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The role of ferritin in liver disease assessment 铁蛋白在肝病评估中的作用
Q3 Medicine Pub Date : 2023-11-10 DOI: 10.17749/2070-4909/farmakoekonomika.2023.200
V. G. Radchenko, V. B. Grinevich, E. S. Ivanyuk, L. B. Lazebnik
Background. Ferritin is an important integral and diagnostic marker of liver diseases. In 1/3 of patients with nonalcoholic fatty liver disease (NAFLD), manifestations of hyperferritinemia are revealed. Increased ferritin level indicates the severity of the disease course and affects the prognosis. Objective: to determine the prevalence and character of hyperferritinemia manifestations in NAFLD patients and to evaluate the effectiveness of its correction with human placenta hydrolysate. Material and methods . We examined 158 patients aged from 20 to 63 years (92 men and 66 women). There were no significant differences in age between men and women. The control group consisted of 20 practically healthy individuals. Molecular mechanisms of peptide components of human placenta hydrolysate (Laennec®) impact on pathophysiological processes of serum ferritin disorders, iron metabolism indicators, and inflammation manifestations were analyzed. Results. Nineteen peptides potentially important for regulation of iron homeostasis were identified in Laennec® composition. These peptides contribute to the elimination of iron metabolism disorders by regulating the levels of hepcidin (the main hormone of iron homeostasis), reducing ferritin synthesis, as well as exhibiting anti-inflammatory, and immunomodulatory effects. The efficacy of the drug monotherapy in patients with hyperferritinemia was shown. Conclusion. Laennec® was found to be one of the medicines contributing to the reduction of hyperferritinemia manifestations, iron metabolism disorders, and systemic inflammatory process in NAFLD.
背景。铁蛋白是肝脏疾病的重要积分和诊断指标。在1/3的非酒精性脂肪性肝病(NAFLD)患者中,可表现为高铁蛋白血症。铁蛋白水平升高提示病程的严重程度,影响预后。目的:了解NAFLD患者高铁蛋白血症的发生率和特点,并评价人胎盘水解物对其纠正的效果。材料和方法。我们检查了158例年龄在20至63岁之间的患者(92名男性和66名女性)。男性和女性在年龄上没有显著差异。对照组由20名基本健康的人组成。分析人胎盘水解液(Laennec®)肽组分对血清铁蛋白紊乱、铁代谢指标及炎症表现的病理生理过程影响的分子机制。结果。在Laennec®组合物中鉴定了19个可能对铁稳态调节重要的肽。这些肽通过调节hepcidin(铁稳态的主要激素)的水平,减少铁蛋白的合成,以及表现出抗炎和免疫调节作用,有助于消除铁代谢紊乱。结果表明,单药治疗高铁蛋白血症的疗效显著。结论。Laennec®被发现是一种有助于减少NAFLD高铁蛋白血症表现、铁代谢紊乱和全身炎症过程的药物。
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引用次数: 0
An open-label, controlled trial of the clinical effects of Laennec® in patients with nonalcoholic steatohepatitis or cirrhosis 一项关于Laennec®治疗非酒精性脂肪性肝炎或肝硬化患者临床效果的开放标签对照试验
Q3 Medicine Pub Date : 2023-11-10 DOI: 10.17749/2070-4909/farmakoekonomika.2023.206
M. Imawari, M. Nagase, I. Yu. Torshin, O. A. Gromova
Objective: to evaluate the efficacy and safety of human placenta hydrolysate (HPH) Laennec® in the treatment of nonalcoholic fatty liver disease (NAFLD) in a clinical trial. Material and methods. The study involved hospitalized NAFLD patients (with non-alcoholic steatohepatitis, cirrhosis) (n=34, mean age 53±14 years). In the therapy group (n=17), patients received Laennec® HPH (4 ml intravenous drip infusion in a solution of 5% glucose 5 times a week for 2 weeks). In the control group (n=17), patients hospitalized in other departments of the clinic did not receive any therapy for NAFLD. The effectiveness of therapy was assessed after 2 and 3 weeks by subjective NAFLD symptoms (fatigue, anorexia, bloating, constipation, nausea, and pain in hypochondrium) and biochemical indicators of liver function: levels of blood serum aspartate aminotrans-ferase (AST), alanine notransferase (ALT), gamma-glutamyltransferase (GGT). Results . At the start of the study, there were no significant differences between the groups in the values of the studied indicators of liver function: blood levels of AST, ALT, GGT, etc. By the end of Week 1, a significant decrease in AST levels was registered in the group receiving Laennec® (–35 U/l; control: –8 U/l; p<0.001), ALT (–45 U/l; control: –10 U/l; p<0.001), and GGT (–23 U/l; control: –8 U/l; p=0.084; trend). At the end of the study (Week 3), the decrease in AST, ALT and GGT levels towards the normal range was even more pronounced for all three biomarkers: AST (–62 U/l; control: –23 U/l; p<0.001), ALT (–78 U/l; control: –20 U/l; p<0.001), GGT (–40 U/l; control: –15 U/l; p=0.005). Subjective NAFLD symptoms significantly improved after 3 weeks. No adverse effects were identified with the use of HPH. Conclusion . Laennec® is an effective and safe treatment for NAFLD.
目的:在一项临床试验中评价人胎盘水解物(HPH) Laennec®治疗非酒精性脂肪性肝病(NAFLD)的有效性和安全性。材料和方法。本研究纳入住院NAFLD患者(合并非酒精性脂肪性肝炎、肝硬化)(n=34,平均年龄53±14岁)。治疗组(n=17)患者接受Laennec®HPH (4 ml静脉滴注5%葡萄糖溶液,每周5次,持续2周)。对照组(n=17)在其他科室住院的患者未接受任何治疗。2周和3周后,通过主观NAFLD症状(疲劳、厌食、腹胀、便秘、恶心和忧郁症疼痛)和肝功能生化指标:血清天冬氨酸转氨酶(AST)、丙氨酸不转移酶(ALT)、γ -谷氨酰转移酶(GGT)水平来评估治疗的有效性。结果。研究开始时,两组间所研究的肝功能指标:血中AST、ALT、GGT等水平均无显著差异。在第1周结束时,接受Laennec®治疗的组AST水平显著下降(-35 U/l;控制:- 8u /l;p<0.001), ALT (-45 U/l;控制:-10 U/l;p<0.001), GGT (-23 U/l;控制:- 8u /l;p = 0.084;趋势)。在研究结束时(第3周),所有三种生物标志物的AST, ALT和GGT水平向正常范围的下降更加明显:AST (-62 U/l;控制:-23 U/l;p<0.001), ALT (-78 U/l;控制:-20 U/l;p<0.001), GGT (-40 U/l;控制:-15 U/l;p = 0.005)。3周后主观NAFLD症状明显改善。未发现使用HPH的不良反应。结论。Laennec®是一种有效且安全的治疗NAFLD的药物。
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引用次数: 0
Updated pharmacoeconomic analysis of atesolizumab efficiency compared with other PD-1 inhibitors in patients with advanced non-small cell lung cancer after chemotherapy atesolizumab与其他PD-1抑制剂在化疗后晚期非小细胞肺癌患者中的疗效的最新药物经济学分析
Q3 Medicine Pub Date : 2023-11-10 DOI: 10.17749/2070-4909/farmakoekonomika.2023.211
S. K. Zyryanov, I. N. Dyakov
Objective: to evaluate the pharmacoeconomic efficiency of atezolizumab (inhibitor of programmed death ligand 1 (PD-L1)) in comparison with other checkpoint inhibitors (inhibitors of programmed cell death protein 1 (PD-1)) in patients with advanced non-small cell lung cancer (NSCLC) after previous chemotherapy in the current conditions of the Russian healthcare system. Material and methods. The study design was a retrospective analysis of publications and modeling. The previously performed pharmacoeconomic study was updated considering a decrease in the cost of pembrolizumab after the generic form was released on the market and actualization of calculated target population. Cost minimization analysis was carried out and the impact on the healthcare system budget was estimated when treating all NSCLC patients provided with PD-1/ PD-L1 inhibitors in the second and third lines of therapy with atezolizumab. For calculations, we used registered prices according to the state register of maximum selling prices and average weighted marginal wholesale markup according to the Federal Antimonopoly Service. Results. In the cost minimization analysis, atezolizumab showed greater clinical and economic efficiency, its use reduces costs by 28.6% over 3 years compared to nivolumab and by 8.8% compared to pembrolizumab in the second and third lines of NSCLC therapy. The budget impact analysis demonstrated that if all patients in the target group currently receiving various PD-1/PD-L1 inhibitors in the second and third lines of NSCLC therapy were initially provided with atezolizumab, it would reduce the budget load over 3 years by 11.6%, or by 722.4 mln rubles. Conclusion. The use of atezolizumab is pharmacoeconomically justified and feasible compared to nivolumab and pembrolizumab, even after a release of the generic version of the latter, and will reduce the costs of PD-1/PD-L1 inhibitors in the second and third lines of NSCLC therapy.
目的:评价atezolizumab(程序性死亡配体1抑制剂(PD-L1))与其他检查点抑制剂(程序性细胞死亡蛋白1抑制剂(PD-1))在俄罗斯医疗系统当前条件下对晚期非小细胞肺癌(NSCLC)患者既往化疗后的药物经济学效率。材料和方法。研究设计是对出版物和模型进行回顾性分析。考虑到仿制药上市后派姆单抗成本的下降和计算目标人群的实现,先前进行的药物经济学研究进行了更新。本研究进行了成本最小化分析,并评估了在用atezolizumab治疗所有非小细胞肺癌患者的二线和三线治疗中使用PD-1/ PD-L1抑制剂对医疗保健系统预算的影响。为了进行计算,我们使用了根据州最高销售价格登记的注册价格和根据联邦反垄断局的平均加权边际批发加价。结果。在成本最小化分析中,atezolizumab显示出更高的临床和经济效率,在NSCLC治疗的二线和三线中,与纳武单抗相比,atezolizumab的使用在3年内降低了28.6%的成本,与派姆单抗相比降低了8.8%。预算影响分析表明,如果目标组中目前在二线和三线NSCLC治疗中接受各种PD-1/PD-L1抑制剂的所有患者最初都提供atezolizumab,那么3年内的预算负担将减少11.6%,即7.224亿卢布。结论。与纳武单抗和派姆单抗相比,使用atezolizumab在药物经济学上是合理和可行的,即使后者的仿制药发布后,也将降低PD-1/PD-L1抑制剂在二线和三线非小细胞肺癌治疗中的成本。
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引用次数: 0
The prospects for the use of vitamin B12 derivatives in pharmacology 维生素B12衍生物在药理学上的应用前景
Q3 Medicine Pub Date : 2023-11-10 DOI: 10.17749/2070-4909/farmakoekonomika.2023.198
I. Yu. Torshin, O. A. Gromova, L. A. Maiorova
Background. The structure of corrin tetrapyrrole macrocycles (compounds similar in structure to vitamin B12) is a kind of universal chemical template for targeted drug delivery, and the development of chemical sensors and antidotes. Objective: systematization of information on targeted modulation of certain corrins’ properties through chemical modifications. Material and methods . Literature analysis using modern methods of topological and metric data analysis was carried out. All relevant publications (n=863) were extracted from the PubMed/MEDLINE database on request “(cobalamin OR Cobyrinic OR vitamin B12) AND (Molecular Conformation [MeSH Terms] OR Vitamin B 12/*analogs & derivatives/*chemistry [MeSH Terms] OR Vitamin B 12/*chemistry [MeSH Terms] OR Structure-Activity Relationship [MeSH Terms])”. Results. Information was systematized on how it is possible to regulate the properties of vitamin B12 (cobalamin) derivatives by introducing specific substitutions of groups in the corrin ring, on chemical modifications of cobalamin derivatives, biosynthetic approaches to the synthesis of cobalamin derivatives, and the effects of interactions of these modified corrins with “small” inorganic and organic molecules. Conclusion. The results obtained by systematic computer analysis of publications on corrins make it possible to reasonably form samples of candidate molecules for corrin studies in silico, in vitro, and in vivo.
背景。corrin四吡咯大环(结构类似维生素B12的化合物)是一种通用的化学模板,可用于靶向给药,开发化学传感器和解毒剂。目的:通过化学修饰有针对性地调节某些科林斯性质的信息的系统化。材料和方法。采用现代拓扑和度量数据分析方法进行文献分析。根据要求从PubMed/MEDLINE数据库中提取所有相关出版物(n=863)“(cobalamin OR Cobyrinic OR vitamin B12) AND (Molecular构象[MeSH术语]OR vitamin B12 /*类似物&衍生物/*化学[MeSH术语]或维生素b12 /*化学[MeSH术语]或构效关系[MeSH术语])”。结果。通过在钴胺环中引入特定的取代基团来调节维生素B12(钴胺素)衍生物的特性,对钴胺素衍生物的化学修饰,合成钴胺素衍生物的生物合成方法,以及这些修饰的钴胺素与“小”无机和有机分子相互作用的影响的信息进行了系统的整理。结论。通过对有关科林斯的出版物进行系统的计算机分析获得的结果,可以合理地形成候选分子样品,用于科林斯在硅、体外和体内的研究。
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引用次数: 1
Efficacy of alectinib in comparison with lorlatinib in patients with ALK-positive non-small cell lung cancer: pharmacoeconomic study 阿勒替尼与氯拉替尼在alk阳性非小细胞肺癌患者中的疗效比较:药物经济学研究
Q3 Medicine Pub Date : 2023-11-10 DOI: 10.17749/2070-4909/farmakoekonomika.2023.210
A. S. Kolbin, Yu. M. Gomon, M. A. Proskurin, Yu. E. Balykina
Objective: to evaluate the clinical and economic effectiveness of alectinib in comparison with lorlatinib in adult patients with advanced anaplastic lymphoma kinase (ALK) positive non-small cell lung cancer (NSCLC). Materials and methods. The calculations included the direct costs of the healthcare system: the costs of drug therapy, detecting and relieving adverse events, palliative care. A Markov model consisting of three patient states (“alive without progression”, “alive with progression”, “death”) was constructed, the probabilities of which were obtained from previously conducted clinical studies. Due to the equivalence of strategies regarding overall and non-progressive survival, the cost minimization analysis was applied. Results. The total costs per 1 patient when using lorlatinib were 40.63% higher than for alectinib (12,551,770 and 7,451,522 rubles, respectively). At the same time, the difference was mainly determined by different costs of targeted therapy: in the alectinib group, the cost of drug therapy per 1 patient amounted to 6,646,247 rubles, in lorlatinib group – to 11,922,814 rubles (44% higher). Conclusion. The use of alectinib in the treatment of patients with ALK-positive NSCLC is justified not only from clinical, but also from an economic point of view.
目的:评价阿勒替尼与氯拉替尼在成年晚期间变性淋巴瘤激酶(ALK)阳性非小细胞肺癌(NSCLC)患者中的临床和经济效果。材料和方法。计算包括医疗保健系统的直接成本:药物治疗的成本,检测和缓解不良事件的成本,姑息治疗的成本。构建了由三种患者状态(“活着但无进展”、“活着但有进展”、“死亡”)组成的马尔可夫模型,这些状态的概率由先前进行的临床研究获得。由于总体生存和非渐进式生存策略的等效性,应用了成本最小化分析。结果。每1名患者使用氯拉替尼的总费用比阿勒替尼高40.63%(分别为12,551,770和7,451,522卢布)。与此同时,这种差异主要是由靶向治疗的不同费用决定的:在alectinib组,每1名患者的药物治疗费用为6,646,247卢布,在lorlatinib组-为11,922,814卢布(高出44%)。结论。使用alectinib治疗alk阳性NSCLC患者不仅从临床角度,而且从经济角度来看都是合理的。
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引用次数: 0
Retrospective pharmacoeconomic study of antibiotic therapy in community-acquired pneumonia 社区获得性肺炎抗生素治疗的回顾性药物经济学研究
Q3 Medicine Pub Date : 2023-11-10 DOI: 10.17749/2070-4909/farmakoekonomika.2023.190
A. A. Taube, T. V. Alexandrova, O. A. Demidova, M. V. Zhuravleva
Background. The global recommendations for the treatment strategy of community-acquired pneumonia (CAP) include the empirical prescription of antibiotic therapy (ABT) – beta-lactams, fluoroquinolones, macrolides until the results of laboratory tests are obtained to identify the etiological agent responsible for CAP to determine etiotropic therapy. According to the national Russian clinical guidelines, macrolides, fluoroquinolones, cephalosporins and aminopenicillins are recommended for empirical prescription. Meta-analyses found better outcomes in patients treated with a combination of macrolides with beta-lactam compared to beta-lactam alone. At the same time, the clinical benefit of adding macrolides to beta-lactams for the empirical treatment of moderate CAP remains controversial, since the difference in the results of therapy may depend on the age and comorbid conditions of patients. Objective: to analyze the costs of treating CAP with various ABT strategies in order to optimize the cost structure of a medical organization and plan the budget of local healthcare systems. Material and methods. A retrospective epidemiological analysis of extracts from 157 medical records of middle-aged patients in accordance with the World Health Organization classification treated in multidisciplinary medical organizations was carried out. The methods included frequency analysis, cost of illness analysis, cost minimization analysis, and cost-effectiveness analysis. Depth of research was 2 years. Results. Frequency analysis revealed that the initial strategy of ceftriaxone and azithromycin combination (n=74; 47%) prevailed in prescriptions. In terms of the rate of prescriptions, ceftriaxone monotherapy (n=37; 24%) was in the second place. The analysis of the effectiveness of the selected ABT strategies showed that, in general, 113 (72%) of prescriptions were effective. Standard therapy strategies were equivalent in absolute costs and had a similar cost structure. Conclusion . Doctors’ adherence to national clinical guidelines for CAP treatment was found when prescribing the initial empirical ABT, the dominant strategies were identified. Cost of illness analysis demonstrated that the applied strategies were optimal in terms of cost minimization, and cost-effectiveness ratio. The costs structure in therapy with various ABT strategies did not have significant differences. In medical organizations, they adhere to the most rational and cost-effective strategy for CAP treatment and prescribe ABT regimens in each individual case based on risk factors, as well as the results of studies of CAP pathogens sensitivity.
背景。关于社区获得性肺炎(CAP)治疗策略的全球建议包括经验性处方抗生素治疗(ABT) - β -内酰胺类药物、氟喹诺酮类药物、大环内酯类药物,直到获得实验室检测结果以确定导致CAP的病因,以确定致病因治疗。根据俄罗斯国家临床指南,大环内酯类药物、氟喹诺酮类药物、头孢菌素和氨基霉素类药物被推荐用于经验处方。荟萃分析发现,大环内酯类药物与β -内酰胺联合治疗的患者比单独使用β -内酰胺治疗的患者预后更好。与此同时,在β -内酰胺类药物中加入大环内酯类药物治疗中度CAP的临床疗效仍存在争议,因为治疗结果的差异可能取决于患者的年龄和合病情况。目的:分析不同ABT策略治疗CAP的成本,以优化医疗机构的成本结构,规划当地医疗系统的预算。材料和方法。对157例在多学科医疗机构按世界卫生组织分类治疗的中年患者病历摘录进行回顾性流行病学分析。方法包括频率分析、疾病成本分析、成本最小化分析和成本-效果分析。研究深度为2年。结果。频次分析显示,头孢曲松与阿奇霉素联合用药的初始策略(n=74;47%)在处方中盛行。处方率方面,头孢曲松单药治疗(n=37;24%)排在第二位。对所选ABT策略的有效性分析表明,总体而言,113张(72%)处方有效。标准治疗策略在绝对成本和成本结构上是相同的。结论。发现医生在处方初始经验性ABT时遵守国家CAP治疗临床指南,确定了主导策略。疾病成本分析表明,在成本最小化和成本-效果比方面,所采用的策略是最优的。不同ABT治疗策略的成本结构无显著差异。在医疗机构中,他们坚持最合理和最具成本效益的CAP治疗策略,根据风险因素和CAP病原体敏感性研究结果,为每个病例开出ABT方案。
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引用次数: 0
Possibilities of using coenzyme Q10 for the treatment of diseases associated with mitochondrial dysfunction and chronic inflammation 使用辅酶Q10治疗与线粒体功能障碍和慢性炎症相关疾病的可能性
Q3 Medicine Pub Date : 2023-11-09 DOI: 10.17749/2070-4909/farmakoekonomika.2023.187
O. A. Gromova, I. Yu. Torshin, A. N. Gromov
Background. The enzymatic cofactor coenzyme Q10 (CoQ10) is involved in the synthesis of adenosine triphosphate in mitochondria. The CoQ10 biosynthesis declines when using statin drugs. Objective : systematization of the impact of coenzyme Q10 on chronic, sluggish systemic inflammation leading to the development of atherosclerosis, liver and pancreas pathologies, and neurodegeneration. Material and methods. Systematic computer analysis of 16,788 publications on CoQ10 found by the query “coenzyme Q10 OR ubiquinone” in PubMed/MEDLINE database of biomedical publications was carried out. Current methods of topological and metric data analysis developed at the scientific school of Academician of the Russian Academy of Sciences Yu.I. Zhuravlev were used. Results. CoQ10 is involved in the regulation of inflammation and exhibits lipid-lowering, hepatoprotective, nephroprotective, anti-asthenic, cardioprotective, and neuroprotective effects. CoQ10 favorably affects carbohydrate metabolism and a wide range of neurological diseases. Conclusion. CoQ10 supplementation improves glycemic control in insulin resistance, kidney function, and is useful in the treatment of migraine and neurodegenerative pathologies (Parkinson’s disease, etc.).
背景。辅酶辅酶Q10 (CoQ10)参与线粒体中三磷酸腺苷的合成。使用他汀类药物时,辅酶q10的生物合成下降。目的:系统化研究辅酶Q10对导致动脉粥样硬化、肝脏和胰腺病变以及神经变性的慢性、迟缓的全身性炎症的影响。材料和方法。对在PubMed/MEDLINE生物医学出版物数据库中通过查询“coenzyme Q10 OR ubiquinone”查询到的辅酶Q10相关文献16,788篇进行了系统的计算机分析。目前的拓扑和度量数据分析方法是由俄罗斯科学院院士yui的科学学院开发的。朱拉夫列夫被使用了。结果。辅酶q10参与炎症调节,并表现出降脂、保肝、保肾、抗衰弱、保心脏和保神经的作用。辅酶q10积极影响碳水化合物代谢和广泛的神经系统疾病。结论。补充辅酶q10可改善胰岛素抵抗、肾功能的血糖控制,并可用于治疗偏头痛和神经退行性疾病(帕金森病等)。
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引用次数: 0
Clinical and economic assessment of feasibility of using quadritherapy in patients with reduced ejection fraction chronic heart failure in medical organizations of the Moscow Region 莫斯科地区医疗机构对射血分数降低的慢性心力衰竭患者使用四疗法可行性的临床和经济评估
Q3 Medicine Pub Date : 2023-11-09 DOI: 10.17749/2070-4909/farmakoekonomika.2023.195
A. D. Ermolaeva, T. N. Ermolaeva, K. A. Kokushkin
Objective: assessment of feasibility of using four-component drug therapy for patients with chronic heart failure with reduced ejection fraction (CHFrEF) in medical organizations of the Moscow Region (MR). Material and methods. Clinical and economic analysis of combined standard therapy with angiotensin-converting enzyme inhibitors, beta-blockers, and mineralocorticoid-receptor antagonists in combination with dapagliflozin (a sodium-glucose cotransporter 2) in the treatment of patients with CHFrEF was carried out. The effectiveness criteria were the number of prevented cardiovascular (CV) deaths and the percentage of the contribution to the achievement of the target indicator to reduce mortality from circulatory diseases within the framework of the regional program “Health care development”. In order to determine the economic feasibility of quadritherapy, direct medical costs for the implemented technology were calculated, the cost of one prevented CV death was determined based on the values of the number needed to treat (NNT) indicator. Budget impact analysis was performed which allowed to build two analytical models. Results . It was shown that the use of quadritherapy can significantly contribute to achieving the target indicator by additionally preventing 512 CV deaths by 2024, which will make it possible to fulfill up to 74.74% of the indicator set by the MR state program “Health care of the Moscow Region” (451.4 persons per 100 thousand population). Using quadruple therapy in 1000 target patients during the first year will prevent 11 CV deaths (NNT 90 persons). The cost of one prevented CV death was 3.860 million rubles. The budget impact analysis made it possible to determine that when CHF patients switch from standard treatment regimens to quadritherapy, including in combination with a drug of the angiotensin/neprilysin receptor inhibitor group (valsartan + sacubitril), this will entail an increase in healthcare system budget costs by 18.8%. Conclusion. The results demonstrate that the standard therapy in combination with the innovative drug dapagliflozin leads to a proven reduction in mortality from circulatory diseases. This technology is a cost-effective approach to organizing medical care for adult patients with CHFrEF on the MR territory.
目的:评价莫斯科地区(MR)医疗机构使用四组分药物治疗慢性心力衰竭伴射血分数降低(CHFrEF)患者的可行性。材料和方法。对血管紧张素转换酶抑制剂、受体阻滞剂和矿皮质激素受体拮抗剂联合达格列净(钠-葡萄糖共转运蛋白2)治疗CHFrEF患者的联合标准疗法进行了临床和经济分析。有效性标准是预防心血管疾病死亡的人数,以及在区域"保健发展"方案框架内对实现降低循环系统疾病死亡率目标指标的贡献百分比。为了确定四疗法的经济可行性,计算实施技术的直接医疗成本,根据治疗所需人数(NNT)指标的值确定预防1例CV死亡的成本。进行了预算影响分析,从而建立了两个分析模型。结果。结果表明,到2024年,使用四联疗法可以大大有助于实现目标指标,从而额外防止512例CV死亡,这将有可能实现MR国家方案“莫斯科州卫生保健”设定的指标的74.74%(每10万人中有451.4人)。在第一年对1000名目标患者使用四联疗法将预防11例CV死亡(NNT 90人)。预防一例CV死亡的费用为3860万卢布。预算影响分析可以确定,当CHF患者从标准治疗方案转向四联治疗时,包括与血管紧张素/neprilysin受体抑制剂组(缬沙坦+ sacubitril)的药物联合治疗,这将导致医疗保健系统预算成本增加18.8%。结论。结果表明,标准疗法与创新药物达格列净联合使用可降低循环系统疾病的死亡率。这项技术是一种成本效益高的方法,可以为MR地区的成年CHFrEF患者组织医疗保健。
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引用次数: 0
Analysis of tariff agreements of the constituent entities of the Russian Federation: form and completeness of data presentation 分析俄罗斯联邦各组成实体的关税协定:数据呈现的形式和完整性
Q3 Medicine Pub Date : 2023-11-09 DOI: 10.17749/2070-4909/farmakoekonomika.2023.203
D. V. Fedyaev, F. S. Nikitin, T. N. Artamonova, S. A. Kovaleva, V. V. Omelyanovskiy
Background. Each constituent entity of the Russian Federation (RF) on the basis of the territorial programme of state guarantees of free medical care for citizens forms a tariff agreement (TA) on payment for medical care. Despite the list of requirements to the content and structure of the tariff agreement established by the decree of the Ministry of Health of the RF, there are significant differences among the regional tariff agreements in terms of content and completeness of the information provided. Objective: a comparative analysis of TA of the RF constituent entities and additional agreements to them to identify differences in their structure and content. Material and methods . To carry out the analysis, the data of TA for the full calendar year 2022 were systematised into a single database with the allocation of the main parameters regulated by legal documents. On the basis of the database, the availability and form of information presentation in the TA were analysed. Results. The differences were revealed, which can be divided into two groups. In the first group, they relate to the content and structure of TA; in the second group, to the presentation of TA in public domain. The differences are related to the information content of TA, details of tariffs for medical services, the presence or absence of tariffs for separate medical services, as well as the presentation and formats of TA files on the websites of territorial compulsory health insurance funds. Conclusion. To date, there are still a significant number of differences between TA of the RF constituent entities. The lack of unification in data presentation in the regions increases the risk of errors in comparative analysis, which may ultimately affect the correctness of its results presented to the authorities for decision-making in the health care sector. The new unified form of TA will make it possible to eliminate the above-mentioned differences in content and presentation by bringing the data to a single format.
背景。俄罗斯联邦各组成实体根据国家保障公民免费医疗的领土方案,就医疗费用支付达成关税协定。尽管南斯拉夫联邦共和国卫生部的法令规定了关税协定的内容和结构要求清单,但各区域关税协定之间在所提供信息的内容和完整性方面存在重大差异。目的:比较分析RF组成实体的TA及其附加协议,以确定其结构和内容的差异。材料和方法。为了进行分析,将2022年全年的TA数据系统化到一个数据库中,主要参数的分配由法律文件规定。在数据库的基础上,分析了TA的可用性和信息表示形式。结果。差异被揭示出来,可以分为两组。在第一组中,它们与助教的内容和结构有关;在第二组中,TA在公共领域的呈现。这些差异与TA的信息内容、医疗服务关税细节、单独医疗服务是否征收关税以及领土强制性健康保险基金网站上TA文件的呈现方式和格式有关。结论。迄今为止,TA和RF组成实体之间仍然存在大量差异。各区域在数据呈现方面缺乏统一,增加了比较分析出错的风险,这可能最终影响其提交给保健部门决策当局的结果的正确性。新的、统一的数据交换格式将使数据采用单一格式,从而消除上述在内容和表示方面的差异。
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引用次数: 0
Comparative analysis of using atezolizumab vs. durvalumab in combination with platinum-containing chemotherapy in adult patients with advanced small cell lung cancer atezolizumab与durvalumab联合含铂化疗治疗成年晚期小细胞肺癌患者的比较分析
Q3 Medicine Pub Date : 2023-11-09 DOI: 10.17749/2070-4909/farmakoekonomika.2023.208
I. S. Krysanov, E. V. Makarova, V. Yu. Ermakova
Background . In recent decades, a course of chemotherapy with etoposide (EP) and platinum preparations (сarboplatinum, CP) has been recommended as a standard first-line treatment option in patients with advanced small cell lung cancer (SCLC), but with the advent of new immunological drugs, immune checkpoint inhibitors, approaches to therapy have changed. Based on randomized clinical trials, courses combining traditional platinum-containing chemotherapy with inhibitors of programmed death-ligand 1 (PD-L1) atezolizumab (ATZ) or durvalumab (Durv) have been included in many clinical recommendations for oncologists. Objective: to evaluate the clinical and cost-effectiveness of using ATZ and Durv as first-line therapy in advanced SCLC adult patients within the Russian healthcare system. Material and methods. The model of treatment of advanced SCLC adult patients in conditions of the healthcare system of the Russian Federation included the most popular options for first-line immunochemotherapy: CP/EP + ATZ and CP/EP + Durv courses. Pharmacoeconomic cost-effectiveness analysis, sensitivity analysis of the selected model to changes in its initial parameters, budget impact analysis were carried out. Results. The total medical costs for CP/EP + ATZ course (2,310,546.07 rubles) were significantly lower than for the CP/EP + Durv course (4,081,833.98 rubles). With comparable costs for the treatment of complications (426,175.17 and 407,704.50 rubles, respectively), the cost of Durv exceeded ATZ by 94.8%. When conducting a cost-effectiveness analysis, the advantage was retained by the CP/EP + ATZ course, the cost-effectiveness ratios for which amounted to 187,849.27 rubles per month of patient's life and 444,335.78 rubles per month of patient's life without progression (for CP/EP + Durv, 316,421.24 and 800,359.60 rubles, respectively). When choosing the CP/ET + ATZ strategy, the savings will be 128,571.96 rubles per month of life and 356,023.82 rubles per month of life without progression. Sensitivity analysis demonstrated the stability of the developed model: to increase in the price of the CP/EP + ATZ course up to +68%; to decrease in overall survival with the course of CP/EP + ATZ up to –40%; to decrease in progression-free survival with the course of CP/EP + ATZ to –44%. Budget impact analysis showed that with a possible cohort size of 4,448 people an increase in the proportion of patients receiving CP/EP + ATZ course from 70% to 90% will reduce budget costs by 1,575,737,725.38 rubles per year, which will allow additional treatment of 681.9 advanced SCLC patients per year (+15.3%). Conclusion. The use of ATZ combined with standard platinum-containing chemotherapy in advanced SCLC adult patients as the first-line therapy is clinically and cost-effective strategy within the Russian healthcare system, as it allows to reduce therapy costs compared to Durv and treat more SCLC patients, which fully corresponds to the target indicators of the federal program “Oncol
背景。近几十年来,依托泊苷(EP)和铂制剂( arboplatinum, CP)的化疗疗程被推荐为晚期小细胞肺癌(SCLC)患者的标准一线治疗选择,但随着新的免疫药物、免疫检查点抑制剂的出现,治疗方法发生了变化。基于随机临床试验,将传统含铂化疗与程序性死亡配体1 (PD-L1)抑制剂atezolizumab (ATZ)或durvalumab (Durv)相结合的方案已被纳入许多肿瘤学家的临床推荐。目的:评估ATZ和Durv作为俄罗斯医疗系统内晚期SCLC成年患者一线治疗的临床和成本效益。材料和方法。在俄罗斯联邦医疗系统的条件下,晚期SCLC成年患者的治疗模式包括最流行的一线免疫化疗方案:CP/EP + ATZ和CP/EP + Durv疗程。进行药物经济学成本-效果分析、所选模型对初始参数变化的敏感性分析、预算影响分析。结果。CP/EP + ATZ课程的总医疗费用(2,310,546.07卢布)明显低于CP/EP + Durv课程(4,081,833.98卢布)。治疗并发症的费用相当(分别为426,175.17和407,704.50卢布),Durv的费用比ATZ高94.8%。在进行成本效益分析时,CP/EP + ATZ课程保持了优势,其成本效益比为患者生命周期每月187,849.27卢布和无进展患者生命周期每月444,335.78卢布(CP/EP + Durv分别为316,421.24卢布和800,359.60卢布)。当选择CP/ET + ATZ策略时,每月可节省128,571.96卢布,每月可节省356,023.82卢布。敏感性分析证实了所建立模型的稳定性:CP/EP + ATZ疗程的价格增加了+68%;CP/EP + ATZ病程中总生存率下降高达-40%;CP/EP + ATZ疗程的无进展生存期降低至-44%。预算影响分析显示,可能的队列规模为4,448人,接受CP/EP + ATZ疗程的患者比例从70%增加到90%,每年将减少预算成本1,575,737,725.38卢布,这将允许每年额外治疗681.9名晚期SCLC患者(+15.3%)。结论。ATZ联合标准含铂化疗作为一线治疗晚期SCLC成人患者在俄罗斯医疗系统内是临床和成本效益的策略,因为与Durv相比,它可以降低治疗成本,治疗更多的SCLC患者,这完全符合联邦计划“肿瘤学”的目标指标。
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引用次数: 0
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Farmakoekonomika
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