Background. The pandemic coronavirus infection has contributed to the development of effective preventive methods to slow the spread of the virus. Mass vaccination is the only way to protect oneself from infection. The development of drugs, including vaccines, involves clinical trials (CT). The problem of conducting a CT is recruiting the necessary number of volunteers. Goal: to identify specifics of motivation of patients participating in the clinical trial of COVID-19 vaccines, as it is a very important medical and sociological issue requiring more detailed study. Materials and Methods. The results of an anonymous questionnaire survey of volunteers participating in the “EpiVacCorona” vaccine CT are presented. Overall, 203 questionnaires were analyzed, containing 19 questions answered by the residents of Kaliningrad, aged 20 to 84 years. At the stage of completion of participation in the clinical trial, information was obtained about the respondent’s attitudes to the trial, the main factors of motivation or demotivation to participate, the degree of their trust in the trial. Results. Information disseminated through the employer was an effective way to organize patient recruitment for the vaccine CT; the effectiveness of using the media was quite low. The positives of participation in the CT for volunteers were ethical considerations. Negatives for participants were the risks associated with adverse reactions or receiving a placebo. Relatives had the greatest influence on the volunteers’ decision to participate in the CT, and medical professionals, media personalities, and scientists had less influence. Conclusion. The results will help to improve patient recruitment, patient awareness of the CT, and the benefits to medicine and society. Motivating and demotivating factors will improve patient recruitment.

Recruiting patients to a clinical trial is a process with many limitations. First of all, the time-limited and lengthening of the patient recruitment process in time increases the risk of failure of the entire study. In addition to the time factor, many other factors affect the recruitment of patients. The influence of factors is multidirectional and one factor can affect both positively and negatively the recruitment of patients. We have considered some of the factors within the framework of our proposed classification. Materials and methods. A retrospective analysis of 4 international multicenter clinical trials (MSCI) of phases II–III on the recruitment of patients, depending on the influence of factors, was carried out. The purpose of the study. To consider the influence of various factors on the set of patients by changing the set of patients and some other parameters and indicators. Statistical analysis. Descriptive statistics with typing. Results. The factors are classified into two groups and their influence on the recruitment of patients is considered. Discussion. According to the literature, the authors have developed a large number of classifications of groups, and we have proposed our own classification.

Relevance. Due to the constant improvement of the technical base for laboratory research, the number of laboratory tests, both necessary for the patient and secondary, is increasing everywhere, which cannot but affect the financial costs of laboratory support for a medical organization. The growth of costs requires the search for various ways to optimize costs. Given the widespread introduction of medical and laboratory information systems, it is necessary to develop algorithms for optimizing laboratory appointments and with their help. Goal. To show possible ways to optimize the costs of laboratory research, including using the integration of a medical information system and a laboratory information system. Results. The article describes the main possibilities for optimizing the costs of laboratory research in a multidisciplinary hospital, the feature of which is the territorial removal of clinical units and laboratories. The main optimization mechanisms are considered — an adequate ratio of centralization of laboratory research and decentralization (conducting analyzes at the patient’s treatment site — point of care testing), the creation of “specializations” for clinical diagnostic laboratories, depending on the profile of clinical units and the number of prescribed analyzes by profile. The principle of introduction into the medical information system of control over the appointments of laboratory tests is shown. The economic evaluation of the results of the integration of the medical information system and the laboratory information system was carried out. Conclusion. The joint use of all existing methods of optimizing laboratory service costs will reduce the financial costs of laboratory support while maintaining the quality of medical care.

Aim. To conduct a pharmacoeconomic analysis of the use of the drug Eliquis® (apixaban), belonging to direct oral anticoagulants (DOACs), for the treatment and prevention of deep vein thrombosis (DVT) and/or pulmonary embolism (PE), including in patients suffering from cancer disease compared with other anticoagulants. Materials and Methods. The economic assessment was made from the standpoint of the healthcare of the Russian Federation. Comparative evaluation of the effectiveness of DOACs was carried out on the basis of the combined rate of the incidence of VTE and death from VTE, as well as death from any cause. Safety assessment — based on the rate of major bleeding (MB) and clinically significant non-severe bleeding (CSNSB). The evaluation was performed on the basis of data obtained in the course of previously performed meta-analyses, the results of which were published. The total cost of patient management for each of the compared alternative treatment tactics was estimated by calculating the cost of a course of drug therapy, as well as the cost of managing adverse events in the study horizon, which was 12 months. The conclusion about the most preferred alternative was made on the basis of data on the relationship between the effectiveness and cost of treating the patient. Results. Apixaban compared with dabigatran and rivaroxaban was associated with a lower risk of developing MB and CSNSB. In addition, in patients taking apixaban, there was a trend towards a decrease in the risk of death from any cause compared with patients who used dabigatran and rivaroxaban, which did not reach statistical significance, which in turn led to the choice of the method of pharmacoeconomic analysis — “cost minimization”. It has been established that the use of apixaban is characterized by the lowest costs, the cost of managing one patient amounted to 59 271,89 rubles per year, which is 28,8 % and 27,2 % lower than similar costs for treatment regimens with the original drugs dabigatran and rivaroxaban, respectively. The difference in costs was due to both the cost of treating complications (1362.8 rubles vs. 2536.3 rubles vs. 3170.9 rubles for apixaban, rivaroxaban and dabigatran, respectively), and the cost of treatment and prophylaxis of DOACs (31 514,20 RUB vs 46 434,8 RUB vs 46 790,6 RUB, respectively). Similar results were achieved in the group of patients suffering from oncological diseases, as DOACs also allowed to reduce costs by 4–5 times compared with the use of LMWH. Conclusion. Among the original DOACs and traditional LMWH therapies, the apixaban regimen has the best cost-effectiveness ratio and is the most preferred alternative in terms of pharmacoeconomic analysis.

Aim. To compare the effectiveness of direct oral anticoagulants (DOACs) in patients with non-valvular atrial fibrillation (AF) for preventing stroke and systemic thromboembolism (embolism in the vessels of the systemic circulation, systemic embolism) in terms of pharmacoeconomic indicators. Materials and Methods. The economic assessment was carried out from the standpoint of the healthcare system of the Russian Federation. We used published data on the clinical efficacy and safety of DOACs, which were obtained earlier in clinical trials. The efficacy of therapy was assessed by the incidence of ischemic stroke (IS) of systemic embolism (SE), while the safety was assessed by the incidence of major bleeding (MB) and clinically signifi cant minor bleeding (CSNMB). The total cost of patient management for each alternative treatment option included both the cost of drug therapy and the cost of managing adverse events over a study horizon of 12 months. The conclusion about the most preferred alternative was made on the basis of the ratio of effectiveness and cost of treating the patient. Results. The use of apixaban to prevent IS or SE in patients with AF was accompanied by a decrease in the incidence of their development (HR 0.80, 95 % CI 0.73–0.89; HR 0.72, 95 % CI 0.60–0.85 — compared with rivaroxaban and dabigatran, respectively), as well as a decrease in the frequency of MB compared with other DOACs (HR 0.55, 95 % CI 0.53–0.59; HR 0.78, 95 % CI 0.70–0.87 — compared with rivaroxaban and dabigatran, respectively). Since apixaban was more effective and safer than rivaroxaban and dabigatran, a cost-effectiveness approach was applied in this study. The least expensive treatment regimen included apixaban, the direct cost was 33,263 roubles per patient. The advantage was achieved both due to the lower of therapy with apixaban (29.6–34.0 % lower than other DOACs) and the minimum cost of managing the adverse events: for MB and CSNMB, it was reduced by 20.7 % compared to dabigatran and by 44.7 % compared to rivaroxaban; for stroke/SE, it was reduced by 25.9 % and 20.6 %, respectively. Conclusion. In patients with AF, apixaban was more cost-effective compared with rivaroxaban or dabigatran for preventing IS and SE, as it led to higher clinical efficacy and safety while requiring less healthcare system costs.

Introduction. Adverse drug reactions (ADR) to administration of radiographic contrast media (RCM) are observed in 10–20 % of patients. Individual tolerability of drugs is affected by RCM properties (ionicity, osmolarity). Aim. Evaluation of ADR in patients during diagnostic studies using high- and low-osmolar RCM. Methods. Analysis of 52 reports of adverse reactions to RCM registered in medical organizations of Voronezh region in 2014–2021 was performed. Group 1 included 21 patients with ADR to high-osmolar RCM (sodium amidotrizoate, yoxitalamic acid), group 2–31 patients with ADR to low-osmolar drugs (yogexol, yopromide, yopamidol, yoversol). Results. Age of patients is 6–82 years, median 48.5 years, children — 8 persons (15.4 %), women — 31 patients (59.6 %), serious reactions — 28 (53.8 %). Since 2017 there has been an increase in the number of ADRs with constant frequency of serious reactions. In 2020–2021 ADRs to low-osmolar drugs were mainly registered. Life-threatening conditions (anaphylactic shock, arterial hypotension, arrhythmia) were observed in 70.2 % of group 2, in 28.6 % of group 1 (p=0.007). One patient with initial renal dysfunction and comorbid pathology was reported to develop nephrotoxicity to yogexol. Pharmacological correction was performed in 92.3 % of cases. In 57.7 % of the patients ADR ended in recovery, in the  other cases — state improvement. Conclusion. Side effects of high-osmolar and low-osmolar RCM mainly had form of hyperergic reactions of immediate type and were reversible. High frequency of serious reactions to lowosmolar RCM against an increase in their use requires a more careful selection of patients for X-ray contrast studies.

Non-steroidal anti-inflammatory drugs are widely used by patients and medical workers, both in the Russian Federation and abroad. Despite the well-established public opinion about the safety of this group of drugs, their use is associated with toxic reactions. This study analyzed the download of the national database “Pharmacovigilance” for 11 years (for the period 2010 to 2020) with the identification of the main representatives of this class of drugs that cause adverse reactions. To compare several independent samples of patients who received different groups of NSAIDs, Kruskel-Wallis ANOVA rank analysis of variations was used using Microsoft Excel 2013, STATISTICA 10.0 packages. Based on the results obtained, it can be concluded that the main proportion of adverse drug reactions (ADR) is associated with the female sex and the use of metamizole sodium. In addition, fatal AEs have been reported, most of which are associated with the use of paracetamol.

The article is dedicated to the outstanding scientist, doctor, teacher, public figure, corresponding member of the Russian Academy of Sciences, professor, doctor of medical sciences Belousov Yuri, who would have turned 80 on September 23, 2022. The presented materials make it possible to recall the main milestones in the biography of this remarkable person. The article is based on materials collected by relatives, friends, colleagues and students of Yuri Belousov.