Objective: To conduct a clinical and economic analysis of antibacterial therapy for severe nosocomial pneumonia within the context of real clinical practice at a multidisciplinary hospital in Moscow.

Material and methods. The medical records of patients admitted to Yudin City Clinical Hospital in Moscow in 2019–2021 were analyzed retrospectively. Pharmacoepidemiological analysis included the structure of prescriptions of antibacterial drugs (ABDs), features of empirical and etiotropic therapy, duration of using ABDa and other parameters. In total, 110 cases of severe nosocomial pneumonia caused by ESKAPE pathogens were selected for analysis. Direct medical costs and cost-effectiveness coefficients were calculated based on real world data.

Results. It was established that nosocomial pneumonia is the most common complication among hospitalized patients in the intensive care unit (ICU). The etiology of nosocomial pneumonia was mostly presented by K. pneumoniae, A. Baumanii, and P. aeruginosa. The administered ABDs included 31 international nonproprietary names of the group J01 Systemic antibacterial drugs. The direct medical costs of empirical antibacterial therapy averaged for 9367 rubles (2118 rubles [1462; 3525]). Comparative cost-effectiveness analysis was performed based on surrogate and endpoints. It was found that direct medical costs associated with ESKAPE pathogens spend about 70% of the budget of established tariff to pay for medical care of the compulsory health insurance program for the patient's stay in the ICU.

Conclusion. Antibacterial therapy costs for nosocomial pneumonia significantly increase the total cost of a patient's hospital stay. Сlinical and economic assessment of drug use help optimize therapy costs and develop a hospital formulary of antimicrobial drugs.

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. Modern oncology is facing a paradoxical situation in which the rapid increase in the cost of anticancer therapy is not always accompanied by a proportional improvement in its effectiveness. This creates serious economic barriers for healthcare systems worldwide. In the context of limited resources, methods for the rational allocation of the pharmaceutical budgets are becoming particularly important. The combined ABC/VEN analysis serves as an effective tool to address this challenge. This approach is especially valuable when analyzing contemporary oral anticancer drugs, which are playing an increasingly significant role in cancer treatment.

Objective: To evaluate the cost structure of oral anticancer therapy using ABC/VEN and frequency analysis methods.

Material and methods. Distribution by ABC categories was conducted according to generally accepted methodology. Group A (the most expensive drugs) included regimens whose total cost accounted for 80% of all expenditures. Group C (the least expensive) comprised regimens with no more than 5% of total costs. The remaining regimens formed Group B (moderately expensive), which consumed 15% of total expenditures. Final expenditures were determined based on the cost of drug therapy per regimen in a day hospital setting and the number of medical interventions provided under each regimen in 2022. The formal methodology of VEN analysis involved categorizing regimens according to the presence of drugs from the World Health Organization Model List of Essential Medicines. Separately, both ABC and VEN analyses were carried out for chemotherapy, hormone therapy, targeted therapy, and combination treatment regimens. Frequency analysis was conducted based on the number of hospitalizations of patients who received particular anticancer regimens according to real-world data from depersonalized hospitalization registry records.

Results. The resource distribution analysis confirmed the Pareto principle, with 80% of financial expenditures attributed to 9.3% (95% CI 6.0–13.7) of therapeutic regimens (23 regimens) constituting the high-cost Group A. Group C (accounting for no more than 5% of expenditures) included 164 regimens (66.7%; 95% CI 60.4–72.5). The remaining drugs fell into Group B (15% of expenditures) – 24 regimens (9.8%; 95% CI 6.4–14.2). Meanwhile, 35 regimens (14.2%; 95% CI 10.1–19.2) were not used in 2022. The distribution of regimens by VEN groups was consistent with recommendations: 149 regimens (60.6%; 95% CI 54.2–66.7) for Group V, 63 regimens (25.6%; 95% CI 20.3–31.5) for Group E, and 34 regimens (13.8%; 95% CI 9.8–18.8) for Group N. The combined ABC/VEN analysis demonstrated that Group A predominantly included drugs from Group V (52.2%). However, it also revealed disproportions: a significant proportion (39.1%) of Group N drugs in Group A requires special attention and indicates the need for mechanisms to regulate the prescription of high-cost drugs.

Conclusion. The findings provide a foundation for developing balanced approaches to pharmaceutical provision in oncology, combining the principles of clinical appropriateness and economic efficiency. The study justifies the need for resource allocation strategies that ensure the priority provision of evidence-based treatment regimens in the context of limited resources.

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.

Background. Studies on the pharmaceutical provision of neovascular age-related macular degeneration with angiogenesis inhibitors in the Russian Federation have repeatedly indicated a mismatch between the level of consumption and the actual need for these drugs. This highlights the importance of further research on the issue through marketing analysis.

Objective: To conduct a marketing analysis of the market for angiogenesis inhibitors used in the treatment of neovascular age-related macular degeneration, including assessment of the product range, price dynamics, demand and consumption, as well as index analysis for the period of 2018–2024.

Material and methods. The study was based on open data on the procurement of angiogenesis inhibitors in the public sector, price characteristics, and information on consumption with compulsory health insurance system (24-hour and day hospitals as well as high-tech medical care). The scientific and methodological framework of the study included methods for analyzing the sales of drugs from the group of angiogenesis inhibitors registered for medical use in the Russian Federation, as well as methodological tools for calculating a series of chain indices (including the weighted average price index, price index, structural shift index, index of changes in sales volumes in physical terms, modified Herfindahl–Hirschman index). Methods for analyzing the life cycle of the drugs and comparing the volumes of their procurement and consumption volumes were also used.

Results. During the study period, there was a noticeable increase in the demand for and consumption of angiogenesis inhibitors: procurement volumes in physical terms grew 2.53-fold, and in monetary terms 1.62-fold. The positive dynamics of the market for the studied group of drugs were accompanied by an increase in weighted average prices and a growing share of more expensive drugs in the procurement structure. Between 2021 and 2023, uneven growth was observed in procurement volumes in physical terms and in the number of hospitalizations involving the use of these drugs. The ratio of hospitalization volumes to procurement volumes during this period was 1.21, 1.46, and 1.47, respectively, indicating that a single vial of the drug was used for multiple patients. The disproportion between procurement volumes and the number of hospitalizations points to a significant additional potential demand for angiogenesis inhibitors. The current market conditions can be characterized as attractive for manufacturers and suppliers.

Conclusion. It was established that the market for angiogenesis inhibitors was characterized by both qualitative and quantitative growth, with sustained positive development dynamics. The identified features of procurement and consumption indicate the need for further research aimed at developing optimal solutions for ensuring the pharmaceutical provision of angiogenesis inhibitors to consumers in the required range and sufficient volumes.

Background. Omega-3 polyunsaturated fatty acids (ω3-PUFA) are an important factor in somatic and reproductive health. Micronutrient and pharmaceutical preparations based on ω3-PUFA are widely used for cardioprotection (prevention of atherosclerosis, endothelial dysfunction, chronic inflammation, and excessive thrombosis), support of reproductive function during pregnancy and improvement of neurological development in children. The effectiveness of ω3-PUFA preparations is determined by their fatty acid composition: the amounts of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and other types of unsaturated and saturated fatty acids.

Objective: To analyze the fatty acid composition of micronutrient and pharmaceutical ω3-PUFA preparations.

Material and methods. The fatty acid composition of 16 ω3-PUFA preparations was analyzed. A quantitative chromatographic method was used to determine more than 50 fatty acids, their derivatives, and other compounds.

Results. Previously identified pharmacomarkers of fatty acid composition were confirmed, and new ones were obtained, that allow for highly reliable differentiation between highly standardized ω3-PUFA preparations (such as Omacor^®, NFO^® Omega-3 Premium, NFO^® Omega-3 Strong DHA, NFO^® Omega-3 Ultima, etc.) and less standardized products (Fish oil-Teva^®, Omeganol^®, etc.). New, more effective criteria for assessing the quality of the fatty acid composition of ω3-PUFA preparations were proposed. In particular, compliance with the criteria “ω11<3%” and “EPA+DHA>55%” corresponds to more standardized preparations with better purification quality. The usefulness of our proposed standardization coefficient for evaluating the conformity of measured ω3-PUFA levels to the amounts claimed by manufacturers was confirmed.

Conclusion. Compliance with the criteria “ω11<3%” and “EPA+DHA>55%” corresponds to more standardized preparations. The identification of highly standardized compositions allows physicians and patients to make informed choices when selecting ω3-PUFA products.

Background. Value-based healthcare (VBHC) is a model of medical care that focuses on analyzing treatment outcomes and takes into account patient-relevant results (values), clinical effectiveness, and economic costs. Although standardized assessment systems exist, such as those developed by the International Consortium for Health Outcomes Measurement (ICHOM), their practical application remains limited, slows the implementation of VBHC. The lack of unified methodologies reduces data comparability between healthcare organizations, hinders the identification of best practices, and ultimately impedes the practical realization of VBHC.

Objective: To analyze and adapt standardized approaches for assessing VBHC parameters and the methodologies for their collection based on ICHOM sets.

Material and methods. A comprehensive analysis was conducted on 49 ICHOM Standard Sets and 43 related publications in peer-reviewed journals. A structured study of the research objects was carried out, and potential barriers to the implementation of data collection methodologies by healthcare organizations were identified. Methods of qualitative content analysis and comparative data analysis were applied.

Results. The article presents a structure of indicators for the assessment of VBHC. Particular attention is given to three key components of outcomes assessment: patient-oriented outcomes – patient-reported outcomes, clinical outcomes, and indicators of healthcare resource utilization. Standardized approaches to data collection were identified, each of which has its own limitations. Optimal monitoring timelines were determined, varying depending on the type of nosology. The results demonstrate that ICHOM standards provide a comprehensive framework for assessing value-based healthcare; however, they require adaptation to specific organizational conditions. The developed data categorization and presented conclusions provide a foundation for healthcare institutions to initiate the implementation of a value-based approach, with a focus on outcomes that matter to patients.

Conclusion. The conducted analysis justifies the necessity of value-based healthcare research in accordance with the unified ICHOM Standard Sets. A unified methodology can provide a comprehensive and objective assessment of care effectiveness and foster a common understanding of the concept among all stakeholders. This approach will facilitate the transition from theory to global practice in value assessment in medicine. The next step in this direction should be the adaptation of data collection for specific sets, taking into account national characteristics and capabilities in Russia.

Objective: To analyze competition and the level of dominance in the cosmetics sector within pharmacy sales, identifying trends in three key segments: selective, mass-market, and active (therapeutic) cosmetics.

Material and methods. The study was based on annual reports on the Russian pharmaceutical market published by DSM Group. The analysis employed the Linda index and the Herfindahl–Hirschman Index (HHI), as well as the strength/variety (SV) matrix, which includes concentration ratios and the modified Hall–Tideman index. The degree of market concentration was assessed, the presence of dominant groups was identified, and the market structure and dynamics of major players’ rankings were analyzed.

Results. The Russian cosmetics market within pharmacy sales demonstrates both similarities and significant differences across segments. In the selective cosmetics segment, where foreign players dominate (with the exception of the domestic brand Librederm^®), a transformation has occurred – from high brand differentiation to a state close to a natural oligopoly. This trend has been accompanied by the strengthening of positions of Russian brands since 2014. In contrast, the mass-market cosmetics segment, characterized by high dynamism and competition, shows low market concentration and more diffuse leadership. The ambiguous dynamics of international players after 2014 have been accompanied by the strengthening of domestic brands such as Moe Solnyshko^®, which indicates the effect of geopolitics not only on the selective cosmetics segment, but also on mass-market cosmetics. The active (therapeutic) cosmetics, where Russian manufacturers are market leaders, show relative stability of individual brands, such as Alerana^®, against a backdrop of high market variability. The absence of a dominant group confirms the high level of competition.

Conclusion. There are differences in the development of cosmetic segments within pharmacy sales; the selective cosmetics segment is the most concentrated, in contrast to the mass-market and active (therapeutic) cosmetics segments, which are characterized by a high level of competition. The significance of domestic brands has increased following the introduction of sanctions.

Background. Gastroenterological side effects (esophageal, gastric, and intestinal erosions) associated with the use of drugs from the group of nonsteroidal anti-inflammatory drugs (NSAIDs) highlight the need to explore new molecule candidates with reduced ulcerogenic effects. The zinc-containing molecule candidate рilim-1 has the potential to exhibit anti-inflammatory effects and improve the regenerative properties of the gastric mucosa.

Objective: To explore the anti-inflammatory, ulcerogenic, analgesic, and antivitamin effects of the рilim-1 molecule using chemoreactomic methods.

Material and methods. The chemoreactomic assessment of the pharmacological properties of рilim-1 and zinc derivatives of well-known NSAIDs (ketorolac, diclofenac, and nimesulide) was carried out using the methods of chemoinformatic analysis of molecules developed within the scientific school of Academician Yu.I. Zhuravlev.

Results. Pilim-1 exhibits a distinct anti-inflammatory effect realized through modulation of cytokine activity as well as prostaglandin and leukotriene metabolism. A key distinguishing feature of the рilim-1 molecule is its neutrality with respect to vitamin metabolism while demonstrating a comparable anti-inflammatory potency to zinc-containing NSAID derivatives. The analgesic effect of рilim-1 is based on the inhibition of kinin and histamine receptors. The nociceptin receptor ORL1 can be inhibited by pilim-1 more effectively (IC50 198–214 nM) than zinc-NSAIDs (IC50 361–1093 nM). In the phenylquinone-induced writhing test in rats, pilim-1 demonstrated a slightly higher percentage of analgesia (44%; zinc-NSAIDs: 21–43%). The incidence of gastric ulcers at an oral dose of 100 mg/kg was estimated at 35% (compared to 75% with other molecules). Compared to other zinc-derived NSAID derivatives, рilim-1 exhibits minimal impact on vitamin and mineral metabolism.

Conclusion. Chemoreactomic analysis of рilim-1 indicates promising prospects for its application as an anti-inflammatory drug.

Objective: to evaluate the effectiveness of preliminary differential diagnostics of benign and malignant skin tumors during initial medical consultations in primary health care using the Derma Onko Check artificial intelligence (AI) program for electronic computing devices (smartphone application).

Material and methods. The effectiveness of the Derma Onko Check program for visual identification of benign and malignant skin tumors was evaluated in 135 patients aged 22 to 78 years with various skin lesions that appeared visually suspicious for malignancy. The conclusions generated by the program were compared with the results of dermatoscopic and morphological examinations.

Results. The diagnostic accuracy of the Derma Onko Check program in determining the likelihood of a patient having a benign or malignant skin tumor was 96%, sensitivity was 98%, specificity was 96%, the proportion of false-positive results was 4.3%, and the propor

Conclusion. The use of modern AI-based software for electronic computing devices enables early detection of malignant skin tumors during initial examinations in primary health care. This is particularly relevant for medical institutions and regions with a shortage or absence of dermatologists and oncologists.

tion of falsenegative results was 2.4%.

Objective: To identify potential predictors of chronic kidney disease (CKD) based on the analysis of interrelationships between somatometric (including bioimpedance), biochemical, and clinical indicators in CKD patients.

Material and methods. The values of 58 indicators describing the condition of 357 participants were collected: 128 patients with CKD and 229 participants in the control group (without kidney pathology). Demographic, anthropometric, anamnestic data (19 diagnoses according to the International Classification of Diseases, 10^th revision), bioimpedance values, results of general and biochemical blood tests (19 indicators), and diet indicators (using the CINDI survey) were studied. New mathematical approaches were applied to establish informative value intervals for numerical indicators, to find metric clusters in the multidimensional space of biomedical indicators, and to construct metric maps.

Results. In the CKD group, a predominance of older patients (mean age 54.1±13.1 years) as well as overweight people (82.18±19 kg) was observed compared to the control group (48.78±9.75 years and 74.7±17.45 kg, respectively). Patients with CKD exhibit disturbances in adipose tissue metabolism, decreased active and reactive bioimpedance resistance, high systolic blood pressure, and multiple organ pathology.

Conclusion. The analysis of the cluster of interrelationships between indicators made it possible to outline promising areas for further research. These include a more detailed investigation of informativeness and predictive strength of CKD predictors, a comprehensive assessment of treatment effectiveness, identification of differences between subgroups of patients with different nosologies and stages of CKD, evaluation of the efficacy of various therapeutic approaches, the role of physical activity, and micronutrient status.

Background. Treatment of vulvovaginal atrophy (VVA) in women diagnosed with gynecologic or breast cancer presents challenges. Treatment options for VVA, the genital manifestation of the genitourinary syndrome of menopause (GSM), generally mirror those used for natural menopause; however, efficacy and safety data specific to this patient group are limited due to their exclusion from clinical trials.

Objective: To review the literary data on new approaches to the treatment of VVA as a manifestation of GSM in women with gynecological or breast cancer.

Material and methods. The search in PubMed/MEDLINE, Web of Science, Google Scholar, eLibrary, and Scopus databases was performed using the following key phrases: “vulvovaginal atrophy”, “vulvar atrophy after cancer”, “treatment of vulvar atrophy in women with cancer”, “low dose estrogen therapy”, “laser therapy of vulvovaginal atrophy”, “vulvovaginal atrophy following treatment for oncogynecologic pathologies”, “genitourinary syndrome of menopause in breast cancer survivors”, “low dose estrogen therapy”, “laser therapy of vulvovaginal atrophy” in Russian and English. We also reviewed important sources cited in the bibliographies of relevant studies. The review included original and review articles containing the mentioned key phrases and published from 1996 to March 2025.

Results. In women with a history of gynecological or breast cancer, treatment of VVA should be tailored to the individual, and non-hormonal options such as lubricants during sexual activity and regular use of long-lasting vaginal moisturizers are typically the first line of treatment. Fractional CO₂ laser therapy is an effective and safe method for gynecological cancer survivors, enhancing sexual life and overall quality of life. In this patient population, hyaluronic acid combined with vitamins A and E has demonstrated a beneficial effect, reducing vaginal dryness and dyspareunia. The use of topical hormonal therapy may be an option for women who do not respond to non-pharmacologic and nonhormonal treatments after discussing the risks and benefits and consulting with an oncologist.

Conclusion. Not all available treatment options are suitable for women with a history of cancer due to the risk of recurrence of hormonedependent cancer associated with estrogen therapy. In this patient population, new treatments such as laser therapy and vaginal injections show promising results with minimal side effects and hormone-independent mechanisms.

Immunoglobulin A (IgA) nephropathy is the most common form of chronic glomerulonephritis and one of the leading causes of end-stage renal disease. Currently, the ability to accurately predict the risk of this progression at the individual patient level is limited. This paper analyzes the scientific literature containing research results focused on identifying independent predictors of IgA nephropathy progression risk. According to most studies, variables such as proteinuria, arterial hypertension, and baseline kidney function have a stable and independent association with worse kidney prognosis. Histological changes in kidney biopsy serve as independent predictors. The combination of morphologic and clinical data improves predictive accuracy. To enhance treatment outcomes and long-term prognosis, further research is necessary, including the search for new biomarkers and the development of a universally accepted risk stratification system.