Background. Anovulatory infertility remains one of the leading causes of impaired fertility in women of reproductive age. The efficacy of in vitro fertilization (IVF) programs demonstrates interindividual variability, which necessitates the identification of reliable predictive markers to optimize personalized stimulation protocols. The role of pharmacogenetic variants of cytochrome P450 genes in predicting IVF outcomes in this condition remains insufficiently studied, which determines the relevance of this pilot study. Objective. To evaluate the association of polymorphic variants of cytochrome P450 genes ( CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP3A4, CYP3A5 ) with the achievement of clinical pregnancy in IVF programs in patients with an-ovulatory infertility. Materials and methods. This prospective pilot cohort study included 96 patients divided into two groups: those who achieved pregnancy after their first IVF attempt (group 1, n = 48) and those with three or more failed cycles in their history (group 2, n = 48). Genotyping of 19 single-nucleotide polymorphisms was performed using whole-genome typing on Infinium Global Screening Array-24 v3.0 biochips. Statistical analysis included the Pearson χ² test, Fisher's exact test, and the Monte Carlo permutation test (10,000 permutations). Results. Statistically significant associations were identified between polymorphisms in CYP2A6 (rs8192733, rs56113850, rs57897628) and CYP2C19 (rs4244285) and IVF outcomes. For rs8192733, associations were found for the G/G genotype of CYP2A6 with an unsuccessful IVF cycle (OR = 0.105; 95 % CI 0.105–0.316; p < 0.001) and for the C/C and C/G genotypes with a successful procedure (OR = 4.795; 95 % CI 1.212–18.963; p = 0.031 and OR = 3.176; 95 % CI 1.202–8.395; p = 0.031, respectively). For the rs56113850 polymorphism in CYP2A6 , the C/T genotype was associated with a favorable outcome (OR = 3.095; 95 % CI 1.284–7.458; p = 0.010), while the T/T genotype was associated with a negative outcome (OR = 0.286; 95 % CI 0.100–0.812; p = 0.015). The homozygous A/A genotype of the rs57897628 polymorphism in CYP2A6 was associated with a lower probability of pregnancy (OR = 0.256; 95 % CI 0.091–0.725; p = 0.005). For the CYP2C19 gene (rs4244285), the G/A genotype was associated with effective IVF (OR = 7.500; 95 % CI 2.016–27.901; p = 0.001). Conclusion. According to the obtained results, CYP gene polymorphisms can serve as potential pharmacogenetic markers for predicting IVF effectiveness in patients with anovulatory infertility.
Background. Acute postoperative pain remains a significant clinical challenge despite advances in anaesthesiology. Multimodal analgesia with non-opioid analgesics is the standard of care. Intravenous (IV) ibuprofen and IV paracetamol are widely used, but their comparative efficacy has been insufficiently studied.Objective. To perform a systematic review and indirect comparison (network meta-analysis) of the efficacy and safety of IV ibuprofen versus IV paracetamol in adult patients with moderate-to-severe acute postoperative pain.Methods. A systematic search was conducted in PubMed/MEDLINE, Cochrane Central, Google Scholar, Semantic Scholar up to November 2025. Inclusion criteria: randomized controlled trials (RCTs) in adults comparing IV ibuprofen (800 mg q6h) or IV paracetamol (1000 mg q6h) combined with opioids against a control (placebo + opioids). The primary outcome was pain intensity reduction measured by the area under the curve of the visual analogue scale on movement (AUC–VASM) over 6–24 h. Secondary outcomes were opioid consumption, incidence of any adverse events (AEs), and postoperative nausea and vomiting (PONV). Risk of bias was assessed with the RoB 2.0 tool. Pairwise and network meta-analyses were performed using a random-effects model (DerSimonian — Laird). We calculated standardized mean differences (SMD) and risk ratios (RR) with 95 % confidence intervals (CI). Heterogeneity was evaluated with the I2 statistic. A frequentist network meta-analysis was used for indirect comparison.Results. Six RCTs (879 patients) were included: four on ibuprofen (n=726) and two on paracetamol (n=153). The risk of bias was low/unclear for ibuprofen trials and unclear/high for paracetamol trials. Pairwise meta-analysis confirmed the efficacy of both drugs versus placebo: for ibuprofen, SMD = –0.60 (95 % CI –0.78 to –0.42); for paracetamol, SMD = –0.53 (95 % CI –0.85 to –0.20). Network meta-analysis showed a statistically significant advantage of ibuprofen over paracetamol: SMD = –0.60 (95 % CI –0.78 to –0.42) in favour of ibuprofen, corresponding to a moderate effect size. The pooled reduction in AUC–VASM was 25.68 % (95 % CI 12.60–38.76) for ibuprofen and 13.68 % (95 % CI 7.74–19.62) for paracetamol. Opioid-sparing effects were comparable: 23.3 % vs 27.3 %, respectively. The incidence of any AEs and PONV with ibuprofen did not differ from placebo (RR=1.03, 95 % CI 0.96–1.10 and RR=0.94, 95 % CI 0.58–1.53). Safety data for paracetamol were limited.Conclusion. Intravenous ibuprofen provides a statistically significant and clinically greater analgesic effect than IV paracetamol in the treatment of moderate-to-severe acute postoperative pain, with a comparable safety profile. These findings support the preferential use of IV ibuprofen in multimodal analgesia regimens for patients without contraindications to NSAIDs.
Relevance. Real-world evidence (RWE) can be widely used in cost-effectiveness analysis (CEA) and budget impact analysis (BIA) conducted to justify the inclusion of new medicines in restrictive drug lists. However, researches of RWE use experience in drug assessment in the Russian Federation is currently limited, which makes it necessary to conduct such a research.Our goal is to analyze of the practice of using RWE in preparation of dossiers, conducting CEA and BIA for drugs proposed for inclusion in the restrictive drug lists in the Russian Federation.Materials and methods. The practice of using RWE in a drug assessment was studied through a content analysis of 28 proposals for the inclusion of drugs in restrictive lists (vital and essential drugs list, high-cost nosology list) in 2022, published CEA (n=109) and BIA (n=82) which were used for drug inclusion in 2018–2024.Results. In the dossier, real-world studies were used primarily for descriptive purposes, to characterize the proposed drug, current treatment practice, and the therapeutic area. In published CEAs RWE was most often used to increase the completeness of costs taken into account (34 % of uses), increase the accuracy of cost calculations (24 %), and take effectiveness into account when calculating the cost-effectiveness ratios (19 %). In the BIA RWE was most often used to calculate the target patient population (51 % of evidence uses), increase the accuracy of cost calculations (22 %), and more fully account for costs (18 %). RWE characterized the proposed drug and/or comparator in only 44 % of cases in CEAs and 22 % in BIAs; in the remaining cases, it described patients, characteristics of medical care, or the use of medical interventions after or as a result of the use of the compared medicinal products. The use of RWE from other countries is prevalent in CEAs (62 % of uses) and accounts for a significant share in the BIAs (31 % of uses).Conclusions. In drug assessment RWE is used for a wide range of purposes and characterizes a wide range of parameters for the drugs under scope, target patient groups, treatment patterns, and the long-term outcomes of using the drug. The identified specific features of the RWE use practice differ from expectations, according to which its use should be focused primarily on the compared drugs and describe their effectiveness and safety. It was shown that RWE most often did not describe compared drugs and did not address their efficacy and safety. The significant share of non-local RWE necessitatesthe development of measures aimed at increasing the volume of local RWE.
Gene therapy is one of the most promising areas of modern medicine and requires the development of robust regulatory mechanisms due to the potential irreversibility of interventions and potential long-term risks.The aim of the study was a comparative analysis of international and national regulations governing the development, clinical use, and post-marketing monitoring of gene therapy drugs.A systemic analysis of regulations from the European Union (EU), the United States, the United Kingdom, Japan, China, and the Russian Federation was conducted. It was found that in all legal systems examined, gene therapy is permitted exclusively for therapeutic purposes and is limited to interventions in somatic cells, while heritable genetic changes are prohibited or significantly limited. Regulatory models in the EU and the United States provide for accelerated registration procedures with mandatory long-term monitoring and the implementation of risk management plans. In the Russian Federation, gene therapy is regulated within the framework of pharmaceutical legislation, without classifying it as a separate category. These results demonstrate the need for further harmonization of international approaches to gene therapy regulation.
Background. Glucagon-like peptide-1 (GLP-1) receptor agonists are widely used as pharmacotherapy for type 2 diabetes mellitus and obesity.Objective. This study aimed to characterize adverse reactions (ARs) and assess the disproportionality of reporting for GLP-1 agonists registered in the Russian Federation using the national pharmacovigilance database.Materials and methods. We analyzed all reports submitted to the "Pharmacovigilance" database of the Roszdravnadzor Automated Information System between January 1, 2020, and December 31, 2025, concerning the use of dulaglutide, lixisenatide, liraglutide, semaglutide, tirzepatide, and exenatide. Reporting odds ratios (ROR) and proportional reporting ratios(PRR) were calculated for the most frequent system organ classes of adverse reactions.Results. A total of 181 reports concerning GLP-1 agonists were submitted to the Roszdravnadzor database, of which 154 were primary reports. The maximum number of reports (n = 101) was associated with semaglutide. Adverse reactions were mainly represented by type B reactions (allergic reactions, including injection site reactions) and type A reactions (gastrointestinal disorders: nausea, vomiting, abdominal pain). Among the seriousness criteria for all GLP-1 agonists, the clinical significance of the event predominated. There was no statistically significant disproportionality in reporting concerning the development of serious ARs, therapeutic ineffectiveness, ARs related to the system organ classes "gastrointestinal disorders" or "immune system disorders", cases of acute pancreatitis, or the frequency of therapy discontinuation due to AR development.Conclusions. The assessment of the risks of ARs during GLP-1 agonist therapy based on the analysis of the Russian pharmacovigilance database is limited due to the extremely low frequency of reporting. Active monitoring is required for this drug class, in the form of post-authorization safety studies (PASS). A potential tool for this is the establishment of a Russian registry for patients receiving medication for obesity.
Introduction. CDK4/6 inhibitors in combination with endocrine therapy (ET) represent the current standard of care for patients with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2 — ) locally advanced or metastatic breast cancer (LABC, MBC). Evidence of the clinical efficacy of CDK4/6 inhibitors has been obtained from a series of randomized clinical trials (RCTs) as well as from real-world clinical practice (RWCP) studies in various countries.Objective. The aim of the ICEDORA study was to analyze the clinical and demographic characteristics and treatment patterns of patients with HR+ HER2– LABC and MBC receiving CDK4/6 inhibitors in RWCP in Moscow (Russia).Materials and methods. ICEDORA is a non-interventional, retrospective study based on the analysis of data from patients who received CDK4/6 inhibitors in Moscow. Clinical characteristics and treatment details were extracted from primary medical documents (outpatient charts and medical histories) for all patients with HR+ HER2– breast cancer who received ribociclib, palbociclib, or abemaciclib from January 2020 to the end of December 2022. Differences between treatment groups were assessed using the log-rank test. Overall survival (OS) was calculated from the time of breast cancer diagnosis to patient death using the Kaplan-Meier method.Results. A total of 2,051 patients were included in the analysis. Based on the CDK4/6 inhibitor administered, selected based on clinical assessment in routine clinical practice, the overall population was divided into three treatment groups: 58.7 % of patients received palbociclib, 34.7 % received ribociclib, and 6.6 % received abemaciclib. The median age in the overall population and in the ribociclib and palbociclib groups was 58 years; in the abemaciclib group, it was higher (62 years). In 83.5 % of cases, the human epidermal growth factor receptor 2 (Her2/neu) status was negative, and thegroups were homogeneous regarding this parameter. Ki-67 and estrogen receptor (ER) levels were significantly higher in the abemaciclib group. Among all patients (2,051), 42.1 % were diagnosed with de novo MBC (stage IV). The distribution of disease stages was comparable across groups. The groups differed significantly in the number of metastases due to a larger proportion of patients with a single metastasis in the abemaciclib group (31.9 %) compared to the ribociclib (19.0 %) and palbociclib (16.6 %) groups, where more than one metastatic site was more common. Comorbidity was observed in 90 % of patients. Caution is necessary when interpreting the study results due to differences in the baseline characteristics of patients receiving the different drugs.Conclusion. The ICEDORA study represents one of the most extensive analyses of the clinical and demographic characteristics and treatment patterns of patients with HR+ HER2– LABC receiving CDK4/6 inhibitors in RWCP. The study clearly demonstrated that comparing the effectiveness of ribociclib, palbociclib, and abemaciclib in the RWCP setting is challenging due to differences in patient clinical and demographic characteristics. Larger, multicenter data with balanced cohorts and long-term follow-up are needed.
In real-world clinical practice, NSAID prescribing is frequently associated with risks of NSAID-induced gastropathy and nephrotoxicity, particularly when the pharmacokinetic profiles of these drugs in elderly patients are overlooked. A retrospective process audit of NSAID prescriptions was conducted from January 1 to October 1, 2025; the analysis included 149 medical records selected via simple random sampling. Deviations were classified in accordance with the Summary of Product Characteristics (SmPC), Order No. 1094n of the Russian Ministry of Health, and clinical audit principles (WHO, NICE). The assessment covered dosing deviations, duration of therapy, correctness of prescribing regimens, drug-drug interactions, and documentation defects. Formal defects were identified in the majority of patients (use of brand names — 83.9 %; omission of concentration — 50.3 %). Clinically significant deviations included undefined pro re nata regimens (22.1 %), excessive duration of therapy (18.1 %), exceeding the daily dose (16.8 %), and potentially hazardous drug-drug interactions (2.0 %); critical violations were recorded in 20.8 % of patients. The high prevalence of identified deviations highlights the need to update local pain management protocols.
Hypopituitarianism is a chronic disease based on insufficient secretion of hormones in the anterior pituitary gland. Clinical manifestations of hypopituitarism are varied, often the lack of tropic hormones does not have pronounced symptoms, but the impairment of the function of the pituitary depends on the severity of the hormone deficiency. The most common causes of primary pituitarism are pituitary adenoma and complications after surgery or radiation therapy to treat pituitary adenoma. In addition to the formation of a pituitary gland, various types of brain injury such as craniocerebral trauma, iatrogenic trauma during surgery or cranial radiation can also cause a pituitary syndrome. Hypopituitarism caused by radiation exposure to the brain is very rare, but cases have been reported in the literature of patients undergoing radiation therapy. Despite the relevance of this problem, the mechanism of development of pathology is not well researched. The patients who encountered iatrogenic hypopituitarism, as a result of long-term dynamic observation allowed to trace the similarity in the consistent development of symptoms, with each case being unique clinical picture.
Objective . To develop and validate a hybrid biostatistical methodology for generating Real-World Evidence (RWE) to assess the efficacy and safety of food supplements. Methods . The proposed framework integrates causal inference techniques (Inverse Probability of Treatment Weighting, IPTW) with ensemble machine learning methods (CatBoost, Random Forest) and Multiple Imputation by Chained Equations (MICE). Validation was performed using two pilot non-interventional studies (N=249) and a high-dimensional synthetic dataset (N=6000) with missingness up to 83.33%. Multi-objective Pareto optimization was applied for benefit–risk assessment. Results . IPTW achieved a standardized mean difference (SMD) <0.10 across all baseline covariates. The efficacy regression model attained an R² of 0.3596. The CatBoost-based safety classification model, after threshold optimization, achieved a PRfor Magnesium 400 mg). Pareto optimization provided an objective comparison of supplement profiles without subjective AUC of 0.123 and an F1-score of 0.218, enabling the detection of latent adverse event signals (e.g., 12.47% indicator weighting. Conclusion . The developed methodology improves the consistency and reliability of post-market supplement evaluation using RWD and can support regulatory activities of organizations such as Food and Drug Administration, European Food Safety Authority, and Roszdravnadzor RF.
Background . Healthcare evidence generation is shifting beyond randomized controlled trials (RCTs) to embrace real-world data (RWD). Collected from diverse routine care settings, RWD underpins real-world evidence (RWE), offering insights into patient outcomes, treatment effectiveness, and healthcare delivery. While RWE enhances generalizability and cost-effectiveness compared with RCTs, its inherent complexities such as data quality issues, missingness, confounding, and selection bias demand rigorous analytical approaches. Methods . This critical review synthesizes the spectrum of analytical methodologies applied to RWD, ranging from traditional statistical techniques and causal inference frameworks to machine learning and advanced methods including natural language processing (NLP), Bayesian modeling, and network analysis. Each approach is appraised in terms of strengths, limitations, and suitability for addressing the unique challenges of RWD. Results . Traditional statistical models provide interpretability and control for observed confounding but are limited by strong assumptions and vulnerability to unmeasured confounders. Causal inference methods, such as instrumental variables and target trial emulation, strengthen causal interpretation but require strong assumptions and specialized expertise. Machine learning approaches excel in prediction and high-dimensional data analysis but face interpretability and generalizability challenges. Advanced methods, including NLP and Bayesian models, extend analytical capacity but demand significant expertise and computational resources. Across categories, triangulation of multiple methods enhances robustness and credibility. Conclusions . RWE plays a critical role in drug development, post-market surveillance, comparative effectiveness research, health economics and outcomes research, and personalized medicine. Future progress hinges on emerging innovations such as federated learning, synthetic data generation, and explainable AI (XAI), alongside advances in data integration, harmonization, and reproducibility. Methodological transparency, rigorous validation, and interdisciplinary collaboration are essential to ensure that RWE delivers trustworthy, ethical, and clinically actionable insights capable of informing regulatory decisions and optimizing healthcare globally.
Introduction. Real-world evidence (RWE) plays a critical role in pharmaceutical companies at all stages of a medical product’s life cycle. Contract research organizations and research infrastructure suppliers ensure that RWE studies. Understanding what the industry thinks about an ideal ecosystem is important for conducting high-quality RWE studies. Objective. To identify the strengths and weaknesses of existing RWE study processes in Russia, needs, and proposals in this area, which can later be used by key parties of the RWE ecosystem to create a regulatory framework and ensure the methodology and quality of RWE studies. The objective was to develop an ideal RWE ecosystem model. Materials and methods. The study used semi-structured in-depth interviews with experts in the RWE field: 10 pharmaceutical companies, 6 CROs, and 3 providers of study infrastructure. From September 23 to November 14, 2025, 19 expert interviews were conducted, each of which included 23 questions combined into 4 blocks: 1) a description of the respondents, 2) problems in conducting RWE studies, 3) ensuring RWE study quality, and 4) regulatory needs. Results. The analysis of the respondents’ answers enabled the identification of eight interrelated components that form the ideal RWE ecosystem model: regulatory certainty and regulatory framework, quality of source data, data infrastructure, study parties’ competencies, quality management systems, study planning, transparency and traceability, financing, and resource ensuring. Conclusion. The ideal RWE model is a complex ecosystem that requires the coordinated development of regulatory, organizational, technological, and educational components.
Background. In October 2024, a new antibiotic, pazufloxacin, was registered in Russia. Information on the efficacy and safety of injectable pazufloxacin is lacking in the Russian literature. Objective. To conduct a systematic literature review and meta-analysis of data on the efficacy and safety of pazufloxacin, an infusion solution. Methods. This review included clinical trials (CTs) evaluating the efficacy and safety of injectable pazufloxacin, conducted in adult volunteers, considering the clinical conditions for which the drug is indicated in the Russian Federation. A meta-analysis was performed based on published results of randomized clinical trials (RCTs) conducted in adult patients with urinary tract infections (UTIs). Results. Of the 1,068 articles identified, 10 were included in this review. Four studies were RCTs, and the remaining studies were before-and-after studies. The efficacy of pazufloxacin varied depending on the site, type of infection, and dose, ranging from 78.7 % to 100 % for UTIs, 75.1 % to 100 % for respiratory tract infections, and 80.0 % to 95.2 % for obstetric and gynecological infections. Despite a trend toward higher efficacy values for pazufloxacin in RCTs, a meta-analysis confirmed the absence of significant differences in efficacy between the compared groups. Notably, 15 years or more have elapsed since most studies were conducted. Given the increasing antibiotic resistance of infectious agents over time, the efficacy of drugs in the Russian population may differ from that in RCTs. This primarily applies to the comparator drugs considering a history of their long-term use in Russia. Unlike the comparator drugs, pazufloxacin is a new drug with a lower risk of antibiotic resistance in Russian clinical practice. In most clinical trials, pazufloxacin was well tolerated by patients. Conclusions. According to CTs in the Russian Federation, pazufloxacin has a high safety profile and is highly effective when used within its approved indications. The use of antibacterial drugs should consider current data on the resistance of infectious agents to prescribed drugs.
Introduction. Antipsychotics are widely used off-label for treating resistant forms of anxiety-depressive disorders, necessitating a thorough safety data collection for this class of medicinal products. Objective. To assess the safety profile of antipsychotics recommended by the Russian Federation for treating patients with neurotic disorders. Materials and methods. Spontaneous reports submitted to the "Pharmacovigilance" database of the Roszdravnadzor Automated Information System between 2019 and 2024 were analyzed for chlorprothixene, sulpiride, amisulpride, quetiapine, olanzapine, risperidone, and aripiprazole. For each international nonproprietary name, Reporting Odds Ratios (ROR) and Proportional Reporting Ratios (PRR) were calculated to assess statistically significant disproportionality. Results. We obtained data from 1392 spontaneous reports, of which 1359 were primary reports. The number of spontaneous reports increased for most drugs, except for sulpiride, amisulpride, flupentixol, and ziprasidone. The total number of reports over the 5‑year observation period did not exceed 50 for flupentixol (n=21), lurasidone (n=35), ziprasidone (n=18), cariprazine (n=29), and amisulpride (n=14). The highest number of statistically significant associations between drug use and the development of adverse reactions across several system-organ classes was demonstrated for risperidone: disorders of the musculoskeletal and connective tissue (dystonia, tremor, hypertonia), disorders of the reproductive system and mammary glands (galactorrhea, amenorrhea), and laboratory/instrumental findings (hyperprolactinemia). Associations were confirmed with injuries, poisonings, procedural complications (poisoning, intentional poisoning, and neurotoxicity), and nervous system disorders (depressed level of consciousness, headache, and dizziness) for chlorprothixene. Associations between quetiapine and nervous system disorders (tremor, stupor, somnolence), injuries, poisonings, and procedural complications (neurotoxicity, poisoning, and overdose) Associations were found between aripiprazole, flupentixol, and lurasidone with musculoskeletal and connective tissue disorders (dystonia). Cariprazine was associated with psychiatric disorders (agitation, anxiety, and 1 case of completed suicide). Conclusions. The overall reporting level remains extremely low. Considering the international experience in collecting safety data on antipsychotics, a significant number of cases may be underreported, including suicides and self-harm, overdoses, rhabdomyolysis, neuroleptic malignant syndrome, closed-angle glaucoma associated with olanzapine use, and acute pancreatitis associated with quetiapine use.
This article presents the results of a safety study of oral anticoagulants in surgical patients with polypharmacy. An analysis of medical records of inpatients receiving oral anticoagulants for the prevention of venous thromboembolic complications was conducted. Postoperative venous thromboembolism is one of the most common indications for the use of direct oral anticoagulants. Serious problems may arise during treatment and may be associated with age-related changes in the body, gender, and concomitant drug therapy.
Relevance. The goal of rehabilitation is to maximize the restoration of lost functions, reduce disability, and return the patient to an active life in society. The effectiveness of rehabilitation depends on the comprehensiveness, validity, and individualized approach to each patient. Objective. Rehabilitation aims to maximize the restoration of lost functions, minimize disability, and help patients return to an active life in society. Methods. System analysis of various sources of rehabilitation knowledge is used to identify and organize cause-andeffect relationships. Ontological knowledge modeling includes a semantic representation structure and a set of ontological agreements that define the reasoning principles when solving current rehabilitation problems. Ontological modeling ensures transparency, verifiability, and interpretability of knowledge. Results. The semantic model of cause-and-effect relationships in this subject area was constructed, encompassing the interrelationships between observations, diagnostic profiles, and rehabilitation measures. This model considers the combined influence of symptoms, factors, and standard scale ratings on human functioning, linking specific impairments and their severity to elements of the ICF profile, rehabilitation goals, and recovery methods. A consistent set of concept types and their relationships enable the structural and verbal representation of knowledge from two types of sources — clinical guidelines and expert materials. Conclusions. The novelty of these results in terms of developing methods for constructing and using ontological models lies in the development of a new ontological knowledge model that incorporates a semantic representation structure from the most reliable sources and automatic processing in clinical decision support systems. The proposed ontological model with IACPaaS technology forms a flexible tool for combining heterogeneous data and enabling explainable artificial intelligence, which is critical for medical applications. This allows for the development of intelligent services that enhance rehabilitation quality by standardizing approaches, incorporating best practices, and customizing processes.
The article provides a conceptual analysis of the fundamental categories underpinning the assessment of the value of medicinal products and other health technologies, including good, intangible benefits, service, utility, cost, quality, and quality of life (QOL). Health is interpreted as an intangible good and a supreme value for the individual and society, whereas a medicinal product is considered a tangible economic good whose value is determined by the balance between its utility for the patient and the total costs of its development and use. Drawing on philosophical and economic approaches, value is substantiated as an integration of utility and cost, the distinction between the categories of “quality” and “utility” is emphasized, and the role of QOL and utility measures (including QALY and their possible alternatives) in contemporary pharmacoeconomic models is highlighted. From the standpoint of clinical pharmacology and health technology (HT) assessment, the article examines the concept of pharmacology as an integrative approach to accompanying a medicinal product throughout its entire life cycle — from preclinical and clinical research to real-world use, pharmacovigilance, and real-world data analysis. Within this framework, the value of a medicinal product is understood as a dynamic characteristic formed by clinical effectiveness, safety profile, economic parameters, organizational aspects, inclusion in drug lists and HTA outcomes, and patient-relevant attributes (QoL, adherence, accessibility). The integration of these factors underpins rational resource allocation, funding priority setting, and managerial healthcare decision justification. Special attention is paid to the ISPOR “value flower”, in which the value of HT is structured into traditional (costs, QALY), relatively new (productivity, adherence), and innovative components (improved predictability, fear of contagion, insurance value, consideration of disease severity, equity in resource distribution, scientific spillover, etc.). Accounting for these additional dimensions enables an expansion beyond a purely clinico-economic view and captures the social, ethical, and behavioral aspects of medicinal interventions at the patient, health system, and society levels. Comprehensive assessment of the special importance of medicinal products for population health — including health system needs, disease severity, therapeutic value, and strength of evidence — is an essential tool for accelerating evaluation and shaping contemporary pharmaceutical and health policy.
Relevance. Acute respiratory infections are the leading cause of disease worldwide. Kagocel® is a synthetic antiviral agent indicated for influenza and other acute respiratory viral infections (ARVI). It induces the production of interferon, thereby enhancing the immune response to viral pathogens. Objective. To evaluate changes in quality of life and symptom dynamics when prescribing Kagocel® to patients with ARVI. Materials and methods. This open, multicenter, observational, non-interventional study enrolled 1000 adult patients, 467 with mild and 533 with moderate ARVI. All patients were prescribed Kagocel® tablets for 4 days within 24–72 h from the ARVI symptom onset. Results. In patients with mild ARVI, a statistically significant (p <0,001) improvement in the EuroQol-5 Dimension 3-level (EQ-5D-3L) score was observed by day 3, with scores increasing from 84.3±10.0 to 90.4±5.1 on day 3 and further to 95.7±4.9 by day 6. Similarly, in patients with moderate ARVI, there was also a statistically significant (p <0,001) improvement noted by day 3, with scores rising from 70.4±13.6 to 85.4±8.2 on day 3 and reaching 99.1±3.7 by day 6. By days 3 and 6, 22.1% and 88.0% of patients with mild ARVI, respectively, had no remaining symptoms. By day 3, 10.5% of patients with moderate ARVI undergoing therapy reported the absence of ARVI symptoms, and 89.9% of patients were symptom-free by day 6. No adverse events were reported. Conclusion. The oral administration of Kagocel® to ambulatory patients with mild to moderate ARVI was effective and safe; therefore, it may be routinely recommended.
This study systematically analyzed the current approaches to analgesic therapy in dental practice based on scientific publications of the last decade. This study examined the main groups of analgesic medications used in dentistry, including nonsteroidal anti-inflammatory drugs, opioid analgesics, local anesthetics, and their combinations. Particular attention is paid to the mechanisms of action of various classes of medications, their efficacy, and safety profiles when used in various patient categories. The current trends in multimodal analgesia and personalized pain relief approaches tailored to individual patient characteristics, age groups, and comorbidities are analyzed. Innovative drug delivery technologies, including nanosomal formulations, extended-release systems, and transdermal systems, are considered. Data on the use of artificial intelligence and digital technologies to optimize analgesic therapy are presented. A systematic review was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology, and 42 sources selected from 1,247 initially identified publications in international databases were analyzed. The results of this study demonstrate the evolution of approaches to dental pain relief from universal protocols to personalized medicine. This study demonstrated the importance of combining different analgesic groups to achieve an optimal balance of efficacy and safety. Promising areas for developing analgesic therapy related to the integration of advances in molecular biology, nanotechnology, and digital technologies into dental clinical practice are identified.
This article examines the challenge of bridging the "valley of death" in medical research and development (R&D) — a critical phase where many promising projects fail to advance to implementation and commercialization. This study analyzes organizational, legal, financial, economic, and methodological obstacles that hinder the translation of scientific discoveries into practical healthcare. This study focuses on the Russian legislative framework governing scientific research and analyzes the socioeconomic impact of adopting new medical technologies based on international experience. The article highlights a paradox: despite substantial investments in medical R&D, many projects fail due to difficulties in assessing their innovative potential, inadequate coordination among stakeholders, and stringent regulatory requirements. The authors propose potential solutions, such as fostering public-private partnerships, streamlining regulatory processes, advancing translational medicine, and implementing knowledge management systems. This article is intended for researchers, regulators, pharmaceutical industry representatives, and healthcare policymakers seeking to accelerate the adoption of medical innovations.
This article presents the outcomes of the VI Annual Scientific and Practical Conference with international participation "RWD/RWE. Possible and Real", which focused on the use of Real-World Data (RWD) and Real-World Evidence (RWE) in healthcare. The event facilitated a comprehensive analysis of the current state of RWD/RWE regulatory frameworks, methodological approaches, and practical applications in the Russian Federation and the Eurasian Economic Union (EAEU). Key systemic limitations were identified, including gaps in legislation, the lack of standardized methods for data collection and analysis, interoperability issues of information systems, and challenges related to confidentiality and personal data processing. A set of specific proposals and recommendations aimed at improving the regulatory framework, developing in- frastructure for working with RWD, integrating such data into health technology assessment processes, developing clinical guidelines, and implementing innovative drug supply models. Harmonizing approaches at the EAEU level, data standardization, and creating secure mechanisms for researchers and developers to access anonymized medical information are of particular importance. The resolution materials are intended for legislative and executive authorities, regulators, medical and scientific organizations, pharmaceutical industry representatives, and patient communities.
