Pub Date : 2023-07-31DOI: 10.37489/2588-0519-2023-2-35-41
A. Eleskina, N. V. Pyatigorskaya, O. Filippova
Background. No clinical trial could be initiated and conducted without appropriate clinical trial protocol. Any change in information relating to patients’ safety and health during the trial must be recorded and approved by a form of amendment to the clinical trial protocol, which is a time-consuming and financially expensive process for the Sponsors of these studies.Goal. To analyze the probability of releasing of clinical trials protocols amendments and to determine the most "pregnable" period for their occurrence in the course of the trials.Materials and Methods. The results of clinical trial protocols analysis are presented, which were approved by Russian Health Authorities between three years from 2017 to 2019 inclusive. In total, 20 protocols and 39 amendments were analyzed. Results. In the first year of the study, 21 amendments were issued, representing slightly more than half (54%) of the total number of amendments. During the second year, 12 amendments were issued, (31%). For the third year of the trial, only 3 amendments (7%) were made and for the fourth — 4, which is 8% of the total.Conclusion. The largest number of protocol amendments came out at first two years of clinical trial. Thus, they are the most "dangerous" years in the life of a clinical study in connection with the examination of developed protocol in real life. These first two years show how carefully the protocol was designed, how it meets the requirements of regulatory authorities, criteria and recommendations of professional associations, how feasible and effective the various criteria and procedures are.
{"title":"Risks of clinical trial protocol amendments according to duration of the trial","authors":"A. Eleskina, N. V. Pyatigorskaya, O. Filippova","doi":"10.37489/2588-0519-2023-2-35-41","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-2-35-41","url":null,"abstract":"Background. No clinical trial could be initiated and conducted without appropriate clinical trial protocol. Any change in information relating to patients’ safety and health during the trial must be recorded and approved by a form of amendment to the clinical trial protocol, which is a time-consuming and financially expensive process for the Sponsors of these studies.Goal. To analyze the probability of releasing of clinical trials protocols amendments and to determine the most \"pregnable\" period for their occurrence in the course of the trials.Materials and Methods. The results of clinical trial protocols analysis are presented, which were approved by Russian Health Authorities between three years from 2017 to 2019 inclusive. In total, 20 protocols and 39 amendments were analyzed. Results. In the first year of the study, 21 amendments were issued, representing slightly more than half (54%) of the total number of amendments. During the second year, 12 amendments were issued, (31%). For the third year of the trial, only 3 amendments (7%) were made and for the fourth — 4, which is 8% of the total.Conclusion. The largest number of protocol amendments came out at first two years of clinical trial. Thus, they are the most \"dangerous\" years in the life of a clinical study in connection with the examination of developed protocol in real life. These first two years show how carefully the protocol was designed, how it meets the requirements of regulatory authorities, criteria and recommendations of professional associations, how feasible and effective the various criteria and procedures are.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132067408","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 : 2023-07-31DOI: 10.37489/2588-0519-2023-2-14-25
O. Reshetko, A. Gris
Relevance. Headaches are one of the most important health problems both in Russia and around the world, as well as one of the most common reasons for self-treatment in a pharmacy due to the availability of over-the-counter drugs. Pharmaceutical workers play an important role in the control of self-medication, and the rationality of drug recommendations determines the quality of pharmaceutical care.Aim. To assess the rationality of drug recommendations for a patient with a headache and pharmaceutical drug counseling using the simulated patient method.Materials and methods. Trained simulated patients (women aged 20, 40 and 58 years) visited a total of 101 pharmacies. The dialogue was recorded on a voice recorder, all the features of the interaction were additionally recorded aſter the visit. Special forms were filled out based on the information received. The data was processed using Microsoſt Excel 2010 and STATISTIKA 10.0.Results. There was a high frequency of spontaneous recommendations without preliminary questions (66.3%), recommendations (14.9%) and dispensing of prescription drugs (5.0%), frequent recommendations of combined drugs (91.0%). Trade name Pentalgin (46.5%) and trade name Nurofen (42.6%), INN Ibuprofen (47.5%) were the most recommended. Combination analgesics were purchased in most of the visits (72.0%), information on the duration of use of the drug and the need to visit a doctor was never provided.Conclusion. Pharmacists' recommendations are in most cases irrational, focused on the drug as a product and sometimes unsafe, and counseling is practically non-existent. Improving the quality of pharmaceutical care at this stage should include the development of standards for drug recommendations and adequate counseling.
{"title":"Quality assessment of pharmaceutical care to patients with headaches using the simulated patient method: drug recommendations and pharmaceutical counseling","authors":"O. Reshetko, A. Gris","doi":"10.37489/2588-0519-2023-2-14-25","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-2-14-25","url":null,"abstract":"Relevance. Headaches are one of the most important health problems both in Russia and around the world, as well as one of the most common reasons for self-treatment in a pharmacy due to the availability of over-the-counter drugs. Pharmaceutical workers play an important role in the control of self-medication, and the rationality of drug recommendations determines the quality of pharmaceutical care.Aim. To assess the rationality of drug recommendations for a patient with a headache and pharmaceutical drug counseling using the simulated patient method.Materials and methods. Trained simulated patients (women aged 20, 40 and 58 years) visited a total of 101 pharmacies. The dialogue was recorded on a voice recorder, all the features of the interaction were additionally recorded aſter the visit. Special forms were filled out based on the information received. The data was processed using Microsoſt Excel 2010 and STATISTIKA 10.0.Results. There was a high frequency of spontaneous recommendations without preliminary questions (66.3%), recommendations (14.9%) and dispensing of prescription drugs (5.0%), frequent recommendations of combined drugs (91.0%). Trade name Pentalgin (46.5%) and trade name Nurofen (42.6%), INN Ibuprofen (47.5%) were the most recommended. Combination analgesics were purchased in most of the visits (72.0%), information on the duration of use of the drug and the need to visit a doctor was never provided.Conclusion. Pharmacists' recommendations are in most cases irrational, focused on the drug as a product and sometimes unsafe, and counseling is practically non-existent. Improving the quality of pharmaceutical care at this stage should include the development of standards for drug recommendations and adequate counseling.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"116121679","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 : 2023-04-19DOI: 10.37489/2588-0519-2023-1-15-25
E. A. Luchinin, M. Zhuravleva, T. Shelekhova, V. S. Bogova, E. Luchinina
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.
{"title":"Application of the cost-effectiveness method in improving the pharmacotherapy of multiple myeloma","authors":"E. A. Luchinin, M. Zhuravleva, T. Shelekhova, V. S. Bogova, E. Luchinina","doi":"10.37489/2588-0519-2023-1-15-25","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-1-15-25","url":null,"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.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"126945351","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 : 2023-04-19DOI: 10.37489/2588-0519-2023-1-47-55
L. D. Firsova, V. Ogarev, A. Kanatbek kyzy, N. V. Romashkina, T. Yanova, A. Danishevich, N. Bodunova
Relevance. Informing patients about the carriage of a pathogenic mutation may result in a psychologically traumatizing situation, characterized by acute stress reactions, post-traumatic stress disorder symptoms, or anxiety-depressive disorder. This highlights the importance of psychological counseling.Objective. To investigate the effectiveness of psychological support in a patient with mutations in genes associated with hereditary breast cancer.Materials and methods. Description of patient's medical history and results of instrumental psychological diagnosis after identifying a pathogenic mutation in the CHEK2 gene, which increases a risk of developing breast cancer to 20–40 % via genetic testing.Results. The nature of emotional response in this case is determined by personal history — identification of ideas about one's possible disease with mother's one. The conducted psychological consultations mitigated acute stress reactions and minimized the perception of received genetic information as a psychologically traumatic event. Furthermore, significant positive shifts were observed in the formation of adaptive stresscoping strategies, awareness of one's own mental resources, and reinforcement of adherence to the dynamic observation plan.Conclusion: Patients in situations involving the identification of mutations in genes associated with hereditary breast cancer require a personalized approach. Development of criteria for psychological support should be aimed at improving patients' quality of life not only in the immediate aftermath of information disclosure but also in the long term.
{"title":"Psychological support for carriers of mutations in genes associated with hereditary breast cancer","authors":"L. D. Firsova, V. Ogarev, A. Kanatbek kyzy, N. V. Romashkina, T. Yanova, A. Danishevich, N. Bodunova","doi":"10.37489/2588-0519-2023-1-47-55","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-1-47-55","url":null,"abstract":"Relevance. Informing patients about the carriage of a pathogenic mutation may result in a psychologically traumatizing situation, characterized by acute stress reactions, post-traumatic stress disorder symptoms, or anxiety-depressive disorder. This highlights the importance of psychological counseling.Objective. To investigate the effectiveness of psychological support in a patient with mutations in genes associated with hereditary breast cancer.Materials and methods. Description of patient's medical history and results of instrumental psychological diagnosis after identifying a pathogenic mutation in the CHEK2 gene, which increases a risk of developing breast cancer to 20–40 % via genetic testing.Results. The nature of emotional response in this case is determined by personal history — identification of ideas about one's possible disease with mother's one. The conducted psychological consultations mitigated acute stress reactions and minimized the perception of received genetic information as a psychologically traumatic event. Furthermore, significant positive shifts were observed in the formation of adaptive stresscoping strategies, awareness of one's own mental resources, and reinforcement of adherence to the dynamic observation plan.Conclusion: Patients in situations involving the identification of mutations in genes associated with hereditary breast cancer require a personalized approach. Development of criteria for psychological support should be aimed at improving patients' quality of life not only in the immediate aftermath of information disclosure but also in the long term.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125087681","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 : 2023-04-19DOI: 10.37489/2588-0519-2023-1-4-14
A. Taube, B. Romanov
The implementation of pharmacovigilance activities is impossible in isolation from compliance with the quality requirements of medicines and the activities of pharmaceutical and medical organizations throughout the pharmaceutical practice, as well as without access to sales plans, sales results and full relevance of information on drug conditions in all markets and in all cases of application. Properly conducted audit or inspection evaluation of the pharmacovigilance system makes it possible to identify and prevent drug safety problems at all stages of its life cycle.The aim. Development of a risk-based strategy for planning and passing audits and inspections of the pharmacovigilance system for the subsequent creation of effective programs for assessing the pharmacovigilance system on its basis.Material and methods. The study used structurallogical, empirical methods, general logical methods of scientific knowledge, methods of generalization and extrapolation.Results. The plans and results of audits and inspections of pharmacovigilance systems of Russian and foreign pharmaceutical organizations and their pharmacovigilance vendors were analyzed. A risk-based strategy and a checklist for planning internal and external audits of pharmacovigilance systems of Russian pharmaceutical organizations and their vendors for pharmacovigilance have been developed and recommendations for training internal auditors of pharmacovigilance systems and audit teams have been developed for them.Conclusion. Risk assessment indicators adapted for Russia have been developed, according to which Russian pharmaceutical organizations and their pharmacovigilance vendors can assess the likelihood of the risk of priority inclusion in the plan of Russian inspections of pharmacovigilance systems for compliance with the requirements of the good pharmacovigilance practice of the Eurasian Economic Union. Recommendations were prepared for the executive management and pharmacovigilance specialists of Russian pharmaceutical organizations in terms of assessing regulatory risks for the quality system of the pharmacovigilance system, planning and conducting audits; evaluating the relationship of pharmacovigilance with other good practices and with information from the plans and results of the organization as a whole. The indicators adapted for Russia for assessing the compliance of the pharmacovigilance system with the rules of the NPF EAEU are given.
{"title":"Audits and inspections of pharmacovigilance systems in Russia","authors":"A. Taube, B. Romanov","doi":"10.37489/2588-0519-2023-1-4-14","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-1-4-14","url":null,"abstract":"The implementation of pharmacovigilance activities is impossible in isolation from compliance with the quality requirements of medicines and the activities of pharmaceutical and medical organizations throughout the pharmaceutical practice, as well as without access to sales plans, sales results and full relevance of information on drug conditions in all markets and in all cases of application. Properly conducted audit or inspection evaluation of the pharmacovigilance system makes it possible to identify and prevent drug safety problems at all stages of its life cycle.The aim. Development of a risk-based strategy for planning and passing audits and inspections of the pharmacovigilance system for the subsequent creation of effective programs for assessing the pharmacovigilance system on its basis.Material and methods. The study used structurallogical, empirical methods, general logical methods of scientific knowledge, methods of generalization and extrapolation.Results. The plans and results of audits and inspections of pharmacovigilance systems of Russian and foreign pharmaceutical organizations and their pharmacovigilance vendors were analyzed. A risk-based strategy and a checklist for planning internal and external audits of pharmacovigilance systems of Russian pharmaceutical organizations and their vendors for pharmacovigilance have been developed and recommendations for training internal auditors of pharmacovigilance systems and audit teams have been developed for them.Conclusion. Risk assessment indicators adapted for Russia have been developed, according to which Russian pharmaceutical organizations and their pharmacovigilance vendors can assess the likelihood of the risk of priority inclusion in the plan of Russian inspections of pharmacovigilance systems for compliance with the requirements of the good pharmacovigilance practice of the Eurasian Economic Union. Recommendations were prepared for the executive management and pharmacovigilance specialists of Russian pharmaceutical organizations in terms of assessing regulatory risks for the quality system of the pharmacovigilance system, planning and conducting audits; evaluating the relationship of pharmacovigilance with other good practices and with information from the plans and results of the organization as a whole. The indicators adapted for Russia for assessing the compliance of the pharmacovigilance system with the rules of the NPF EAEU are given.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"133047954","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 : 2023-04-19DOI: 10.37489/2588-0519-2023-1-34-46
S. Mishinova, Y. Gomon, A. Kolbin, E. V. Verbitskaya, T. I. Galimov
Aims. To consider factors associated with adverse outcome among hospitalized patients with moderate and severe COVID-19.Materials and methods. Data from 345 case histories of adult patients hospitalized with moderate to severe COVID-19 were analyzed in a single-center retrospective study. Characteristics by sex, age, number of days from disease onset to admission to hospital, duration of hospitalization, duration of disease, population characteristics by medical history of comorbidities and self-medication, outcome of hospitalization and medical technologies used in hospital conditions were given for the whole cohort of patients. All parameters were analyzed using descriptive statistics methods. Qualitative variables are given in absolute (n) and relative (%) values with 95% confidence interval. Continuous variables were presented as median and quartiles. Risk factors for mortality were determined across groups using the χ2 criterion and odds ratio.Results. There was no demonstrated effect of gender, degree of pulmonary tissue lesions on computed tomography data, or time of initiation of respiratory support on disease outcome. At the same time, the age older than 65 years as well as neoplasms, type 2 diabetes mellitus, dementia, Stage 3 arterial hypertension, chronic heart failure, coronary heart disease, myocardial infarction and stroke history, chronic obstructive pulmonary disease, bronchiectatic disease, urogenital diseases were the predictors of unfavorable outcome in patients with moderate and severe COVID-19 form. Prehospital use of antiplatelet agents, direct and indirect oral anticoagulants, drugs affecting the renin-angiotensin system, systemic glucocorticosteroids, antibiotics, antiviral drugs, and analgesics was associated with a decrease in the mortality rate in patients with moderate-to-severe COVID-19, as well as timely use of pronposition and transfer to intensive care unit.Conclusions. Our findings are partially consistent with previous reports on the effect of risk factors on COVID-19 outcomes.
{"title":"Factors associated with adverse outcome among hospitalized patients with moderate to severe COVID-19","authors":"S. Mishinova, Y. Gomon, A. Kolbin, E. V. Verbitskaya, T. I. Galimov","doi":"10.37489/2588-0519-2023-1-34-46","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-1-34-46","url":null,"abstract":"Aims. To consider factors associated with adverse outcome among hospitalized patients with moderate and severe COVID-19.Materials and methods. Data from 345 case histories of adult patients hospitalized with moderate to severe COVID-19 were analyzed in a single-center retrospective study. Characteristics by sex, age, number of days from disease onset to admission to hospital, duration of hospitalization, duration of disease, population characteristics by medical history of comorbidities and self-medication, outcome of hospitalization and medical technologies used in hospital conditions were given for the whole cohort of patients. All parameters were analyzed using descriptive statistics methods. Qualitative variables are given in absolute (n) and relative (%) values with 95% confidence interval. Continuous variables were presented as median and quartiles. Risk factors for mortality were determined across groups using the χ2 criterion and odds ratio.Results. There was no demonstrated effect of gender, degree of pulmonary tissue lesions on computed tomography data, or time of initiation of respiratory support on disease outcome. At the same time, the age older than 65 years as well as neoplasms, type 2 diabetes mellitus, dementia, Stage 3 arterial hypertension, chronic heart failure, coronary heart disease, myocardial infarction and stroke history, chronic obstructive pulmonary disease, bronchiectatic disease, urogenital diseases were the predictors of unfavorable outcome in patients with moderate and severe COVID-19 form. Prehospital use of antiplatelet agents, direct and indirect oral anticoagulants, drugs affecting the renin-angiotensin system, systemic glucocorticosteroids, antibiotics, antiviral drugs, and analgesics was associated with a decrease in the mortality rate in patients with moderate-to-severe COVID-19, as well as timely use of pronposition and transfer to intensive care unit.Conclusions. Our findings are partially consistent with previous reports on the effect of risk factors on COVID-19 outcomes.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129043806","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 : 2023-04-19DOI: 10.37489/2588-0519-2023-1-55-65
Yu. A. Bobylov
The features of ensuring the biosafety of the population and important production and economic facilities in Russia due to the growth of external military threats with the secret use of new types of biological weapons are described. Several new tasks of Russian medicine and pharmaceuticals, as well as regulation of the corresponding market of goods and services, have been formulated. It is important to create a protective integral military-biological potential for populating Russia for a group of dangerous infectious diseases based on many new achievements of science and technology. The definition of the term «genocide» as an object of international law at the level of the UN and Russian law is given. These are actions committed with the intent to destroy, in whole or in part, any national, ethnic, racial, or religious group in Russia. The diagnosis of the detection of deadly infectious and gene biologics can be problematic. The article provides recommendations for the mobilization strengthening of the health system and biosafety in general.
{"title":"On the biosafety of the Russian population","authors":"Yu. A. Bobylov","doi":"10.37489/2588-0519-2023-1-55-65","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-1-55-65","url":null,"abstract":"The features of ensuring the biosafety of the population and important production and economic facilities in Russia due to the growth of external military threats with the secret use of new types of biological weapons are described. Several new tasks of Russian medicine and pharmaceuticals, as well as regulation of the corresponding market of goods and services, have been formulated. It is important to create a protective integral military-biological potential for populating Russia for a group of dangerous infectious diseases based on many new achievements of science and technology. The definition of the term «genocide» as an object of international law at the level of the UN and Russian law is given. These are actions committed with the intent to destroy, in whole or in part, any national, ethnic, racial, or religious group in Russia. The diagnosis of the detection of deadly infectious and gene biologics can be problematic. The article provides recommendations for the mobilization strengthening of the health system and biosafety in general.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"127565098","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 : 2023-04-19DOI: 10.37489/2588-0519-2023-1-26-33
S. Fitilev, A. Vozzhaev, L. N. Saakova, I. B. Bondareva, D. Kliuev, I. I. Shkrebniova
Introduction. Incidence of inadequate medication adherence to secondary prevention medications among Russian coronary patients is around 50 %, but the question, how this might influence on the risk of unfavorable outcomes, still has no answer.Aim. To determine the effect of medication adherence on the risk of unfavorable clinical outcomes in outpatients with stable coronary artery disease (CAD). Methods. Prospective observational cohort study was conducted. 281 subjects with verified stable CAD were included in line with the pre-specified criteria. Medication adherence was measured by validated 8-item Morisky scale. Data on cardiovascular events were obtained over the 24-month monitoring period. Study endpoint was a composite cardiovascular event (all-cause mortality, acute myocardial infarction, unstable angina, revascularization surgery, acute heart failure, decompensation of chronic heart failure). Survival analysis by Kaplan — Meier method was performed.Results. 26.0 % of coronary outpatients had low medication adherence (below 6 points by Morisky scale). Groups of patients with satisfactory and low medication adherence were comparable by demography, medical history, and pharmacotherapy. Over the monitoring period composite cardiovascular event was registered in 115 patients (40.9 %). 46.6 % of patients from the low adherence group suffered from the composite event, 38.9 % — from the satisfactory adherence group. Time to the event was lower in the low adherence group — median 24.2 (IQR 7.5-29.2) vs. median 27.9 (IQR 17.4-34.5) months. Cumulative incidence of the composite cardiovascular event over the monitoring period was higher in the low adherence group compared to satisfactory adherence group (p=0.032; log-rank test), also when adjusted for history of cardiovascular events (p=0.033; log-rank test). Satisfactory medication adherence reduced risk of composite cardiovascular event by 37 % (HR 0.63; 95 % CI 0.42-0.94; р=0.025; Cox-regression adjusted for history of cardiovascular events).Conclusion. Coronary outpatients with satisfactory medication adherence had lower risk of cardiovascular events over the 24-month monitoring period.
介绍。俄罗斯冠状动脉患者中二级预防药物依从性不足的发生率约为50%，但这如何影响不良结局的风险仍然没有答案。确定药物依从性对稳定型冠心病(CAD)门诊患者不良临床结局风险的影响。方法。进行前瞻性观察队列研究。281例经证实稳定的CAD受试者符合预先规定的标准。采用经验证的8项Morisky量表测量药物依从性。在24个月的监测期间获得心血管事件的数据。研究终点为复合心血管事件(全因死亡率、急性心肌梗死、不稳定型心绞痛、血运重建手术、急性心力衰竭、慢性心力衰竭失代偿)。Kaplan - Meier法进行生存分析。26.0%的冠心病门诊患者药物依从性较低(Morisky评分低于6分)。在人口统计学、病史和药物治疗方面，满意和低药物依从性的患者组具有可比性。在监测期间，有115例(40.9%)患者发生复合心血管事件。低依从性组46.6%的患者出现复合事件，满意依从性组38.9%。低依从性组的事件发生时间较短，中位为24.2个月(IQR为7.5-29.2)，中位为27.9个月(IQR为17.4-34.5)。在监测期间，低依从组的复合心血管事件累积发生率高于满意依从组(p=0.032;Log-rank检验)，校正心血管事件史后也是如此(p=0.033;生存率较)。满意的药物依从性使复合心血管事件的风险降低37% (HR 0.63;95% ci 0.42-0.94;р= 0.025;cox回归校正心血管事件史)。在24个月的监测期内，依从性良好的冠状动脉门诊患者发生心血管事件的风险较低。
{"title":"Effect of medication adherence on the risk of cardiovascular events in outpatients with stable coronary artery disease: results of two-year monitoring","authors":"S. Fitilev, A. Vozzhaev, L. N. Saakova, I. B. Bondareva, D. Kliuev, I. I. Shkrebniova","doi":"10.37489/2588-0519-2023-1-26-33","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-1-26-33","url":null,"abstract":"Introduction. Incidence of inadequate medication adherence to secondary prevention medications among Russian coronary patients is around 50 %, but the question, how this might influence on the risk of unfavorable outcomes, still has no answer.Aim. To determine the effect of medication adherence on the risk of unfavorable clinical outcomes in outpatients with stable coronary artery disease (CAD). Methods. Prospective observational cohort study was conducted. 281 subjects with verified stable CAD were included in line with the pre-specified criteria. Medication adherence was measured by validated 8-item Morisky scale. Data on cardiovascular events were obtained over the 24-month monitoring period. Study endpoint was a composite cardiovascular event (all-cause mortality, acute myocardial infarction, unstable angina, revascularization surgery, acute heart failure, decompensation of chronic heart failure). Survival analysis by Kaplan — Meier method was performed.Results. 26.0 % of coronary outpatients had low medication adherence (below 6 points by Morisky scale). Groups of patients with satisfactory and low medication adherence were comparable by demography, medical history, and pharmacotherapy. Over the monitoring period composite cardiovascular event was registered in 115 patients (40.9 %). 46.6 % of patients from the low adherence group suffered from the composite event, 38.9 % — from the satisfactory adherence group. Time to the event was lower in the low adherence group — median 24.2 (IQR 7.5-29.2) vs. median 27.9 (IQR 17.4-34.5) months. Cumulative incidence of the composite cardiovascular event over the monitoring period was higher in the low adherence group compared to satisfactory adherence group (p=0.032; log-rank test), also when adjusted for history of cardiovascular events (p=0.033; log-rank test). Satisfactory medication adherence reduced risk of composite cardiovascular event by 37 % (HR 0.63; 95 % CI 0.42-0.94; р=0.025; Cox-regression adjusted for history of cardiovascular events).Conclusion. Coronary outpatients with satisfactory medication adherence had lower risk of cardiovascular events over the 24-month monitoring period. ","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-04-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"114480112","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 : 2023-03-02DOI: 10.37489/2588-0519-2022-4-83-90
P. Tatarinov, N. Teplova, D. V. Kuznechenkov, A. Ermilin, A. Gratsianskaya, M. Kostyleva, S. Postnikov, E. O. Borisova, Y. Eremina, N. A. Egorova
{"title":"The era of Belousov Yuri: continuing the tradition. To the 80th birthday","authors":"P. Tatarinov, N. Teplova, D. V. Kuznechenkov, A. Ermilin, A. Gratsianskaya, M. Kostyleva, S. Postnikov, E. O. Borisova, Y. Eremina, N. A. Egorova","doi":"10.37489/2588-0519-2022-4-83-90","DOIUrl":"https://doi.org/10.37489/2588-0519-2022-4-83-90","url":null,"abstract":"","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"134461695","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 : 2023-03-01DOI: 10.37489/2588-0519-2022-4-38-49
A. Kolbin, A. Kasimova, S. R. Gilyarevskiy
{"title":"Pharmacoeconomic evaluation of apixaban use for the treatment and prevention of venous thromboembolism in the general population and patients with oncological diseases","authors":"A. Kolbin, A. Kasimova, S. R. Gilyarevskiy","doi":"10.37489/2588-0519-2022-4-38-49","DOIUrl":"https://doi.org/10.37489/2588-0519-2022-4-38-49","url":null,"abstract":"","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"128943572","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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