Widespread use of cephalosporin antibiotics in clinical practice calls for greater attention to the risk of adverse drug reactions. Information on serious or unexpected adverse events reported during post-marketing experience is submitted to national and international pharmacovigilance databases. Analysis of these reports helps to identify new adverse drug reactions.The aim of the study was to analyse the safety profile of cephalosporin antibiotics based on spontaneous reports in the international VigiBase database.Materials and methods: the analysis of the adverse reaction profile of cephalosporin antibiotics was based on MedDRA system organ classes and included spontaneous reports submitted to VigiBase from the moment of its creation until August 2020.Results: the authors identified the most clinically significant adverse reactions for different cephalosporin generations. They compared and analysed information on adverse events in VigiBase and in patient information leaflets of medicinal products authorised in the Russian Federation. It was demonstrated that some serious events described in VigiBase spontaneous reports for V-generation cephalosporins are not included in the “Side effects” section of the patient information leaflets. According to VigiBase, the use of ceftaroline was associated with the development of generalised exfoliative dermatitis, Stevens–Johnson syndrome, tubulointerstitial nephritis, while the use of ceftolozane was associated with acute kidney injury, renal insufficiency, sepsis, pneumonia, and respiratory insufficiency.Conclusion: reporting of unexpected and serious adverse drug reactions to cephalosporin antibiotics is an important task of healthcare practitioners. Availability of information on class-specific and generation-specific serious adverse reactions will help predict and prevent their development.

Introduction. IBS is a functional bowel disorder that has a significant impact on patients and society, especially in terms of quality of life and medical costs.Pathogenesis. It is believed that the pathogenesis of IBS consists of several mechanisms: the syndrome of intersection of functional disorders (gut-brain), stress, visceral hypersensitivity and changes in motor skills.Visceral hypersensitivity. Changes in visceral sensitivity in IBS are characterized by central abnormalities in areas of the cerebral cortex. Motility impairment in IBS manifests itself as abnormal myoelectric activity in the colon, resulting in repetitive contractions of the small intestine and colon, which appear to cause pain.Intestinal microflora. FODMAPs are found in high amounts in some fruits, artificial sweeteners, legumes, and green vegetables and are poorly absorbed by all people. FODMAPs have enzymatic and osmotic effects that may contribute to the onset of symptoms in some patients.The principles of IBS therapy. Treatment for IBS should be based on the type and severity of symptoms. For the treatment of IBS, drugs of various pharmacological groups are used, depending on the prevailing symptoms. These include opioid receptor agonists, bile acid sequestrants, guanylate cyclase agonists, chlorine channel activators, as well as antibiotics, probiotics, antidepressants, 5-HT3 receptor antagonists, and antispasmodics.Myotropic antispasmodics. Drugs with antispasmodic activity are used to treat functional and organic diseases of the gastrointestinal tract as a basic therapy or «on demand». Mebeverine quickly and effectively relieves spasm, pain and the entire complex of intestinal symptoms, in addition, the drug reduces visceral hypersensitivity due to a local anesthetic effect. The drug has a high safety profile and has a number of advantages over drugs of the same pharmacological group.Conclusion. Myotropic antispasmodics have been shown to be highly effective in the treatment of IBS. Mebeverine occupies a special place among myotropic antispasmodics. Its combined action provides a pronounced antispasmodic activity along with a high safety profile.

The aim of the study is to evaluate the clinical efficacy, safety, and impact of the complex metabolic neuroprotector on the patients’ quality of life (CMN) Cytoflavin in tablets, as well as in the course of stepwise pharmacotherapy of patients with chronic cerebral ischemia (CCI) of various etiologies, followed by meta-analysis, on the basis of a systematic review of published clinical studies.Material and methods. A selection of randomized controlled trials was carried out over the past 15 years, in which CMN Cytoflavin was used in the tablet dosage form or in a stepwise course of therapy in at least 25 patients diagnosed with chronic cerebral ischemia with a total course of therapy of at least 25 days. The assessment of CMP clinical efficacy and the analysis of formalized indicators of clinical efficacy (relative risk, odds ratio, frequency of outcomes, values of absolute and relative benefits, etc.) was carried out.Results and conclusion. 403 publications for 2000–2017 describing the use of CMN Cytoflavin were analyzed. 16 studies were selected for the systematic review, the meta-analysis included 6 randomized clinical trials and one non-randomized study of the use of CMN in patients with CCI. The data of the systematic review and meta-analysis showed a sufficient efficacy of complex metabolic neuroprotector use in patients with chronic cerebral ischemia. However, the meta-analysis revealed significant heterogeneity between the studies. The drug has a beneficial effect on the quality of life of patients, increases the likelihood of a positive outcome in relation to the relief of asthenic and vestibular-atactic syndromes, in relation to complaints of increased fatigue, headache, dizziness, noise in the head, impaired coordination. It improves cognitive functions, exhibits sufficiently high tolerance and safety.

Хроническая ишемия головного мозга (ХИМ) — распространенный синдром, который при отсутствии адекватной терапии характеризуется прогрессирующим течением, нарастанием когнитивных, эмоциональных, двигательных и других нарушений, в итоге приводящих к стойкой инвалидизации пациента. При лечении больных с ХИМ показано применение препаратов с мультимодальным нейропротективным действием. Приведены результаты анализа серии клинических исследований препаратов Мексидол и Мексидол ФОРТЕ у пациентов с ХИМ. Рассматриваются эффекты препарата в отношении когнитивных, эмоциональных, астенических, вегетативных и других проявлений ХИМ. Делается вывод о целесообразности последовательного применения препаратов Мексидол и Мексидол ФОРТЕ у таких больных.

INTRODUCTION. It is essential to monitor the efficacy and safety of medicinal products as part of post-marketing surveillance to identify, assess, and prevent adverse drug reactions (ADRs). The effectiveness of pharmacovigilance depends largely on healthcare professionals’ adherence to the requirements and timeframes for reporting information to regulatory authorities.AIM. This study aimed to identify and systematise the key aspects of pharmacovigilance through an analysis of experience in organising pharmacovigilance in Moscow-based healthcare institutions in 2018–2024 to determine the focus areas for implementing, monitoring, and improving the pharmacovigilance system operating in medical organisations.DISCUSSION. The significance of pharmacovigilance systems and the need for their continuous improvement are underpinned by experience in establishing pharmacovigilance databases, including the global VigiBase database, the European Union’s EudraVigilance database, and the Eurasian Economic Union’s database. The main pharmacovigilance tools include active surveillance and collection of unsolicited/solicited reports of suspected ADRs. The Russian Federal Service for Surveillance in Healthcare (Roszdravnadzor) has developed clear operational criteria for pharmacovigilance in medical organisations. These criteria require that medical organisations should have in-house regulations for collecting, registering, and reporting data on ADRs to Roszdravnadzor, appointing qualified persons responsible for pharmacovigilance, and obtaining access to the Pharmacovigilance database of Roszdravnadzor’s Automated Information System. This article provides a detailed description of tools for establishing an effective pharmacovigilance system in a medical organisation, as well as the focus areas for organising pharmacovigilance in medical organisations, identified by analysing the experience of a territorial entity of the Russian Federation.CONCLUSIONS. To improve the effectiveness of pharmacovigilance in medical organisations, it is necessary to ensure the quality, integrity, and completeness of data submitted in spontaneous ADR reports. Spontaneous reporting should be supplemented with active surveillance methods, including the Global Trigger Tool. The current pharmacovigilance system in Moscow demonstrates a steady increase in reporting ADRs to Roszdravnadzor.

The prevalence of GERD in most European countries and the Russian Federation is at the level of 15–20%. Hydrochloric acid plays a significant and sometimes major role in damage to the mucosa of the upper gastrointestinal tract (GIT) in patients with various acid-related diseases. Despite the presence of various classes of drugs that reduce the damaging effect of hydro-chloric acid on the mucous membrane of the upper gastrointestinal tract, acid-related diseases continues to be an urgent medical problem. The review article discusses the issues of pharmacological treatment of acid-related diseases. Such classes of drugs as antacids, H2-histamine blockers, gastroprotectors, potassium-competitive blockers of hydrochloric acid secretion are described in detail. Particular attention is paid to the group of proton pump inhibitors (PPIs). The paper evaluates the merits of each class of drugs, their significance in the treatment of acid-related diseases. One of the most popular PPIs in the Russian Federation is omeprazole. The effectiveness of the drug is determined by pharmacokinetic parameters, in particular bioavailability. The bioavailability of omeprazole of various trade names varies widely. To increase the rate and completeness of dissolution, and hence the bioavailability of poorly soluble molecules in the modern pharmaceutical industry, various disintegrants are used as excipients. The addition of sodium superdisintegrant carboxymethyl starch to the new Omez® dosage form with MiniCaps technology promotes an accelerated and more complete intake of omeprazole into the systemic circulation, helping to increase bioavailability. In addition, the innovative dosage form has a volume that is 30% smaller than the classic capsule, which improves ease of use and adherence to treatment.