302 clinical medicine, рандомизированное клиническое исследование, предменструальный синдром, доза-реакция, chasteberry, randomized controlled trial, premenstrual syndrome, Ze 440, 3. Good health

Применение абатацепта у пациентов с ювенильным идиопатическим артритом – обзор клинических исследований

Subject Terms: генно-инженерная биологическая терапия, абатацепт, juvenile idiopathic arthritis, T cells, Т-лимфоциты, genetically engineered biological therapy, clinical trial, клиническое исследование, ювенильный идиопатический артрит, abatacept

СТАТИН-ИНДУЦИРОВАННЫЕ МЕХАНИЗМЫ НАРУШЕНИЙ УГЛЕВОДНОГО ОБМЕНА

Authors: L. V. Nikonova, S. V. Tishkovskiy, О. А. Shidlovskaya

Source: Žurnal Grodnenskogo Gosudarstvennogo Medicinskogo Universiteta, Vol 19, Iss 2, Pp 147-152 (2021)

Subject Terms: статины, сахарный диабет 2 типа, клиническое исследование, инсулинорезистентность, углеводный обмен, Medicine

File Description: electronic resource

Relation: http://journal-grsmu.by/index.php/ojs/article/view/2581; https://doaj.org/toc/2221-8785; https://doaj.org/toc/2413-0109

Access URL: https://doaj.org/article/a7142e834d0142cea26b373008250171

Clinical Signs and Medical History as Predictors of Enalapril-Associated Dry Cough in Cardiovascular Patients ; Клинико-анамнестические предикторы развития сухого кашля у пациентов с кардиоваскулярной патологией на фоне приема эналаприла

Authors: I. V. Sychev, N. P. Denisenko, A. A. Kachanova, A. V. Lapshtaeva, Sh. P. Abdullaev, L. N. Goncharova, K. B. Mirzaev, D. A. Sychev, И. В. Сычев, Н. П. Денисенко, А. А. Качанова, А. В. Лапштаева, Ш. П. Абдуллаев, Л. Н. Гончарова, К. Б. Мирзаев, Д. А. Сычев

Contributors: This study was sponsored by the Ministry of Health of the Russian Federation. It was carried out as part of publicly funded research project “New Pharmacogenetic Biomarkers of the Safety of Pharmacotherapy of Certain Socially Significant Diseases” (Unified State Information System for Accounting of Scientific Research, Experimental Design and Technological Works for Civil Purposes, No. 121110800062-6)., Работа выполнена при финансовой поддержке Министерства здравоохранения Российской Федерации. Тематика государственного задания: «Новые фармакогенетические биомаркеры безопасности фармакотерапии некоторых социально-значимых заболеваний» (ЕГИСУ НИОКТР № 121110800062-6).

Source: Safety and Risk of Pharmacotherapy; Том 11, № 2 (2023); 231-240 ; Безопасность и риск фармакотерапии; Том 11, № 2 (2023); 231-240 ; 2619-1164 ; 2312-7821

Subject Terms: клиническое исследование, enalapril, dry cough, adverse drug reaction, adverse drug reaction predictors, cardiovascular pathology, history of allergies, clinical study, эналаприл, сухой кашель, нежелательная реакция, предикторы нежелательных реакций, кардиоваскулярная патология, аллергологический анамнез

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Relation: https://www.risksafety.ru/jour/article/view/361/789; https://www.risksafety.ru/jour/article/downloadSuppFile/361/323; https://www.risksafety.ru/jour/article/downloadSuppFile/361/325; https://www.risksafety.ru/jour/article/downloadSuppFile/361/326; https://www.risksafety.ru/jour/article/downloadSuppFile/361/327; https://www.risksafety.ru/jour/article/downloadSuppFile/361/363; Chan NJ, Soliman AM. Angiotensin converting enzyme inhibitor-related angioedema: onset, presentation, and management. Ann Otol Rhinol Laryngol. 2015;124(2):89–96. https://doi.org/10.1177/0003489414543069; Soo Hoo GW, Lin HK, Junaid I, Klaustermeyer WB. Angiotensin-converting enzyme inhibitor angioedema requiring admission to an intensive care unit. Am J Med. 2015;128(7):785–9. https://doi.org/10.1016/j.amjmed.2015.02.006; Brugts JJ. Discontinuation of angiotensin conver ting enzyme inhibitors due to dry cough: incidence and clinical determinants. Clin Pharmacol Ther. 2019;105(3):563. https://doi.org/10.1002/cpt.1130; Borghi C, Cicero AF, Agnoletti D, Fiorini G. Pathophysiology of cough with angiotensin-converting enzyme inhibitors: how to explain within-class differences? Eur J Intern Med. 2023;110:10–5. https://doi.org/10.1016/j.ejim.2023.01.005; Morimoto T, Gandhi TK, Fiskio JM, Seger AC, So JW, Cook EF, et al. An evaluation of risk factors for adverse drug events associated with angiotensin-converting enzyme inhibitors. J Eval Clin Pract. 2004;10(4):499–509. https://doi.org/10.1111/j.1365-2753.2003.00484.x; Ng LP, Goh PS. Incidence of discontinuation of angiotensin-converting enzyme inhibitors due to cough, in a primary healthcare centre in Singapore. Singapore Med J. 2014;55(3):146–9. https://doi.org/10.11622/smedj.2014034; Nasser J, Al Aradi K, Kubra SE, Omran A. High incidence of cough among users of angiotensin-converting enzyme inhibitors. Bahrain Med Bull. 2018;40(2):97–9. https://doi.org/10.12816/0047558; Jamshed F, Jaffry H, Hanif H, Kumar V, Naz U, Ahmed M, Fareed S. Demographic and clinical characteristics of patients presenting with angiotensin-converting enzyme inhibitors induced cough. Cureus. 2019;11(9):e5624. https://doi.org/10.7759/cureus.5624; Lavorini F, Chellini E, Innocenti M, Campi G, Egan CG, Mogavero S, Fontana GA. A crossover randomized comparative study of zofenopril and ramipril on cough reflex and airway inflammation in healthy volunteers. Cough. 2014;10(1):7. https://doi.org/10.1186/s12997-014-0007-5; Boonyapisit W, Tresukosol D. Comparison of the incidence of imidapril and enalapril induced cough. J Med Assoc Thai. 2010;93 Suppl 1:S48–53. PMID: 20364557; Loo HC, Osman F, Ho SL, An SY, Yong YMA, Khoo EM. Incidence of angiotensin-converting enzyme inhibitor-induced cough in a Malaysian public primary care clinic: a retrospective cohort study. Malays Fam Physician. 2022;17(1):66–70. https://doi.org/10.51866/oa.80; Liang L, Kung JY, Mitchelmore B, Gill J, Cave A, Banh HL. Angiotensin-converting enzyme inhibitor induced cough in Chinese patients: a systematic review and meta-analysis. J Pharm Pharm Sci. 2021;24:137–47. https://doi.org/10.18433/jpps31632; Mateti UV, Nekkanti H, Vilakkathala R, Rajakannan T, Mallayasamy S, Ramachandran P. Pattern of angiotensin-converting enzyme inhibitors induced adverse drug reactions in South Indian teaching hospital. N Am J Med Sci. 2012;4(4):185–9. https://doi.org/10.4103/1947-2714.94945; Olowofela AO, Isah AO. A profile of adverse effects of antihypertensive medicines in a tertiary care clinic in Nigeria. Ann Afr Med. 2017;16(3):114-119. https://doi.org/10.4103/aam.aam_6_17; Schröder H. Reizhusten bei ACE-Hemmer-Einnahme [Dry cough from ACE inhibitors]. Med Monatsschr Pharm. 2005;28(9):321–2. German. PMID: 16163883; Tebha SS, Zaidi ZA, Sethar S, Virk MAA, Yousaf MN. Angiotensin converting enzyme inhibitor associated spontaneous herniation of liver mimicking a pleural mass: a case report. World J Hepatol. 2022;14(4):854–9. https://doi.org/10.4254/wjh.v14.i4.854; Trovato DA, Sousa JE, Bruetman JE, Finn BC, Young P. Fracturas costales simétricas asociadas a tos [Symmetrical rib fractures associated with chronic cough. Report of one case]. Rev Med Chil. 2018;146(3):391–3. Spanish. https://doi.org/10.4067/s0034-98872018000300391; Pinto B, Jadhav U, Singhai P, Sadhanandham S, Shah N. ACEI-induced cough: a review of current evidence and its practical implications for optimal CV risk reduction. Indian Heart J. 2020;72(5):345–50. https://doi.org/10.1016/j.ihj.2020.08.007; Fox AJ, Lalloo UG, Belvisi MG, Bernareggi M, Chung KF, Barnes PJ. Bradykinin-evoked sensitization of airway sensory nerves: a mechanism for ACE-inhibitor cough. Nat Med. 1996;2(7):814–7. https://doi.org/10.1038/nm0796-814; Yılmaz İ. Angiotensin-converting enzyme inhibitors induce cough. Turk Thorac J. 2019;20(1):36–42. https://doi.org/10.5152/TurkThoracJ.2018.18014; Fernandez-Rando M, Herrera MD, Almeida-González CV, Grilo A. Days needed for the disappearance of a cough due to the use of an angiotensin-converting enzyme inhibitor and identification of predisposing factors associated with its appearance in a clinical cohort of hypertensive patients. J Clin Pharmacol. 2021;61(5):591–7. https://doi.org/10.1002/jcph.1786; Teklay G, Gebremedhin A, Ayalew E. Prevalence of cough among patients treated with angiotensin converting enzyme inhibitors. International Journal of Pharma Sciences and Research. 2014;12(5):992–8.; Sato A, Fukuda S. A prospective study of frequency and characteristics of cough during ACE inhibitor treatment. Clin Exp Hypertens. 2015;37(7):563–8. https://doi.org/10.3109/10641963.2015.1026040; Wyskida K, Jura-Szołtys E, Smertka M, Owczarek A, Chudek J. Factors that favor the occurrence of cough in patients treated with ramipril—a pharmacoepidemiological study. Med Sci Monit. 2012;18(9):PI21–8. https://doi.org/10.12659/msm.883336; https://www.risksafety.ru/jour/article/view/361

Availability: https://www.risksafety.ru/jour/article/view/361
https://doi.org/10.30895/2312-7821-2023-11-2-231-240

Antibiotic-Associated Drug-Induced Liver Injury in Critically Ill Children: A Prospective Observational Study ; Лекарственное поражение печени, ассоциированное с антибиотиками, у детей в критических состояниях: проспективное наблюдательное исследование

Authors: A. V. Vlasova, Yu. F. Shubina, D. A. Sychev, А. В. Власова, Ю. Ф. Шубина, Д. А. Сычев

Contributors: The study was performed without external funding, Работа выполнена без спонсорской поддержки

Source: Safety and Risk of Pharmacotherapy; Том 12, № 2 (2024); 155-166 ; Безопасность и риск фармакотерапии; Том 12, № 2 (2024); 155-166 ; 2619-1164 ; 2312-7821 ; 10.30895/2312-7821-2024-12-2

Subject Terms: клиническое исследование, antibiotics, drug-induced liver diseases, DILI, hepatotoxicity, cholestatic hepatitis, adverse drug reactions, Global Trigger Tool, clinical trial, антибиотики, лекарственно-индуцированные заболевания печени, гепатотоксичность, холестатический гепатит, нежелательные реакции, метод глобальных триггеров

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Availability: https://www.risksafety.ru/jour/article/view/389
https://doi.org/10.30895/2312-7821-2023-389

Efficacy and safety of Vespireit® (buspirone) prolonged-release tablets (PR) 15 mg in the therapy of patients with functional dizziness: results of the double-blind, placebo-controlled, multicenter, randomized, phase 3 clinical trial ; Эффективность и безопасность препарата Веспирейт® (буспирон), таблетки с пролонгированным высвобождением, 15 мг, у пациентов с функциональным головокружением: результаты двойного слепого плацебоконтролируемого многоцентрового рандомизированного клинического исследования III фазы

Authors: M. V. Zamergrad, V. A. Parfenov, A. S. Agafina, N. V. Lyamina, M. M. Gavrik, L. R. Kuchumova, E. R. Barantsevich, V. S. Krasnov, A. A. Ivanova, A. L. Vladykin, K. А. Ishchenko, М. В. Замерград, В. А. Парфенов, А. С. Агафьина, Н. В. Лямина, М. М. Гаврик, Л. Р. Кучумова, Е. Р. Баранцевич, В. С. Краснов, А. А. Иванова, А. Л. Владыкин, К. А. Ищенко

Contributors: This article has been supported by Valenta Pharm, Статья спонсируется компанией «Валента Фарм»

Source: Neurology, Neuropsychiatry, Psychosomatics; Vol 15, No 5 (2023); 20-34 ; Неврология, нейропсихиатрия, психосоматика; Vol 15, No 5 (2023); 20-34 ; 2310-1342 ; 2074-2711 ; 10.14412/2074-2711-2023-5

Subject Terms: клиническое исследование, functional dizziness, persistent postural-perceptual dizziness, chronic subjective dizziness, phobic postural vertigo, buspirone, Vespireit®, prolonged-release tablets, clinical trial, функциональное головокружение, персистирующее постурально-перцептивное головокружение, хроническое субъективное головокружение, постуральная фобическая неустойчивость, буспирон, Веспирейт®, таблетки с пролонгированным высвобождением

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https://doi.org/10.14412/2074-2711-2023-5-20-34

Planning of clinical trial programmes for medicines for the treatment of obesity ; Планирование программы клинических исследований препаратов для лечения ожирения

Authors: I. A. Proskurina, T. E. Gorskaya, D. V. Goryachev, И. А. Проскурина, Т. Е. Горская, Д. В. Горячев

Contributors: The study reported in this publication was carried out as part of publicly funded research project No. 056-00052-23-00 and was supported by the Scientific Centre for Expert Evaluation of Medicinal Products (R&D public accounting No. 121021800098-4)., Работа выполнена в рамках государственного задания ФГБУ «НЦЭСМП» Минздрава России № 056- 00052-23-00 на проведение прикладных научных исследований (номер государственного учета НИР 121021800098-4)

Source: Regulatory Research and Medicine Evaluation; Том 13, № 4 (2023); 503-518 ; Регуляторные исследования и экспертиза лекарственных средств; Том 13, № 4 (2023); 503-518 ; 3034-3453 ; 3034-3062

Subject Terms: безопасность, clinical trial, medicinal products, efficacy, endpoints, safety, клиническое исследование, лекарственные препараты, эффективность, конечные точки

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https://doi.org/10.30895/1991-2919-2023-452