Magnetic properties of Gd_{1-x}Pr_xBa_2Cu_3O_{7-y} single crystals

Magnetic properties were studied for the high quality Al-free orthorhombic Gd_{1-x}Pr_xBa_2Cu_3O_{7-y} single crystals (0<=x<=1.0) grown by the flux method. An indication on the interaction between the Pr and Cu(2) magnetic sublattices was found for Pr123. Different signs of magnetic anisotropy were established for the Pr and Gd ions at low temperatures. It was also shown that superconductivity reported by Zou et al. [Phys. Rev. Lett. 80 (1998) 1074] for Pr123 single crystals grown by TSZF method seems to be connected with partial substitution of Ba for the Pr-sites.Comment: 2 pages (LaTeX2e), 4 EPS figures, phbauth style file included. LT22 conference paper accepted to Physica

STRUCTURAL ORGANIZATION OF AGGRESSIVENESS IN ADOLESCENTS WITH DIFFERENT LEVELS OF «END-NON-IMPRESSURE» AND «END-UNY»

The research of the structural organization of the components of aggressiveness in adolescents with different levels of envy-dislike and envy-despondency has been conducted. With the assistance of structural-psychological analysis, it has established that the structures of aggressiveness in adolescents with medium and high levels of envy-despondency are heterogeneous, that is, qualitatively differing in weight of elements in the compared structures. The structure of aggressiveness in adolescents with an average level of envy-despondency is more consistent, in adolescents with a high level of envy-despondency, on the contrary, the degree of functioning of the structure of aggressiveness is lower, that is the latter it is more independent

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

ПЛАНИРОВАНИЕ И ОЦЕНКА ИССЛЕДОВАНИЙ БИОЭКВИВАЛЕНТНОСТИ ПРЕПАРАТОВ АТАЗАНАВИРА

The Government of the Russian Federation approved the State strategy of combating the spread of HIV aimed at prevention of HIV epidemic. One of the goals of the Strategy is to increase the coverage of antiretroviral therapy for people infected with HIV, which includes extensive use of generic drugs. In order for a generic drug to be authorised, the applicant has to submit a report on the results of the bioequivalence studies in which the generic product was compared to the reference product. Atazanavir is an antiretroviral drug, which is also the drug of choice for the treatment and prevention of mother-to-child transmission of HIV. The aim of this study was to analyze the protocols and reports of atazanavir products bioequivalence studies, which were submitted for expert examination  to the FSBI “SCEEMP” of the Ministry of Health of the Russian Federation, and to prepare recommendations  for planning of bioequivalence studies of atazanavir products. The analysis of a number of studies revealed significant differences in the study design and number of subjects. The main reason for these differences is the conflicting data on the intrasubject coefficient of variation of atazanavir, which means that atazanavir may be considered a highly variable drug. The analysis helped to formulate  recommendations for the design of bioequivalence  studies of atazanavir products,  including studies of the maximum dose, studies under fed conditions, and consideration  of atazanavir variation when planning the study design.С целью предупреждения развития  эпидемии, связанной с распространением ВИЧ-инфекции,  Правительством Российской Федерации была утверждена Государственная стратегия  противодействия распространению ВИЧ. Одной  из  задач  стратегии  является  увеличение  охвата антиретровирусной терапией  зараженных  ВИЧ-инфекцией, в том числе за счет широкого применения воспроизведенных лекарственных препаратов. Для регистрации воспроизведенного препарата необходимо представление отчета о результатах исследования его биоэквивалентности в сравнении с референтным препаратом. Атазанавир,  используемый в антиретровирусной терапии,  является  приоритетным препаратом при лечении и профилактике вертикальной передачи ВИЧ у беременных.  Был проведен анализ протоколов  и отчетов исследований биоэквивалентности препаратов  атазанавира, поступивших  на экспертизу  в ФГБУ «НЦЭСМП» Минздрава России,  с целью подготовки  рекомендаций по планированию исследований их биоэквивалентности. В результате проведенного анализа  ряда исследований выявлены  существенные отличия  в дизайне  исследований и количестве добровольцев. Основной причиной указанных  отличий  являются  противоречивые данные  о коэффициенте внутрииндивидуальной вариабельности атазанавира, указывающие  на возможное  отнесение атазанавира к высоковариабельным препаратам. На основании анализа сформулированы рекомендации по планированию исследований биоэквивалентности препаратов  атазанавира, включающие  в себя проведение  исследования на максимальной дозировке препарата, проведение  исследования после  еды и учет данных  по вариабельности атазанавира при выборе  дизайна исследования

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