Bezopasnost'' i risk farmakoterapii最新文献

{"title":"Safety of Lipid-Lowering Therapy with Statins according to a Regional Pharmacovigilance Centre","authors":"E. O. Kochkina, N. V. Verlan","doi":"10.30895/2312-7821-2023-11-3-271-278","DOIUrl":"https://doi.org/10.30895/2312-7821-2023-11-3-271-278","url":null,"abstract":"Scientific relevance. Since statins are widely used to prevent cardiovascular diseases, the control of statin-related complications is essential from both medical and social perspectives.Aim. The study aimed to analyse unsolicited reports on adverse drug reactions (ADRs) to control the safety of statin therapy.Materials and methods. The study analysed information on ADRs observed during statin treatment from the reporting forms submitted by medical organisations in Irkutsk to the database of the Regional Centre for Drug Safety Monitoring of the Irkutsk Region in 2011–2022. The causal relationship between ADRs and statin therapy was assessed using the Naranjo scale.Results. The database contained 1068 ADR reporting forms; 12 (1.1%) were spontaneous reports of statin-related complications, including 4 cases (33.4%) of myalgia, 7 cases (58.3%) of myalgia with moderately elevated transaminase levels (3–5 times the upper limit of normal), and 1 case of rhabdomyolysis that required statin discontinuation. In all cases, a reduction in the statin dose resulted in a regression in the clinical symptoms of ADRs. Most ADRs were observed in women with comorbidities (diabetes mellitus, obesity, and hypothyroidism), but the small sample size prevented the authors from testing the identified differences for statistical significance.Conclusions. According to the study results, statins have a reliable safety profile. Adequate and patient-specific selection of statin doses and ADR prevention are important responsibilities of clinical practitioners.","PeriodicalId":32736,"journal":{"name":"Bezopasnost'' i risk farmakoterapii","volume":"93 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135719298","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Opportunities and Prospects for Preclinical Drug Safety Assessment Using Alternative Methods: Experience from the Toxicology in the 21st Century (Tox21) Programme in the USA","authors":"V. N. Perfilova","doi":"10.30895/2312-7821-2023-379","DOIUrl":"https://doi.org/10.30895/2312-7821-2023-379","url":null,"abstract":"Scientific relevance. The Tox21 (Toxicology in the 21st Century) programme was developed by the US Tox21 Consortium with the aim to replace animal-based toxicity assessments of chemicals with a wide range of in vitro and in silico testing approaches and has since been successfully applied in practice. Aim. The study aimed to review information on alternative in vitro models developed as part of the Tox21 programme for testing the toxicity of chemical compounds. Discussion. According to the information provided by the National Toxicology Program, Environmental Protection Agency, National Center for Advancing Translational Sciences, and other Tox21 Consortium members on their official websites and in the literature, the Tox21 Consortium has developed a quantitative high-throughput screening technology for testing the safety of chemicals and created the Tox21 10K library of chemical compounds using this screening technology. The library has been successfully used to create models that predict the toxicity of chemicals prior to preclinical studies. Researchers have proposed new approaches to studying the safety of chemical compounds in human cell lines to replace in vivo studies. Innovative organ-on-chip, multi-organ-on-chip, and organoid models are free from the drawbacks and limitations of cell-line models and offer more accurate representations of complex cell–matrix and organ–organ interactions. Developed under the Tox21 programme to search for new chemical toxicity biomarkers and gene signatures, novel transcriptomics (toxicogenomics) technologies can be used to classify toxicants according to their health risks and to identify potential side effects long before discovering any pathological changes in the body. The Interagency Coordinating Committee on the Validation of Alternative Methods conducts technical evaluation of alternative testing methods and promotes their implementation into regulatory practice. Conclusions. Thus, new tools and technologies provide an opportunity for switching from in vivo toxicity testing of candidate medicinal products to in silico and in vitro methods.","PeriodicalId":32736,"journal":{"name":"Bezopasnost'' i risk farmakoterapii","volume":"47 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134960641","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Statin-Induced Myopathy","authors":"D. A. Sychev, T. M. Ostroumova, O. D. Ostroumova, A. I. Kochetkov, S. V. Batyukina, E. V. Mironova","doi":"10.30895/2312-7821-2023-11-3-252-270","DOIUrl":"https://doi.org/10.30895/2312-7821-2023-11-3-252-270","url":null,"abstract":"Scientific relevance . Being the main class of medicinal products for dyslipidaemia treatment, statins are widely used in clinical practice in various patient populations. However, statins can cause statin-associated muscle symptoms (SAMS), which are the most frequent and, in some cases, even life-threatening adverse reactions associated with these medicinal products. Aim. The study aimed to perform a systematic review of the epidemiology, classification, and physiological pathogenesis of SAMS, risk factors for this complication, and clinical guidelines for primary care physicians regarding the identification and treatment of patients with SAMS. Discussion. SAMS is an umbrella term that covers various forms of myopathies associated with satin therapy. According to the published literature, the prevalence of SAMS varies considerably and may depend on the study design, inclusion criteria, and the medicinal product used. SAMS has multiple putative pathogenic pathways that include genetically determined processes, abnormalities in mitochondrial function, defects in intracellular signalling and metabolic pathways, and immune-mediated reactions. The main known risk factors for developing SAMS include high-dose statins, drug–drug interactions, genetic polymorphisms, female sex, older age, Asian race, history of kidney, liver, and muscle disease, and strenuous physical activity. Given the lack of universally recognised algorithms for diagnosing SAMS, clinicians should consider the clinical presentation and the temporal relationship between statin therapy and symptoms. Other factors to consider include changes in muscle-specific enzyme levels and, in some cases, the results of blood tests for antibodies to 3-hydroxy-3-methyl-glutaryl-coenzyme A reductase. Conclusions. To ensure the safety of statin therapy, it is essential to raise clinicians’ awareness of the risk factors for SAMS, indicative clinical and laboratory findings, and the need for dynamic patient monitoring, including the involvement of clinical pharmacologists.","PeriodicalId":32736,"journal":{"name":"Bezopasnost'' i risk farmakoterapii","volume":"24 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135719378","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A Case of Diabetes Mellitus after COVID-19 Vaccination in a Patient with Impaired Glucose Metabolism","authors":"I. V. Maiborodin, V. I. Maiborodina, M. G. Klinnikova, E. L. Lushnikova","doi":"10.30895/2312-7821-2023-372","DOIUrl":"https://doi.org/10.30895/2312-7821-2023-372","url":null,"abstract":"Scientific relevance. The clinical features of COVID-19 in patients with comorbidities, including diabetes mellitus (DM), have already been discussed in the medical literature. However, the available data on blood glucose levels in patients with DM during SARS-CoV-2 infection and after COVID-19 vaccination are clearly insufficient to estimate the importance of the changes taking place. Aim. The study aimed to show that patients with DM or impaired glucose metabolism need glycaemic monitoring during COVID-19 disease and after COVID-19 vaccination, drawing on the example of a clinical case. Materials and methods. The study analysed the medical records of a 58-year-old male patient newly diagnosed with DM. He received inpatient and outpatient treatment after COVID-19 vaccination and SARS-CoV-2 infection in February–November 2021. In 2014, the patient was diagnosed with impaired glucose metabolism, including fasting hyperglycaemia (≤ 9 mmol/L), which was corrected by diet. Results. After vaccination with Gam-COVID-Vac component 1 in February 2021, the patient developed polydipsia, polyuria, and arterial hypertension. His laboratory findings were as follows: blood glucose, 25 mmol/L; glycated haemoglobin, 10.7%; fasting insulin, 28.4 μIU/mL; calcium, 2.45 mmol/L; and 25-hydroxyvitamin D, 21 ng/mL. The patient was diagnosed with new-onset type 2 DM, admitted to the endocrinology department of a multidisciplinary hospital, and discharged when his condition stabilised after 14 days of treatment. After vaccination with Gam-COVID-Vac component 2, the patient’s glucose levels did not change. In November 2021, the patient was diagnosed with SARS-CoV-2 infection. Even though all symptoms had resolved within 3 days, the virus persisted in the blood for 12 days without clinical manifestations of the disease. This was confirmed by repeated polymerase chain reaction testing. The patient had moderate hyperglycaemia despite antidiabetic treatment; his glucose levels were restored to normal without hospitalisation. Conclusions. Timely vaccination against COVID-19 in patients with DM, hypertension, and obesity contributes to a mild course of COVID-19 and helps avoid complications in the lungs and other organs. For patients with DM or glucose metabolism disorders, blood glucose monitoring is advisable for detecting and correcting possible hyperglycaemia after vaccination and/or recovery from COVID-19.","PeriodicalId":32736,"journal":{"name":"Bezopasnost'' i risk farmakoterapii","volume":"13 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135981085","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ПРОБЛЕМЫ ПРАВОВОГО РЕГУЛИРОВАНИЯ ТРУДОВЫХ ОТНОШЕНИЙ ГРАЖДАН НА ГОСУДАРСТВЕННОЙ ГРАЖДАНСКОЙ СЛУЖБЕ","authors":"Б.В. Брынцев","doi":"10.33580/9785001289388_327","DOIUrl":"https://doi.org/10.33580/9785001289388_327","url":null,"abstract":"","PeriodicalId":32736,"journal":{"name":"Bezopasnost'' i risk farmakoterapii","volume":"5 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74266123","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ЭКОЛОГИЧЕСКИЕ ПРОБЛЕМЫ ИСПОЛЬЗОВАНИЯ АВИАЦИОННОГО ТРАНСПОРТА","authors":"У.А. Абдуллаева","doi":"10.33580/9785001289388_199","DOIUrl":"https://doi.org/10.33580/9785001289388_199","url":null,"abstract":"","PeriodicalId":32736,"journal":{"name":"Bezopasnost'' i risk farmakoterapii","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72529881","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"ПРОБЛЕМЫ ПРАВОВОГО РЕГУЛИРОВАНИЯ КРАУДФАНДИНГА В РОССИЙСКОЙ ФЕДЕРАЦИИ","authors":"Калимат Гасановна Сапарова","doi":"10.33580/9785001289388_157","DOIUrl":"https://doi.org/10.33580/9785001289388_157","url":null,"abstract":"","PeriodicalId":32736,"journal":{"name":"Bezopasnost'' i risk farmakoterapii","volume":"16 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77631155","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"АКТУАЛЬНЫЕ ВОПРОСЫ ПРИРОДОПОЛЬЗОВАНИЯ","authors":"Рисалат Магдибеговна Магомедова","doi":"10.33580/9785001289388_252","DOIUrl":"https://doi.org/10.33580/9785001289388_252","url":null,"abstract":"","PeriodicalId":32736,"journal":{"name":"Bezopasnost'' i risk farmakoterapii","volume":"32 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81086898","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"СРАВНИТЕЛЬНО-ПРАВОВОЙ АНАЛИЗ ИНСТИТУТА ПРЕДСТАВИТЕЛЬСТВА В ГРАЖДАНСКОМ ПРОЦЕССЕ И СУБЪЕКТОВ, УКАЗАННЫХ В СТАТЬЯХ 45, 46 ГПК РФ","authors":"Анна Сергеевна Кислицкая, А.Б. Алиева","doi":"10.33580/9785001289388_45","DOIUrl":"https://doi.org/10.33580/9785001289388_45","url":null,"abstract":"","PeriodicalId":32736,"journal":{"name":"Bezopasnost'' i risk farmakoterapii","volume":"20 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82372252","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"СУДЕБНОЕ ПРЕДСТАВИТЕЛЬСТВО В ГРАЖДАНСКОМ ПРОЦЕССЕ","authors":"А. Р. Алиева, А.Б. Алиева","doi":"10.33580/9785001289388_19","DOIUrl":"https://doi.org/10.33580/9785001289388_19","url":null,"abstract":"","PeriodicalId":32736,"journal":{"name":"Bezopasnost'' i risk farmakoterapii","volume":"11 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88345429","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}