Backgr о und. Immunoglobulin A nephropathy (IgA-N) is a common form of chronic glomerulonephritis. Its basis is the accumulation of IgA immune complexes in the glomeruli, associated with impaired glycosylation of the IgA molecule. Exogenous antigens, such as gluten, play an important role in the development of the disease. It has been experimentally confirmed that oral immunization with gluten induces mesangial IgA deposits, and a gluten-free diet can improve the course of nephropathy, indicating the significance of the enterorenal axis in the pathogenesis of IgA-N. Objective: To study structural changes in renal tissue in IgAN patients and to evaluate the clinical and diagnostic significance of IgA antibodies to deamidated gliadin peptides (anti-DGP IgA) in the blood serum. Material and methods . The study involved 105 patients aged 18 to 64 years diagnosed with IgAN based on a lifetime nephrobiopsy with morphological examination according to the Oxford classification. Patients were divided into two groups: the main group (n=20) included IgAN patients with detected anti-DGP IgA, and the control group (n=85) included IgAN patients seronegative for anti-DGP IgA, IgA antibodies to tissue transglutaminase, and to endomysium. Results. When comparing fibrous-sclerotic changes, no statistically significant intergroup differences were obtained. However, a clear trend of predominance of irreversible light-optical changes within the area of the nephrobiopsy specimen was noted in patients of the main group compared to the control group: 82.4% and 56.9%, respectively (p=0.059). Conclusion. The obtained results reflect a high frequency of irreversible fibrous-sclerotic changes in the nephrobiopsy in patients with IgAN and anti-DGP IgA in the blood serum. Timely detection of anti-DGP IgA can improve the ability to predict the outcome of the disease and optimize therapeutic strategies.

Objective : To analyze foreign experience in the use of artificial intelligence (AI) in oncology, as well as examine current advances in AI and its impact on clinical practice. Material and methods. A systematic review of foreign literature was carried out, current AI programs and technologies in oncology were analyzed. The total number of identified records via the PubMed/MEDLINE search was 7680. After publication selection in accordance with the PRISMA guidelines, 32 studies that met all criteria were randomly included in the review and formed the basis for the analysis. Results . AI demonstrates high efficiency in cancer diagnostics, including early detection of tumors, analysis of medical images and pathological data. A literature review on the use of AI models in oncology revealed exponential growth from 2010 to 2022, confirming the active development of the field. Diagnostic and treatment reports generated by the AI technologies indicated a comparable level of accuracy to that of experienced oncologists; they also revealed the ability to improve clinical outcomes. Furthermore, the introduction of AI stimulates the development of personalized treatment, increased patient adherence to therapy and optimization of the work of medical organizations. AI’s impact was revealed on physicians (reduced diagnostic and treatment errors), patients (personalized support), and hospitals (smart management systems). Conclusion . AI is becoming an integral part of modern oncology, offering new opportunities to improve diagnostics, treatment, outcome prediction, and patient support. A study of the dynamics of publications and AI models indicates that the use of AI in clinical oncology is rapidly developing, opening up new prospects for the creation of smart hospitals, simplification of medical data exchange, development of personalized medicine, and improvement of the quality of patient care. The integration of AI with emerging technologies such as wearable devices and multimodal analysis promises to revolutionize oncology practice.

Background . Specialists in health technology assessment consider real-world evidence (RWE) a promising path for improving comprehensive drug assessment (CDA). Therefore, it is particularly important to elicit opinions from CDA experts on the necessity of incorporating RWE analysis into the assessment process. Objective : To present the results of a survey of CDA specialists demonstrating their views on the necessity and variability of incorporating RWE into the CDA process. Material and methods . The survey was conducted in the form of a specially developed original questionnaire between July 2024 and February 2025 among two groups: regulatory authority representatives and pharmaceutical industry representatives involved in CDA. Results . The survey involved 29 representatives from both regulatory authorities and pharmaceutical industry. The majority of respondents support the inclusion of RWE in CDA: 96.6% of regulatory authority representatives vs 75.9% of industry representatives. The most favored assessment areas using RWE were safety, efficacy, impact on economy, and the quality of evidence base for medicinal products. The predominant view was that in decision-making, the role of RWE should be informative rather than restrictive. Conclusion . The surveyed respondents specialising in CDA predominantly hold positive attitudes towards incorporating RWE into the assessment procedure. The support of this incorporation by experts implies that work on specific implementations of RWE in CDA is fully justified and promises to be successful.

Objective : To explore approaches to improving medical care for patients with chronic hepatitis С (CHC) at the national level. Material and methods. A Markov model was used to predict the direct medical costs and outcomes (e.g., number of cured and died patients, cases of complications) for the treatment of CHC for 6 years in 300,000 patients. Two modeling scenarios were considered: a basic scenario included therapy administered with drugs in accordance with clinical guidelines and the standard of medical care for CHC patients; an alternative scenario focused on therapy with pan-genotypic drugs only. Results . In the basic scenario, 298,034 people, or 99.3% of the cohort are treated over a period of 6 years. During this time, the disease develops into 236 cases of decompensated liver cirrhosis, 2,073 cases of hepatocellular carcinoma, 62 liver transplants required, and 430 deaths from complications of progressive liver decompensation. Total direct medical costs for this period are estimated at 105.3 billion rubles. Annual costs range from 16.5 billion rubles in the first year to 18.2 billion rubles in the sixth year. In the alternative scenario, a slight improvement in clinical outcomes is observed; however, the treatment cost increases from 105.8 billion rubles to 114.5 billion rubles (+8.7 billion rubles). It was found that decrease in the cost of drugs by 10%, 20%, 30%, or 40% can provide additional treatment for 31,706, 70,907, 120,615, and 185,707 patients, respectively. Conclusion . The study made possible to assess the efficiency of the proposed measures for treating patients with CHC over a 6-year horizon, as well as the financial requirements for their implementation. Furthermore, possible measures to improve the effectiveness of CHC control activities and prospective ways to realize the benefits that could be achieved by reducing the cost of drug therapy were considered.

Objective: An analysis of pharmaceutical information as a factor in self-medication and the loyalty of pharmacy visitors.Material and methods. Sociological survey was conducted with 2888 respondents, poll`s period February – March 2025 inclusive. The geographical coverage included 58 subjects of the Russian Federation. The questionnaire consisted of questions to identify the respondent's characteristics (gender, age, region of residence), frequency of self-medication, attitude of pharmacy visitors to pharmaceutical specialists and their recommendations. Kendall's and Spearman's rank correlation coefficients were used when processing the questionnaires.Results. 88,3% of respondents use self-medication, and 42,8% do it often and constantly. Factors that increase the tendency toward self-medication are the female sex and young age. There is no correlation between the high frequency of self-medication and visits to pharmacy organizations. The main criteria for choosing a pharmacy organization are the price of the desired product, proximity to home/work, and the range of products offered. Most often, respondents are interested in the drug as well as the assortment of goods. Internet ordering is also popular. Searching for information on the Internet about a drug, assortment, pharmacy, or online order correlates with more frequent self-treatment. Respondents indicated time and/or cash savings as the main reasons for searching for information. Only 37,1% of respondents always fully follow the recommendations of pharmacy workers, and patient compliance naturally negatively correlates with self-medication. 20,6% of respondents indicated distrust of the qualifications of a pharmacy specialist and/or considered, that their recommendations optional. Reluctance to change lifestyles, as well as a lack of belief in the outcome, correlated with male gender and younger age. Among the positive trends in pharmacies, the most often noted were an increase in the range of drugs, an improvement in equipment, and the number of organizations. Among the negative trends in the pharmaceutical industry, respondents noted an increase in self-interest (commercial interest) among pharmacy workers – 24,7% of respondents answered so. Only 38,4% of respondents noted the possibility of error or subjectivity in someone else's negative opinion about the pharmacy. A more positive attitude toward the pharmacy worker generally correlated with a lower frequency of self-medication.Conclusion. The results of the sociological study demonstrate the importance of pharmaceutical information and attitudes toward pharmacy workers as factors in self-medication. The data obtained can serve as the basis for targeted advertising, considering age and gender preferences, and popularizing the appeal to a specialist. It is also necessary to monitor and update information freely available on the Internet.

Background. Primary open-angle glaucoma (POAG) is a chronic, progressive eye condition causing optic nerve damage and irreversible vision loss by increasing intraocular pressure (IOP). Therapy primarily aimed at reducing IOP to prevent disease progression. Pharmacoeconomic evaluation of fixed-dose combinations (FDCs) has attracted growing interest in recent years as a strategy to enhance both treatment efficacy and accessibility.Objective: To review the cost and clinical effectiveness for FDCs of travoprost/timolol (TT) and latanoprost/timolol (LT) for POAG treatment.Material and methods. A systematic literature review was conducted using PubMed/MEDLINE, Web of Science, ScienceDirect, and Google Scholar databases. The sampling included studies evaluating FDCs of TT and LT in terms of its cost and clinical effectiveness, as well as cost-effectiveness and cost-utility ratios.Results. TT-FCD proved to be more cost-effective than LT-FDC in several European countries and the Philippines, resulting in lower long-term costs and slowing the progression of vision loss. Conversely, in China identified LT-FDC was more cost-effective due to lower daily costs. Both FDC options improved patient adherence to treatment due to their simplified administration.Conclusion. TT-FCD may be a more favorable treatment option for POAG in certain regions, considering its pharmacoeconomic and clinical advantages. However, treatment selection should be individualized based on regional healthcare dynamics, medicine pricing, and patient access to medicines.

Background. Organization of effective and safe pharmacotherapy for pain and inflammation requires knowledge of the mechanisms and spectrum of action of nonsteroidal anti-inflammatory drugs (NSAIDs). These concern their anti-inflammatory, analgesic (including central) effects, effects on the proteome, micronutrient metabolism and other aspects of the body's metabolism depending on the administration route.Objective: To compare the effects of tenoxicam, meloxicam, celecoxib, ketoprofen, nimesulide, diclofenac, ibuprofen molecules using the methods of chemoreactomic, chemoproteomic and pharmacoinformatic analysis.Material and methods. The comparison of tenoxicam with other NSAIDs was conducted using the methods of topological analysis of Yu.I. Zhuravlev and K.V. Rudakov scientific school. These methods were developed based on the combinatorial theory of solvability and the classification theory of feature values ​​as applied to chemographs, i.e. mathematical structures describing the chemical structures of molecules.Results. In silico estimates of anti-inflammatory, central, and analgesic effects of tenoxicam and comparison molecules were obtained. The profiles of belonging to various anatomical-therapeutic-chemical classification groups and the profiles of side effect frequencies of the NSAIDs (including the effect on micronutrient metabolism through the loss of vitamins and microelements) were analyzed. A comparison of the effects of molecules under oral, topical and parenteral administration was carried out. The profile of the pharmacological effects of tenoxicam differed significantly from those of other NSAIDs, indicating, in particular, potential antithrombotic, hypoglycemic, and antihistamine effects. Tenoxicam, unlike other molecules, exhibits a significant effect on the synthesis, secretion and activity of leukotriene B4 along with inhibitory effects on kinin receptors. In comparison with other NSAIDs, tenoxicam does not stimulate stronger losses of micronutrients. Chemoreactome assessments of the central effects of tenoxicam showed its comparability with other NSAIDs. The effects of tenoxicam under its topical, oral and parenteral administration are comparable to the anti-inflammatory action of other NSAIDs. The frequency analysis of various side effects, averaged over the studied sample of side effects, showed that tenoxicam was characterized by the lowest frequency of all the indicated side effects (3%; other molecules: 4–7%).Conclusion. The chemoreactomic, chemoproteomic and pharmacoinformatic profiling of tenoxicam indicated its improved efficacy-safety balance compared to other NSAIDs.

Objective: To analyze the legal and ethical aspects of regulating artificial intelligence (AI) in medicine in key jurisdictions (United States, European Union, China, Russia), to identify regulatory gaps, ethical dilemmas and prospects for harmonization of standards.Material and methods. National and international regulatory documents (GDPR, AI Act, FDA, NMPA), scientific publications, clinical cases and regulatory initiatives (IMDRF, WHO) were reviewed. Methods for comparative legal analysis and systematization of ethical and legal norms were used.Results. Considerable differences in approaches to AI regulation were identified, including flexibility in the US, the ethical centricity in the EU, centralization in China and an emerging framework in Russia. Key issues were emphasized, such as algorithmic bias, AI transparency, responsibility, and the conflict between innovation and security.Conclusion. The harmonization of international standards, the introduction of dynamic regulation and the strengthening of interdisciplinary cooperation should be pursued to achieve a balance between innovation and the protection of patients' rights.

Background. In 2021, the Russian Foundation “Circle of Kindness” was established to provide additional financial support for children with severe life-threatening and chronic diseases (including rare and orphan ones) requiring essential treatment, particularly expensive medicines. At the same time, the predominant part of the provided medicines is intended for the treatment of rare diseases. Methodological support for decision-making regarding the inclusion of diseases in the list of diseases and medicines in the procurement lists of the “Circle of Kindness” Foundation is provided by health technology assessment conducted in the Center for Healthcare Quality Assessment and Control.Objective: To analyze the characteristics of medicines that underwent assessment during the four years of operation of the “Circle of Kindness” Foundation, depending on their inclusion status in the procurement lists, as well as to review the evidence base confirming the clinical effectiveness of the analyzed medicines.Material and methods. A total of 187 pairs of “medicine – disease” that underwent assessment were analyzed based on the following characteristics: registration status of the medicines in the Russian Federation, the United States of America (USA), and the European Union (EU), and data on orphan status for registered technologies; the presence of unmet therapeutic needs for the given medicine (absence of alternative therapy options); and data on the availability of generic medicines. Characteristics of published studies on the clinical efficacy of the medicines included in the analysis contained information on study design, used endpoints (surrogate or clinical outcomes), median follow-up duration, control group, as well as the presence of comparative studies for each “medicine – disease” pair.Results. It was found that medicines included in the procurement lists, compared to the analyzed non-included medicines, were characterized by a higher frequency of obtaining orphan status in the USA (84.6% vs. 67.8%) and the EU (65.7% vs. 38.8%) as well as by the absence of alternative therapy options (50.6% vs. 32.0%). Use of surrogate endpoints only was reported in 56% of published studies on the clinical efficacy of the medicines; the median time follow-up for outcome assessment was 12.00 months (interquartile range 5.52–35.94). Among study designs, randomized controlled trials and single-arm studies predominated (36.7% and 30.9%, respectively). Published data on the results of comparative studies were absent for 36.8% of all analyzed “medicine – disease” pairs.Conclusion. Pairs of “medicine – disease” included in the “Circle of Kindness” Foundation lists are characterized by a high unmet medical need (absence of alternative treatment options) and, in more than half of the cases, by the corresponding orphan status in the EU and/or USA. The obtained results also correspond to data from domestic and international authors regarding the predominant use of surrogate endpoints and the prevalence of single-arm study designs justifying the efficacy of orphan medicines. These findings highlight the relevance of conducting health technology assessments of medicines with high uncertainty regarding their effectiveness, which, on the one hand, allows for consideration of the limitations of evidence from their clinical studies, and on the other hand, summarizes data on other significant characteristics of the medicines and rare diseases.

Background. In the modern population, cardiovascular diseases associated with arterial hypertension and dyslipidemia predominate in the structure of non-communicable diseases, which justifies the need for long-term pharmacotherapy with antihypertensive and lipid-lowering drugs.Objective: To study the consumption profile of antihypertensive and lipid-lowering drugs by the population of the Russian Federation (RF), which can be considered key cardiovascular drugs.Material and methods. A long-term retrospective pharmacoepidemiological study was conducted. The statistics of pharmacy sales of these drug groups were analyzed, both as single-ingredient drugs and as fixed-dose combinations (FDCs), from 2017 to 2022 across 5,221 pharmacy organizations in 83 regions of the RF, out of a total of 70,400 pharmacy organizations registered in the country in 2022.Results. It was found that the consumption of the following single-ingredient drugs predominates: angiotensin-converting enzyme inhibitors (31.9%), β-blockers (22.7%), calcium channel blockers (10.5%), and diuretics (10.3%). Among single-ingredient drugs, the leading positions are held by amlodipine (13.6%), enalapril (11.6%), and indapamide (9.7%). Among FDCs, the most common are “losartan + hydrochlorothiazide” (20.6%), “perindopril + indapamide” (15.4%), “amlodipine + indapamide + perindopril” (9.1%). Average cost of 1 defined daily dose (DDD) was 2.8 rubles for diuretics, 3.2 rubles for calcium channel blockers, 4.0 rubles for angiotensin-converting enzyme inhibitors, 8.0 rubles for sartans, 10.0 rubles for β-blockers, 9.0 rubles for statins. The cost of 1 DDD for FDCs is significantly higher – ranging from 15 to 40 rubles – which may be a key factor contributing to their extremely low consumption (7.1% for antihypertensive FDCs and 6.9% for statin FDCs), inconsistent with current clinical guideline recommendations.Conclusion. The structure of pharmacy sales of key cardiological drugs from 2017 to 2022 has remained conservative, with a predominance of single-ingredient medications and a lack of alignment with current cardiology trends toward increased use of FDCs and statins. To date, no domestically produced polypill formulations combining an antihypertensive agent and a statin exist on the Russian market, and the share of imported polypill multitarget drugs remains extremely low.