Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice

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ISSN / EISSN : 2588-0519 / 2618-8473
Published by: Publishing House OKI (10.37489)
Total articles ≅ 82
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A. P. Pereverzev,
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; https://doi.org/10.37489/2588-0519-2021-3-31-38

Abstract:
Any drug is potentially associated with the risk of adverse drug reactions (ADRs), the incidence of which in developed and developing countries is estimated at 6.3 (3.3—11.0) and 5.5 % (1.1—16.9), respectively. Many ADRs increase mortality and / or morbidity and / or cause clinical manifestations that require a patient to seek medical help or hospitalization; a special term has been introduced — drug-induced diseases. Food can interact with drugs and increase the risk of ADRs, including serious ones. The simultaneous intake of food and drugs can affect the bioavailability, pharmacokinetics, pharmacodynamics and therapeutic efficacy of drugs due to changes in drug absorption and metabolism. A striking example of the effect of food on the pharmacokinetic profile of drugs is the change in the bioavailability of the tyrosine kinase inhibitor lapatinib: compared with taking on an empty stomach, the bioavailability of lapatinib in a single dose of 1 500 mg after taking it together with high-calorie standard food increases by an average of 325 % — 4.25 times. In other words, the concentration of the drug in the blood serum after taking one tablet at the same time with food is comparable to taking 4 tablets on an empty stomach. Currently, there are no recommendations for choosing a dosage regimen for drugs depending on the qualitative and quantitative composition of food, as well as taking into account potential interactions with food components, although these recommendations are extremely necessary for patients and healthcare professionals. In this regard, this article summarizes the data available at the time of writing in open sources concerning the effect of food on the absorption and metabolism of drugs, and also describes the possible mechanisms of interaction.
A. S. Luchinin,
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; https://doi.org/10.37489/2588-0519-2021-3-57-63

Abstract:
The current strategy of chronic lymphocytic leukemia (CLL) treatment is based on genetic risk factors such as del(17p), TP53 mutations and/or unmutated variant of IGHV genes. Guidelines recommend the usage of targeted drugs, e.g. ibrutinib, in the first line for patients with unfavorable risk factors due to dismal results of other treatment options. Unfortunately, in real-life treatment decisions are often made without full knowledge of genetic risk factors in the treated patient. Our aimwas to find the optimal therapeutic strategy for such patients, that is, those providing the best 5-year progression-free survival (PFS). Using a relatively simple game theory-based approach we here show, that currently, the used strategy is more advantageous (success rate 71%) compared to administration of immunochemotherapy to all patients (success rate with fludarabine + cyclophosphamide + rituximab — 45%, bendamustine + rituximab — 32%). However, the optimal strategy for CLL treatment in the conditions of unknown genetic risks is the administration of ibrutinib to all patients (success rate 73%). Our simple method can be used for optimization of treatment strategy of any oncologic disease and can be integrated into relevant clinical decision support systems.
, N. I. Buromskaya, P. V. Shimanov, R. V. Deitsch, M. I. Nastovich, , A. A. Kachanova, E. A. Grishina, L. M. Savchenko, Y. S. Shevchenko, et al.
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; https://doi.org/10.37489/2588-0519-2021-3-39-49

Abstract:
Introduction. Pharmacokinetic genetic factors are prognostically relevant when prescribing antipsychotics to adult patients. Currently, there is a dearth of research on adolescents with an acute psychotic episode. Aim. To identify possible associations of CYP2D6, CYP3A4/5 and ABCB1 gene polymorphic variants with the efficacy and safety of pharmacotherapy in adolescents with an acute psychotic episode within 28 days. Materials and methods. The study included 68 adolescents with an established diagnosis of acute polymorphic psychotic disorder at the time of admission (F23.0-9 according to ICD- 10). All patients received an antipsychotic as their main therapy. Patients were monitored for 28 days. The effectiveness of antipsychotics was assessed using the Children’s Global Assessment Scale (CGAS), Positive and Negative Symptoms Scale (PANSS), Clinical Global Impression Severity (CGI-S) and Improvement (CGI-I). The safety of pharmacotherapy was assessed using the UKU Side Effects Rating Scale (UKU SERS), Sympson-Angus Scale (SAS), Barnes Akathisia rating scale (BARS). From each patient we obtained a buccal scraped epithelium, extracted DNA from it by sorbent method and detected carriage of genetic polymorphisms CYP3A4*22 (rs2740574), CYP3A5*3 (6986A>G, rs776746), CYP2D6*4, *9, *10 (rs3892097, rs4986774, rs1065852), ABCB1 1236C>T (rs1128503), 2677G>T/A (rs2032582), 3435C>T (rs1045642) by real-time PCR. Results. Carriers of ABCB1 2677G>T/A significantly less frequently demonstrated response to pharmacotherapy according to PANSS scale on day 14 compared to GG homozygotes (64.6 % vs. 94.7 %; p=0.014). Carriers of the ABCB1 3435C>T differed by a higher total UKU SERS score on day 14 compared to CC genotype carriers (9.21±5.95 vs. 5.1±4.48; p=0.037). Patients with «intermediate» CYP2D6 metabolism were more likely to have reduced sleep duration (13.6 % vs. 0 %; p=0.031). ABCB1 2677G>T/A (51 % vs. 15.8 %; p=0.012) and 3435C>T (46.6 % vs. 10 %; p=0.039) were more frequently associated with dry mouth. ABCB1 3435C>T carriers were also more likely to have orthostatic vertigo (34.5 % vs. 0 %; p=0.028). Conclusion. Carriage of the ABCB1 3435C>T was associated with greater efficacy of pharmacotherapy for acute psychotic episode in adolescents after 28 days, but also increases the risk of adverse reactions in the first 2 weeks of treatment. The ABCB1 2677G>T/A was associated with an increased risk of adverse reactions as well as less reduction of psychotic symptoms on day 14 of pharmacotherapy.
A. E. Cheberda, D. Yu. Belousov
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; https://doi.org/10.37489/2588-0519-2021-3-73-81

Abstract:
Diabetes is increasingly widespread in the Russian Federation. It is a severe chronic disease that both independently reduces quality of life and causes exacerbation of other pathologies. This makes evaluation of quality of diabetes management and understanding of clinical and economic properties of various technologies used to screen blood glucose levels, including portable blood glucose meters. Previously there already were clinical-economic evaluations of blood glucose meters within context of Russian Federation but they have not included modern high-precision equipment, thus ensuring attractiveness of current research effort into HTA of modern blood glucose meters that accounts for real life hospital practice. Goal. To assess the clinic-economic properties of modern blood glucose portable measurement systems of OneTouch family and the real-world practics of their use in Russian healthcare facilities. Methodology. The research was performed from the perspective of the Russian healthcare system. Target population was represented by a virtual cohort of 100 patients. Only direct costs were accounted for, specifically all costs caused by consumables involved in operating multifunctional laboratory complexes and all consumables involved in operating portable glucose meters. Employee salaries were also included (accounting for number of personnel involved in different procedures as based on a real clinical practice survey performed as part of this research). Since it is known that modern, standard-compliant portable glucose meters have an accuracy that is more than sufficient for routine screening, cost minimization analysis was used for assessment of economic effects when comparing different approaches to organizing glucose level screening. Research results.The survey during this research effort has indicated that not all medical facilities utilize “tandem usage” of multifunction laboratory complexes and portable glucose meters, however, such “tandem use” is the most widespread approach to organizing blood glucose screening. Cost minimization analysis has demonstrated that “tandem usage” is also the most economically attractive approach and results in cost savings for the medical facility. Conclusions.Current research effort which included cost analysis and cost minimization analysis has demonstrated that “tandem usage” approach which involves combined use of both multifunction laboratory complexes and portable glucose meter systems has substantial economic advantage (over 60 % for analysis with 5 year time horizon). Multiple sensitivity analyses have confirmed robustness of this result. This research further establishes the importance of communicating advantages of modern portable glucose meters to healthcare organizers since this technology is not only clinically rational but also economically optimal.
A. V. Sokolov, T. E. Lipatova,
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; https://doi.org/10.37489/2588-0519-2021-3-50-56

Abstract:
Despite clinical guidelines for the treatment of atrial fibrillation (AF) patient adherence to oral anticoagulants (OACs) in routine clinical practice remains low. Assessing the factors affecting adherence to the OACs regimen and developing strategies for its improvement is important. Aim.To assess the adherence of patients with AF to the prescribed anticoagulant therapy at the outpatient stage of treatment. Methodology.The object of the study was 165 patients with nonvalvular AF undergoing treatment in a specialized cardiology department or receiving outpatient treatment in a specialized cardiological dispensary in Saratov from February 2018 to December 2019. After 3, 6, 12 months, a telephone contact with the patients was carried out, a specially designed questionnaire was filled out, in which the anticoagulant therapy received by AF patients was reflected, the Morisky-Green questionnaire was filled out, the answers of patients about the reasons for skipping or stopping the administration of the OACs were recorded. Results.After 3 months. 16.6 % of AF patients replaced the OACs intake with antiplatelet agents, 16 % refused antithrombotic therapy; 43.1 % of AF patients were adherent to OACs. After 6 months. antiplatelet agents were taken by 24.5 % patients (p<0.05), 11.9 % completely stopped taking antithrombotic drugs; 30.8 % of patients were adherent to OACs (p<0.05). After 12 29,5 % patients replaced OACs treatment with antiplatelet agents, 7.6 % patients did not take any antithrombotic drugs; 31.8 % of AF patients were adherent to OACs. The most common reasons for a decrease in the adherence to OACs therapy were the cost of drugs, lack of understanding of the value of OACs administration in AF, and the lack of appreciable effect of OACs administration. Conclusion.At the outpatient stage of treatment, there was an insufficient level of adherence of AFpatients to OACs treatment.
I. N. Kozhanova
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; https://doi.org/10.37489/2588-0519-2021-3-64-72

Abstract:
Purpose: to identify factors influencing the results of health technology assessment (HTA). Methods. This analysis is based on previously performed clinical (pharmaco-) economic studies in the Republic of Belarus. The primary data analysis methods for inclusion in this publication have been cost-of-illness analysis (COI). The studies were carried out from 2010 to 2021. All costs are presented in US dollars based on exchange rates at the time of execution. Ranges are presented as maximum and minimum values. Results. The analysis of the influence of the stage of the disease, the stage of medical care, the form of release for drugs, the age of the target population for the use of health technology, the source of information on the price of technology on the results of the procedure for assessing medical technology has been performed. Evaluation of the ratio of the results of COI for implementation the clinical protocol and capabilities of the healthcare system (stable angina pectoris, type 2 diabetes mellitus), as well as for a number of special health technologies (hemophilia A; post-stroke spasticity; mantle cell lymphoma; chronic lymphocytic leukemia; chronic myeloid leukemia; lung cancer). Conclusions. It can be concluded that there is a need for clear formulations of goals and objectives at the stage of formation of the study design, considering the influence of the position of the researcher, the source of costs, the selected population, form of release (for drugs) on the main clinical and economic indicators and on the subsequent interpretation of the results of HTA.
, V. S. Krysanova,
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; https://doi.org/10.37489/2588-0519-2021-3-4-15

Abstract:
Background. Mucopolysaccharidosis Type I (MPS I) has clinical heterogeneity without specific symptoms leading to difficulties with diagnostic on time. In-depth screening for MPS I in children has aim of early detection and timely treatment with an enzyme replacement therapy. Aim. The purpose of this study was to conduct a clinical and economic assessment of the feasibility of screening for MPS I in children at group of risks. Materials and methods. Model for evaluation of the social-economic burden of MPS I with calculation of expenditures has been created. Costs of diagnosed and non-diagnosed patients in group of risks were identified, including direct medical costs (pharmacotherapy, out-patient cure, hospital admission, complications treatment, hematopoietic stem cell transplantation; direct non-medical (payments for disability); indirect (expenses related to the reduction or loss of the ability to work of one of the parents performing the duties of caring for a disabled child). Results.The weighted average cost per 1 diagnosed patient with mild forms of MPS I with selective screening, was 405,974.22 rubles, which is 184,421.85 rubles less vs average cost per 1 undiagnosed patient. The management and treatment of patients with mild forms of MPS I after selective screening will allow saving up to 17.7 million rubles/year, which would possible to additionally screen 705 patients. Taking into account the size of the population of patients with undiagnosed MPS I, currently the costs for this group amount to 56.7 million rubles, while the «overspend» of budget funds for untimely diagnosis of MPS I for this cohort of children is about 22.6 million rubles/year. Conclusion. Selective screening for MPS I in children at group of risks is economically proved and can lead to treatment on-time for disability and complications prevention.
I. S. Krysanov, V. S. Krysanova, V. Yu. Ermakova
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; https://doi.org/10.37489/2588-0519-2021-3-16-30

Abstract:
Rhinosinusitis with nasal polyps (RwNP) is a one of most common comorbidities in asthma and contrariwise and can lead to exacerbation of severe asthma (SA). Dupilumab is a perspective medicine for treatment of both, because it decreases exacerbations and prevents of a necessity of surgeon. Economics aspects of dupilumab treatment in RwNP + SA are not examined yet. Thus aim of this study was evaluation of social-economic burden of RwNP + SA in the Russian Federation and dupilumab influence on it. Materials and methods.Direct medical (cost of medicines, treatment in outpatients department and in hospital, including surgery and rate of exacerbations per year) and non-medical (payment for temporary and stable disability) and indirect costs (GDP loses) in RwNP + SA patients have been evaluated. Medical cure of a patient with RwNP + SA was created according to survey of experts from different regions of Russia. Modelling of expenditures was prepared on all calculated cohort of potential patients with RwNP + SA from “State” position and growing approach. Results.Expenditures for cure of one patient with RwNP were as 234 217,71 RUR/year. Weighted average costs for one patient with RwNP + SA were 1 881 883,39 RUR, and mostly were associated with indirect costs. Dupilumab can decrease expenditures for one patient with RwNP + SA till 1 593 162,87 RUR (on 15,3 %) annually. Potential cohort with RwNP + SA has been estimated above 39 thousand patients. Total economic burden of RwNP + SA in Russia were estimated as 1,7 bln RUR. Dupilumab usage in patients with RwNP + SA fixed in Register can help decrease economic burden on 259 mln RUR annually. Hidden economic burden of comorbidity can reach 73,4 bln RUR (for all calculated / modelled cohort of patients with RwNP + SA), dupilumab saves 11,3 bln RUR annually in this scenario. Conclusion.Comorbid pathology — RwNP+SA has a sufficient social-economic burden in Russia, that could be decreased by modern biologic drugs, in particular, with dupilumab.
, L. V. Fedina, N. I. Buromskaya, P. V. Shimanov, R. V. Deitsch, M. I. Nastovich, , A. A. Kachanova, E. A. Grishina, L. M. Savchenko, et al.
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; https://doi.org/10.37489/2588-0519-2021-2-78-88

Abstract:
Introduction. Antipsychotics are the main drugs for treatment of schizophrenia spectrum disorders. Pharmacodynamic genetic factors are being actively studied to improve the accuracy of antipsychotic selection based on pharmacogenetic testing. Purpose of this study: to establish associations of genetic polymorphisms of the DRD2, DRD3, DRD4, HTR2A, COMT, ZNF804A, and ANKS1B genes with the efficacy and safety of antipsychotics in adolescents with an acute psychotic episode during a 28-day follow-up. Materials and methods. The study included 68 adolescents with an established diagnosis of acute polymorphic psychotic disorder at the time of admission (F23.0-9 according to ICD-10). All patients received an antipsychotic as their main therapy. Patients were monitored for 28 days. The effectiveness of antipsychotics was assessed using the Children’s Global Assessment Scale (CGAS), Positive and Negative Symptoms Scale (PANSS), Clinical Global Impression Severity (CGI-S) and Improvement (CGI-I). The safety of pharmacotherapy was assessed using the UKU Side Effects Rating Scale (UKU SERS), Sympson-Angus Scale (SAS), Barnes Akathisia rating scale (BARS). From each patient we obtained a buccal scraped epithelium, extracted DNA from it by sorbent method and detected carriage of genetic polymorphisms DRD2 rs1800497 (C>T), DRD3 rs6280 (C>T), DRD3 rs324026 (C>T), DRD4 rs1800955 (C>T), HTR2A rs6313 (T>C), COMT rs4680 (Val158Met, G>A), ZNF804A rs1344706 (A>C), ANKS1B rs7968606 (C>T) by real-time PCR. Results. DRD2 rs1800497 T allele carriers had a stronger reduction in the PANSS subscore «Productive Symptomatics» on day 14 (Me=-7.0 [-9.0;-5.0] vs Me=-7.0 [-8.0;-2.0]; p=0.018) and day 28 of follow-up (Me=-11.0 [-9.0;-5.5] vs Me=-8.0 [-8.0;-2.0]; p=0.019). Also, greater improvement on the CGAS scale on day 14 of follow-up was seen in TC+CC HTR2A rs6313 carriers (Me=2.0 [1.0;3.0] vs. Me=2.0 [1.0;2.0]; p=0.029). DRD3 rs324026 homozygous carriers (TT) had a significantly lower SAS score (Me=0.5 [0.0; 1.0] vs. Me=1.0 [0.0; 5.0]; p=0.016) and UKU subscore «Neurological Disorders» on 28 days of antipsychotic therapy (Me=0.0 [0.0; 0.0] vs. Me=1.0 [0.0; 3.8]; p=0.005). DRD3 rs324026 TT carriers also had lower severity of akathisia according to the BARS scale. Carriers of the T DRD4 rs1800955 allele had a higher SAS scale score on day 28 of therapy compared with CC homozygotes (Me=1.0 [0.0;4.0] vs Me=0.0 [0.0;1.0]; p=0.036). Conclusion. The DRD2 rs1800497 was a predictor of better reduction of productive symptoms; HTR2A rs6313 demonstrated a similar association. The DRD2 rs1800497 polymorphic variant was a predictor of better reduction of productive symptomatology; HTR2A rs6313 demonstrated a similar association. DRD3 rs324026 and HTR2A rs6313 were associated with a lower frequency of neurological adverse reactions and akathisia. In contrast, carriers of the DRD4 rs1800955 were more prone to adverse reactions on pharmacotherapy.
E. A. Zhidkova, E. M. Gutor, Yu. A. Tkachenko, I. V. Rogova, I. A. Popova,
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; https://doi.org/10.37489/2588-0519-2021-1-16-21

Abstract:
Relevance. A viral pandemic caused by the SARS-CoV-2 coronavirus has led to the development of a new coronavirus disease-2019 (COVID-19). The COVID-19 pandemic has forced the mobilization of all available health system resources. There are separate publications on reducing the risk of developing coronavirus infection in people vaccinated against influenza. Objective: to study the cost-effectiveness of influenza vaccination in the conditions of the» first « wave of COVID-19. Materials and methods. The archival data of 2,452 people from among the sick employees of JSC «Russian Railways» were analyzed. The control group consisted of 2,911 employees who were not infected with COVID-19, comparable by gender, age and territory of residence. Scores on the Charlson comorbidity scale were calculated for all individuals. The pharmacoeconomical cost of the patient’s treatment was predicted using the Markov model. Results. Having a flu shot reduced the likelihood of getting COVID-19 by 1.3 times. In the presence of a diagnosis of coronavirus infection, inpatient treatment for influenza vaccinated patients was required 2 times less often than for unvaccinated patients. Compared to the situation of the absence of vaccinated persons, in the «first wave», the estimated cost savings for the treatment of patients with coronavirus infection amounted to 124 million rubles. When the number of points on the comorbidity scale increased from 1 to 8, the average cost of treatment of patients without previous influenza vaccination increased by 2 times, and in the presence of vaccination, the average cost of treatment increased by 1.7 times. Conclusion. Thus, this study shows that influenza vaccination is cost-effective against COVID-19. The effect is achieved by reducing the likelihood of getting a coronavirus infection in the presence of a flu shot.
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