Semantics and Pragmatics of Palindromes in Language and Internet Communication

The semantic and pragmatic features of palindromes are considered as an important component of the Russian linguistic picture of the world. The question of establishing the scope and boundaries of the concept of “palindrome” is raised, the specificity of the analysis and interpretation of palindromes in modern linguistic science is characterized, the author’s schemes and classifications of palindromes are proposed based on their structure and semantics. Particular attention is paid to palindromes as an example of linguistic creativity, present both in a literary text and in virtual communication. A review of linguistic research on polyndromia is made. The novelty of the research is seen in the fact that for the first time a comprehensive linguistic analysis of palindromes is carried out as an element of Internet communication, highlighting the most valuable topics and ideas that underlie the modeling of palindromes. It is proved that when palindromes are implemented in the current Internet space, their specificity changes: in contexts, there is a shift in emphasis from aesthetics (form) to pragmatics (content) of palindromes, which fully corresponds to the idea of an anthropocentric paradigm and a semantic-cognitive approach in the study of language

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

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

ВЕДЕНИЕ БЕРЕМЕННОСТИ, РОДОВ И ПОСЛЕРОДОВОГО ПЕРИОДА У ПАЦИЕНТКИ С ЛЕКАРСТВЕННО-УСТОЙЧИВЫМ, ДЕСТРУКТИВНЫМ ТУБЕРКУЛЕЗОМ ЛЕГКИХ ПОСЛЕ ЭТАПНОГО ХИРУРГИЧЕСКОГО ЛЕЧЕНИЯ

The article describes a clinical case of the successful management of pregnancy, delivery and post-natal period in the female patient with fibrous cavernous tuberculosis with extensive drug resistance and multiple thoracic surgeries in the past. This clinical case demonstrates that it is possible for a mother with the advanced form of tuberculosis to give birth to a healthy mature newborn.Представлено клиническое наблюдение успешного ведения беременности, родов и послеродового периода у пациентки с фиброзно-кавернозным туберкулезом с широкой лекарственной устойчивостью возбудителя и многократными торакальными операциями в анамнезе. Показана возможность рождения здорового доношенного ребенка у матери с тяжелой формой туберкулеза

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