Pub Date : 2023-10-20DOI: 10.37489/2588-0519-2023-3-55-65
E. A. Orlova
Relevance. Polypharmacy in taking medicines as one of the main consequences of comorbid pathology is a well-known risk factor for adverse drug reactions (ADRs). ADRs are often the cause of worsening disease course, disability, and mortality, especially in the elderly. This trend necessitates optimization of pharmacotherapy used in elderly patients using analytical algorithms for safety assessment. Objective. To analyze the safety of antibacterial and bronchodilator pharmacotherapy in COPD patients over 65 years old by means of comparative analysis of the data obtained according to EURO FORTA system methods and STOPP/START criteria. Methods. To conduct the study, a patient portrait was made on the basis of inpatient records data with the determination of Charlson and ADO indices. The influence of the severity of COPD course and comorbid pathology on polypharmacy was determined using the Spearman correlation coefficient (r). Evaluation of efficiency in the application of EURO FORTA and STOPP/START analytical criteria was carried out using a comparative analysis method. Statistical processing of the obtained data was performed using the StatPlus 7.0 program. Results. 113 inpatient records of elderly patients with moderately severe and severe COPD were studied. On the background of high severity of comorbid pathology, polypharmacy was observed in 102 patients (90.2%). The application of EURO FORTA and STOPP/START analytical tools in the analysis of bronchodilator and antibacterial therapy revealed 71 prescriptions of potentially unrecommended drugs in 61 (53,9%) patients. Conclusion. The analysis showed a high rate of prescribing drugs with significant risk in elderly patients. The conducted comparative analysis of two analytical tools for evaluation of the used pharmacotherapy EURO FORTA and STOPP/START demonstrated the necessity of their joint use to achieve the best results in ensuring safety of treatment of elderly patients, as they successfully complement each other.
{"title":"Optimization of pharmacotherapy of COPD patients using EURO FORTA and STOPP/START criteria","authors":"E. A. Orlova","doi":"10.37489/2588-0519-2023-3-55-65","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-3-55-65","url":null,"abstract":"Relevance. Polypharmacy in taking medicines as one of the main consequences of comorbid pathology is a well-known risk factor for adverse drug reactions (ADRs). ADRs are often the cause of worsening disease course, disability, and mortality, especially in the elderly. This trend necessitates optimization of pharmacotherapy used in elderly patients using analytical algorithms for safety assessment. Objective. To analyze the safety of antibacterial and bronchodilator pharmacotherapy in COPD patients over 65 years old by means of comparative analysis of the data obtained according to EURO FORTA system methods and STOPP/START criteria. Methods. To conduct the study, a patient portrait was made on the basis of inpatient records data with the determination of Charlson and ADO indices. The influence of the severity of COPD course and comorbid pathology on polypharmacy was determined using the Spearman correlation coefficient (r). Evaluation of efficiency in the application of EURO FORTA and STOPP/START analytical criteria was carried out using a comparative analysis method. Statistical processing of the obtained data was performed using the StatPlus 7.0 program. Results. 113 inpatient records of elderly patients with moderately severe and severe COPD were studied. On the background of high severity of comorbid pathology, polypharmacy was observed in 102 patients (90.2%). The application of EURO FORTA and STOPP/START analytical tools in the analysis of bronchodilator and antibacterial therapy revealed 71 prescriptions of potentially unrecommended drugs in 61 (53,9%) patients. Conclusion. The analysis showed a high rate of prescribing drugs with significant risk in elderly patients. The conducted comparative analysis of two analytical tools for evaluation of the used pharmacotherapy EURO FORTA and STOPP/START demonstrated the necessity of their joint use to achieve the best results in ensuring safety of treatment of elderly patients, as they successfully complement each other.","PeriodicalId":34000,"journal":{"name":"Kachestvennaia klinicheskaia praktika","volume":"25 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135618058","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-20DOI: 10.37489/2588-0519-2023-3-66-71
M. V. Markovtseva, E. N. Zguralskaya
Relevance. The high prevalence of chronic lymphocytic leukemia (CLL) in elderly and senile patients of the European population dictates the need to find a publicly available solution to the problem of prognosis in this cohort of patients. Previously, a relationship was established between the survival of patients with CLL and the value of the glomerular filtration rate (GFR) at the time of diagnosis. The purpose of the study : to assess the relationship of GFR with the survival of CLL patients in the course of the disease. Materials and methods: 207 patients (98 men and 109 women) aged 45 to 80 years with CLL A-C according to Binet and known overall survival were studied. Annually from the 1st to the 5th year of the course of the disease, the maximum value of the patient's GFR was taken into account according to the CKD-EPI formula. The data was processed by data mining using a logical classification algorithm. Results. With a GFR value of more than 76 ml/min/1.73 m2 during the first year of the disease, more than 75 ml/min/1.73 m2 during the second year of the disease, more than 70 ml/min/1.73 m2 during the third year of the disease, more than 68 ml/min/1.73 m2 during the fourth and fifth years of the disease, the patient will overcome the calculated parameters of the median survival for the corresponding stage of CLL according to Binet. Otherwise, the overall survival of the patient will be less than the calculated median survival according to Binet. This article provides illustrative clinical examples. Conclusion. It was found that the value of GFR in CLL patients gradually decreases with the course of the disease, however, the value of this parameter in the dynamics of the disease can be considered as a significant factor in predicting the survival of patients with CLL. Based on the results, an application for an invention No. 2023108368 was filed.
{"title":"Predicting the overall survival of patients with chronic lymphocytic leukemia in the dynamics of the disease","authors":"M. V. Markovtseva, E. N. Zguralskaya","doi":"10.37489/2588-0519-2023-3-66-71","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-3-66-71","url":null,"abstract":"Relevance. The high prevalence of chronic lymphocytic leukemia (CLL) in elderly and senile patients of the European population dictates the need to find a publicly available solution to the problem of prognosis in this cohort of patients. Previously, a relationship was established between the survival of patients with CLL and the value of the glomerular filtration rate (GFR) at the time of diagnosis. The purpose of the study : to assess the relationship of GFR with the survival of CLL patients in the course of the disease. Materials and methods: 207 patients (98 men and 109 women) aged 45 to 80 years with CLL A-C according to Binet and known overall survival were studied. Annually from the 1st to the 5th year of the course of the disease, the maximum value of the patient's GFR was taken into account according to the CKD-EPI formula. The data was processed by data mining using a logical classification algorithm. Results. With a GFR value of more than 76 ml/min/1.73 m2 during the first year of the disease, more than 75 ml/min/1.73 m2 during the second year of the disease, more than 70 ml/min/1.73 m2 during the third year of the disease, more than 68 ml/min/1.73 m2 during the fourth and fifth years of the disease, the patient will overcome the calculated parameters of the median survival for the corresponding stage of CLL according to Binet. Otherwise, the overall survival of the patient will be less than the calculated median survival according to Binet. This article provides illustrative clinical examples. Conclusion. It was found that the value of GFR in CLL patients gradually decreases with the course of the disease, however, the value of this parameter in the dynamics of the disease can be considered as a significant factor in predicting the survival of patients with CLL. Based on the results, an application for an invention No. 2023108368 was filed.","PeriodicalId":34000,"journal":{"name":"Kachestvennaia klinicheskaia praktika","volume":"72 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135569819","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-20DOI: 10.37489/2588-0519-2023-3-44-54
V. N. Fedorov, V. P. Vdovichenko, M. K. Korsakov, V. V. Strakhov, A. A. Popova, A. I. Khokhlov, S. S. Suleymanov
Glaucoma is a disease associated with increased intraocular pressure (IOP). Of the pharmacological agents for treating glaucoma, there are drugs of the first (most effective and safe) and second-line treatment. First-line treatment includes prostaglandin analogs and beta-blockers. The currently used prostaglandin analogs (latanoprost, bimatoprost, tafluprost and travoprost) are PG F2α analogs that act through stimulation of FP receptors. They are distinguished by the optimal ratio of effectiveness and risk of side effects. They are convenient for the patient because for the therapeutic effect, it is enough to prescribe 1 time per day. As a result, it is rational to start the treatment of glaucoma with a drug in this group. In terms of pharmacoeconomics, the most affordable prostaglandin drug is latanoprost, which is generally as effective as other prostaglandin analogs. β-adrenergic blockers reduce the production of intraocular fluid, the formation of which is controlled by β1- and β2-adrenergic receptors. Therefore, non-selective β-blockers (timolol, levobunolol, metipranolol, and carteolol) have a pharmacodynamic advantage over selective β1-adrenergic antagonists (betaxolol). Conducted clinical studies of β-blockers have shown that given the cost, efficacy and safety, timolol was the most preferable treatment for glaucoma. In the presence of medical contraindications to the use of first-line drugs or to enhance their effectiveness, α2-agonists (apraclonidine and brimonidine), carbonic anhydrase inhibitors (usually local action: dorzolamide and brinzolamide), M-cholinomimetics (pilocarpine, carbachol and echothiopate), and also Rho-kinase inhibitors (ripasudil)
{"title":"Pharmacotherapy of glaucoma in terms of evidence-based medicine","authors":"V. N. Fedorov, V. P. Vdovichenko, M. K. Korsakov, V. V. Strakhov, A. A. Popova, A. I. Khokhlov, S. S. Suleymanov","doi":"10.37489/2588-0519-2023-3-44-54","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-3-44-54","url":null,"abstract":"Glaucoma is a disease associated with increased intraocular pressure (IOP). Of the pharmacological agents for treating glaucoma, there are drugs of the first (most effective and safe) and second-line treatment. First-line treatment includes prostaglandin analogs and beta-blockers. The currently used prostaglandin analogs (latanoprost, bimatoprost, tafluprost and travoprost) are PG F2α analogs that act through stimulation of FP receptors. They are distinguished by the optimal ratio of effectiveness and risk of side effects. They are convenient for the patient because for the therapeutic effect, it is enough to prescribe 1 time per day. As a result, it is rational to start the treatment of glaucoma with a drug in this group. In terms of pharmacoeconomics, the most affordable prostaglandin drug is latanoprost, which is generally as effective as other prostaglandin analogs. β-adrenergic blockers reduce the production of intraocular fluid, the formation of which is controlled by β1- and β2-adrenergic receptors. Therefore, non-selective β-blockers (timolol, levobunolol, metipranolol, and carteolol) have a pharmacodynamic advantage over selective β1-adrenergic antagonists (betaxolol). Conducted clinical studies of β-blockers have shown that given the cost, efficacy and safety, timolol was the most preferable treatment for glaucoma. In the presence of medical contraindications to the use of first-line drugs or to enhance their effectiveness, α2-agonists (apraclonidine and brimonidine), carbonic anhydrase inhibitors (usually local action: dorzolamide and brinzolamide), M-cholinomimetics (pilocarpine, carbachol and echothiopate), and also Rho-kinase inhibitors (ripasudil)","PeriodicalId":34000,"journal":{"name":"Kachestvennaia klinicheskaia praktika","volume":"79 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135617346","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-19DOI: 10.37489/2588-0519-2023-3-15-28
E. V. Verbitskaya, D. Yu. Belousov, A. S. Kolbin
The review is focused on discussing new trends in DM, rethinking the evidence base medicine with an emphasis on demonstrating the efficacy and safety of new therapeutic agents and medical technologies, from gene editing to AI algorithms. At the same time, clinical trials of drugs are also not standing still, there is active development, new approaches, methods and designs are being developed. The process of drug development, registration and market launch of any drug takes a significant period of time, requires high financial costs and human resources. The gold standard of evidence-based medicine was initially considered to be RCTs, but at the same time, they have objective disadvantages: limited sample, inability to control all factors; insufficient follow-up time,negative impact on participants, inability to determine cause-and-effect relationships; limited measurement methods, limited budget and others. This review discusses the trends in the methodology of clinical research. The active implementation of new designs such as Adaptive Clinical Trials, "Master" protocols including Umbrella Study, Basket Study, Platform Studies, Master Observational Trials and the increased use of Single Patient Trials (N-of-1 trials) are allowing studies to become more efficient, relevant and applicable to real-life health care practice settings and patient-centered. In the review, we also look at both the pros and cons of the expanded use of biomarkers and Digital Endpoints in clinical trials and virtual clinical trials, which use mathematical models to study patient heterogeneity and its impact on various therapeutic questions. The process of expertise and regulatory approval continues to slow down the entry of drugs into the pharmaceutical market. The review considers changes in the approaches of regulators (FDA, EMEA and Russian Ministry of Health) to the drug registration procedure. The COVID-19 pandemic and sanctions have led to the need to expand the list of drugs with authorized accelerated registration. However, accelerated registration raises many questions regarding the sufficiency of the level of evidence and safety. As we can see a deep synthesis and integration of all available data is needed to achieve the next generation of evidence-based medicine. The major challenge in the next two decades will be to exploit the potential of multidimensional evidence generation by extracting, collating and generating large data sets of natural course of disease, genomics and all other omics analyses, all published clinical trials, RWD to provide next generation evidence.
{"title":"Evidence-based medicine: new in the search for evidence","authors":"E. V. Verbitskaya, D. Yu. Belousov, A. S. Kolbin","doi":"10.37489/2588-0519-2023-3-15-28","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-3-15-28","url":null,"abstract":"The review is focused on discussing new trends in DM, rethinking the evidence base medicine with an emphasis on demonstrating the efficacy and safety of new therapeutic agents and medical technologies, from gene editing to AI algorithms. At the same time, clinical trials of drugs are also not standing still, there is active development, new approaches, methods and designs are being developed. The process of drug development, registration and market launch of any drug takes a significant period of time, requires high financial costs and human resources. The gold standard of evidence-based medicine was initially considered to be RCTs, but at the same time, they have objective disadvantages: limited sample, inability to control all factors; insufficient follow-up time,negative impact on participants, inability to determine cause-and-effect relationships; limited measurement methods, limited budget and others. This review discusses the trends in the methodology of clinical research. The active implementation of new designs such as Adaptive Clinical Trials, \"Master\" protocols including Umbrella Study, Basket Study, Platform Studies, Master Observational Trials and the increased use of Single Patient Trials (N-of-1 trials) are allowing studies to become more efficient, relevant and applicable to real-life health care practice settings and patient-centered. In the review, we also look at both the pros and cons of the expanded use of biomarkers and Digital Endpoints in clinical trials and virtual clinical trials, which use mathematical models to study patient heterogeneity and its impact on various therapeutic questions. The process of expertise and regulatory approval continues to slow down the entry of drugs into the pharmaceutical market. The review considers changes in the approaches of regulators (FDA, EMEA and Russian Ministry of Health) to the drug registration procedure. The COVID-19 pandemic and sanctions have led to the need to expand the list of drugs with authorized accelerated registration. However, accelerated registration raises many questions regarding the sufficiency of the level of evidence and safety. As we can see a deep synthesis and integration of all available data is needed to achieve the next generation of evidence-based medicine. The major challenge in the next two decades will be to exploit the potential of multidimensional evidence generation by extracting, collating and generating large data sets of natural course of disease, genomics and all other omics analyses, all published clinical trials, RWD to provide next generation evidence.","PeriodicalId":34000,"journal":{"name":"Kachestvennaia klinicheskaia praktika","volume":"38 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135779801","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-19DOI: 10.37489/2588-0519-2023-3-38-43
S. N. Kotlyarov, I. A. Suchkov, O. M. Uryasev
Chronic obstructive pulmonary disease (COPD) is often associated with atherosclerotic cardiovascular disease (ASCVD), of which obliterating atherosclerosis of lower limb arteries or peripheral arterial disease (PAD) is an important component. The aim of the study was to evaluate the clinical, functional and immunological characteristics of COPD with the phenotype of frequent exacerbations in combination with PAD. Materials and methods. Four groups of COPD patients were included: 20 COPD patients with infrequent exacerbations without ASCVD, 20 COPD patients with frequent exacerbations without ASCVD, 20 patients with frequent exacerbations and PAD, and 20 COPD patients with a phenotype of frequent exacerbations and PAD. Data from 20 healthy controls were analysed for comparison. Clinical and spirometric data were evaluated. General clinical laboratory data and immunological markers (interleukin 1 beta (IL1b) and tumor necrosis factor (TNF) in exhaled breath condensate (EBC) and serum were analysed. Results. Higher levels of IL1b and TNF in EBC and serum were found in patients with COPD and PAD compared to COPD patients without ASCVD (p<0.05) and healthy controls (p<0.001). The high prevalence of COPD exacerbates the clinical and immunological characteristics of disease severity both without ASCVD and with concomitant PAD. Conclusions. COPD with the phenotype of frequent exacerbations and PAD is characterized by greater severity of local and systemic inflammation, which corresponds to increased inflammatory markers in EBC and serum.
{"title":"Clinical and immunological characteristics of chronic obstructive pulmonary disease with frequent exacerbations associated with obliterating atherosclerosis of lower limb arteries","authors":"S. N. Kotlyarov, I. A. Suchkov, O. M. Uryasev","doi":"10.37489/2588-0519-2023-3-38-43","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-3-38-43","url":null,"abstract":"Chronic obstructive pulmonary disease (COPD) is often associated with atherosclerotic cardiovascular disease (ASCVD), of which obliterating atherosclerosis of lower limb arteries or peripheral arterial disease (PAD) is an important component. The aim of the study was to evaluate the clinical, functional and immunological characteristics of COPD with the phenotype of frequent exacerbations in combination with PAD. Materials and methods. Four groups of COPD patients were included: 20 COPD patients with infrequent exacerbations without ASCVD, 20 COPD patients with frequent exacerbations without ASCVD, 20 patients with frequent exacerbations and PAD, and 20 COPD patients with a phenotype of frequent exacerbations and PAD. Data from 20 healthy controls were analysed for comparison. Clinical and spirometric data were evaluated. General clinical laboratory data and immunological markers (interleukin 1 beta (IL1b) and tumor necrosis factor (TNF) in exhaled breath condensate (EBC) and serum were analysed. Results. Higher levels of IL1b and TNF in EBC and serum were found in patients with COPD and PAD compared to COPD patients without ASCVD (p<0.05) and healthy controls (p<0.001). The high prevalence of COPD exacerbates the clinical and immunological characteristics of disease severity both without ASCVD and with concomitant PAD. Conclusions. COPD with the phenotype of frequent exacerbations and PAD is characterized by greater severity of local and systemic inflammation, which corresponds to increased inflammatory markers in EBC and serum.","PeriodicalId":34000,"journal":{"name":"Kachestvennaia klinicheskaia praktika","volume":"237 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135779803","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-19DOI: 10.37489/2588-0519-2023-3-29-37
A. S. Luchinin, N. V. Minaeva
Relevance. Despite significant improvements in therapeutic options, patients with multiple myeloma (MM) experience a series of remissions and relapses requiring further lines of therapy, which requires the prescription of new lines of therapy. Methods. We analyzed the types and outcomes of treatment, attrition rates (AR) — the proportion of patients who dropped out of program therapy, and refractoriness to different lines of therapy (LOT) in 447 patients with MM between 2010 and 2022. Resalts. The AR was 17% between LOT-1 and LOT-2, 15% between LOT-2 and LOT-3, and 25% between LOT-3 and LOT- 4. In multivariate regression analysis, only high MM risk significantly increased AR risk. Each new progression of MM increased the number of patients with refractory to bortezomib, lenalidomide, or daratumumab. After LOT-1, LOT-2, and LOT-6%, 26%, and 53% of patients were double-refractory, respectively, and 54% were triple-refractory. Bortezomib- or lenalidomide-refractory patients had a 2.6-fold lower chance of achieving a very good partial response or better (VGPR+). From LOT-1 to LOT-4, the overall response rate and VGPR+ decreased from 74% and 53% to 25% and 15%, respectively. Overall survival (OS) in the entire population was 7.6 years, with an actuarial 5-year OS of 67% and a 10-year OS of 44%. The median of progression-free survival (PFS) was 20 months on LOT-1, 19 months on LOT-2, and 7 months on LOT-3, and the actuarial 5-year PFS was 25%, 18%, and 10%, respectively. Conclusions: In this regard, we observe a continuing trend in the use of cisplatin-containing "rescue" chemotherapy regimens, especially in patients with an aggressive course, including extramedullary forms of MM. These patients could be candidates for bispecific antibody therapy and CAR T-cell therapy, but these options are not yet available in Russia.
{"title":"Real-world assessment of treatment multiple myeloma patients on the example of one hematology center","authors":"A. S. Luchinin, N. V. Minaeva","doi":"10.37489/2588-0519-2023-3-29-37","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-3-29-37","url":null,"abstract":"Relevance. Despite significant improvements in therapeutic options, patients with multiple myeloma (MM) experience a series of remissions and relapses requiring further lines of therapy, which requires the prescription of new lines of therapy. Methods. We analyzed the types and outcomes of treatment, attrition rates (AR) — the proportion of patients who dropped out of program therapy, and refractoriness to different lines of therapy (LOT) in 447 patients with MM between 2010 and 2022. Resalts. The AR was 17% between LOT-1 and LOT-2, 15% between LOT-2 and LOT-3, and 25% between LOT-3 and LOT- 4. In multivariate regression analysis, only high MM risk significantly increased AR risk. Each new progression of MM increased the number of patients with refractory to bortezomib, lenalidomide, or daratumumab. After LOT-1, LOT-2, and LOT-6%, 26%, and 53% of patients were double-refractory, respectively, and 54% were triple-refractory. Bortezomib- or lenalidomide-refractory patients had a 2.6-fold lower chance of achieving a very good partial response or better (VGPR+). From LOT-1 to LOT-4, the overall response rate and VGPR+ decreased from 74% and 53% to 25% and 15%, respectively. Overall survival (OS) in the entire population was 7.6 years, with an actuarial 5-year OS of 67% and a 10-year OS of 44%. The median of progression-free survival (PFS) was 20 months on LOT-1, 19 months on LOT-2, and 7 months on LOT-3, and the actuarial 5-year PFS was 25%, 18%, and 10%, respectively. Conclusions: In this regard, we observe a continuing trend in the use of cisplatin-containing \"rescue\" chemotherapy regimens, especially in patients with an aggressive course, including extramedullary forms of MM. These patients could be candidates for bispecific antibody therapy and CAR T-cell therapy, but these options are not yet available in Russia.","PeriodicalId":34000,"journal":{"name":"Kachestvennaia klinicheskaia praktika","volume":"4 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135779802","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2023-10-19DOI: 10.37489/2588-0519-2023-3-4-14
S. V. Svetlichnaya, L. N. Mazankova, L. D. Popovich, L. A. Elagina
Meningococcal infection (MI) is one of the most serious and life-threatening with an average mortality rate of 15 %. Infection accounts for the largest number of deaths of all infectious diseases among children under 17 years of age. Aim. Using simulation mathematical modeling to evaluate the potential epidemiological and economic benefits of vaccination against MI for children under the age of 1 year in Moscow with a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine. Methods. The assessment of potential indicators of morbidity and mortality of children under the age of 1 year after vaccination in a hypothetic cohort was carried out, considering a period of the stable post-vaccination immunity. Data were compared with the indicators of the MI incidence in Moscow. Monetary equivalents of economic benefits are calculated, considering the cost of vaccination, direct and indirect costs. Results. It is possible to reduce the number of MI cases by 73 %, mortality by an average on 85 % after vaccination, in the horizon of 5 years of maintaining immunity tension, Vaccination of children under one year old can reduce the number of disability cases that occur after severe forms of infection. As a result, the economic impact from the mentioned disease can be reduced by 75 %. Conclusion. The resulting economic benefits in the future may significantly exceed the cost of vaccination. It seems expedient to accelerate the introduction of vaccination of children's contingents against MI.
{"title":"An economic evaluation of vaccination in children against meningococcal infection in Moscow","authors":"S. V. Svetlichnaya, L. N. Mazankova, L. D. Popovich, L. A. Elagina","doi":"10.37489/2588-0519-2023-3-4-14","DOIUrl":"https://doi.org/10.37489/2588-0519-2023-3-4-14","url":null,"abstract":"Meningococcal infection (MI) is one of the most serious and life-threatening with an average mortality rate of 15 %. Infection accounts for the largest number of deaths of all infectious diseases among children under 17 years of age. Aim. Using simulation mathematical modeling to evaluate the potential epidemiological and economic benefits of vaccination against MI for children under the age of 1 year in Moscow with a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine. Methods. The assessment of potential indicators of morbidity and mortality of children under the age of 1 year after vaccination in a hypothetic cohort was carried out, considering a period of the stable post-vaccination immunity. Data were compared with the indicators of the MI incidence in Moscow. Monetary equivalents of economic benefits are calculated, considering the cost of vaccination, direct and indirect costs. Results. It is possible to reduce the number of MI cases by 73 %, mortality by an average on 85 % after vaccination, in the horizon of 5 years of maintaining immunity tension, Vaccination of children under one year old can reduce the number of disability cases that occur after severe forms of infection. As a result, the economic impact from the mentioned disease can be reduced by 75 %. Conclusion. The resulting economic benefits in the future may significantly exceed the cost of vaccination. It seems expedient to accelerate the introduction of vaccination of children's contingents against MI.","PeriodicalId":34000,"journal":{"name":"Kachestvennaia klinicheskaia praktika","volume":"16 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135779804","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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