Pub Date : 2022-03-15DOI: 10.17749/2070-4909/farmakoekonomika.2022.126
О. Gromova, А. M. Lila, I. Torshin, I. А. Reier
Background. Osteoarthritis (OA) is associated with an acute activation of local and systemic inflammation and involves subchondral tissue of the joint.Objective: to conduct a systemic analysis of the publications on the association between OA and metabolic disorders in bones.Material and methods. The authors analyzed 3,296 publications on the studies of OA and metabolic disorders in bones tissue by the method of a topologic theory of recognition selected by the request “osteoarthritis AND (bone resorption OR osteopenia OR osteoporosis)” in the database of biomedical publications PubMed/MEDLINE. The control sampling included 4,000 articles randomly selected out of 97,331 found by the request “osteoarthritis NOT bone NOT resorption NOT osteopenia NOT osteoporosis” (i.e. publications on OA that do not cover issues of bone metabolism).Results. The associations between cartilaginous pathology and bone tissue destruction are mediated by anti-inflammatory cytokines, osteoblast and osteoclast balance impairments, steroid hormone imbalance, and carbohydrate metabolism. Bone metabolism disorders are associated with an intensification of OA-associated pain syndrome. Chondroprotective agents (chondroitin sulfate (CS), glucosamine sulfate (GS), and undenaturated collagen) block the activity of antiinflammatory cytokines (NF-κB and toll-receptors), stimulate the activity of osteoblasts (bone tissue synthesizing cells), and decrease the excessive activity of osteoclasts (cells that degrade bone tissue).Conclusion. Pharmaceutically standardized forms of CS and GS can be used for the normalization of bone metabolism along with safe osteoptotective means (vitamin D, calcium, etc.) in patients with OA.
{"title":"Application of chondroprotective agents to inhibit osteodestructive processes in the subchondral bone in patients with osteoarthritis","authors":"О. Gromova, А. M. Lila, I. Torshin, I. А. Reier","doi":"10.17749/2070-4909/farmakoekonomika.2022.126","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2022.126","url":null,"abstract":"Background. Osteoarthritis (OA) is associated with an acute activation of local and systemic inflammation and involves subchondral tissue of the joint.Objective: to conduct a systemic analysis of the publications on the association between OA and metabolic disorders in bones.Material and methods. The authors analyzed 3,296 publications on the studies of OA and metabolic disorders in bones tissue by the method of a topologic theory of recognition selected by the request “osteoarthritis AND (bone resorption OR osteopenia OR osteoporosis)” in the database of biomedical publications PubMed/MEDLINE. The control sampling included 4,000 articles randomly selected out of 97,331 found by the request “osteoarthritis NOT bone NOT resorption NOT osteopenia NOT osteoporosis” (i.e. publications on OA that do not cover issues of bone metabolism).Results. The associations between cartilaginous pathology and bone tissue destruction are mediated by anti-inflammatory cytokines, osteoblast and osteoclast balance impairments, steroid hormone imbalance, and carbohydrate metabolism. Bone metabolism disorders are associated with an intensification of OA-associated pain syndrome. Chondroprotective agents (chondroitin sulfate (CS), glucosamine sulfate (GS), and undenaturated collagen) block the activity of antiinflammatory cytokines (NF-κB and toll-receptors), stimulate the activity of osteoblasts (bone tissue synthesizing cells), and decrease the excessive activity of osteoclasts (cells that degrade bone tissue).Conclusion. Pharmaceutically standardized forms of CS and GS can be used for the normalization of bone metabolism along with safe osteoptotective means (vitamin D, calcium, etc.) in patients with OA.","PeriodicalId":36464,"journal":{"name":"Farmakoekonomika","volume":"15 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-03-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84692305","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 : 2022-01-16DOI: 10.17749/2070-4909/farmakoekonomika.2021.091
A. N. Koterov, O. A. Tikhonova, L. Ushenkova, A. Biryukov
The three-report review is aimed to describe the historical development of clinical trials, controlled trials (CT) and randomized controlled trials (RCT), and the inclusion of these approaches in health-related disciplines (Medicine and Epidemiology). Report 3 summarizes historical milestones (ideas and studies) for quasi-randomized CT (‘alternate allocation’; 88 milestones) and RCT (37 milestones). It was found that although the ideas of both designs are a thing of the past (from A. Lesassier Hamilton (1816) and J.B. Van Helmont (1648), respectively), the bulk of the tests were carried out in the 20th century, when both designs existed in parallel. Overall, the alternate allocation was used nearly three times longer than randomization.Analysis of the sources showed that the first RCT in medicine was the work of D. Colebrook, 1925 (Great Britain), and the first close to the modern RCT, including randomization according to the table of random numbers, was J.A. Bell, 1941 (USA). Often referred to as the ‘new era in CT’ and ‘the origine of RCT’, a study of the effects of streptomycin on tuberculosis in 1946–1948, which was also designed by A.B. Hill is only 13th known RCT, only 9th RCT in medicine and only the 2nd with modern randomization. Other facts of insufficient reflection of the priorities and real history of CT/RCT in West and Russian publications were found, including dozens of Western textbooks on epidemiology and evidence-based medicine of recent decades. True priorities are often omitted, and the most frequent references to the history of CT (progressively) are the experience of the prophet Daniel, the experience of the surgeon J. Lind, and the study on the effect of streptomycin on tuberculosis in 1946–1948.Based on a PubMed/MEDLINE search, a summary of alternate allocation CT, and RCT for the period 1960–1990 to 2020 is provided. In the first case, single publications were found, but the fact that design with alternation survives to this day is important. For RCT, since 1990s, an increase in the number of papers (up to tens of thousands per year) has been revealed. The data are given for the total number of RCTs performed by countries, continents and parts of the world for 2020. According to the calculated index of the ratio of the number of RCTs to the specific number of doctors (per 100,000 population) among 45 countries of Eurasia (from France to Tajikistan), Russia ranks 12th.A three-report review based on the originals of nearly all publications from the late 19th century and including the necessary references and citations can serve as a reference guide to the historical development of CT and related topics.
这三篇综述旨在描述临床试验、对照试验(CT)和随机对照试验(RCT)的历史发展,以及这些方法在健康相关学科(医学和流行病学)中的应用。报告3总结了准随机CT的历史里程碑(思想和研究)(“交替分配”;88个里程碑)和随机对照试验(37个里程碑)。人们发现,虽然这两种设计的想法都是过去的事情(分别来自a . Lesassier Hamilton(1816)和J.B. Van Helmont(1648)),但大部分测试是在20世纪进行的,当时两种设计并行存在。总的来说,替代分配的使用时间几乎是随机分配的三倍。对资料来源的分析表明,医学上的第一个随机对照试验是1925年(英国)的D. Colebrook的工作,而第一个接近现代随机对照试验(包括根据随机数表随机化)的是1941年(美国)的J.A. Bell。通常被称为“CT的新时代”和“随机对照试验的起源”,1946-1948年由A.B. Hill设计的一项关于链霉素对结核病的影响的研究仅是已知的第13项随机对照试验,医学上的第9项随机对照试验,也是第2项现代随机化的随机对照试验。在西方和俄罗斯的出版物中,包括近几十年西方流行病学和循证医学教科书中,还发现了其他未能充分反映CT/RCT优先级和真实历史的事实。真正的优先级往往被忽略,而最常提到的CT史(逐步)是先知丹尼尔的经验,外科医生J.林德的经验,以及1946-1948年关于链霉素对结核病的影响的研究。基于PubMed/MEDLINE检索,提供了1960-1990至2020年期间交替分配CT和RCT的摘要。在第一种情况下,发现了单一的出版物,但具有交替的设计存在到今天的事实很重要。对于随机对照试验,自20世纪90年代以来,论文数量有所增加(每年多达数万篇)。这些数据是2020年世界各国、各大洲和部分地区进行的随机对照试验的总数。根据欧亚大陆45个国家(从法国到塔吉克斯坦)的随机对照试验数量与医生具体人数(每10万人)之比的计算指数,俄罗斯排名第12位。一份基于19世纪末几乎所有出版物原件的三份报告综述,包括必要的参考文献和引文,可以作为CT和相关主题历史发展的参考指南。
{"title":"History of controlled trials in medicine: real priorities are little-known. Report 3. Quasi-randomized and randomized trials in humans and animals","authors":"A. N. Koterov, O. A. Tikhonova, L. Ushenkova, A. Biryukov","doi":"10.17749/2070-4909/farmakoekonomika.2021.091","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2021.091","url":null,"abstract":"The three-report review is aimed to describe the historical development of clinical trials, controlled trials (CT) and randomized controlled trials (RCT), and the inclusion of these approaches in health-related disciplines (Medicine and Epidemiology). Report 3 summarizes historical milestones (ideas and studies) for quasi-randomized CT (‘alternate allocation’; 88 milestones) and RCT (37 milestones). It was found that although the ideas of both designs are a thing of the past (from A. Lesassier Hamilton (1816) and J.B. Van Helmont (1648), respectively), the bulk of the tests were carried out in the 20th century, when both designs existed in parallel. Overall, the alternate allocation was used nearly three times longer than randomization.Analysis of the sources showed that the first RCT in medicine was the work of D. Colebrook, 1925 (Great Britain), and the first close to the modern RCT, including randomization according to the table of random numbers, was J.A. Bell, 1941 (USA). Often referred to as the ‘new era in CT’ and ‘the origine of RCT’, a study of the effects of streptomycin on tuberculosis in 1946–1948, which was also designed by A.B. Hill is only 13th known RCT, only 9th RCT in medicine and only the 2nd with modern randomization. Other facts of insufficient reflection of the priorities and real history of CT/RCT in West and Russian publications were found, including dozens of Western textbooks on epidemiology and evidence-based medicine of recent decades. True priorities are often omitted, and the most frequent references to the history of CT (progressively) are the experience of the prophet Daniel, the experience of the surgeon J. Lind, and the study on the effect of streptomycin on tuberculosis in 1946–1948.Based on a PubMed/MEDLINE search, a summary of alternate allocation CT, and RCT for the period 1960–1990 to 2020 is provided. In the first case, single publications were found, but the fact that design with alternation survives to this day is important. For RCT, since 1990s, an increase in the number of papers (up to tens of thousands per year) has been revealed. The data are given for the total number of RCTs performed by countries, continents and parts of the world for 2020. According to the calculated index of the ratio of the number of RCTs to the specific number of doctors (per 100,000 population) among 45 countries of Eurasia (from France to Tajikistan), Russia ranks 12th.A three-report review based on the originals of nearly all publications from the late 19th century and including the necessary references and citations can serve as a reference guide to the historical development of CT and related topics.","PeriodicalId":36464,"journal":{"name":"Farmakoekonomika","volume":"21 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84661358","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 : 2022-01-15DOI: 10.17749/2070-4909/farmakoekonomika.2021.090
А. Sokolov, О. V. Reshet’ko
Objective: To study the evolution of consumption of antithrombotic drugs used for the treatment of atrial fibrillation (AF) at the outpatient stage in the Saratov Region using the ATC/DDD (Anatomical Therapeutic Chemical Classification / Defined Daily Doses) and drug utilization 90% (DU90%) analysis.Material and methods. We analyzed the outpatient stage of treatment using the data reflected in 511 case histories of AF patients hospitalized in specialized cardiology departments of the Saratov Region in 2011–2018. The study of the consumption volumes of antithrombotic drugs was carried out using the ATC/DDD- and DU90%-analysis methodology. The consumption of drugs with proven efficacy in AF was expressed as the number of daily doses (NDDD) per 1000 AF patients per day.Results. In 2011, the number of prescribed DDD of oral anticoagulants (OACs) was 5.29 NDDD per 1000 AF patients per day, and all of them were represented by warfarin; in 2018, this indicator increased up to 277.51 NDDD per 1000 AF patients per day, of which direct OACs amounted to 237.06. The consumption of antiplatelet agents remained at a high level, and in 2018, was 582.53 NDDD per 1000 AF patients per day. Acetylsalicylic acid was included in the group of drugs accounting for 90% of all antithrombotic drugs at the outpatient stage – 99.02% in 2011, 93.08% in 2012, 58.55% in 2016, 60.27% in 2017, and 46.66% in 2018.Conclusion. The consumption volumes of OACs used at the outpatient stage of treatment of AF in the Saratov Region increased significantly in the period from 2011 to 2018, mainly due to direct OACs. At the same time, the consumption volumes of antiplatelet agents remained at a high level.
{"title":"Analysis of the consumption volumes of antithrombotic drugs used for pharmacotherapy of atrial fibrillation in Saratov Region","authors":"А. Sokolov, О. V. Reshet’ko","doi":"10.17749/2070-4909/farmakoekonomika.2021.090","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2021.090","url":null,"abstract":"Objective: To study the evolution of consumption of antithrombotic drugs used for the treatment of atrial fibrillation (AF) at the outpatient stage in the Saratov Region using the ATC/DDD (Anatomical Therapeutic Chemical Classification / Defined Daily Doses) and drug utilization 90% (DU90%) analysis.Material and methods. We analyzed the outpatient stage of treatment using the data reflected in 511 case histories of AF patients hospitalized in specialized cardiology departments of the Saratov Region in 2011–2018. The study of the consumption volumes of antithrombotic drugs was carried out using the ATC/DDD- and DU90%-analysis methodology. The consumption of drugs with proven efficacy in AF was expressed as the number of daily doses (NDDD) per 1000 AF patients per day.Results. In 2011, the number of prescribed DDD of oral anticoagulants (OACs) was 5.29 NDDD per 1000 AF patients per day, and all of them were represented by warfarin; in 2018, this indicator increased up to 277.51 NDDD per 1000 AF patients per day, of which direct OACs amounted to 237.06. The consumption of antiplatelet agents remained at a high level, and in 2018, was 582.53 NDDD per 1000 AF patients per day. Acetylsalicylic acid was included in the group of drugs accounting for 90% of all antithrombotic drugs at the outpatient stage – 99.02% in 2011, 93.08% in 2012, 58.55% in 2016, 60.27% in 2017, and 46.66% in 2018.Conclusion. The consumption volumes of OACs used at the outpatient stage of treatment of AF in the Saratov Region increased significantly in the period from 2011 to 2018, mainly due to direct OACs. At the same time, the consumption volumes of antiplatelet agents remained at a high level.","PeriodicalId":36464,"journal":{"name":"Farmakoekonomika","volume":"24 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77161640","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 : 2022-01-15DOI: 10.17749/2070-4909/farmakoekonomika.2021.114
I. Torshin, О. Gromova, V. Zgoda, А. Chuchalin, V. A. Maksimov, О. V. Tikhonova
Objective: identification of peptides in the composition of Laennec®, which can inhibit the development of endotheliopathy (endothelial dysfunction).Material and methods. Hybrid mass spectrometry followed by data analysis based on topological recognition theory was performed. The analysis of the peptide composition of Laennec® included four stages: purification of the drug, chromatographic separation of peptides, determination of the multidimensional mass spectrum of the peptide fraction, and de novo sequencing of the isolated peptides.Results. The preparation contains peptides-inhibitors of specific target proteins (PRKCZ, PKB, PKD1, MAPK14, IKKB, PDPK1) involved in the activation of the pro-inflammatory transcription factor NF-κB. Inhibition of CDK5 and SHC1 kinases helps to reduce endothelial cell apoptosis. The peptides of the drug also block enzymes involved in the synthesis and maturation of the tumor necrosis factor alpha (MAPKAPK2/3, ADAM17).Conclusion. In the composition of Laennec®, peptides have been found that contribute to a complex pathogenetic action against endotheliopathy. Endothelial regeneration is especially important in the rehabilitation of patients who have recovered from COVID-19.
{"title":"Peptides of Laennec® preparation that contribute to the elimination of endotheliopathy","authors":"I. Torshin, О. Gromova, V. Zgoda, А. Chuchalin, V. A. Maksimov, О. V. Tikhonova","doi":"10.17749/2070-4909/farmakoekonomika.2021.114","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2021.114","url":null,"abstract":"Objective: identification of peptides in the composition of Laennec®, which can inhibit the development of endotheliopathy (endothelial dysfunction).Material and methods. Hybrid mass spectrometry followed by data analysis based on topological recognition theory was performed. The analysis of the peptide composition of Laennec® included four stages: purification of the drug, chromatographic separation of peptides, determination of the multidimensional mass spectrum of the peptide fraction, and de novo sequencing of the isolated peptides.Results. The preparation contains peptides-inhibitors of specific target proteins (PRKCZ, PKB, PKD1, MAPK14, IKKB, PDPK1) involved in the activation of the pro-inflammatory transcription factor NF-κB. Inhibition of CDK5 and SHC1 kinases helps to reduce endothelial cell apoptosis. The peptides of the drug also block enzymes involved in the synthesis and maturation of the tumor necrosis factor alpha (MAPKAPK2/3, ADAM17).Conclusion. In the composition of Laennec®, peptides have been found that contribute to a complex pathogenetic action against endotheliopathy. Endothelial regeneration is especially important in the rehabilitation of patients who have recovered from COVID-19.","PeriodicalId":36464,"journal":{"name":"Farmakoekonomika","volume":"43 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84238713","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 : 2022-01-15DOI: 10.17749/2070-4909/farmakoekonomika.2021.112
I. Torshin, A. M. Lila, O. Gromova
Background. Long-term use of chondroprotective agents – chondroitin sulfate (CS) and glucosamine sulfate (GS) in the treatment of osteoarthritis puts forward increased requirements for the safety of drugs, primarily in terms of effects on the liver and kidneys.Objective: systematization of data on the effect of chondroprotectors on liver structure and functions.Material and methods. Using the methods of the theory of topological text analysis, an intellectual analysis of 2319 publications on fundamental and clinical studies of the relationship of CS and GS with liver function was carried out. The search was performed by a key query “(chondroitine OR glucosamine) AND (liver OR hepatic OR hepatocy*)” in the PubMed/MEDLINE database.Results. The systematic analysis indicated a pronounced hepatoprotective effect of CS and GS pharmaceutical substances with a high degree of purification from inorganic and organic impurities. By regulating inflammation processes, lymphocyte function, fat and carbohydrate metabolism in the liver, standardized forms of CS and GS have a beneficial effect on fat metabolism, reduce chronic inflammation in the liver, exhibit antitumor and pronounced hepatoprotective effects on various models of liver intoxication.Conclusion. The results of this analysis allow us to assert the high safety of drugs based on pharmaceutical standardized forms of CS and GS in terms of liver function.
背景。长期使用软骨保护剂硫酸软骨素(CS)和硫酸氨基葡萄糖(GS)治疗骨关节炎,对药物的安全性提出了更高的要求,主要是在对肝脏和肾脏的影响方面。目的:整理软骨保护剂对肝脏结构和功能影响的资料。材料和方法。采用拓扑文本分析理论的方法,对2319篇有关CS、GS与肝功能关系的基础和临床研究文献进行智力分析。在PubMed/MEDLINE数据库中通过关键查询“(chondroitine OR glucosamine) AND (liver OR liver OR hepatocy*)”进行搜索。系统分析表明,CS和GS原料药具有明显的保肝作用,且从无机和有机杂质中纯化程度高。通过调节肝脏的炎症过程、淋巴细胞功能、脂肪和碳水化合物代谢,标准化的CS和GS对多种肝中毒模型具有有益的脂肪代谢、减轻肝脏慢性炎症、抗肿瘤和明显的肝保护作用。这项分析的结果使我们能够根据CS和GS在肝功能方面的药物标准化形式断言药物的高度安全性。
{"title":"Hepatoprotective effects of chondroitin sulfate and glucosamine sulfate","authors":"I. Torshin, A. M. Lila, O. Gromova","doi":"10.17749/2070-4909/farmakoekonomika.2021.112","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2021.112","url":null,"abstract":"Background. Long-term use of chondroprotective agents – chondroitin sulfate (CS) and glucosamine sulfate (GS) in the treatment of osteoarthritis puts forward increased requirements for the safety of drugs, primarily in terms of effects on the liver and kidneys.Objective: systematization of data on the effect of chondroprotectors on liver structure and functions.Material and methods. Using the methods of the theory of topological text analysis, an intellectual analysis of 2319 publications on fundamental and clinical studies of the relationship of CS and GS with liver function was carried out. The search was performed by a key query “(chondroitine OR glucosamine) AND (liver OR hepatic OR hepatocy*)” in the PubMed/MEDLINE database.Results. The systematic analysis indicated a pronounced hepatoprotective effect of CS and GS pharmaceutical substances with a high degree of purification from inorganic and organic impurities. By regulating inflammation processes, lymphocyte function, fat and carbohydrate metabolism in the liver, standardized forms of CS and GS have a beneficial effect on fat metabolism, reduce chronic inflammation in the liver, exhibit antitumor and pronounced hepatoprotective effects on various models of liver intoxication.Conclusion. The results of this analysis allow us to assert the high safety of drugs based on pharmaceutical standardized forms of CS and GS in terms of liver function.","PeriodicalId":36464,"journal":{"name":"Farmakoekonomika","volume":"2012 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74223878","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 : 2022-01-15DOI: 10.17749/2070-4909/farmakoekonomika.2021.092
D. S. Yurochkin, К. V. Nasonova, Z. М. Golant, I. Narkevich, V. Trukhin
Objective: to study features of intellectual property protection mechanisms on the example of drugs for the treatment of rare (orphan) diseases.Material and methods. Analysis of pharmaceutical market data was performed with the DSM Group analytical database. The approach proposed by the Russian Federal Industrial Property Service was used for creating patent landscape. The method supposes conducting a patent search and analysis of the documents found for date of filing, office (country) of filing, applicant, as well as analysis of the patent activity (dynamics) for the subject, in this case, for orphan drugs having a defined structure.Results. We proposed the complex conclusions to increase national drug safety. Intellectual property limitations for importing countries such as data exclusivity, do not allow to reproduce clinical trials, which leads to non-disclosure of medical data to all parties – medical society and patients, all other market participants, including local pharmaceutical producers. Current intellectual property restrictions conceal crucial data from medical and patient society and other market players and affect accuracy of diagnosis and treatment. Along with outstanding cost of new therapies it causes enormous budget burden for the healthcare system and prevents the introduction of objective criteria in the appointment and use of medicines. Prior to the approval and submission of the registration certificate by the regulatory authority, it is necessary to establish reasonable marginal prices, to form a sufficient set and volume of clinical guidelines and to determine in advance the sources of financing and mechanisms of integration into the national system of drug provision.Conclusion. The introduction of drugs for the treatment of rare diseases into circulation leads to a sharp increase in the burden on the budgets of the healthcare system at all levels. Current restrictions and obligations in the field of intellectual property rights protection, the degree of disclosure of medical data in the process of registration and admission to the market require significant changes to the traditional system of drug provision and the system of placing state orders, as well as the introduction of new regulatory mechanisms (for example, compulsory licensing or producing individual dosage forms in pharmacy organizations), contributing to the development of the local pharmaceutical industry and providing the national health system with the necessary volume of drugs with a sufficient level of quality and safety.
{"title":"Features of intellectual property protection mechanisms on the example of orphan drugs circulation","authors":"D. S. Yurochkin, К. V. Nasonova, Z. М. Golant, I. Narkevich, V. Trukhin","doi":"10.17749/2070-4909/farmakoekonomika.2021.092","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2021.092","url":null,"abstract":"Objective: to study features of intellectual property protection mechanisms on the example of drugs for the treatment of rare (orphan) diseases.Material and methods. Analysis of pharmaceutical market data was performed with the DSM Group analytical database. The approach proposed by the Russian Federal Industrial Property Service was used for creating patent landscape. The method supposes conducting a patent search and analysis of the documents found for date of filing, office (country) of filing, applicant, as well as analysis of the patent activity (dynamics) for the subject, in this case, for orphan drugs having a defined structure.Results. We proposed the complex conclusions to increase national drug safety. Intellectual property limitations for importing countries such as data exclusivity, do not allow to reproduce clinical trials, which leads to non-disclosure of medical data to all parties – medical society and patients, all other market participants, including local pharmaceutical producers. Current intellectual property restrictions conceal crucial data from medical and patient society and other market players and affect accuracy of diagnosis and treatment. Along with outstanding cost of new therapies it causes enormous budget burden for the healthcare system and prevents the introduction of objective criteria in the appointment and use of medicines. Prior to the approval and submission of the registration certificate by the regulatory authority, it is necessary to establish reasonable marginal prices, to form a sufficient set and volume of clinical guidelines and to determine in advance the sources of financing and mechanisms of integration into the national system of drug provision.Conclusion. The introduction of drugs for the treatment of rare diseases into circulation leads to a sharp increase in the burden on the budgets of the healthcare system at all levels. Current restrictions and obligations in the field of intellectual property rights protection, the degree of disclosure of medical data in the process of registration and admission to the market require significant changes to the traditional system of drug provision and the system of placing state orders, as well as the introduction of new regulatory mechanisms (for example, compulsory licensing or producing individual dosage forms in pharmacy organizations), contributing to the development of the local pharmaceutical industry and providing the national health system with the necessary volume of drugs with a sufficient level of quality and safety.","PeriodicalId":36464,"journal":{"name":"Farmakoekonomika","volume":"6 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89280578","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 : 2022-01-15DOI: 10.17749/2070-4909/farmakoekonomika.2021.087
R. A. Yakhina, I. Lakman, D. Valishin, R. Bakhitova
Background. The spread of chronic viral hepatitis C (CVHC) among the population entails significant costs for society, both direct, associated with the treatment of such patients, and indirect, associated with the shortfall in fiscal payments to the budget, due to the disability of this category of patients. Therefore, an important task remains to assess the global economic burden of the disease, taking into account the pathological conditions of the human body associated with it.Objective: to systematize studies of published sources devoted to assessing the global economic burden of chronic viral hepatitis C.Material and methods. A feature of the proposed review design is paying attention not only to the objects of assessment under study, but also to the instrumental (including mathematical) means of scenario assessment of the global burden. The study analyzed 29 sources published between 2014 and 2020 and dedicated to assessing and forecasting the global economic burden of CVHC both in individual countries and continents as a whole, and in individual regions of countries. The main criterion for the selection of studies was the availability of an estimate of the global burden of CVHC, taking into account the use of direct antiviral drugs for the treatment of hepatitis C. The search was conducted in PubMed/MEDLINE and eLibrary databases, and in the ResearchGate network.Results. Of the 29 analyzed sources, 40% of the works consider the burden for CVHC only of certain genotypes; in the overwhelming number of articles (80%), when assessing the burden, the distribution of patients by the degree of liver fibrosis is taken into account. In 50% of the studies reviewed, quality of life adjustment tools (QALY or DALY) were used to estimate the global economic burden. A third of the publications took into account both the direct costs of treating CVHC and indirect costs, including those associated with a shortfall in the contribution to the gross national product due to temporary or permanent disability of this category of patients.Conclusion. The analysis showed that interest in assessing the global burden of CVHC began to appear in recent years, when expensive directacting antivirals for the treatment appeared. This is explained by the emergence of a question about the cost of implementing a scenario in which by a certain year it will be possible to completely exclude the spread of the disease. The results of this work may be useful in conducting such studies, including the determining of their design and the use of modern mathematical modeling tools.
{"title":"Economic burden of chronic viral hepatitis C","authors":"R. A. Yakhina, I. Lakman, D. Valishin, R. Bakhitova","doi":"10.17749/2070-4909/farmakoekonomika.2021.087","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2021.087","url":null,"abstract":"Background. The spread of chronic viral hepatitis C (CVHC) among the population entails significant costs for society, both direct, associated with the treatment of such patients, and indirect, associated with the shortfall in fiscal payments to the budget, due to the disability of this category of patients. Therefore, an important task remains to assess the global economic burden of the disease, taking into account the pathological conditions of the human body associated with it.Objective: to systematize studies of published sources devoted to assessing the global economic burden of chronic viral hepatitis C.Material and methods. A feature of the proposed review design is paying attention not only to the objects of assessment under study, but also to the instrumental (including mathematical) means of scenario assessment of the global burden. The study analyzed 29 sources published between 2014 and 2020 and dedicated to assessing and forecasting the global economic burden of CVHC both in individual countries and continents as a whole, and in individual regions of countries. The main criterion for the selection of studies was the availability of an estimate of the global burden of CVHC, taking into account the use of direct antiviral drugs for the treatment of hepatitis C. The search was conducted in PubMed/MEDLINE and eLibrary databases, and in the ResearchGate network.Results. Of the 29 analyzed sources, 40% of the works consider the burden for CVHC only of certain genotypes; in the overwhelming number of articles (80%), when assessing the burden, the distribution of patients by the degree of liver fibrosis is taken into account. In 50% of the studies reviewed, quality of life adjustment tools (QALY or DALY) were used to estimate the global economic burden. A third of the publications took into account both the direct costs of treating CVHC and indirect costs, including those associated with a shortfall in the contribution to the gross national product due to temporary or permanent disability of this category of patients.Conclusion. The analysis showed that interest in assessing the global burden of CVHC began to appear in recent years, when expensive directacting antivirals for the treatment appeared. This is explained by the emergence of a question about the cost of implementing a scenario in which by a certain year it will be possible to completely exclude the spread of the disease. The results of this work may be useful in conducting such studies, including the determining of their design and the use of modern mathematical modeling tools.","PeriodicalId":36464,"journal":{"name":"Farmakoekonomika","volume":"2 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76720540","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 : 2022-01-15DOI: 10.17749/2070-4909/farmakoekonomika.2021.109
O. Volkova, S. S. Budarin, E. V. Smirnova, Yulia V. Elbek
Background. Today, the development and widespread use of digital technologies in medicine is considered as one of the most promising mechanisms for optimizing costs and improving the efficiency of healthcare and the quality of life of the aging society.Objective: to study the experience of using telemedicine technologies for providing medical care in the health systems of different countries, including the Russian Federation.Material and methods. To obtain the necessary information, an overview of the most relevant studies published in Medscape, PubMed/ MEDLINE, ScienceDirect, Scopus, eLibrary, CyberLeninka databases, World Health Organization repository and open sources from Google and Yandex search, as well as relevant regulatory documents was carried out.Results. The experience of using telemedicine technologies for medical care in healthcare systems of different countries, including Russia, presented in the article, demonstrates both the advantages of these technologies, and the limitations for their use in healthcare.Conclusion. Despite all the undisputed advantages of telemedicine technologies, their development should not become an end in itself. The expediency of their use in each specific case of providing medical care and exclusively as another, additional tool to improve the quality and accessibility of medical care should be considered.
背景。如今,数字技术在医学领域的发展和广泛应用被认为是优化成本、提高医疗保健效率和老龄化社会生活质量的最有前途的机制之一。目的:研究包括俄罗斯联邦在内的不同国家卫生系统使用远程医疗技术提供医疗服务的经验。材料和方法。为了获得必要的信息,我们对Medscape、PubMed/ MEDLINE、ScienceDirect、Scopus、eLibrary、CyberLeninka数据库、World Health Organization repository以及Google和Yandex搜索的开放资源中发表的最相关的研究以及相关的监管文件进行了综述。本文介绍了在包括俄罗斯在内的不同国家的医疗保健系统中使用远程医疗技术进行医疗保健的经验,既展示了这些技术的优点,也展示了它们在医疗保健中使用的局限性。尽管远程医疗技术具有无可争议的优势,但其发展本身不应成为目的。应考虑在提供医疗保健的每一具体情况下使用它们的便利性,并专门作为提高医疗保健质量和可及性的另一种额外工具。
{"title":"Experience of using telemedicine technologies in healthcare systems of foreign countries and the Russian Federation: systematic review","authors":"O. Volkova, S. S. Budarin, E. V. Smirnova, Yulia V. Elbek","doi":"10.17749/2070-4909/farmakoekonomika.2021.109","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2021.109","url":null,"abstract":"Background. Today, the development and widespread use of digital technologies in medicine is considered as one of the most promising mechanisms for optimizing costs and improving the efficiency of healthcare and the quality of life of the aging society.Objective: to study the experience of using telemedicine technologies for providing medical care in the health systems of different countries, including the Russian Federation.Material and methods. To obtain the necessary information, an overview of the most relevant studies published in Medscape, PubMed/ MEDLINE, ScienceDirect, Scopus, eLibrary, CyberLeninka databases, World Health Organization repository and open sources from Google and Yandex search, as well as relevant regulatory documents was carried out.Results. The experience of using telemedicine technologies for medical care in healthcare systems of different countries, including Russia, presented in the article, demonstrates both the advantages of these technologies, and the limitations for their use in healthcare.Conclusion. Despite all the undisputed advantages of telemedicine technologies, their development should not become an end in itself. The expediency of their use in each specific case of providing medical care and exclusively as another, additional tool to improve the quality and accessibility of medical care should be considered.","PeriodicalId":36464,"journal":{"name":"Farmakoekonomika","volume":"51 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76593626","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 : 2022-01-15DOI: 10.17749/2070-4909/farmakoekonomika.2021.097
А. V. Larionov, S. Russkikh, S. V. Maslennikov
Objective: to study the potential for the development of financing the Compulsory Health Insurance (CHI) system in Russia.Material and methods. Оur research estimates the amount of funds available in the CHI system based on fractal analysis and ARIMA modeling. The proposed approach makes it possible to determine the critical amount of funds in the CHI system. Once the limit is reached, the chance of violating the economic security requirements will increase. Results. Аn increase in the volume of available funds in the CHI sector is expected in the mid-term perspective on the verge of quarter 1, 2023. The amount of funds required to pay for medical care for the respective period of time will increase by 0.77% quarterly.Conclusion. Gaining additional funds might be possible by optimizing the internal networks for generating cash flows in the CHI system, as well as applying additional ways of financing medical care (particularly Voluntary Health Insurance policies). It would be practical to redistribute the functions of financing health care between the Federal Fund for CHI and its territorial branches. It is essential to review the role of health insurance companies in monitoring the health care quality by improving the communication with citizens.
{"title":"Development of the system of state financing of Compulsory Health Insurance","authors":"А. V. Larionov, S. Russkikh, S. V. Maslennikov","doi":"10.17749/2070-4909/farmakoekonomika.2021.097","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2021.097","url":null,"abstract":"Objective: to study the potential for the development of financing the Compulsory Health Insurance (CHI) system in Russia.Material and methods. Оur research estimates the amount of funds available in the CHI system based on fractal analysis and ARIMA modeling. The proposed approach makes it possible to determine the critical amount of funds in the CHI system. Once the limit is reached, the chance of violating the economic security requirements will increase. Results. Аn increase in the volume of available funds in the CHI sector is expected in the mid-term perspective on the verge of quarter 1, 2023. The amount of funds required to pay for medical care for the respective period of time will increase by 0.77% quarterly.Conclusion. Gaining additional funds might be possible by optimizing the internal networks for generating cash flows in the CHI system, as well as applying additional ways of financing medical care (particularly Voluntary Health Insurance policies). It would be practical to redistribute the functions of financing health care between the Federal Fund for CHI and its territorial branches. It is essential to review the role of health insurance companies in monitoring the health care quality by improving the communication with citizens.","PeriodicalId":36464,"journal":{"name":"Farmakoekonomika","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2022-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89815873","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 : 2021-10-08DOI: 10.17749/2070-4909/farmakoekonomika.2021.065
I. Petrukhina, R. Yagudina, N. V. Veyner, T. K. Ryazanova, E. Gladunova, V. Kurkin, P. R. Blinkova, E. N. Zaitseva
Objective: to analyse of medicines prescriptions for federal beneficiaries with circulatory system diseases and to identify the main trends in the implementation of the federal program for the provision of necessary medicines in the Samara Region in 2014–2017.Material and methods. The authors reviewed the nomenclature of medicines used to treat circulatory system diseases (CSDs) and distributed to the population of the Samara Region as part of the federal program for the provision of necessary medicines for the period from 2014 to 2017. The methods of comparative, retrospective, logical, graphical and content analysis, the method of data grouping according to Anatomical Therapeutic Chemical classification and methods of descriptive statistics were used.Results. In 2014–2017 the share of financial costs for the purchase of medicines in the total budget of the federal program for the provision of necessary medicines in the Samara Region did not exceed 6%. Still, in physical terms (in terms of the number of packages) the share of medicines of this pharmacotherapeutic group in the federal program for the provision of necessary medicines averaged about 25%. Nomenclature of medicines of the analyzed group prescribed to federal beneficiaries in 2014–2017 ranged from 90 to 107 nomenclature items. The number of international nonproprietary names (INN) decreased from 51 in 2014 to 36 in 2017. During the period under review, there was a decrease in the acquisition cost of medicines for the treatment of circulatory system diseases and the weighted average cost of one package (by 63% and 53%, respectively).Conclusion. Perindopril-containing medicines occupied the maximum consumption volumes in monetary terms. There was a decrease in the average cost of one package in 2017, which may be associated with the replacement of original medicines with generics and a concomitant reduction in the number of INN within the subgroup.
{"title":"Peculiarities of administration of medications to patients with circulatory system diseases within the framework of the federal program of preferential provision of medicines","authors":"I. Petrukhina, R. Yagudina, N. V. Veyner, T. K. Ryazanova, E. Gladunova, V. Kurkin, P. R. Blinkova, E. N. Zaitseva","doi":"10.17749/2070-4909/farmakoekonomika.2021.065","DOIUrl":"https://doi.org/10.17749/2070-4909/farmakoekonomika.2021.065","url":null,"abstract":"Objective: to analyse of medicines prescriptions for federal beneficiaries with circulatory system diseases and to identify the main trends in the implementation of the federal program for the provision of necessary medicines in the Samara Region in 2014–2017.Material and methods. The authors reviewed the nomenclature of medicines used to treat circulatory system diseases (CSDs) and distributed to the population of the Samara Region as part of the federal program for the provision of necessary medicines for the period from 2014 to 2017. The methods of comparative, retrospective, logical, graphical and content analysis, the method of data grouping according to Anatomical Therapeutic Chemical classification and methods of descriptive statistics were used.Results. In 2014–2017 the share of financial costs for the purchase of medicines in the total budget of the federal program for the provision of necessary medicines in the Samara Region did not exceed 6%. Still, in physical terms (in terms of the number of packages) the share of medicines of this pharmacotherapeutic group in the federal program for the provision of necessary medicines averaged about 25%. Nomenclature of medicines of the analyzed group prescribed to federal beneficiaries in 2014–2017 ranged from 90 to 107 nomenclature items. The number of international nonproprietary names (INN) decreased from 51 in 2014 to 36 in 2017. During the period under review, there was a decrease in the acquisition cost of medicines for the treatment of circulatory system diseases and the weighted average cost of one package (by 63% and 53%, respectively).Conclusion. Perindopril-containing medicines occupied the maximum consumption volumes in monetary terms. There was a decrease in the average cost of one package in 2017, which may be associated with the replacement of original medicines with generics and a concomitant reduction in the number of INN within the subgroup.","PeriodicalId":36464,"journal":{"name":"Farmakoekonomika","volume":"4 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2021-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88403241","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}