Pub Date : 2024-04-18DOI: 10.37489/2588-0519-2024-1-86-90
E. M. Esedov, L. N. Musaeva
The purpose. To study the content of melatonin in venous blood, to assess the seasonal variability of the hormone in patients with duodenal ulcer (DU) and to establish a possible relationship between the studied parameters.Material and methods. 45 patients with varying clinical activity of DU during exacerbation and during treatment were examined. Determination of melatonin in venous blood was carried out using high-performance liquid chromatography with tandem mass spectrometry. To assess the condition of the duodenum, fibrogastroduodenoscopy of the gastroduodenal zone we used Exera (cIF160) and Olympus endoscopes.Results. It has been established that in the active stage of DU the levels of the hormone melatonin are reduced. In order to study the possible effect of light illumination on melatonin content, we studied the production of this indole in groups of patients with DU at different times of the year. It turned out that the melatonin content was significantly lower in the group of patients with peptic ulcer disease in winter and spring.Conclusion. The regression and correlation analysis carried out revealed a positive moderate dependence of the melatonin indicator on the duration of daylight hours in the venous blood. Clinical remission of DU after 2 months was accompanied by an increase in melatonin production.
研究目的研究静脉血中褪黑激素的含量，评估十二指肠溃疡（DU）患者体内褪黑激素的季节性变化，并确定研究参数之间可能存在的关系。研究人员对 45 名十二指肠溃疡患者在病情加重和治疗期间的不同临床活动进行了调查。采用高效液相色谱-串联质谱法测定静脉血中的褪黑激素。为了评估十二指肠的状况，我们使用了Exera（cIF160）和奥林巴斯内窥镜对胃十二指肠区进行纤维胃十二指肠镜检查。已经证实，在 DU 的活动期，荷尔蒙褪黑激素的水平会降低。为了研究光照对褪黑激素含量可能产生的影响，我们研究了一组 DU 患者在一年中不同时期吲哚的分泌情况。结果发现，消化性溃疡病患者组在冬季和春季的褪黑激素含量明显较低。进行的回归和相关分析表明，静脉血中的褪黑激素指标与日照时间的长短呈中度正相关。2 个月后，DU 的临床缓解伴随着褪黑激素分泌的增加。
{"title":"Circadian marker in duodenal ulcer","authors":"E. M. Esedov, L. N. Musaeva","doi":"10.37489/2588-0519-2024-1-86-90","DOIUrl":"https://doi.org/10.37489/2588-0519-2024-1-86-90","url":null,"abstract":"The purpose. To study the content of melatonin in venous blood, to assess the seasonal variability of the hormone in patients with duodenal ulcer (DU) and to establish a possible relationship between the studied parameters.Material and methods. 45 patients with varying clinical activity of DU during exacerbation and during treatment were examined. Determination of melatonin in venous blood was carried out using high-performance liquid chromatography with tandem mass spectrometry. To assess the condition of the duodenum, fibrogastroduodenoscopy of the gastroduodenal zone we used Exera (cIF160) and Olympus endoscopes.Results. It has been established that in the active stage of DU the levels of the hormone melatonin are reduced. In order to study the possible effect of light illumination on melatonin content, we studied the production of this indole in groups of patients with DU at different times of the year. It turned out that the melatonin content was significantly lower in the group of patients with peptic ulcer disease in winter and spring.Conclusion. The regression and correlation analysis carried out revealed a positive moderate dependence of the melatonin indicator on the duration of daylight hours in the venous blood. Clinical remission of DU after 2 months was accompanied by an increase in melatonin production.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140689518","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-04DOI: 10.37489/2588-0519-2023-4-120-122
D. Sychev
In 2023, the book “Practical Issues of Rational Antibacterial Therapy” under general ed. Yarovoy SK, Khokhlov AL, was published. This monograph is devoted to practical issues of empirical therapy for the most common nonspecific infectious and inflammatory diseases. The monograph presents the main provisions of antimicrobial therapy from the perspective of clinical pharmacology. The general patterns of prescription and distribution of antibacterial agents, the concepts of basic and reserve drugs, selection of hospital strains, natural and acquired resistance are explained. Antibacterial drugs are compared in pairs with each other based on an analysis of their spectra of antimicrobial activity. Combination (multicomponent) antibacterial therapy is being considered. Undesirable regimens of antimicrobial therapy are described, options with insufficient effectiveness and an unsatisfactory safety profile are analyzed.
{"title":"Review of the book “Practical issues of rational antibacterial therapy”","authors":"D. Sychev","doi":"10.37489/2588-0519-2023-4-120-122","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-4-120-122","url":null,"abstract":"In 2023, the book “Practical Issues of Rational Antibacterial Therapy” under general ed. Yarovoy SK, Khokhlov AL, was published. This monograph is devoted to practical issues of empirical therapy for the most common nonspecific infectious and inflammatory diseases. The monograph presents the main provisions of antimicrobial therapy from the perspective of clinical pharmacology. The general patterns of prescription and distribution of antibacterial agents, the concepts of basic and reserve drugs, selection of hospital strains, natural and acquired resistance are explained. Antibacterial drugs are compared in pairs with each other based on an analysis of their spectra of antimicrobial activity. Combination (multicomponent) antibacterial therapy is being considered. Undesirable regimens of antimicrobial therapy are described, options with insufficient effectiveness and an unsatisfactory safety profile are analyzed.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140266362","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-03-04DOI: 10.37489/2588-0519-2023-4-108-119
O. Obuhova, A. S. Bogomazova, A. N. Meshkov, M. Ezhov
The federal program of preferential drug provision in cardiology shows its effectiveness. However, hypercholesterolemia (HCH) remains a significant problem in patients in whom high-dose statin therapy does not provide the target level of low-density lipoprotein cholesterol (LDL cholesterol). The solution to the problem lies in the plane of prescribing lipid-lowering drugs of a different mechanism of action, for example, inhibitors of the PCSK9 enzyme. To recommend the inclusion of such kind drugs in the program, it is necessary not only to have evidence of their life-saving effect, but also the economic feasibility of their use. Aim: to evaluate the economic efficacy of alirocumab (INN) including in the federal program for patients who have suffered an acute coronary event, are receiving statins and have an LDL CH level of 5.0 mmol/l and higher.Materials and methods. Modeling was applied in a target group of 3029 patients of working age who had undergone ACS during the previous 12 months with severe, including familial, HCH, with LDL cholesterol 5.0 mmol/l and higher, receiving statins taking into account previously determined outcomes when using alirocumab + statins for 5 years. Direct medical and non-medical costs, as well as indirect costs, are identified. The cost-effectiveness analysis was applied from the point of view of the effectiveness of treatment (effects on mortality, temporary disability, disability) and direct health care costs (additional drug provision and outpatient follow-up, specialized, including high-tech, medical care in a 24‑hour hospital). Two healthcare technologies were compared: statin therapy and use of alirocumab + statins. The calculations used according to domestic methods used the cost of medical treatment, temporary disability, hospitalizations, loss of GDP and other parameters.Results. Modeling has shown a decrease in mortality, morbidity and disability when using alirocumab in even the first year of use. The economic effect of alirocumab from a decrease in temporary disability in the 1st year is 304.5 mln rub., in the 2nd — 301.5 mln rub., in the 3rd — 321.1 mln rub., in the 4th — 333.1 mln rub. The estimated amount of prevented GDP losses from mortality in the target group for 4 years in the case of alirocumab use amounted to 1,260.2 mln rub. The annual amount of avoidable GDP losses from mortality in the target group in the case of alirocumab is 27–30 %. The annual average savings per patient in the case of alirocumab use are from 7 to 17 %. The greatest impact on reducing losses from disability and mortality of the target group is noted in the group of people aged 40–59 years. Only for this group, if alirocumab is used, it is possible to reduce losses from disability and mortality by 159.2 million rubles per year (83 % of the total economic effect). Starting from the 4th year of alirocumab use, it is possible to obtain a positive economic effect in terms of hospitalization costs.Conclusion. When alirocumab i
{"title":"Economic aspects of the cardiology program expansion of additional drugs provision by effective lipidlowering drugs for hypercholesterolemia control","authors":"O. Obuhova, A. S. Bogomazova, A. N. Meshkov, M. Ezhov","doi":"10.37489/2588-0519-2023-4-108-119","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-4-108-119","url":null,"abstract":"The federal program of preferential drug provision in cardiology shows its effectiveness. However, hypercholesterolemia (HCH) remains a significant problem in patients in whom high-dose statin therapy does not provide the target level of low-density lipoprotein cholesterol (LDL cholesterol). The solution to the problem lies in the plane of prescribing lipid-lowering drugs of a different mechanism of action, for example, inhibitors of the PCSK9 enzyme. To recommend the inclusion of such kind drugs in the program, it is necessary not only to have evidence of their life-saving effect, but also the economic feasibility of their use. Aim: to evaluate the economic efficacy of alirocumab (INN) including in the federal program for patients who have suffered an acute coronary event, are receiving statins and have an LDL CH level of 5.0 mmol/l and higher.Materials and methods. Modeling was applied in a target group of 3029 patients of working age who had undergone ACS during the previous 12 months with severe, including familial, HCH, with LDL cholesterol 5.0 mmol/l and higher, receiving statins taking into account previously determined outcomes when using alirocumab + statins for 5 years. Direct medical and non-medical costs, as well as indirect costs, are identified. The cost-effectiveness analysis was applied from the point of view of the effectiveness of treatment (effects on mortality, temporary disability, disability) and direct health care costs (additional drug provision and outpatient follow-up, specialized, including high-tech, medical care in a 24‑hour hospital). Two healthcare technologies were compared: statin therapy and use of alirocumab + statins. The calculations used according to domestic methods used the cost of medical treatment, temporary disability, hospitalizations, loss of GDP and other parameters.Results. Modeling has shown a decrease in mortality, morbidity and disability when using alirocumab in even the first year of use. The economic effect of alirocumab from a decrease in temporary disability in the 1st year is 304.5 mln rub., in the 2nd — 301.5 mln rub., in the 3rd — 321.1 mln rub., in the 4th — 333.1 mln rub. The estimated amount of prevented GDP losses from mortality in the target group for 4 years in the case of alirocumab use amounted to 1,260.2 mln rub. The annual amount of avoidable GDP losses from mortality in the target group in the case of alirocumab is 27–30 %. The annual average savings per patient in the case of alirocumab use are from 7 to 17 %. The greatest impact on reducing losses from disability and mortality of the target group is noted in the group of people aged 40–59 years. Only for this group, if alirocumab is used, it is possible to reduce losses from disability and mortality by 159.2 million rubles per year (83 % of the total economic effect). Starting from the 4th year of alirocumab use, it is possible to obtain a positive economic effect in terms of hospitalization costs.Conclusion. When alirocumab i","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-03-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140266273","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-28DOI: 10.37489/2588-0519-2023-4-58-67
D. Fokina, O. V. Zhukova, S. A. Volkova, A. L. Khokhlov
It is important for public health to monitor and improve the health indicators of the population using the system of patient's quality of life (HRQoL) assessment regardless of the nosology of the disease. The use of HRQoL assessment provides health authorities with a tool for additional analysis of the performance of health services and for making decisions about funding priorities. The definition of HRQoL is one of the decisive factors in the calculation of QALYs because it measures the effectiveness of medical treatment in terms of how much it prolongs and/or improves patients' lives. The aim of the study is to determine the QALYs of hemophilia patients in Nizhny Novgorod region by means of electronic questionnaire using the SF-36 questionnaire. Methods. A validated SF-36 short form questionnaire was used in the study, which was distributed to adult patients with hemophilia A, B and Willebrand's disease of Nizhny Novgorod region together with a short form of informed voluntary consent. Twenty-eight people participated in the questionnaire. Calculation of general and final indicators of the HRQoL was carried out according to the instructions for processing data obtained with the SF-36 questionnaire. Results. The lowest score among all respondents was for GH "General Health Status" with a mean value of 61.00, and the highest score was for PF "Physical Functioning" with a mean value of 81.43. The study revealed that the majority of the surveyed patients were receiving Emicizumab (42.86 %). After comparing the ranges of values of the final indicators of physical (PH) and mental (MN') health in patients with different forms of hemophilia, the highest values of HRQoL indicators are observed in patients with hemophilia B, and the highest range of extreme values — in patients with hemophilia A. Conclusion. Patients with different forms of hemophilia are determined to have satisfactory values of HRQoL indicators, as all the results obtained in the course of the questionnaire are above the average value of the indicators. Mean HRQoL scores in patients receiving emicizumab are at a similar level compared to patients receiving other LPs, and fluctuations in HRQoL scores in these patients are less marked than in the other patients with hemophilia A.
{"title":"Quality of life of patients with different forms of hemophilia on the example of Nizhny Novgorod region","authors":"D. Fokina, O. V. Zhukova, S. A. Volkova, A. L. Khokhlov","doi":"10.37489/2588-0519-2023-4-58-67","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-4-58-67","url":null,"abstract":"It is important for public health to monitor and improve the health indicators of the population using the system of patient's quality of life (HRQoL) assessment regardless of the nosology of the disease. The use of HRQoL assessment provides health authorities with a tool for additional analysis of the performance of health services and for making decisions about funding priorities. The definition of HRQoL is one of the decisive factors in the calculation of QALYs because it measures the effectiveness of medical treatment in terms of how much it prolongs and/or improves patients' lives. The aim of the study is to determine the QALYs of hemophilia patients in Nizhny Novgorod region by means of electronic questionnaire using the SF-36 questionnaire. Methods. A validated SF-36 short form questionnaire was used in the study, which was distributed to adult patients with hemophilia A, B and Willebrand's disease of Nizhny Novgorod region together with a short form of informed voluntary consent. Twenty-eight people participated in the questionnaire. Calculation of general and final indicators of the HRQoL was carried out according to the instructions for processing data obtained with the SF-36 questionnaire. Results. The lowest score among all respondents was for GH \"General Health Status\" with a mean value of 61.00, and the highest score was for PF \"Physical Functioning\" with a mean value of 81.43. The study revealed that the majority of the surveyed patients were receiving Emicizumab (42.86 %). After comparing the ranges of values of the final indicators of physical (PH) and mental (MN') health in patients with different forms of hemophilia, the highest values of HRQoL indicators are observed in patients with hemophilia B, and the highest range of extreme values — in patients with hemophilia A. Conclusion. Patients with different forms of hemophilia are determined to have satisfactory values of HRQoL indicators, as all the results obtained in the course of the questionnaire are above the average value of the indicators. Mean HRQoL scores in patients receiving emicizumab are at a similar level compared to patients receiving other LPs, and fluctuations in HRQoL scores in these patients are less marked than in the other patients with hemophilia A.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140418216","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-28DOI: 10.37489/2588-0519-2023-4-78-85
O. A. Kupriushina, D. Strelkova, A. S. Yasneva, S. Rachina, S. N. Avdeev, A. Vlasenko, L. Fedina, O. V. Ivanova, I. V. Kaledina, N. Ananicheva
Relevance. During and after the COVID-19 pandemic, viruses have become a more common cause of pulmonary infections in adults; therefore, the distinction between viral lung injury and community-acquired bacterial pneumonia is of increasing importance. Aim. Development of a model for differentiating community-acquired bacterial pneumonia and viral lung injury, including COVID-19. Materials and methods. This retrospective case–control study included 300 adult patients with viral lung injury and 100 adult patients with community-acquired bacterial pneumonia. Clinical, laboratory, and instrumental data were analyzed, significant factors were selected by which the samples differed, and a model was developed using logistic regression to distinguish between community-acquired bacterial pneumonia and viral lung damage, including COVID-19. Results. The developed model included the following parameters: total protein level, neutrophil/lymphocyte index, heart rate, unilateral infiltration on CT or chest x-ray, vasopressor prescription in the first 24 h of hospitalization, altered level of consciousness, chills, and fatigue. The model had the following characteristics: AUC = 0.94 (0.92–0.96), AUC_PR = 0.84 (0.76 to 0.92), prediction accuracy — 90%, sensitivity — 76%, specificity — 95%, positive predictive value — 83 %. Conclusion. The use of this model can facilitate the differential diagnosis of community-acquired bacterial pneumonia and viral lung injury, including COVID-19, in adults in general wards and intensive care units.
{"title":"Development of a model for the differential diagnosis of community-acquired bacterial pneumonia and viral lung injury in hospitalized adult patients","authors":"O. A. Kupriushina, D. Strelkova, A. S. Yasneva, S. Rachina, S. N. Avdeev, A. Vlasenko, L. Fedina, O. V. Ivanova, I. V. Kaledina, N. Ananicheva","doi":"10.37489/2588-0519-2023-4-78-85","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-4-78-85","url":null,"abstract":"Relevance. During and after the COVID-19 pandemic, viruses have become a more common cause of pulmonary infections in adults; therefore, the distinction between viral lung injury and community-acquired bacterial pneumonia is of increasing importance. Aim. Development of a model for differentiating community-acquired bacterial pneumonia and viral lung injury, including COVID-19. Materials and methods. This retrospective case–control study included 300 adult patients with viral lung injury and 100 adult patients with community-acquired bacterial pneumonia. Clinical, laboratory, and instrumental data were analyzed, significant factors were selected by which the samples differed, and a model was developed using logistic regression to distinguish between community-acquired bacterial pneumonia and viral lung damage, including COVID-19. Results. The developed model included the following parameters: total protein level, neutrophil/lymphocyte index, heart rate, unilateral infiltration on CT or chest x-ray, vasopressor prescription in the first 24 h of hospitalization, altered level of consciousness, chills, and fatigue. The model had the following characteristics: AUC = 0.94 (0.92–0.96), AUC_PR = 0.84 (0.76 to 0.92), prediction accuracy — 90%, sensitivity — 76%, specificity — 95%, positive predictive value — 83 %. Conclusion. The use of this model can facilitate the differential diagnosis of community-acquired bacterial pneumonia and viral lung injury, including COVID-19, in adults in general wards and intensive care units.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140417692","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-28DOI: 10.37489/2588-0519-2023-4-52-57
S. S. Milovanov
Actuality. The search for parameters of clinical trials (CT) associated with the recruitment of patients is primarily associated with the search for parameters that can predict the recruitment — predictors of patient recruitment, since patient recruitment is an important and one of the most complex processes in clinical trials, the success of which depends on the entire study. The authors propose to use the parameters of the recruitment of patients assumed by the center, the number of exclusion criteria according to the protocol, and other simple methods that allow predicting the upcoming recruitment; however, the proposed approaches are unclaimed. The parameter of success in enrolling patients in the previous 10 or more studies proposed by the authors obviously has its drawbacks because clinical centers that did not participate in 10 successful studies are automatically excluded. However, the search for a simple parameter to predict upcoming recruitment continues; for example, the time of the first screening has its own predictor potential. We investigated changes in this parameter and its derivatives during the recruitment of patients to selected international multicenter clinical trials (IMCTs). Materials and methods. A retrospective analysis of 4 IMCTs of II–III phases was performed on the recruitment of patients and changes in the time parameters of the first screening and its derivatives. Aim. Consider changes in the time parameter of the first screening and its derivatives during patient recruitment. Statistical analysis. Descriptive statistics with typing. Results. The change in the time parameter of the first screening during the recruitment of patients for CT was considered. The time of the first screening varies depending on the type of clinical center and the experience of the principal investigator. Discussion. According to the literature, a change in the time parameter of the first screening may indicate the success of the recruitment of patients in the center. Conclusion. The changes in the time of the screening set studied by us will allow us to apply the obtained values in clinical trials.
{"title":"Changing the first screening parameters for patients and their derivatives in Phase II–III clinical studies","authors":"S. S. Milovanov","doi":"10.37489/2588-0519-2023-4-52-57","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-4-52-57","url":null,"abstract":"Actuality. The search for parameters of clinical trials (CT) associated with the recruitment of patients is primarily associated with the search for parameters that can predict the recruitment — predictors of patient recruitment, since patient recruitment is an important and one of the most complex processes in clinical trials, the success of which depends on the entire study. The authors propose to use the parameters of the recruitment of patients assumed by the center, the number of exclusion criteria according to the protocol, and other simple methods that allow predicting the upcoming recruitment; however, the proposed approaches are unclaimed. The parameter of success in enrolling patients in the previous 10 or more studies proposed by the authors obviously has its drawbacks because clinical centers that did not participate in 10 successful studies are automatically excluded. However, the search for a simple parameter to predict upcoming recruitment continues; for example, the time of the first screening has its own predictor potential. We investigated changes in this parameter and its derivatives during the recruitment of patients to selected international multicenter clinical trials (IMCTs). Materials and methods. A retrospective analysis of 4 IMCTs of II–III phases was performed on the recruitment of patients and changes in the time parameters of the first screening and its derivatives. Aim. Consider changes in the time parameter of the first screening and its derivatives during patient recruitment. Statistical analysis. Descriptive statistics with typing. Results. The change in the time parameter of the first screening during the recruitment of patients for CT was considered. The time of the first screening varies depending on the type of clinical center and the experience of the principal investigator. Discussion. According to the literature, a change in the time parameter of the first screening may indicate the success of the recruitment of patients in the center. Conclusion. The changes in the time of the screening set studied by us will allow us to apply the obtained values in clinical trials.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140422679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-28DOI: 10.37489/2588-0519-2023-4-68-77
I. E. Bachmakov, A. N. Fedoseev, V. E. Denisova
Chronic kidney disease (CKD) and cardiovascular diseases are widespread throughout the world and are closely related to each other. Sympathetic hyperactivity, characteristic of CKD, increases cardiovascular risk and accelerates the progression of kidney disease by activating beta-adrenergic receptors. Beta-blockers play an important role in preventing the negative effects of in creased activity of the sympathetic nervous system on the cardiovascular system and kidneys, can slow the progression of renal disease, and have proven effective in reducing overall and cardiovascular mortality and treatment of coronary heart disease, heart failure, arterial hypertension, and arrhythmias in patients with CKD. Despite this, beta-blockers are still underused in patients with CKD, especially in its later stages, including ESRD. Although there are currently no clear recommendations for the choice of any specific beta blocker in CKD, factors such as the CKD stage, presence of diabetes mellitus or reduced insulin sensitivity, and pharmacodynamics (cardioselectivity, α1-blocking- and vasodilating properties) and pharmacokinetic properties (metabolism, routes of elimination from the body, degree of binding to plasma proteins and dualizability) should be considered. At present, along with ACE inhibitors, AT1-receptor antagonists, and SGLT2 inhibitors, beta-blockers remain indispensable drugs for treating cardiovascular diseases with proven positive effects on the progression of kidney failure in patients with CKD. Their broader use in this population is expected to further reduce cardiovascular mortality and delay the initiation of renal replacement therapy.
{"title":"Beta-blockers and chronic kidney disease: a literature review","authors":"I. E. Bachmakov, A. N. Fedoseev, V. E. Denisova","doi":"10.37489/2588-0519-2023-4-68-77","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-4-68-77","url":null,"abstract":"Chronic kidney disease (CKD) and cardiovascular diseases are widespread throughout the world and are closely related to each other. Sympathetic hyperactivity, characteristic of CKD, increases cardiovascular risk and accelerates the progression of kidney disease by activating beta-adrenergic receptors. Beta-blockers play an important role in preventing the negative effects of in creased activity of the sympathetic nervous system on the cardiovascular system and kidneys, can slow the progression of renal disease, and have proven effective in reducing overall and cardiovascular mortality and treatment of coronary heart disease, heart failure, arterial hypertension, and arrhythmias in patients with CKD. Despite this, beta-blockers are still underused in patients with CKD, especially in its later stages, including ESRD. Although there are currently no clear recommendations for the choice of any specific beta blocker in CKD, factors such as the CKD stage, presence of diabetes mellitus or reduced insulin sensitivity, and pharmacodynamics (cardioselectivity, α1-blocking- and vasodilating properties) and pharmacokinetic properties (metabolism, routes of elimination from the body, degree of binding to plasma proteins and dualizability) should be considered. At present, along with ACE inhibitors, AT1-receptor antagonists, and SGLT2 inhibitors, beta-blockers remain indispensable drugs for treating cardiovascular diseases with proven positive effects on the progression of kidney failure in patients with CKD. Their broader use in this population is expected to further reduce cardiovascular mortality and delay the initiation of renal replacement therapy.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140419846","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-28DOI: 10.37489/2588-0519-2023-4-15-24
D. Fokina, O. Zhukova, A. L. Khokhlov, S. A. Volkova
Relevance. Therapy of hemophilia A, B and Willebrand's disease is carried out under the program of 14 VZN due to the use of federal budget funds. The use of funding is increasing in line with the growth of the total number of patients. In 2022,85.99 billion rubles were allocated, which corresponds to a 1.5‑fold increase in funding compared to 2018. The aim of the study was to conduct an economic analysis of the use of drugs for the therapy of hemophilia A, B and Willebrand's disease. Methods. The materials for the analysis were the dosing regimen of LPs selected on the basis of clinical recommendations, the availability of LPs in the 14 VZN program, and the prices for LPs from the State Register of maximum selling prices for VED drugs. Costs of on demand prophylaxis and treatment regimens for hemophilia A, B and Willebrand's disease according to clinical recommendations for each INN for all trade names (TN) were assessed. Results. For hemophilia A the number of submitted drugs by INN is 7;IN — 14; of them domestic drugs were submitted — 1. The minimum cost of LPs for prophylaxis is 2 584 764,00 rubles. Coit-DVI (Grifols Therapeutics LLC, USA), and the maximum cost is RUR 9,955,517.21. Advait (Takeda Manufacturing AG, Austria). Forhemophilia B, the number of represented PL — 2 INN; INN — 6; domestic drugs — 2. The minimum cost is RUR 1,559,376.00. Innonafactor (AO Generium, Russia), maximum — 3 079 319,88 rubles for a year course of prophylaxis LP Immunin (TakedaManufacturing, Austria). To stop bleeding in patients with inhibitor form use anti-inhibitor coagulant complex (Feiba, Austria), which is necessary on average 9100 units per 1 patient, and the average cost of application — 430 863,52 rubles or eptacog alpha(activated) (Coagil-VII, Russia) at multiple administration to the patient 6 times a day — maximum cost — 2 739 803,64 rubles or once a day — 293 550,35 rubles. Conclusion. In the structure of drug supply for patients with hemophilia, domestic drugs are represented by 5 names: Octofactor (JSC "Generium", Russia); Agemfil B (FGBU "NMIC Hematology" of the Ministry of Health of Russia, Russia) and Innonafactor (JSC "Generium", Russia); ArioSaven (LLC "PSK Pharma", Russia) and Coagil-VII (JSC "SG Biotech", Russia). There are no domestic drugs available for the therapy of Willebrand's disease.
{"title":"Economic analysis of the use of drugs for the treatment of hemophilia A, B and Willebrand's disease","authors":"D. Fokina, O. Zhukova, A. L. Khokhlov, S. A. Volkova","doi":"10.37489/2588-0519-2023-4-15-24","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-4-15-24","url":null,"abstract":"Relevance. Therapy of hemophilia A, B and Willebrand's disease is carried out under the program of 14 VZN due to the use of federal budget funds. The use of funding is increasing in line with the growth of the total number of patients. In 2022,85.99 billion rubles were allocated, which corresponds to a 1.5‑fold increase in funding compared to 2018. The aim of the study was to conduct an economic analysis of the use of drugs for the therapy of hemophilia A, B and Willebrand's disease. Methods. The materials for the analysis were the dosing regimen of LPs selected on the basis of clinical recommendations, the availability of LPs in the 14 VZN program, and the prices for LPs from the State Register of maximum selling prices for VED drugs. Costs of on demand prophylaxis and treatment regimens for hemophilia A, B and Willebrand's disease according to clinical recommendations for each INN for all trade names (TN) were assessed. Results. For hemophilia A the number of submitted drugs by INN is 7;IN — 14; of them domestic drugs were submitted — 1. The minimum cost of LPs for prophylaxis is 2 584 764,00 rubles. Coit-DVI (Grifols Therapeutics LLC, USA), and the maximum cost is RUR 9,955,517.21. Advait (Takeda Manufacturing AG, Austria). Forhemophilia B, the number of represented PL — 2 INN; INN — 6; domestic drugs — 2. The minimum cost is RUR 1,559,376.00. Innonafactor (AO Generium, Russia), maximum — 3 079 319,88 rubles for a year course of prophylaxis LP Immunin (TakedaManufacturing, Austria). To stop bleeding in patients with inhibitor form use anti-inhibitor coagulant complex (Feiba, Austria), which is necessary on average 9100 units per 1 patient, and the average cost of application — 430 863,52 rubles or eptacog alpha(activated) (Coagil-VII, Russia) at multiple administration to the patient 6 times a day — maximum cost — 2 739 803,64 rubles or once a day — 293 550,35 rubles. Conclusion. In the structure of drug supply for patients with hemophilia, domestic drugs are represented by 5 names: Octofactor (JSC \"Generium\", Russia); Agemfil B (FGBU \"NMIC Hematology\" of the Ministry of Health of Russia, Russia) and Innonafactor (JSC \"Generium\", Russia); ArioSaven (LLC \"PSK Pharma\", Russia) and Coagil-VII (JSC \"SG Biotech\", Russia). There are no domestic drugs available for the therapy of Willebrand's disease.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140418781","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-28DOI: 10.37489/2588-0519-2023-4-40-51
Yu. A. Zabolotneva, I. S. Krysanov
Purpose of the study. Conducting an assessment of the economic consequences (clinical and economic analysis) when conducting cytogenetic studies before prescribing various first-line treatment regimens for multiple myeloma (MM). Materialsand methods. The pharmacoeconomic study was carried out using the method of cost analysis, “cost-effectiveness” within the framework of the State Guarantee Program (SGP). Results. A review of the literature demonstrated that a limited number of data are currently available on the clinical effectiveness of the analyzed regimens in the first line, both in patients with normal and high cytogenetic risk. The cost-effectiveness analysis showed that among the three studied 1st-line treatment regimens (VMP, Rd, VRd), in terms of PFS (progression-free survival), the coefficient was minimal for the VMP regimen in patients with high cytogenetic risk. Conclusion. The study showed that the choice and prescription of first-line therapy, depending on the results of a cytogenetic study, is a clinically effective and cost-effective approach to organizing medical care for adult patients with multiple myeloma in the Russian Federation. This could be used in the future to formulate.
{"title":"Pharmacoeconomic study of the effectiveness of cytogenetic studies in patients with MM before prescribing first-line therapy","authors":"Yu. A. Zabolotneva, I. S. Krysanov","doi":"10.37489/2588-0519-2023-4-40-51","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-4-40-51","url":null,"abstract":"Purpose of the study. Conducting an assessment of the economic consequences (clinical and economic analysis) when conducting cytogenetic studies before prescribing various first-line treatment regimens for multiple myeloma (MM). Materialsand methods. The pharmacoeconomic study was carried out using the method of cost analysis, “cost-effectiveness” within the framework of the State Guarantee Program (SGP). Results. A review of the literature demonstrated that a limited number of data are currently available on the clinical effectiveness of the analyzed regimens in the first line, both in patients with normal and high cytogenetic risk. The cost-effectiveness analysis showed that among the three studied 1st-line treatment regimens (VMP, Rd, VRd), in terms of PFS (progression-free survival), the coefficient was minimal for the VMP regimen in patients with high cytogenetic risk. Conclusion. The study showed that the choice and prescription of first-line therapy, depending on the results of a cytogenetic study, is a clinically effective and cost-effective approach to organizing medical care for adult patients with multiple myeloma in the Russian Federation. This could be used in the future to formulate.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140421456","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-28DOI: 10.37489/2588-0519-2023-4-86-95
O. Bobrova, A. Fetisov, S. Zyryanov
Relevance. Monitoring of antibiotic resistance and the frequency of isolation of microorganisms at the regional level in each medical organization is of paramount importance for the implementation of epidemiological safety. Objective. To identify the main microbiological trends based on the analysis of the microflora of patients in a single — profile hospital in order to implement weaknesses in strategic planning activities. Materials and methods. A comprehensive analysis of the pharmacoepidemiological results of the consumption of antimicrobial drugs with calculated drug resistance indices and microbiological monitoring data demonstrated the presence of weaknesses and strengths for the strategic development of a multidisciplinary hospital at the regional level in terms of epidemiological safety. Results . Statistically significant differences in the microbiological structure of pathogens are predetermined by the profile of medical care. The main trends in the change in the microflora of a multidisciplinary hospital as a whole are the prevalence of fungal and gram-negative pathogens over gram-positive ones. The presence of a relatively high index of consumpion of cephalosporins of 3–4 generations, fluoroquinolones, carbapenems, protected penicillins determines the high drug resistance index of Klebsiella pneumoniae (0.86) and characterizes the main microbiological trends of a multidisciplinary clinic. Conclusion. Risk stratification by the level of multidrug-resistant pathogens, the use of deterrent strategies for prescribing antimicrobials, the implementation of educational modules, the evaluation of the effectiveness and monitoring of the risk stratification program with in the framework of antimicrobial technologies, the analysis of microbial landscape data using decision support programs are the main tasks of the functioning of a multidisciplinary team of specialists in a multidisciplinary clinic to control antibiotic resistance.
{"title":"Microbiological monitoring of a multidisciplinary medical organization: the basis of strategic planning in the framework of the implementation of epidemiological safety","authors":"O. Bobrova, A. Fetisov, S. Zyryanov","doi":"10.37489/2588-0519-2023-4-86-95","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-4-86-95","url":null,"abstract":"Relevance. Monitoring of antibiotic resistance and the frequency of isolation of microorganisms at the regional level in each medical organization is of paramount importance for the implementation of epidemiological safety. Objective. To identify the main microbiological trends based on the analysis of the microflora of patients in a single — profile hospital in order to implement weaknesses in strategic planning activities. Materials and methods. A comprehensive analysis of the pharmacoepidemiological results of the consumption of antimicrobial drugs with calculated drug resistance indices and microbiological monitoring data demonstrated the presence of weaknesses and strengths for the strategic development of a multidisciplinary hospital at the regional level in terms of epidemiological safety. Results . Statistically significant differences in the microbiological structure of pathogens are predetermined by the profile of medical care. The main trends in the change in the microflora of a multidisciplinary hospital as a whole are the prevalence of fungal and gram-negative pathogens over gram-positive ones. The presence of a relatively high index of consumpion of cephalosporins of 3–4 generations, fluoroquinolones, carbapenems, protected penicillins determines the high drug resistance index of Klebsiella pneumoniae (0.86) and characterizes the main microbiological trends of a multidisciplinary clinic. Conclusion. Risk stratification by the level of multidrug-resistant pathogens, the use of deterrent strategies for prescribing antimicrobials, the implementation of educational modules, the evaluation of the effectiveness and monitoring of the risk stratification program with in the framework of antimicrobial technologies, the analysis of microbial landscape data using decision support programs are the main tasks of the functioning of a multidisciplinary team of specialists in a multidisciplinary clinic to control antibiotic resistance.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140418177","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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