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The role of real world data and real world evidence in health technology assessment 真实世界数据和真实世界证据在卫生技术评估中的作用
Q3 Medicine Pub Date : 2022-10-09 DOI: 10.17749/2070-4909/farmakoekonomika.2022.120
E. Novoderezhkina, S. Zyryanov
Real world data (RWD) and real world evidence (RWE) is one of the most rapidly developing areas in the modern health care systems, which is caused by the development of technologies for both collecting and analyzing data, the emergence of new data sources and the formation of needs both by regulatory bodies, health technology assessment (HTA) agencies, and by the clinical and scientific communities. However, at the moment, there is no universal approach to RWD/E generation and application in the context of HTA. Over the past few years, the rate of including RWD/E in the HTA dossier has noticeably increased, but the nature of the existing guidelines and recommendations is rather fragmentary, which might create obstacles in the way of RWD/E study development and submission. The publication is aimed to describe and summarize the main and most rapidly developing spheres of RWD/E applications and analyze the possibilities of using RWD/E in various HTA areas in the world and in the Russian Federation considering the main trends in the further HTA development.
真实世界数据(RWD)和真实世界证据(RWE)是现代卫生保健系统中发展最快的领域之一,这是由于收集和分析数据的技术的发展,新数据源的出现以及监管机构,卫生技术评估(HTA)机构以及临床和科学界需求的形成造成的。然而,目前在HTA的背景下,对于RWD/E的产生和应用还没有一个通用的方法。在过去数年,将RWD/E纳入HTA档案的比率明显增加,但现有的指引和建议的性质相当不完整,可能会对RWD/E研究的发展和提交造成障碍。该出版物的目的是描述和总结发展最迅速的RWD/E应用领域,并分析在世界和俄罗斯联邦的各个HTA领域使用RWD/E的可能性,同时考虑到HTA进一步发展的主要趋势。
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引用次数: 4
Prospects for the use of chondroitin sulfate and glucosamine sulfate in the treatment of patients with obesity-associated osteoarthritis (metabolic syndrome) 硫酸软骨素和硫酸氨基葡萄糖治疗肥胖相关性骨关节炎(代谢综合征)的前景
Q3 Medicine Pub Date : 2022-10-09 DOI: 10.17749/2070-4909/farmakoekonomika.2022.145
I. Torshin, О. Gromova, A. Lila
The relationship between the pathophysiology of osteoarthritis (OA) and metabolic disorders (metabolic syndrome, obesity) is provided not only by mechanical causes (increased body weight pressure on the joints). A complex of molecular mechanisms, which mediates OA effect on the development of obesity, was established. Excessive activity of toll receptors, the NF-κB cascade, and metabolic disorders of endogenous chondroitin sulfates (CS) lead to chronic inflammation and the development of a complex of comorbid pathologies, including OA, atherosclerosis, and obesity. The relationship between insulin resistance and CS metabolism is also mediated by impaired genomic DNA methylation. Exogenous CS and glucosamine sulfate (GS) used in the long-term treatment of OA also contribute to the inhibition of the pathophysiology of obesity. By inhibiting O-glucosamination of intranuclear proteins (i.e., p53), GS can accelerate lipolysis of visceral fat. Anti-inflammatory effects of CS and GS is associated with inhibition of toll receptors and NF-κB, increased levels of antioxidant enzymes, regulation of expression of fibroblast growth factor 21, activation of adenosine monophosphate-activated protein kinase, and inhibition of secretion of chemoattractant protein MCP-1 and pancreatic lipase. Positive effect of CS and its oligosaccharides exposure on the pathophysiology of metabolic disorders is associated not only with a decrease in inflammation and normalization of fat metabolism but also with an improvement in the state of the intestinal microbiota. Experimental and clinical studies confirm the effects of CS and GS on body mass control. CS and GS are effective and safe when used in patients with OA associated with metabolic syndrome and/or obesity.
骨关节炎(OA)的病理生理学与代谢紊乱(代谢综合征、肥胖)之间的关系不仅由机械原因(关节体重压力增加)提供。建立了一个复杂的分子机制,介导OA对肥胖的影响。toll受体的过度活性、NF-κB级联和内源性硫酸软骨素(CS)的代谢紊乱导致慢性炎症和并发症的发展,包括OA、动脉粥样硬化和肥胖。胰岛素抵抗和CS代谢之间的关系也通过受损的基因组DNA甲基化介导。用于OA长期治疗的外源性CS和硫酸氨基葡萄糖(GS)也有助于抑制肥胖的病理生理。通过抑制核内蛋白(即p53)的o -葡萄糖氨基化,GS可以加速内脏脂肪的脂肪分解。CS和GS的抗炎作用与抑制toll受体和NF-κB、增加抗氧化酶水平、调节成纤维细胞生长因子21的表达、激活单磷酸腺苷活化蛋白激酶、抑制化学引诱蛋白MCP-1和胰脂肪酶的分泌有关。CS及其寡糖暴露对代谢紊乱病理生理的积极作用不仅与炎症的减少和脂肪代谢的正常化有关,还与肠道菌群状态的改善有关。实验和临床研究证实了CS和GS对体重控制的作用。CS和GS用于伴有代谢综合征和/或肥胖的OA患者是有效和安全的。
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引用次数: 1
Long-term analysis of сanagliflozin budget impact in adult patients with type 2 diabetes mellitus and diabetic nephropathy in the Russian Federation 俄罗斯联邦成年2型糖尿病合并糖尿病肾病患者使用沙列净预算影响的长期分析
Q3 Medicine Pub Date : 2022-10-09 DOI: 10.17749/2070-4909/farmakoekonomika.2022.150
N. Avxentyev, Y. Makarova
Background. Diabetic nephropathy (DN) is a specific kidney lesion in patients with diabetes mellitus, which leads to the development of endstage kidney disease and requires substitutive renal therapy (dialysis or transplantation). Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, which exerts a renoprotective effect. According to the published data, the application of canagliflozin in patients with type 2 diabetes mellitus (DM2) and DN could postpone dialysis therapy for almost 13 years.Objective: to perform a long-term analysis of canagliflozin budget impact in adult patients with DM2 and DN from the point of view of the constituent entities of the Russian Federation.Material and methods. A group of comparison for canagliflozin was placebo (no renoprotective pharmacotherapy). The authors proposed a mathematical model for DN progression in groups of patients who received canagliflozin (100 mg orally, daily, long-term) or placebo. The model was based on the extrapolation of the CREDENCE study data. The model was used for the analysis of the direct costs on the lifetime pharmacotherapy and dialysis per one patient. Epidemiologic data from the federal register on the number of adult patients with DM and DN prevalence among these patients were used to evaluate the size of the target population. Based on the clinical recommendations and the medical care standards for patients with DM and the data on the actual state procurement of SGLT2 inhibitors and glucagon-like peptide-1 receptor agonists in 2021, we evaluated the share of patients with DM2+DN who currently do not receive renoprotective therapy but who must be supplied with canagliflozin according to the standards. Among this population, we determined the patients with the glomerular filtration rate within 30–90 ml/min/1.73 m2, which provides the comparability of the target population with patients included in CREDENCE clinical study.Results. Direct medical costs per one patient receiving canagliflozin therapy were 678 108 rubles, which was 52.8% (759,239 rubles) lower than without renoprotective pharmacotherapy (1,437,347 rubles). As a result, considering the modeling period and current practice, the budget costs for pharmacotherapy of patients with DM2+DN were 99.82 billion rubles, in comparison with the proposed practice, which was 47.09 billion rubles (difference in budget costs is 52.73 billion rubles, or 52.8%). The accumulated costs of the regional health care system were lower in patients receiving canagliflozin in comparison with patients without renoprotective pharmacotherapy 11 years after the beginning of treatment.Conclusion. The expansion of canagliflozin application in the therapy for patients with DM2+DN leads to the budget cost cuts in the long run due to the extension of the dialysis-free period.
背景。糖尿病肾病(Diabetic nephropathy, DN)是糖尿病患者的一种特异性肾脏病变,可发展为终末期肾病,需要肾脏替代治疗(透析或移植)。加格列净是一种钠-葡萄糖共转运蛋白2 (SGLT2)抑制剂,具有保护肾的作用。根据已发表的数据,canagliflozin在2型糖尿病(DM2)和DN患者中的应用可以将透析治疗推迟近13年。目的:从俄罗斯联邦组成实体的角度,对卡格列净对成年DM2和DN患者的预算影响进行长期分析。材料和方法。一组比较卡格列净为安慰剂(无肾保护药物治疗)。作者提出了接受卡格列净(100mg口服,每日,长期)或安慰剂组患者DN进展的数学模型。该模型基于CREDENCE研究数据的外推。该模型用于分析每位患者终身药物治疗和透析的直接成本。来自联邦登记册的糖尿病成年患者数量和这些患者中DN患病率的流行病学数据用于评估目标人群的规模。根据糖尿病患者的临床推荐和医疗护理标准,以及2021年SGLT2抑制剂和胰高血糖素样肽-1受体激动剂的实际国家采购数据,我们评估了目前未接受肾保护治疗但必须按标准给予卡格列净的DM2+DN患者的份额。在该人群中,我们确定了肾小球滤过率在30-90 ml/min/1.73 m2之间的患者,这为目标人群与CREDENCE临床研究中纳入的患者提供了可比性。每位接受canagliflozin治疗的患者的直接医疗费用为678 108卢布,比未接受肾保护药物治疗的患者(1,437 347卢布)低52.8%(759,239卢布)。因此,考虑到建模期和目前的实践,DM2+DN患者药物治疗的预算费用为998.2亿卢布,而拟议的做法为470.9亿卢布(预算费用差异为527.3亿卢布,或52.8%)。与未接受肾保护药物治疗的患者相比,在开始治疗11年后,接受卡格列净的患者在区域卫生保健系统的累积费用较低。扩大canagliflozin在DM2+DN患者治疗中的应用,由于免透析期的延长,从长远来看可以降低预算成本。
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引用次数: 0
Funding for coronavirus health worker payments 为冠状病毒卫生工作者支付的资金
Q3 Medicine Pub Date : 2022-10-09 DOI: 10.17749/2070-4909/farmakoekonomika.2022.122
I. Bocharova, A. Rymanov
Objective: to conduct an analysis of the channels, the volume of COVID payments to medical workers and assess the preliminary effectiveness of funding for coronavirus health worker payments.Material and methods. Statistical comparative analysis of data in the field of health care funding was carried out. The assessment of changes in the level of wages of medical workers was performed using the index method and the grouping method. Relative indicators of the structure were used to evaluate the distribution of transfers by region. The study was conducted on the basis of open Rosstat data on the salaries of medical workers.Results. The regional distribution of transfers was regulated in 2020 by the Federal Government. The main channel for financing COVID payments to medical workers was the allocation of transfers and subsidies. More than half of the funding was accounted for by transfers for incentive payments to health care workers for fulfilling particularly important works. The largest share of allocated transfers fell on the Moscow Region (5.6% of the total volume of transfers), Nizhny Novgorod Region (5.1%), and Saint Petersburg (5.0%), the lowest – on the Republic of Kalmykia, the Republic of Khakassia, the Amur Region (0.2% each), the Nenets Autonomous District (0.1%). Transfers for incentive payments for special working conditions and additional workload were paid in 2020 in a total of 670 thousand persons. Transfers for incentive payments for fulfilling particularly important works were paid in a total of 363 thousand medical workers and 53 thousand ambulance drivers. An assessment of the effectiveness of financing COVID payments in the form of transfers and subsidies showed that it was largely due to them that the medical workers’ mean salary increased.Conclusion. The distribution of aggregated amounts of transfers between the constituent entities of the Russian Federation was carried out until November 2020 on the basis of the number of persons insured under Compulsory Health Insurance program in a corresponding region. In the early months of fighting the pandemic, the use of this aggregate was appropriate.
目的:分析新冠肺炎支付给医务人员的渠道、金额,评估新冠肺炎医护人员支付资金的初步效果。材料和方法。对保健供资领域的数据进行了统计比较分析。采用指数法和分组法对医务人员工资水平变化进行评估。利用结构的相关指标评价区域间转移的分布。这项研究是根据俄罗斯国家统计局关于医务人员工资的公开数据进行的。联邦政府于2020年对转移支付的区域分配进行了规定。新冠肺炎支付资金的主要渠道是转移支付和补贴拨款。其中一半以上的资金用于向完成特别重要工作的保健工作人员转移奖励。分配的转移支付份额最大的是莫斯科州(占转移支付总额的5.6%)、下诺夫哥罗德州(5.1%)和圣彼得堡(5.0%),最低的是卡尔梅克共和国、哈卡斯共和国、阿穆尔州(各0.2%)和涅涅茨自治区(0.1%)。2020年共支付特殊工作条件和额外工作量奖励转移支付67万人。共向36.3万名医务人员和5.3万名救护车司机支付了完成特别重要工作的奖励转移支付。对以转移支付和补贴形式资助新冠肺炎支付的有效性评估表明,这在很大程度上是由于医务人员的平均工资增加。截至2020年11月,在俄罗斯联邦各组成实体之间根据相应地区强制性健康保险方案的参保人数进行了转移支付总额分配。在抗击大流行病的最初几个月,使用这种总量是适当的。
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引用次数: 0
Economic aspects of using new chemotherapy regimens for multidrug and extensively drugresistant tuberculosis 使用新的化疗方案治疗多药和广泛耐药结核病的经济方面
Q3 Medicine Pub Date : 2022-10-09 DOI: 10.17749/2070-4909/farmakoekonomika.2022.131
А. V. Kukurika
Objective: to systematize data on cost-effectiveness evaluation of new multidrug and extensively drug-resistant tuberculosis (MDR/XDR-TB) chemotherapy regimens.Material and methods. An analysis of 19 publications devoted to the economic evaluation of the treatment of active MDR/XDR-TB was carried out. The literature search was performed in the electronic databases PubMed/MEDLINE, Google Scholar, eLibrary for the period from January 2015 to February 2022 inclusively.Results. Economic efficiency was studied in high-, middleand low-income countries. All publications contained calculation of treatment costs, and a third of the studies also estimated additional costs. Bedaquiline, delamanid, and pretomanid regimens were included in treatment alone or compared with a background regimen. The most commonly used economic model was the Markov one. To compare primary outcomes, most studies assessed disabilityand quality-adjusted life years. The overall cost of MDR/XDR-TB treatment varied by country income level. In all cases, bedaquiline-based regimens represented a cost-effective alternative to previous treatment, showed high efficacy in MDR/XDR-TB therapy, and were more cost-effective than delamanid regimens.Conclusion. Cost-effective interventions for active MDR/XDR-TB therapy should include the introduction of new chemotherapy regimens, reduced hospital stays and decentralized treatment, which is especially relevant in countries with high tuberculosis burden.
目的:对新型多药和广泛耐药结核病(MDR/XDR-TB)化疗方案的成本-效果评估数据进行系统整理。材料和方法。对19份专门对活动性耐多药/广泛耐药结核病治疗进行经济评价的出版物进行了分析。在PubMed/MEDLINE,谷歌Scholar, library电子数据库中进行文献检索,检索时间为2015年1月至2022年2月。研究了高、中、低收入国家的经济效率。所有出版物都包含治疗费用的计算,三分之一的研究还估计了额外费用。贝达喹啉、delamanid和pretomanid方案被单独纳入治疗或与背景方案进行比较。最常用的经济模型是马尔可夫模型。为了比较主要结果,大多数研究评估了残疾和质量调整生命年。耐多药/广泛耐药结核病治疗的总费用因国家收入水平而异。在所有病例中,以贝达喹啉为基础的方案代表了一种具有成本效益的替代先前治疗方案,在耐多药/广泛耐药结核病治疗中显示出高效率,并且比delamanid方案更具成本效益。积极的耐多药/广泛耐药结核病治疗的成本效益干预措施应包括采用新的化疗方案、缩短住院时间和分散治疗,这在结核病负担高的国家尤其重要。
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引用次数: 0
Review of international practice of health care provider network planning 卫生保健提供者网络规划的国际实践综述
Q3 Medicine Pub Date : 2022-10-09 DOI: 10.17749/2070-4909/farmakoekonomika.2022.148
V. Omelyanovskiy, D. Lukyantseva, N. Sisigina
Objevtive: to identify and systematize the main approaches to planning health care provider network used in foreign countries.Material and methods. Preliminary search for countries who had an experience of systematical planning of health care provider network and tools that they used for planning was conducted in regular health system reviews made by the European Observatory on Health Systems and Policies. Identified tools became a subject of general Internet search for the official publications about goals, mechanisms and results of their usage. The findings were analysed to reveal the similarities and differences between national health care provider network planning policies as well as the objective preconditions for the formation of such policies.Results. Three main approaches to health care provider network planning were identified in the analysis: (1) through establishing state-owned health care providers, (2) through granting the right to deliver guaranteed health care or (3) through granting the right to deliver health care of all categories. A close relationship between the choice of prevailing approach to planning and specific planning tools and the national health care model and structure of health services supply was shown. The typical policy of countries most similar to Russia on these parameters (“young” insurance systems, operating under conditions of predominant state supply of medical services) is the protection of key providers on the basis of minimum activity or income guarantees with the gradual development of a competitive health care market based on the rest of the Compulsory Health Insurance program.Conclusion. Current Russian health care provider network planning regulation based on the direct control over the state-owned health care providers does not correspond to the changed health care model and does not allow taking full advantages of the social health insurance. The results of the review can be used to develop new tools for planning health care provider network spanning on non-state providers.
目的:对国外医疗服务提供者网络规划的主要方法进行梳理和归纳。材料和方法。在欧洲卫生系统和政策观察站进行的定期卫生系统审查中,对具有系统规划卫生保健提供者网络经验的国家及其用于规划的工具进行了初步搜索。已确定的工具成为Internet上关于其使用目标、机制和结果的官方出版物的一般搜索主题。通过对研究结果的分析,揭示了不同国家医疗服务提供者网络规划政策的异同,以及这些政策形成的客观前提。在分析中确定了卫生保健提供者网络规划的三种主要方法:(1)通过建立国有卫生保健提供者,(2)通过授予提供有保障的卫生保健的权利,或(3)通过授予提供所有类别卫生保健的权利。报告显示,选择流行的规划方法和具体规划工具与国家保健模式和保健服务供应结构之间存在密切关系。在这些参数(“年轻的”保险制度,在国家主要提供医疗服务的条件下运作)上与俄罗斯最相似的国家的典型政策是在最低活动或收入保障的基础上保护主要提供者,并在强制性医疗保险计划的其余部分的基础上逐步发展竞争性医疗保健市场。目前俄罗斯基于对国有卫生保健提供者直接控制的卫生保健提供者网络规划条例不符合改变后的卫生保健模式,也不允许充分利用社会健康保险。审查的结果可用于开发新的工具,以规划跨越非国家提供者的卫生保健提供者网络。
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引用次数: 0
Economic burden of the novel coronavirus infection: a systematic review 新型冠状病毒感染的经济负担:系统综述
Q3 Medicine Pub Date : 2022-10-09 DOI: 10.17749/2070-4909/farmakoekonomika.2022.146
V. Timiryanova, I. Lakman, N. Zagidullin, D. Gareeva
Background. The sudden emergence and rapid spread of the novel coronavirus infection (COVID-19) caused tremendous burden on the health care system including the economic one. In this regard, many questions concerning the prioritization of funding for various restrictive and preventive procedures have arisen; also the introduction of various intervention methods for monitoring and timely treatment of post-COVID consequences became an urgent problem. These challenges actualized the development of pharmacoeconomic methods that improve the quality of decisions making in such extreme conditions.Objective: to systematize available studies on the assessment of the global economic burden of the novel coronavirus infection.Material and methods. A feature of the proposed review design was the highlighting of the observed shortcomings and areas in which scientists make additions to the assessment methods taking into account the chronology of the pandemic determining changes in the information field. Therefore, an analysis was made of 80 studies published in 2020–2022 and dedicated to the assessment and forecast of the global economic burden of COVID-19. The main inclusion criteria for the studies was the estimation of COVID-19 global burden. The search was carried out in PubMed/MEDLINE, Web of Science, Scopus, and eLibrary databases. Using a predefined data collection form, two reviewers independently extracted information characterizing the studies.Results. An analysis of the publications showed a fairly wide variety of studies in the field of the COVID-19 burden, including those determined by the difference in observation objects, analysis methods, factors taken into account, etc. Scientists actively use international (73.8%) and national (90%) databases, and surveys (57.5%). Predominantly, the estimates involve the calculation of quality-adjusted life years lost (QALY) (66.3%), 37.6% of the studies are based on the results of constructing scenario models, 28.8% consume algorithms of epidemiological SIR (susceptible, infected, or recovered) models, and 66.3% provide for cost assessment. As part of the estimated economic burden, the loss of productivity (26.3% of publications), the introduction of vaccination (32.5%), comorbidity (25%), post-COVID complications (17.5%) are considered.Conclusion. A significant interest of the world scientific community in assessing the COVID-19 global burden is observed, determined by the search for the most effective study methods. Further investigations in this area should focus on detailing within the estimated economic burden of losses associated with post-COVID-19 complications, including their various combinations, as well as on the analysis of the correlation and mutual compensation of effects from various types of treatment, with a deeper study of indirect losses. The results of this work will be also useful in conducting similar studies, including for determining their design and applying modern mathematical modeli
背景。新型冠状病毒感染(COVID-19)的突然出现和迅速传播给包括经济在内的医疗卫生系统带来了巨大的负担。在这方面,出现了许多关于为各种限制性和预防性程序提供资金的优先次序的问题;引入各种干预方法来监测和及时治疗新冠肺炎后的后果也成为一个紧迫的问题。这些挑战实现了药物经济学方法的发展,提高了在这种极端条件下决策的质量。目的:对新型冠状病毒感染全球经济负担评估的现有研究进行系统整理。材料和方法。拟议审查设计的一个特点是突出指出观察到的缺点和科学家在考虑到决定信息领域变化的大流行年表的情况下对评估方法作出补充的领域。因此,对2020-2022年发表的80项研究进行了分析,致力于评估和预测COVID-19的全球经济负担。这些研究的主要纳入标准是对COVID-19全球负担的估计。检索在PubMed/MEDLINE、Web of Science、Scopus和library数据库中进行。使用预定义的数据收集表,两位审稿人独立地提取研究特征信息。对出版物的分析显示,在COVID-19负担领域的研究种类繁多,包括由观察对象、分析方法、考虑因素等差异决定的研究。科学家积极使用国际(73.8%)和国内(90%)数据库,以及调查(57.5%)。这些估计主要涉及计算质量调整生命损失年(QALY)(66.3%), 37.6%的研究基于构建情景模型的结果,28.8%的研究使用流行病学SIR(易感、感染或恢复)模型的算法,66.3%的研究提供成本评估。作为估计经济负担的一部分,考虑到生产力损失(占出版物的26.3%)、疫苗接种的引入(32.5%)、合并症(25%)和covid后并发症(17.5%)。通过寻找最有效的研究方法,世界科学界对评估COVID-19全球负担非常感兴趣。这一领域的进一步调查应侧重于详细说明与covid -19后并发症(包括其各种组合)相关的损失在估计经济负担范围内的情况,以及分析各种治疗效果的相关性和相互补偿,并对间接损失进行更深入的研究。这项工作的结果也将有助于进行类似的研究,包括确定其设计和应用现代数学建模工具。
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引用次数: 0
Drug therapy for obesity in the Russian Federation: pharmacoepidemiological study 俄罗斯联邦肥胖症的药物治疗:药物流行病学研究
Q3 Medicine Pub Date : 2022-09-19 DOI: 10.17749/2070-4909/farmakoekonomika.2022.149
V. V. Strizheletsky, Y. Gomon, Е. А. Spichakova, А. Kolbin, А. А. Kalyapin, S. A. Makarov, А. B. Lomiya А.B., F. Sultanova
Objective: аssessment of orlistat, liraglutide and sibutramine consumption in the Russian Federation as drugs recommended by the Russian clinical guidelines for the pharmacotherapy of obesity.Material and methods. From IQVIA database, the information was selected on retail sales and procurement of the specified drugs at the expense of the federal and regional budgets in the period of 2011–2021. The consumed volumes of each drug were recalculated into the number of defined daily doses (DDDs) for each international nonproprietary name in accordance with the World Health Organization methodology.Results. It was demonstrated that over a 10-year period there was a tendency to reduce the consumption of drugs for the treatment of obesity from 83.03 million DDDs in 2011 to 71.7 million in 2021. Sibutramine consumption dominated throughout the observation period: its share ranged from 76% to 84%. The proportion of people receiving obesity pharmacotherapy in the Russian Federation was about 0.5%. Herewith 58–66% of DDDs sales took place in 3 regions: Moscow, Moscow Region and Saint Petersburg.Conclusion. Low efficacy, high frequency of adverse reactions, frequent weight gain after discontinuation of therapy, as well as low orientation of doctors to the need for pharmacotherapy are probably the main factors determining the low prevalence of using drugs for the treatment of obesity in Russia.
目的:评估俄罗斯联邦奥利司他、利拉鲁肽和西布曲明作为俄罗斯肥胖药物治疗临床指南推荐药物的使用情况。材料和方法。从IQVIA数据库中,选择了2011-2021年期间以联邦和地区预算为费用的特定药物的零售和采购信息。根据世界卫生组织的方法,将每种药物的消耗量重新计算为每种国际非专利名称的限定日剂量(DDDs)。研究表明,在10年的时间里,肥胖治疗药物的消费量有从2011年的8303万DDDs减少到2021年的7170万DDDs的趋势。西布曲明在整个观察期间占主导地位:其份额从76%到84%不等。俄罗斯联邦接受肥胖药物治疗的人口比例约为0.5%。其中58-66%的DDDs销售发生在3个地区:莫斯科、莫斯科地区和圣彼得堡。疗效低、不良反应频率高、停药后体重频繁增加,以及医生对药物治疗需求的认识不高,可能是导致俄罗斯肥胖者用药率低的主要因素。
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引用次数: 1
Biophysical modeling indicates a high affinity of ethyl esters of omega-3 polyunsaturated fatty acids to the enzymes of the pro-inflammatory arachidonic acid cascade 生物物理模型表明,omega-3多不饱和脂肪酸乙酯对促炎花生四烯酸级联酶具有很高的亲和力
Q3 Medicine Pub Date : 2022-07-28 DOI: 10.17749/2070-4909/farmakoekonomika.2022.142
I. Torshin, O. Gromova
Background. Omega-3 polyunsaturated fatty acids (ω-3 PUFAs) are widely used in modern cardiology. The anti-inflammatory effect of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) is realized, in particular, by modulating the activity of the arachidonic acid (ARA) cascade.Objective: to conduct biophysical analysis of the interactions of various forms of PUFAs (ARA, EPA, DHA, EPA and DHA ethyl esters) with three target proteins-enzymes of the ARA cascade (cyclooxygenase-1 (COX-1), COX-2, 5-lipoxygenase (5-LPOG)).Material and methods. The minimization of the energy of the ligand-receptor complexes at various initial positions of the molecule relative to the receptor pocket and the molecular energy profiles of the protein (the energy of side chain transfer from solvent to protein) were calculated using the ECMMS package.Results. EPA and DHA ethyl esters were characterized by significantly higher absolute values of specific binding energies of target proteins than ARA or simply EPA/DHA. For example, in the case of COX-2, EPA, DHA and EPA ethyl ester had similar ∆∆G values (–3.0...–3.1 kcal/mol), while the COX-2 complex with DHA ethyl ester was somewhat more stable (∆∆G = –3.4 kcal/mol). In the case of the 5-LPOG enzyme, the complex with EPA ethyl ester was the most stable (∆∆G = –1.62 kcal/mol). Higher absolute binding energies indicate a higher affinity of EPA and DHA ethyl esters to enzymes of the ARA cascade.Conclusion. The results suggest that the high affinity of EPA and DHA ethyl esters to the enzymes of the ARA cascade is one of the molecular bases of therapeutic efficacy of ω-3 PUFAs with high degree of standardization.
背景。ω-3多不饱和脂肪酸(ω-3 PUFAs)在现代心脏病学中被广泛应用。二十碳五烯酸(EPA)和二十二碳六烯酸(DHA)的抗炎作用主要是通过调节花生四烯酸(ARA)级联的活性来实现的。目的:对多种形式PUFAs (ARA、EPA、DHA、EPA和DHA乙酯)与ARA级联的三种靶蛋白酶(环氧化酶-1 (COX-1)、cox - 2,5 -脂氧化酶(5-LPOG))的相互作用进行生物物理分析。材料和方法。利用ECMMS包计算了相对于受体袋不同初始位置的配体-受体复合物的最小能量和蛋白质的分子能量谱(从溶剂到蛋白质的侧链转移的能量)。EPA和DHA乙酯的特征是目标蛋白的比结合能的绝对值明显高于ARA或单纯的EPA/DHA。例如,在COX-2的情况下,EPA、DHA和EPA乙酯具有相似的∆G值(-3.0…-3.1 kcal/mol),而COX-2与DHA乙酯的配合物更为稳定(∆G = -3.4 kcal/mol)。以5-LPOG酶为例,与EPA乙酯的配合物最稳定(∆∆G = -1.62 kcal/mol)。较高的绝对结合能表明EPA和DHA乙酯对ARA级联酶具有较高的亲和力。结果表明,EPA和DHA乙酯对ARA级联酶的高亲和力是ω-3 PUFAs具有高度标准化疗效的分子基础之一。
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引用次数: 0
Experience of implementing a value-based approach in oncodermatology 在肿瘤皮肤科实施基于价值的方法的经验
Q3 Medicine Pub Date : 2022-07-28 DOI: 10.17749/2070-4909/farmakoekonomika.2022.125
Yu.A. Zuenkova, D. Kicha, L. N. Izyurov
Objective: implementation of value-based approach and development of adherence to treatment in patients with non-melanoma cancer.Material and methods. The observational, single-arm, prospective, long-term single-center study of the quality of life and patients’ experience was performed. It included 42 patients aged from 42 to 82 years. Validated questionnaires were used: Patient-Reported Outcome Measures (PROMs) (as a decision support tool), Patient-Reported Experience Measures (PREMs) (3 months after treatment to assess the patient's experience).Results. Mean concern about appearance was 43.5 points (Rasch psychometric model). Younger patients (r=–0.398, p=0.009) and female patients (r=–0.475, p=0.001) were more concerned about appearance. In 10 cases (24%), the involvement was estimated as 4 points, in 18 cases (43%), it was 3 points, in 14 cases (33%), it was 2 points. Older patients were less involved in the choice of treatment method (r=–0633, p<0.001). The level of satisfaction with communications was more than 50 points. The use of a patient-oriented algorithm of communication has a positive effect on a patient's experience.Conclusion. The heads of oncological care are recommended to evaluate the patient's experience on a regular basis, create conditions for patients to choose treatment methods according to their individual needs, analyze the outcomes obtained by the introduction of validated questionnaires on the appropriate nosological profile and take these results into account in treatment. Further studies of the degree of influence of different factors on a patient’s choice of treatment method are needed, as well as conducting studies among other groups of patients with non-melanoma skin cancer (located in other parts of the body, larger than 2 cm).
目的:实施基于价值的方法和发展非黑色素瘤癌症患者的治疗依从性。材料和方法。对生活质量和患者体验进行观察性、单臂、前瞻性、长期单中心研究。纳入42例患者,年龄从42岁到82岁。采用有效问卷:患者报告结果量表(PROMs)(作为决策支持工具),患者报告体验量表(PREMs)(治疗后3个月评估患者体验)。结果。对外表的平均关注度为43.5分(Rasch心理测量模型)。年轻患者(r= -0.398, p=0.009)和女性患者(r= -0.475, p=0.001)更关注外表。10例(24%)受累为4点,18例(43%)受累为3点,14例(33%)受累为2点。老年患者较少参与治疗方法的选择(r= -0633, p<0.001)。对沟通的满意度在50分以上。使用以患者为导向的沟通算法对患者的体验有积极的影响。建议肿瘤护理负责人定期评估患者的体验,为患者根据个人需求选择治疗方法创造条件,根据适当的病理科概况,分析通过引入有效问卷获得的结果,并在治疗中考虑这些结果。需要进一步研究不同因素对患者选择治疗方法的影响程度,并在其他非黑色素瘤皮肤癌(位于身体其他部位,大于2厘米)患者组中进行研究。
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引用次数: 0
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Farmakoekonomika
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