Экологическая культура политического восприятия глобальных природоохранных проблем

The article discusses the theoretical and methodological problems of actively developing in modern conditions ecological culture, determining its place in the system of humanities. The growing importance of new conception of scientific research and sociocultural practices in the context of the global problems of our time is determined.It is necessary to know the experts’ opinion which environmental problems are being identified as most significant. Only afterwards we can find the ways to solve them. Thereby based on the analysis of materials of the Russian scientific-practical conference with international participation “Environmental protection as a factor of the socio-economic development of municipalities: experience and problems” (2017, Rostov-on-Don, Kurgan), and the results of the Russian expert opinion research conducted by scientists of Rostov scientific elitological school it was concluded that there is an objective necessity to create a unified structure of natural resource management and environmental protection in territorial entities (Vorontsov, Mamychev, Ponedelkov, Yanguzin and Vildanov, 2017; Ponedelkov, Starostin, Mamychev, Grigoryan and Verenich, 2018). At the same time, the prerequisites and trends, the problematic aspects of the development of environmentally-oriented processes in modern Russian conditions determine that the organization of an effective environmental protection policy as a factor of socio-economic development and mechanisms of the implementation its strategic goals in the field of environmental development existing public administration system is possible only if appropriate conditions are created for the dynamic development of the system of environmental education and upbringing, as well as the necessity of developing the implementation of a new civilizational paradigm as a new eco-human behavioral paradigmEl artículo discute los problemas teóricos y metodológicos de desarrollar activamente en las condiciones modernas la cultura ecológica, determinando su lugar en el sistema de humanidades. Se determina la importancia creciente de la nueva concepción de la investigación científica y las prácticas socioculturales en el contexto de los problemas globales de nuestro tiempo.Es necesario conocer la opinión de los expertos sobre qué problemas ambientales se están identificando como los más significativos. Solo después podremos encontrar las formas de resolverlos. De este modo, se basa en el análisis de los materiales de la conferencia científico-práctica rusa con participación internacional "La protección del medio ambiente como factor del desarrollo socioeconómico de los municipios: experiencia y problemas" (2017, Rostov-on-Don, Kurgan), y el Los resultados de la investigación de expertos rusos realizada por científicos de la escuela científica elitológica de Rostov concluyeron que existe una necesidad objetiva de crear una estructura unificada de gestión de recursos naturales y protección ambiental en entidades territoriales (Vorontsov, Mamychev, Ponedelkov, Yanguzin y Vildanov, 2017; Ponedelkov, Starostin, Mamychev, Grigoryan y Verenich, 2018). Al mismo tiempo, los prerrequisitos y las tendencias, los aspectos problemáticos del desarrollo de procesos orientados al medio ambiente en las condiciones modernas de Rusia determinan que la organización de una política de protección ambiental efectiva como un factor del desarrollo socioeconómico y los mecanismos de implementación sean estratégicos. objetivos en el campo del desarrollo ambiental El sistema de administración pública existente solo es posible si se crean las condiciones adecuadas para el desarrollo dinámico del sistema de educación y educación ambiental, así como la necesidad de desarrollar la implementación de un nuevo paradigma de civilización como un nuevo eco. -el paradigma del comportamiento humano.Экологические интересы, выступая одной из материализованных предпосылок человеческой деятельности являются также и показателем качества жизни, уровня развитости общественной морали, правовой культуры общества. В современных политических условиях первостепенное значение имеет институциализация экологических интересов в трех основных секторах общества – государство, сфера производства, общественность (в любой последовательности, но обязательно при наличии этих трех компонентов). В этом контексте интерес представляет как свойство определенной социальной общности, отдельного индивида или группы и выступает в качестве одного из самых существенных факторов, воздействующих на поведение этих социальных единиц в экологической среде, так, и определяющих их наиболее существенные поведенческие акции. и социокультурных практик в контексте глобальных проблем современности.Для установления болевых точек и определения путей решения экологических проблем необходимо знать мнение экспертов о том, какие из этих проблем волнуют людей в наибольшей степени. В связи с этим, на основе анализа материалов Всероссийской научно-практической конференции с международным участием «Защита окружающей среды как фактор социально-экономического развития территорий муниципальных образований: опыт и проблемы» (2017 год, Ростов-на-Дону, Курган), а также результатов общероссийского экспертного опроса, проведенного учеными Ростовской научной элитологической школы, были сделаны о том, что объективно назрела необходимость в создании единой структуры природоресурсного и природоохранного регулирования в территориальных образованиях. В то же время предпосылки и тенденции, проблемные аспекты развития эколого-ориентированных процессов в современных российских условиях таковы, что формирование эффективной политики защиты окружающей среды, рассматриваемой как фактор социально-экономического развития и механизмов реализации ее стратегических целей в области экологического развития в рамках функционирования действующей системы государственного управления, возможно только при создании соответствующих условий для динамичного развития системы экологического образования и воспитания, как и необходимость разработки осуществления новой цивилизационной парадигмы в качестве новой поведенческой парадигмы эко-человека в целом.В статье рассматриваются теоретико-методологические проблемы активно развивающейся в современных условиях экологической культуры, определения ее места в системе гуманитарного знания. Определено все возрастающее значение этого нового представления научных исследовани

Recommendations for the Programme of Clinical Trials of Medicinal Products for the Treatment of Influenza

The development of new medicinal products to treat influenza is motivated by the limitations of existing treatment options, the emergence of drug resistance, and the health consequences of influenza epidemics associated with the highly contagious nature of the virus. Proper planning and implementation of clinical programmes providing reliable data on the efficacy and safety of medicinal products under development requires adherence to recommendations of the regulatory authorities. At the moment, the Russian Federation, the Eurasian Economic Union, and the European Union lack documented recommendations on conducting clinical trials of anti-influenza medicines. There is a need in national guidelines that will reflect the procedure for conducting clinical trials and establish the required amount of data to be submitted with marketing applications for new anti-influenza products. The aim of this study was to analyse possible regulatory approaches to planning clinical development programmes for anti-influenza medicinal products. The article pays particular attention to phase III studies, as the main studies confirming efficacy and safety. The authors described a clinical development strategy and the requirements for the volume and quality of efficacy and safety data. This article is based on the current Russian recommendations for the design and development of medicinal products and guidelines on their evaluation, as well as the recommendations by the U.S. Food and Drug Administration (FDA). The analysis results demonstrate the necessity for elaborating Russian recommendations for clinical studies of medicinal products for the treatment of influenza that will take into account the national legislation and clinical development practices. Such recommendations will streamline the implementation of new effective anti-influenza medicinal products

Immuno oriented therapy for mandible fractures in patients at high risk of developing inflammatory complications

Comparative clinical and immunological analysis of treatment of 49 patients with fractures of the mandible, receiving traditional therapy and treatment with use of immumomodulator leukinferon is carried out in this work. The results of the study demonstrate, that use of immunocorrection with leukinferon gives high immunological effect in comparison with traditional patients treatment. Positive dynamics of immunological parameters changes at patients is closely correlates with current of a clinical state in posttraumatic period. Use of leukinferon in complex therapy at patients with fracture of the mandible with high risk of inflammatory complications development allows to improve a condition of patients in shorter period and to warn inflammatory complications development

Рекомендации по программе клинических исследований лекарственных препаратов для лечения гриппа

The development of new medicinal products to treat influenza is motivated by the limitations of existing treatment options, the emergence of drug resistance, and the health consequences of influenza epidemics associated with the highly contagious nature of the virus. Proper planning and implementation of clinical programmes providing reliable data on the efficacy and safety of medicinal products under development requires adherence to recommendations of the regulatory authorities. At the moment, the Russian Federation, the Eurasian Economic Union, and the European Union lack documented recommendations on conducting clinical trials of anti-influenza medicines. There is a need in national guidelines that will reflect the procedure for conducting clinical trials and establish the required amount of data to be submitted with marketing applications for new anti-influenza products. The aim of this study was to analyse possible regulatory approaches to planning clinical development programmes for anti-influenza medicinal products. The article pays particular attention to phase III studies, as the main studies confirming efficacy and safety. The authors described a clinical development strategy and the requirements for the volume and quality of efficacy and safety data. This article is based on the current Russian recommendations for the design and development of medicinal products and guidelines on their evaluation, as well as the recommendations by the U.S. Food and Drug Administration (FDA). The analysis results demonstrate the necessity for elaborating Russian recommendations for clinical studies of medicinal products for the treatment of influenza that will take into account the national legislation and clinical development practices. Such recommendations will streamline the implementation of new effective anti-influenza medicinal products.Последствия вспышек эпидемий гриппа, связанных с высококонтагиозным характером инфекции, а также ограничения существующих методов лечения и возникновение лекарственной резистентности обуславливают актуальность разработки новых лекарственных препаратов для лечения этого заболевания. Надлежащее планирование программы и проведение клинических исследований, гарантирующих получение корректных данных об эффективности и безопасности разрабатываемых препаратов, обеспечивается соблюдением рекомендаций регуляторных органов. На данный момент в Российской Федерации и Евразийском экономическом союзе отсутствуют документы, содержащие рекомендации по проведению клинических исследований противогриппозных препаратов. Существует потребность в разработке отечественного руководства, отражающего порядок проведения клинических исследований, а также регламентирующего необходимый объем данных, которые должны быть представлены при регистрации новых противогриппозных препаратов. Цель работы — изучение основных возможных регуляторных подходов к планированию программ клинических исследований лекарственных препаратов для лечения гриппа. Особое внимание уделено клиническим исследованиям III фазы как основным исследованиям, подтверждающим эффективность и безопасность препарата. Описана стратегия клинических исследований препарата, требования к объему и качеству данных по эффективности и безопасности. Материал подготовлен на основе действующих рекомендаций к планированию и разработке лекарственных средств в Российской Федерации, руководства по экспертизе лекарственных средств и рекомендаций Управления по контролю за качеством продуктов питания и лекарственных средств США. В результате проведенного анализа показана необходимость разработки отечественных рекомендаций по проведению клинических исследований препаратов для лечения гриппа с учетом специфики юридических норм и традиций российской клинической практики. Разработка таких рекомендаций приведет к ускорению ввода в практику новых эффективных препаратов против гриппа

Menstrual function and mental health of medical students during the COVID-19 pandemic: a continuous cross-sectional study

Aim. To assess the impact of new coronavirus infection (NCI) and COVID-19 vaccination on menstrual function in comparison with the frequency of depressive disorders during the COVID-19 pandemic among female students of a medical university. Materials and methods. Data for a continuous transverse (cross-sectional) study were obtained using an online survey. The questions included demographics, characteristics of menstrual function, the history of COVID-19 and vaccinations against it, and the standard CES-D (Center for Epidemiologic Studies Depression Scale) questionnaire. The survey included 1.879 female medical students. The exclusion criteria were age under 18 and over 25 years, hormonal contraceptives, pregnancy, childbirth during the last year, and vaccination after COVID-19. After applying the exclusion criteria, three study groups were formed. Group 1 included female students with a history of NCI (n=140), group 2 included students with no history of NCI, who were initially vaccinated against COVID-19 (n=647), group 3 (control group) included unvaccinated students with no history of NCI (n=55). Results. There were no differences in the prevalence of changes in menstrual function in female students after the NCI (49.3%) and after COVID-19 vaccination (39.6%) compared to the control group (43.6%); p=0.477. The rate of depression in the overall study cohort was 43.3%, without any significant differences between the study groups. Significant predictors of changes in menstrual function during the pandemic were marriage (odds ratio OR 2.33 [1.513.61]), depression (OR 1.72 [1.282.3]), a history of menstrual dysfunction (OR 1.5 [0.121.99]), and later menarche (OR 1.76 [1.023.04]). Multivariate analysis did not show the significance of the history of NCI and vaccination as factors of menstrual dysfunction (OR 1.61 [0.892.90] and OR 0.91 [0.591.41], respectively). Conclusion. During the COVID-19 pandemic, female medical students reported frequent changes in menstrual function and depressive disorders. During the pandemic, the most significant predictors of menstrual disorders in female students were depression, a history of menstrual dysfunction, and marriage. A multicenter prospective study is necessary to clarify the mechanisms of the pandemic's impact on menstrual function

Russian clinical practice guidelines «congenital adrenal hyperplasia»

Congenital adrenal hyperplasia (CAH) is a group of autosomal recessive diseases characterized by a defect in one of the enzymes or transport proteins involved in the cortisol synthesis in the adrenal cortex. The most common form of CAH, which occurs in more than 90% of cases, is a 21-hydroxylase enzyme deficiency. The latter is subdivided into nonclassical and classic (salt-losing and virilizing) forms. The prevalence of classic forms of 21-hydroxylase deficiency ranges from 1: 14,000 to 1:18,000 live births worldwide. According to the data of neonatal screening in the Russian Federation, the prevalence of the disease in some regions ranges from 1: 5000 to 1: 12000, in the country as a whole - 1: 9638 live newborns. The non-classical form of CAH occurs more often - from 1: 500 to 1: 1000 among the general population. In second place is the hypertensive form of CAH - a deficiency of 11β-hydroxylase, which, according to the literature, occurs in about 1 per 100,000 newborns. These clinical guidelines were compiled by a professional community of narrow specialists, approved by the expert council of the Ministry of Health of the Russian Federation, and updated the previous version published in 2016. The clinical guidelines are based on systematic reviews, meta-analyses and original articles, and scientific work on this issue in the Russian Federation and other countries. The purpose of this document is to provide clinicians with the most up-to-date, evidence-based guidelines for the CAH diagnosis and treatmen

The recombinant fusion protein CFP10–ESAT6–dIFN has protective effect against tuberculosis in guinea pigs

Development of effective vaccine candidates against tuberculosis (TB) is currently the most important challenge in the prevention of this disease since the BCG vaccine fails to guarantee a lifelong protection, while any other approved vaccine with better efficiency is still absent. The protective effect of the recombinant fusion protein CFP10–ESAT6–dIFN produced in a prokaryotic expression system (Escherichia coli) has been assessed in a guinea pig model of acute TB. The tested antigen comprises the Mycobacterium tuberculosis (Mtb) proteins ESAT6 and CFP10 as well as modified human γ-interferon (dIFN) for boosting the immune response. Double intradermal immunization of guinea pigs with the tested fusion protein (2 × 0.5 µg) induces a protective effect against subsequent Mtb infection. The immunized guinea pigs do not develop the symptoms of acute TB and their body weight gain was five times more as compared with the non-immunized infected guinea pigs. The animal group immunized with this dose of antigen displays the minimum morphological changes in the internal organs and insignificant inflammatory lesions in the liver tissue, which complies with a decrease in the bacterial load in the spleen and average Mtb counts in macrophages