Social and humanitarian expert assessment of biomedical innovations

Nowadays the necessity of introducing effective constituents of ethical and humanitarian comprehension of innovations to science, especially in the field of biomedicine, is becoming increasingly apparent. In this regard, it is of particular interest to compare the opinions of student-age youth and the experts - well-known Russian scientists on the use of new converging technologies and their impact on an individual and societ

Converting the sociotechnical convergence hazards into the risks of digitalisation

The creation of digital network platforms is accompanied by an ambiguous process of sociotechnical convergence, during which certain hazards arise as factors that destabilize the functioning of a digital platform, and risks as an expectation of the occurrence of these events.   The purpose of the study is to assess the level of conversion of the sociotechnical convergence hazards into the corresponding risks.   The research methodology is based on the ecosystem approach and the concept of platform research, supplemented by the authors with the ideas of sociotechnical convergence.   To study the conversion of the sociotechnical convergence hazards into the risks of digitalization, the method of empirical verification based on a representative sociological survey was applied. Theresult of the taxonomic division was the classification of hazards in such subject areas as (hazard of failure); digital surveillance (hazard of excessive digital surveillance); digital morality (hazard of decision-making by artificial intelligence); digital identification (hazard of identification error); digital privacy (hazard of unauthorized use of personal data); digital communication (hazard of virtualization of social contacts); digital accessibility (hazard of digital inequality); digital clusters (hazard of social network segmentation); digital competence (hazard of digital outsider). The authors come to the conclusion that not all hazards are converted into risks in the same way. Strongly expressed explicit risks are observed as a result of converting the hazard of unauthorized use of personal data. Medium-expressed explicit risks appear in case of hazard of failure of digital platforms, hazard of decision-making by artificial intelligence, hazard of identification error, hazard of digital inequality. Weakly expressed explicit risks are typical for the conversion of the hazard of excessive digital surveillance and the hazard of virtualization of social contacts. The hazard of social network segmentation and the hazard of digital outsider are converted into implicit risks

Безопасность и эффективность 23-валентной полисахаридной пневмококковой вакцины у больных системной красной волчанкой

Objective: to study the safety and efficacy of the 23-valent polysaccharide pneumococcal vaccine (PPV-23) in patients with systemic lupus erythematosus (SLE).Patients and methods. The study included 75 patients with definite diagnosis of SLE at the age of 19–68 years, 10 (13%) of them had high SLE activity, 18 (24%) – moderate, 42 (56%) – low, in 5 (7%) patients the disease was in remission. PPV-23 was injected subcutaneously in a single dose of 0.5 ml. In 60 patients the follow-up period was ≥12 months, in 15 – from 2 to 6 months. Patients were examined before and 1, 3 and 12 months after immunization.Results and discussion. In 38 (50.7%) patients, standard local vaccination reactions of mild and moderate severity were noted, in 1 (1.3%) – a general reaction of mild severity, in 2 (2.7%) – mild diarrhea during 1 day, in 1 (1.3%) – a hyperergic reaction of the Artyus phenomenon type, the symptoms were relieved within 7 days. During 12 months of follow-up, neither exacerbations of SLE, reliably associated with vaccination, nor new autoimmune phenomena, were detected. After 1 year of observation, the number of responders to vaccination was 58%, non-responders – 42%. The duration and activity of the disease, age over 50 years, glucocorticoid therapy > 10 mg per day, did not significantly affect the vaccine response. There was a decrease in the immune response in patients on biologic DMARDs (bDMARDs) therapy compared to patients without such treatment (43 and 68% of cases, respectively), p=0.058. There was no difference between rituximab and belimumab treated subjects. There was a tendency for the prevalence of vaccination responses among patients, who received bDMARDs <1 year before immunization, as well as among patients in whom this therapy was initiated after the administration of PPV-23. There was a positive trend in decrease of pneumonia, acute and exacerbations of chronic bronchitis episodes and sinusitis.Conclusion. Sufficient immunogenicity, good tolerability and clinical efficacy of PPV-23 in patients with SLE, including those who received combined immunosuppressive therapy, have been shown. The use of bDMARDs reduces the number of patients with a vaccine response. The number of responders to vaccination increases when immunization is carried out before the initiation of therapy with bDMARDs or when this therapy is initiated <1 year before immunization. Further long-term prospective studies in large patient cohorts are required.Цель исследования – изучение безопасности и эффективности 23-валентной полисахаридной пневмококковой вакцины (ППВ-23) у больных системной красной волчанкой (СКВ).Пациенты и методы. В исследование включено 75 пациентов с достоверным диагнозом СКВ в возрасте 19–68 лет, 10 (13%) из них имели высокую активность СКВ, 18 (24%) – среднюю, 42 (56%) – низкую, у 5 (7%) – выявлена ремиссия заболевания. ППВ-23 вводили подкожно в разовой дозе 0,5 мл. У 60 пациентов срок наблюдения составлял ≥12 мес, у 15 – от 2 до 6 мес. Больных обследовали до и через 1, 3 и 12 мес после иммунизации.Результаты и обсуждение. У 38 (50,7%) пациентов отмечались стандартные местные вакцинальные реакции легкой и средней степени выраженности, у 1 (1,3%) – общая реакция легкой степени выраженности, у 2 (2,7%) – легкая диарея в течение 1 сут, у 1 (1,3%) – гиперергическая реакция по типу феномена Артюса, симптомы которой были купированы за 7 дней. На протяжении 12 мес наблюдения не выявлено ни одного случая обострения СКВ, достоверно связанного с вакцинацией, а также новых аутоиммунных феноменов. Через 1 год наблюдения число ответивших на вакцинацию составило 58%, не ответивших – 42%. Длительность и активность заболевания, возраст старше 50 лет, прием глюкокортикоидов в дозе >10 мг/сут значимо не влияли на вакцинальный ответ. Отмечено снижение иммунного ответа на фоне терапии генно-инженерными биологическими препаратами (ГИБП) по сравнению с отсутствием данного лечения (43 и 68% случаев соответственно), р=0,058. Различий на фоне применения ритуксимаба и белимумаба не установлено. Обнаружена тенденция к преобладанию ответивших на вакцинацию среди больных, получавших ГИБП <1 года до иммунизации, а также среди пациентов, которым эта терапия была инициирована после введения ППВ-23. Наблюдалась положительная динамика в виде уменьшения эпизодов пневмоний, острого и обострения хронического бронхита, синуситов.Заключение. Показаны достаточная иммуногенность, хорошая переносимость и клиническая эффективность ППВ-23 у больных СКВ, в том числе получавших комбинированную иммуносупрессивную терапию. Применение ГИБП уменьшает число пациентов с вакцинальным ответом. Если иммунизацию проводить до начала терапии ГИБП или на фоне такого лечения длительностью <1 года, то число ответивших на вакцинацию возрастает. Необходимы дальнейшие длительные проспективные исследования на больших выборках пациентов

A centuries-old experience of Buryat branch of the traditional medicine in Russia

The present work reviews the evolution of the traditional medicine in Buryatia; the contribution of Oriental medical schools and the Russian experience of herbal treatment were emphasized. This convergence process was developed in virtue of the geopolitical situation of the Republic. The evolution of the tradition and contribution of ethnic medical schools was schematically presented in the article. The aim of the work was to substantiate the originality of the Buryat traditional medicine. The data elucidating the pervasion of Eastern traditions due to the influence of Buddhism and the experience of the Russian settlers are given in the article. Peculiarity of the traditional medicine in this region involves the use of indigenous plants, original formularies and healing technologies. Approach to health and illness, principles of diagnostics and specific methods of treatment remain common to Eastern medical traditions. The article provides insight into the main findings of the study of this tradition. They include such aspects as the translation of written sources, development of new technologies and methods for the treatment and prevention of some diseases, new medicinal preparations and health-improving means recommended for practical use. Besides, there have been discussed the prospects for integration of rational methods and means from the array of the traditional medicine of Buryatia with modern medical and pharmaceutical technologies

Student research in medicine and their contribution to world science

In May 2021, the conference "Fundamental Medicine. History and Prospects, "at which first-year students of the Faculty of Medicine and Prevention made presentations on the history of the formation and development of physiological sciences in the Urals, outlining the biography of the founder of the physiological school at SGMI-UgMU, academician Vasily Vasilyevich Parin, and with a historical analysis of the role of student science in the development of medicine. This article presents brief points of the last reportВ мае 2021 г. в музее истории медицины УГМУ состоялась конференция «Фундаментальная медицина. История и перспективы», на которой студенты первого курса лечебного-профилактического факультета выступили с докладами по истории становления и развития физиологических наук на Урале с изложением биографии основателя физиологической школы в СГМИ-УГМУ академика Василия Васильевича Парина и c историческим анализом роли студенческой науки в развитии медицины. Данная статья представляет краткие тезисы последнего доклад

Объективная оценка повреждающего действия глюкокортикоидов (индекс токсичности) у пациентов с системной красной волчанкой

Systemic lupus erythematosus (SLE) is a multisystem disease characterized by chronic inflammation and damage to vital organs and systems. Despite the great success achieved in the treatment of SLE, glucocorticoids (GC) remain one of the main methods of therapy. The GC toxicity index is an objective method for assessing adverse events associated with their use, and in future studies can be actively used to monitor the safety of various therapy regimens. Wider introduction of this index in the management of patients with SLE will allow to optimize approaches to the selection of GC doses, to consider earlier prescription of biologic disease modifying antirheumatic drugs, before the development of severe irreversible damage. Системная красная волчанка (СКВ) – мультисистемное заболевание, характеризующееся хроническим воспалением и повреждением жизненно важных органов и систем. Несмотря на большие успехи, достигнутые в лечении СКВ, глюкокортикоиды (ГК) остаются одним из основных методов ее терапии. Индекс токсичности ГК является объективным методом оценки нежелательных явлений, связанных с их применением, и в будущих исследованиях может активно использоваться для контроля безопасности различных режимов терапии. Более широкое внедрение данного индекса у пациентов с СКВ позволит оптимизировать подходы к подбору доз ГК, рассматривать более раннее назначение генно-инженерных биологических препаратов, до развития тяжелых необратимых повреждений.

SEVERITY INDEX IN PATIENTS WITH SYSTEMIC LUPUS ERYTHEMATOSUS

Objective: to assess the clinical and prognostic informative values of SI in patients with SLE.Subjects and methods. One hundred and forty-six male patients aged 15 to 64 years with a valid diagnosis of SLE who had been followed up for 15 years were assessed. The patients underwent conventional clinical, laboratory, and instrumental investigations using the standard methods of disease activity assessment. SI and SLICC/ACR Damage Index (SDI) were used to characterize the course and outcomes of SLE. The SI and SDI were analyzed in 133, 91, and 63 patients over time at 1, 5, and 10 years of the disease, respectively.Results. Significant correlations were found between the SI on study inclusion and the indices reflecting the course and activity of SLE. Analysis of changes in SLE indicated that its maximum increase during the first 5 years of the disease was observed in patients aged < 20 years at the onset of SLE. The patients who had SLE concurrent with secondaryantiphospholipid syndrome showed a more marked SI rise than those without these abnormalities. The highest survival rates were noted in patients with an early SI of 0.Conclusion. SI is a good indicator reflecting the accumulated activity of the disease. It increases with longer disease duration; moreover, its rise may occur at any disease stages. This trend depends on the form of the disease, the time of diagnosis, and the presence of comorbidity. SI correlates well with the activity and damage indices traditionally used in SLE and with the frequency of exacerbations, suggesting that SI may be used as a prognostic marker

Russian registry of patients receiving rituximab: results of pharmacoeconomic analysis

Во всем мире продолжается разработка эффективных средств для диагностики и лечения ревматических заболеваний. В последнее десятилетие сделано большое количество открытий, созданы принципиально новые технологии, основанные на использовании достижений молекулярной биологии, которые позволяют значительно улучшить качество жизни (КЖ) больных тяжелыми воспалительными заболеваниями суставов.Все большее значение приобретает оценка экономической эффективности терапии больных ревматоидным артритом (РА). Это обусловлено быстрыми темпами роста стоимости лечения, особенно вследствие все более широкого применения новых генно-инженерных биологических препаратов, при выборе которых приходится учитывать не только их клиническую эффективность, но и стоимость, а также тенденцией к общему удорожанию медицинских услуг. Ни одно государство не располагает достаточными средствами для того, чтобы полностью покрыть потребности национального здравоохранения, а для рационального их распределения необходимо проведение тщательного экономического анализа [1]