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  • 1
    In: Клиническая онкогематология, Practical Medicine Publishing House, Vol. 16, No. 2 ( 2023-03-03), p. 154-165
    Abstract: Цель. Изучение качества жизни у пациентов с хронической иммунной тромбоцитопенией (ИТП) в процессе терапии ромиплостимом, оценка эффективности и безопасности препарата в условиях реальной клинической практики. Материалы и методы. В исследовании участвовали взрослые пациенты с подтвержденным диагнозом хронической ИТП, имеющие показания для терапии ромиплостимом. Оценку клинических показателей, качества жизни по опросникам RAND SF-36 и FACT-Th6, а также слабости по опроснику FACIT-Fatigue проводили до начала лечения ромиплостимом и через 3, 6, 12 мес. после его начала. Также больные заполняли анкету удовлетворенности пациента лечением на всех точках исследования после начала терапии. Анализ клинической эффективности ромиплостима включал оценку ответа на лечение и время его достижения. Для анализа изменений качества жизни и слабости в процессе наблюдения применяли метод обобщенных оценочных уравнений (GEE). Определяли значимые изменения уровня слабости у пациентов и сопоставляли эту информацию по результатам оценки больными и врачами. Результаты. В исследование включено 60 больных хронической ИТП, получавших ромиплостим в условиях реальной клинической практики (средний возраст 51,9 года, 70 % женщин). Медиана количества тромбоцитов до начала терапии ромиплостимом — 18,5 × 109/л (межквартильный интервал 10,8–22,3 × 109/л). Геморрагический синдром при включении в исследование имелся у 90 % больных. Общий ответ на терапию ромиплостимом составил 98,3 % (полный ответ достигнут у 93,3 % больных). Через 6 мес. терапии ответ сохранялся у 89,5 % пациентов. Геморрагический синдром полностью купирован через 3 мес. терапии у 81 % больных, через 6 мес. — у 93 %. Медиана времени до достижения ответа — 4,4 нед. (95%-й доверительный интервал 3,6–5,3 нед.). Нежелательные явления I–II степени, связанные с ромиплостимом, выявлены у 6,7 % больных. В процессе терапии ромиплостимом продемонстрирована выраженная положительная динамика качества жизни по всем шкалам общего опросника SF-36 и согласно специальному опроснику FACT-Th6 (p  〈  0,001). Наиболее отчетливое улучшение отмечалось по шкалам ролевого физического и ролевого эмоционального функционирования. Продемонстрировано существенное уменьшение слабости уже через 3 мес. лечения с сохранением дальнейшей положительной динамики через 6 и 12 мес. терапии ромиплостимом (p  〈  0,001). Доля больных, испытывающих значительное влияние слабости на разные аспекты функционирования, существенно уменьшилась в процессе терапии ромиплостимом. Подавляющее большинство пациентов (85 %) удовлетворены лечением. Выявлены расхождения между пациентами и врачами в оценках уровня слабости в процессе лечения. Заключение. Результаты настоящего многоцентрового наблюдательного исследования свидетельствуют о высокой эффективности и безопасности ромиплостима у больных хронической ИТП в условиях реальной клинической практики. Терапия ромиплостимом сопровождается значительным улучшением качества жизни и снижением слабости у пациентов. Для улучшения контроля состояния больных и совершенствования пациент-ориентированной медицинской помощи при ИТП в условиях реальной клинической практики целесообразна оценка качества жизни и уровня слабости с использованием стандартизованных опросников.
    Type of Medium: Online Resource
    ISSN: 2500-2139 , 1997-6933
    Language: Russian
    Publisher: Practical Medicine Publishing House
    Publication Date: 2023
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  • 2
    In: Pediatric Hematology/Oncology and Immunopathology, Fund Doctors, Innovations, Science for Children, Vol. 21, No. 1 ( 2022-03-28), p. 66-71
    Abstract: There are only limited data coming from isolated case reports regarding the real-world use of emicizumab for the treatment of children with hemophilia A and inhibitors (HAI) in Russia. The aim of the study was to evaluate the efficacy and safety of emicizumab prophylaxis in children with severe HAI. Ethical approval was not required since the study only involved the use of anonymized and generalized retrospective data obtained during routine clinical practice. We retrospectively analyzed medical records of children with HAI who had been treated with emicizumab at 11 institutions located in Russia, taking into consideration such parameters as annualized bleeding rates (ABR), annualized spontaneous bleeding rates (ASBR), annualized joint bleeding rates (AJBR) and annualized bleeding rates for bleeds requiring additional therapy (ABRRT), as well as the presence and severity of adverse events during the treatment. The median age of patients at the time of initiation of emicizumab prophylaxis was 65 (11–170) months. Before the treatment, ABR was 19.9 (95% confidence interval (CI), 15.4–26.1), ASBR – 13.6 (95% CI, 10.6–17.8), AJBR – 6.6 (95% CI, 4.7–9.7), ABRRT – 16.6 (95% CI, 12.4–22.7). After the initiation of the treatment, bleeding rates changed dramatically: ABR decreased by 98.6% (95% CI, 96.7–99.4), AJBR – by 99.4% (95% CI, 95.3–99.9), ABRRT – by 98.8% (95% CI, 96.8–99.6); and there were no signs of spontaneous bleeding during 10 (1–32) months of treatment. No adverse events leading to the interruption or discontinuation of the treatment with emicizumab were reported. The use of emicizumab in children with HAI in the real-world clinical setting results in a significant ( 〉 98%) and safe reduction in bleeding episodes without any signs of spontaneous bleeding.
    Type of Medium: Online Resource
    ISSN: 2414-9314 , 1726-1708
    Language: Unknown
    Publisher: Fund Doctors, Innovations, Science for Children
    Publication Date: 2022
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  • 3
    In: Russian Journal of Pediatric Hematology and Oncology, OOO Grafika, Vol. 6, No. 2 ( 2019-04-24), p. 30-47
    Abstract: Relevance . In accordance with the guidelines on the clinical investigation of clotting factor VIII products of the European Medicines Agency and guidelines on pharmacovigilance of the Eurasian Economic Union, after registration of a new drug, it is recommended to study its efficacy and safety on a large population of patients in a standard medical practice to clarify and identify new data. Materials and methods . In a prospective, multicenter, open-label, uncontrolled observational study, the efficacy and safety of the domestic recombinant B-domain deleted blood clotting factor FVIII (FVIII) (moroctocog alfa, Octofactor®, JSC “GENERIUM”) in patients with moderate and severe hemophilia A in the context of standard medical practice (study protocol number CI-51/15). Patients received the drug in terms of standard medical practice for the purpose of prophylactic treatment or on demand treatment. For prophylactic treatment Octofactor was administered to patients according to the instructions for medical use in a single dose of 20–40 IU/kg every 2–3 days. In the case of bleeding a single dose of Octofactor was calculated taking into account the severity and localization of bleeding in accordance with the instructions for medical use. The results of the treatment were analyzed for a period of 52 ± 2 weeks. The main parameter for evaluating the efficacy was the frequency of spontaneous bleeding that occurred within 48–72 hours after the administration of the Octofactor. Additional parameters for evaluating the efficacy included: the severity of spontaneous bleeding arising during the prophylactic treatment; the number of injections and the total dose of the Octofactor to stop 1 episode of bleeding; the amount of Octofactor used during the entire observation period (52 ± 2 weeks) and for 1 month both for prophylaxis and for stopping the bleeding that occurred; an indicator of the efficacy of therapy on the scale for determining the response to treatment of acute hemarthrosis (World Federation of Hemophilia, WFH). Results. According to the results of the screening survey 237 male patients aged from 19 to 78 years old (mean age 35.2 ± 11.1 years) with moderate and severe hemophilia A (FAS-population) were included in the study. The efficacy of therapy was evaluated in 202 patients who underwent all the planned procedures during the observation period (PP-population). 193 (95.5 %) patients received prophylactic treatment, 9 (4.5 %) patients received on-demand treatment. Evaluation of the efficacy of treatment was carried out on the basis of basic and additional parameters. The main parameter for evaluating the efficacy – the frequency of spontaneous bleeding that occurred within 48–72 hours after the administration of the Octofactor – was 52 ± 2 weeks within 1.4 ± 2.9 cases. At the same time, the proportion of spontaneous bleeding that occurred within 48–72 hours after administration of the Octofactor preparation was 45.2 % of the total number of spontaneous bleeding and 15.6 % of the total number of all bleeding in patients who received prophylactic treatment. Among 608 spontaneous bleeding that occurred in patients receiving prophylactic treatment, 287 (47.2 %) of the bleeding were mild, 289 (47.5 %) were moderate and 32 (5.3 %) were heavy. Of the 275 spontaneous bleeding that occurred within 48–72 hours after administration of the study drug for prophylactic purposes, 117 (42.5 %) episodes were mild, 146 (53.1 %) were moderate, and 12 (4.4 %) were severe. With prophylactic administration the average single dose of the Octofactor was 2036.3 ± 884.7 IU, or 27.3 ± 11.2 IU/kg, in the treatment of bleeding occured during prophylactic treatment – 2227.7 ± 1087 IU, in the treatment of bleeding in patients receiving the drug only on demand – 2280.7 ± 1037.2 IU. The average monthly intake of the drug by one patient in prophylactic treatment was 19.75 ± 9.75 thousand IU, while the average monthly consumption of the drug for preventing bleeding from one patient was 17.16 ± 9.13 thousand IU for stopping bleeding against the background prevention – 3.87 ± 3.97 thousand IU. One patient who received on-demand treatment had an average monthly average of 13.47 ± 13.46 thousand IU of the Octofactor preparation. For stopping 1 bleeding, on average, 1.7 ± 1.7 injections of the Octofactor preparation were required, in the prophylactic treatment group – 1.8 ± 1.8, and in the on-demand treatment group – 1.5 ± 1.1. In the overwhelming majority of cases, patients of both groups showed excellent and good response to all treatment of acute hemarthrosis on the scale of the WFH on all visits, the reaction was moderate in a few episodes, and only in 1 case of acute hemarthrosis there was no response to the drug administration. The safety of therapy was evaluated in 228 patients who received at least 1 Octofactor administration during the study (mITT-population). There were 66 adverse events in 40 patients, 10 of them were associated with the use of the drug, the most significant of which were the formation of inhibiting antibodies to FVIII in low titer (1.5 U) in 1 patient and the development of allergic reactions in 2 patients. Conclusions. Under the conditions of standard medical practice the efficacy and safety of Octofactor was confirmed for both prophylactic treatment and on-demand bleeding treatment in adult patients with severe and moderate hemophilia A.
    Type of Medium: Online Resource
    ISSN: 2413-5496 , 2311-1267
    URL: Issue
    Language: Unknown
    Publisher: OOO Grafika
    Publication Date: 2019
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  • 4
    Online Resource
    Online Resource
    National Medical Research Center of Hematology of the Ministry of Health of the Russian Federation ; 2019
    In:  Russian journal of hematology and transfusiology Vol. 64, No. 4 ( 2019-12-12), p. 436-446
    In: Russian journal of hematology and transfusiology, National Medical Research Center of Hematology of the Ministry of Health of the Russian Federation, Vol. 64, No. 4 ( 2019-12-12), p. 436-446
    Abstract: Introduction. Primary immune thrombocytopenia (idiopathic thrombocytopenic purpura, ITP) is a rare autoimmune disorder, whose main clinical manifestation consists in the hemorrhagic syndrome of varying severity. The therapy for ITP is aimed at eliminating hemorrhagic manifestations and maintaining patients’ quality of life. There is no information on the incidence of ITP, as well as on the clinical course and response to the treatment of ITP patients, in the Russian Federation. Aim. To estimate the epidemiological and clinical characteristics of ITP in the adult population of the Russian Federation. Materials and methods. We studied clinical and laboratory data derived from electronic medical records of ITP patients having participated in a multi-centre, prospective, observational, cohort study “Epidemiological and Clinical Characteristics of ITP in Adults in Russia” carried out from 2014 to 2017. The data was processed employing methods of descriptive statistics, as well as frequency analysis, event analysis and analysis of variance. The calculations were performed using the SAS V9.4 statistical package. Results. The incidence of ITP in the adult population in three selected regions of the Russian Federation averaged 2.09 per 100 thousand people per year. The highest incidence rate in gender-age groups was observed in women under 40 years of age mounting to 2.7 per 100 thousand. A gradual increase in the incidence rate from 1.09 to 2.5 per 100 thousand was noted in the men over 60 years of age. A significant correlation was found between the risk of developing the hemorrhagic syndrome, its severity and the platelet count at the onset of the disease (p 〈 0.0001). In 92.2 % of cases, glucocorticosteroid hormones were prescribed as the first line of therapy. The analysis of methods used as the second line of therapy revealed that, although splenectomy is performed relatively frequently, its likelihood has decreased from 26 to 17 % over the past three years. In addition, the proportion of patients being treated with thrombopoietin receptor agonists has increased from 5.9 to 45.7 %. Conclusion: The incidence of ITP in three selected regions of the Russian Federation is comparable to that in other European countries. Conflict of interest: the authors declare no conflict of interest.
    Type of Medium: Online Resource
    ISSN: 2411-3042 , 0234-5730
    Language: Unknown
    Publisher: National Medical Research Center of Hematology of the Ministry of Health of the Russian Federation
    Publication Date: 2019
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  • 5
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    Online Resource
    Publishing House OKI ; 2022
    In:  Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice , No. 1 ( 2022-04-30), p. 41-52
    In: Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice, Publishing House OKI, , No. 1 ( 2022-04-30), p. 41-52
    Type of Medium: Online Resource
    ISSN: 2618-8473 , 2588-0519
    Language: Unknown
    Publisher: Publishing House OKI
    Publication Date: 2022
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  • 6
    In: Oncohematology, Publishing House ABV Press, Vol. 17, No. 3 ( 2022-07-20), p. 48-61
    Abstract: Background . The treatment options for patients with multiple myeloma who refractory to previous bortezomib and lenalidomide therapy are limited. Pomalidomide is ап immunomodulatory agent that was registered for the treatment of patients with double refractory multiple myeloma. Aim . To evaluate efficacy, safety and optimal course of the therapy with pomalidomide in routine practice in patients with double refractory multiple myeloma. Materials and methods . Overall, 71 patients with double refractory multiple myeloma were included in the retrospective analysis. There were 36 males and 35 females. The median age was 61 years (range 35-79). According to Durie-Salmon staging system, there were 53 (79.1 %) patients in stage III, 13 (19.4 %) - stage II, and 1 (1.5 %) - stage I. The stage was unknown in 4 patients. Kidney impairment at the onset was in 10 (15 %) patients, the normal function was in 57 (85 %) patients and 4 patients had no data. Most patients ( n = 68, 95.8 %) received pomalidomide in one therapy line, in 3 (4.2 %) patients - drug was given in two lines, totally 74 episodes of use. Median number of drugs prescribed prior to pomalidomide were 4 (2-9) drugs, including target ones - 2 (2-5). In the first remission 31 (43.6 %) patients received high-dose therapy with autologous stem cell transplantation. pomalidomide was administered in combination with low doses of dexamethasone (PomDex, n = 44; 59.4 %) and as a part of triple regimens ( n = 30; 40.6 %). previously exposed ( n = 22; 73.3 %) and new drugs ( n = 8; 26.7 %) were used in the combination treatment. In 44 (61.9 %) patients pomalidomide was administered more than 3 years after the onset of the disease, median 63.5 (37-184) months. In 27 (38.1 %) patients it was given within less than 3 years after the onset, median 21 (6-36) months. The primary endpoint was progression-free survival. Secondary endpoints - pomalidomide tolerability, response rate and optimal third drug in the triple regimen. The dependence of progression-free survival, frequency of response and adverse events from the pretreatment, the choice of the third drug, gender, age, immunochemical variant, stage according to the International Staging System and to Durie-Salmon classification was studied. Results . The median time from the diagnosis to the start of pomalidomide therapy was 44.5 (6-184) months. The median of cycles with pomalidomide was 3 (1-30). The response was achieved in 52 (70 %) patients. The median progression-free survival was 4 (1-30) months, overall survival - 6 (0.5-42) months. Adverse effects were noted in 34 (46.5 %) patients. The most frequent adverse events were neutropenia grade III-IV ( n = 14; 41.3 %), infection (n = 7; 20.7 %) and fatigue with limitation of daily activity ( n = 6; 20.6 %). The rate of adverse events was higher in patients with triplets than doublets regimens of therapy: 43.3 % ( n = 13) and 27.2 % ( n = 12) respectively ( p = 0.008). There were no statistically significant differences in progression-free survival between pomalidomide treatment options (two- or three-component regimen). Conclusion . Compared to the three-component therapy consisting of drugs to which refractoriness was previously diagnosed the PomDex scheme is less toxic and equally effective. Therapy with pomalidomide is effective in the majority of patients with double refractory multiple myeloma even in heavily pretreated. The toxicity is acceptable.
    Type of Medium: Online Resource
    ISSN: 2413-4023 , 1818-8346
    URL: Issue
    Language: Unknown
    Publisher: Publishing House ABV Press
    Publication Date: 2022
    detail.hit.zdb_id: 3043126-8
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  • 7
    Online Resource
    Online Resource
    IRBIS ; 2021
    In:  FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology Vol. 14, No. 2 ( 2021-07-27), p. 136-150
    In: FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology, IRBIS, Vol. 14, No. 2 ( 2021-07-27), p. 136-150
    Abstract: Background. The introduction of innovative drugs has significantly increased the treatment effectiveness in patients with relapsed/refractory multiple myeloma (RRMM), but the question of whether these expensive options can be financially secured remains open. Objective: to assess the cost of triplets of targeted drugs ixazomib, carfilzomib, elotuzumab and daratumumab with lenalidomide and dexamethasone used in the treatment of RRMM, and to determine possible payment options for this therapy at the level of the Russian Federation subjects. Material and methods. The cost of an annual course of treatment with the studied regimens with centralized purchases and the cost of targeted drugs per hospitalization case were calculated based on the maximum registered prices, recommended doses and treatment regimens. The normative legal acts regulating the payment of drug therapy for multiple myeloma were analyzed and possible financing channels and their limitations were identified. Using the example of the Volgograd and Saratov Regions, tariffs under the compulsory medical insurance system were calculated and their sufficiency in covering the cost of targeted therapy was estimated. Results. The cost of an annual course of triplet therapy per patient in the case of centralized procurement of drugs ranged from 5.51 million rubles (regimen with ixazomib) up to 8.03 million rubles (regimen with carfilzomib). The cost per hospitalization, depending on the number of doses, ranged from 80,667–242,000 rubles (ixazomib, 1–3 doses) in the Saratov Region up to 239,618–958,472 rubles (daratumumab, 1–4 doses) in the Volgograd Region. Possible reimbursement channels are High-Cost Nosologies (HCN), Obligatory Medical Insurance (OMI) and Regional Drug Coverage (RDC) programs, nevertheless triplet therapy cannot be purchased via the single channel and the combination of them is required. It has been shown that, in most cases, the costs for a case of targeted drug treatment in studied regions are covered by the average tariff for the corresponding diagnosis-related group (DRG), except for cases with a maximum duration in a day hospital setting. An analysis of the RDC lists and the procurement of drugs in the studied regimens at the expense of regional budgets showed that lenalidomide, ixazomib, carfilzomib, elotuzumab and daratumumab are included in the restrictive list in regions 77, 74, 66, 63 and 47, but they are purchased only in regions 15, 24, 6, 4 and 6, respectively. Conclusion. The use of a triplet with ixazomib is characterized by the lowest costs, which indicates its greater economic attractiveness relative to carfilzomib, daratumumab and elotuzumab in the treatment of patients with RRMM. The tariffs established in the current DRG model retain the possibility of paying for treatment with the high-cost medicines at the expense of the OMI funds in combination with the HCN or RDC programs. There are reasons to believe that the expansion of the list of 14 HCN program will increase the provision of patients with highly effective therapy and also reduce the financial burden on the regions.
    Type of Medium: Online Resource
    ISSN: 2070-4933 , 2070-4909
    Language: Unknown
    Publisher: IRBIS
    Publication Date: 2021
    detail.hit.zdb_id: 3070236-7
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  • 8
    In: Rational Pharmacotherapy in Cardiology, Silicea - Poligraf, Vol. 16, No. 5 ( 2020-11-04), p. 670-677
    Abstract: Aim . To search for new pharmacogenetic biomarkers of bleeding risk in patients taking rivaroxaban and dabigatran for different indications: atrial fibrillation, endoprosthesis of large joints of lower limbs. Material and methods . The study enrolled 29 patients (17 patients received dabigatran and 12 –rivaroxaban), who had hemorrhagic complications during taking direct oral anticoagulants. To find new pharmacogenetic biomarkers of bleeding risk, a next generation sequencing (NGS) was performed for selected candidate genes. Results . Among the patients with bleeding who received dabigatran, 13 variants of the nucleotide sequence showed statistically significant deviation from the population values: 11 in the CES1 gene and 2 in the ABCB1 gene. Among the patients with bleeding who received rivaroxaban, 7 variants of nucleotide sequence showed significant deviation: 4 in the ABCG2 gene, 2 in the CYP3A4 gene, and 1 in the ABCB1 gene. Conclusion . The identified in this study polymorphisms of candidate genes ABCB1, ABCG2, CES1, CYP3A4 were associated with the risk of bleeding in patients taking rivaroxaban and dabigatran. It makes an important contribution to the pharmacogenetics of direct oral anticoagulants and require additional assessment of clinical significance in further studies.
    Type of Medium: Online Resource
    ISSN: 2225-3653 , 1819-6446
    Language: Unknown
    Publisher: Silicea - Poligraf
    Publication Date: 2020
    detail.hit.zdb_id: 2750390-2
    SSG: 15,3
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  • 9
    Online Resource
    Online Resource
    National Pedagogical Dragomanov University ; 2023
    In:  Scientific Journal of National Pedagogical Dragomanov University. Series 15. Scientific and pedagogical problems of physical culture (physical culture and sports) , No. 2(160) ( 2023-02-28), p. 39-45
    In: Scientific Journal of National Pedagogical Dragomanov University. Series 15. Scientific and pedagogical problems of physical culture (physical culture and sports), National Pedagogical Dragomanov University, , No. 2(160) ( 2023-02-28), p. 39-45
    Abstract: Taking into account the results of monitoring of specialized Internet resources (analysis of scientific and methodological, special and reference literature), the members of the research group established, that the urgent issue of organizing a systematic analytical review of the components of the technical and tactical preparation of female athletes who specialize in combat sports in accordance with their world rating in the chosen type of martial arts is devoted to the insufficient number of scientific studies, this, in turn, emphasizes the relevance and practical component of the chosen direction of scientific research. The purpose of the study is an analytical and statistical analysis of the technical preparation of highly qualified female athletes who specialize in Sambo wrestling – finalists of the 2022 World Championship (Bishkek, Kyrgyzstan). Research methods: abstraction, measurement, expert evaluation, survey, comparison, observation, etc. As a result of the theoretical research, the members of the research group conducted an analytical and statistical analysis of the technical readiness of highly qualified athletes (women) (specialization in Sambo wrestling) – finalists of the 2022 World Championship (Bishkek, Kyrgyzstan). We consider it expedient to take the results of the theoretical research into consideration by leading coaches who specialize in Sambo wrestling (sports section). We recommend focusing the attention of the leading coaches on increasing the indicators of activity and efficiency of the competitive actions of female athletes (women who specialize in Sambo wrestling), namely: development and improvement of technical and tactical preparation of fellow fighters (in the rack: focus on improving the technique of undercuts and hooks; on the ground floor: focus on performing pain techniques on the legs after the opponent is fully restrained); reducing the number of warnings for violation of the rules, through a theoretical study of the current Rules (practical training of complex technical and tactical combinations); expanding the arsenal of crown technical actions; development of individual tactical schemes for conducting a competitive fight in the rack and parterre with the use of restraints and pain techniques on the arms and legs; improving indicators of the subsystem of biological control of sportswomen; development of general physical and special physical readiness of wrestlers. Prospects for further research in the chosen field of scientific intelligence include analytical and statistical analysis of the technical readiness of highly qualified Combat Sambo wrestlers, finalists of the 2022 World Championship (Bishkek, Kyrgyzstan).
    Type of Medium: Online Resource
    ISSN: 2311-2220
    URL: Issue
    Language: Unknown
    Publisher: National Pedagogical Dragomanov University
    Publication Date: 2023
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  • 10
    Online Resource
    Online Resource
    Publishing House OKI ; 2023
    In:  Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice , No. 1 ( 2023-04-19), p. 15-25
    In: Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice, Publishing House OKI, , No. 1 ( 2023-04-19), p. 15-25
    Abstract: Multiple myeloma (MM) accounts for 1 % of all cancers and about 10 % of all hemoblastoses. The use of innovative technologies with the inclusion of targeted drugs leads to a significant improvement in the quality of pharmacotherapy and the achievement of overall survival (OS). The aim of the work is to conduct a pharmacoeconomic analysis of the most used MM therapy regimens with the use of targeted drugs and to determine the dominant treatment regimens using a costeffectiveness analysis. Materials and methods. To determine the cost of a course of treatment, we summed up the costs of drugs included in the pharmacotherapy regimen, taking into account taxes, marginal trade markup and duration of the course.  Dosing of the targeted drug included in the regimen was determined according to the official instructions for the drug. Progression-free survival (PFS) was adopted as the main criterion for the effectiveness of treatment. Information on PFS of targeted drugs was obtained from data from international phase III RCTs — ASPIRE, TOURMALINEMM1, POLLUX and ELOQUENT2. Results. Based on the results of the pharmacoeconomic analysis, the dominant treatment regimen for MM was determined — daratumumab / lenalidomide / dexamethasone, which has the best cost-effectiveness ratio. The combination of elotuzumab / lenalidomide / dexamethasone was recognized as the least effective technology.
    Type of Medium: Online Resource
    ISSN: 2618-8473 , 2588-0519
    Language: Unknown
    Publisher: Publishing House OKI
    Publication Date: 2023
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