Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice

Journal Information
ISSN / EISSN : 2588-0519 / 2618-8473
Published by: Publishing House OKI (10.37489)
Total articles ≅ 104
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L. D. Popovich, D. A. Vakhrusheva, S. V. Svetlichnaya
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; https://doi.org/10.37489/2588-0519-2022-2-4-12

Meningococcal infection (MI) is one of the severe illnesses by clinical manifestations and their consequences. Specific prophylaxis of severe MI forms is the most effective measure in the current conditions. It can lead to morbidity and disability reduction as well as and economic burden cut. Aim. Potential economic benefits of society finding in case of meningococcal polysaccharide conjugate vaccine to prevent MI caused by serogroups A, C, W, and Y into the National calendar of prophylactic vaccines (NCPV) for children 9- and 12-months age. Material and methods. The dynamic simulation mathematical model for epidemiological consequences of MI vaccines prophylaxis inclusion into NCPV was created. And economic calculations have been made based on this model also. Cost of vaccination based on prognosis of children amount in age before one year has been calculated, monetary equivalent of economic burden reduction in case of MI vaccines prophylaxis inclusion into NCPV was created. Results. Vaccination reduces mortality on 58–60 %, especially in children less than 5 years old. Correlation of the total epidemiological benefits expressed in years of prevented years of lost life with the projected cost of a statistical year of life gives the following results: starting from the 1st year of vaccination of children, society will receive almost 6.5 billion RUR monetary gain in metrics of life saved years. Monetary benefit on 10 years horizon could be as 70 billion RUR. Conclusion. Expenditures for meningococcal polysaccharide conjugate vaccine to prevent MI caused by serogroups A, C, W, and Y usage in case of inclusion into NCPV for children in 9- and 12-months (twice in the first year of life) are economic proved in frames of monetary equivalent of society gain in certain conditions.
A. S. Luchinin, A. V. Lyanguzov
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; https://doi.org/10.37489/2588-0519-2022-2-13-20

The ICU department’s mortality rate is one of the most important indicators of quality of care. Based on real clinical data, we attempted to build a prognostic model for patients with blood diseases in the ICU with using of the logistic regression method. The study included 202 patients in total. The median age was 57 (19–82) years. There were 112 (55 %) males and 90 (45 %) females. The statistical analysis was performed by using R software, version 3.4.2. The absolute risk of death (mortality rate) was 67 from 202 (33 %), odds — 0.496. The odds of death in ICU grow up to ~20 times if the patient has a Glasgow score of less than 15. Also, the odds of death increase by 1.3 and 11 times of PLT, or serum total protein level decreases by 2 times accordingly. Our model for “high-risk of death” detection classified patients in the test dataset with 0.816 accuracy (95 % CI 0.679–0.912), with sensitivity 0.823, and specificity 0.80. Despite the simple method for data analysis, we got a pretty accurate model of mortality prognosis with efficacy more than qSOFA and MEWS scales. Research in this area should continue.
, , K. S. Chamkina, A. V. Khodyushova
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; https://doi.org/10.37489/2588-0519-2022-2-28-36

Background. The modern rhythm of life has a negative impact on the people lifestyle. Daily stress factors, anxiety, sleep disturbance contribute to the spread of bad habits and excessive consumption of sugars, which, in combination with physical inactivity, leads to weight gain and obesity, and subsequently the development of a number of associated diseases. Methods. Using a specially designed questionnaire, including questions about nutrition, bad habits, physical activity, psychological status, a direct, voluntary survey of 120 socially active, able-bodied men and women was conducted. The risk of developing diabetes mellitus was assessed using the FINDRISK scale, height, body weight, waist circumference were also measured, and body mass index was calculated. Results. The vast majority of respondents (72.5%) noted one or another lack in their lifestyle. More than half of females and males (only 57.5 % of participants) lead a sedentary lifestyle. An increased intake of sugars was revealed in the diet, 18.33 % of the participants consumed fast food weekly, among men there was insufficient consumption of fresh vegetables and fruits. Analysis of bad habits showed that 15.83 % of respondents smoke, 15 % (most men) use energy drinks, 5 % of respondents abuse alcohol. Sleep disorders are widespread in both sexes (generally 55 %), anxiety, mainly among women (51.76 %), depressive background was most often recorded among consumers of energy drinks (66.67 %). Insufficient awareness of rational nutrition was noted in both sexes. When setting goals for lifestyle correction, multitasking was revealed (more than three tasks in 20 % of men and 21.18 % of women) and a high expectation of achieving results. Conclusions. The results of the study highlight numerous risk factors in the lifestyle of socially active people of both sexes which if not corrected in time, can lead to the development of a number of serious diseases.
A. A. Zhuravkov,
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; https://doi.org/10.37489/2588-0519-2022-2-21-27

At the moment, randomized controlled trials (RCTs) are the gold standard for providing evidence of the effectiveness and safety of medicines. If it is impossible to randomize and create an internal control group, alternative methods of collecting evidence are used, for example, the use of so-called external control groups created, among other things, based on real world data (RWD). The increase in the number of studies using RWD and external control is clearly visible in oncology, where there are problems with randomization classically. Meanwhile, this trend is of concern and requires a better understanding of the acceptability of using external control groups and validation of RWD.
, V. M. Merabishvili,
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; https://doi.org/10.37489/2588-0519-2022-2-37-44

Introduction. Lung cancer (LC) is one of the leading causes of mortality in Russia and in all other the world. Late detection of LC is a healthcare system issue because of most of patients are asymptomatic. Aim. The aim of the study was to analyze the structure of healthcare resources in the group of patients with non-small cell LC (NSCLC) in St. Petersburg. Materials and methods. The database of electronic medical records was created by combining the information from National cancer register and governmental medical insurance system, which included the patient with NSCLC diagnosed between 2011 and 2020 years. The data about the high technology medical services received by patients was added in the database as well. Results. None of the existing electronic medical records system is able to make visible all the medical services received by a specific patient. The combined database gives the possibility to follow-up the history of around 8000 patients with NSCLC in St. Petersburg. Conclusions. When building the hospital model of the NSCLC patient aiming the rational planning of healthcare resources the stage of the disease is the most important because it is strongly linked with the healthcare resources provided to the patient.
, V. S. Krysanova,
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; https://doi.org/10.37489/2588-0519-2022-2-45-54

Objectives. Cardiovascular diseases (CVD) are one of the leading causes of death worldwide, including Russia. According to the data obtained from the ESSE-RF study, the most common risk factor for the development of CVD is high level of cholesterol. At the same time, among drugs that lower cholesterol levels, statins are the most studied. The main aim of the study was to conduct a retrospective pharmacoepidemiological study to assess the effect of hypolipidemic therapy on overall and cardiovascular mortality in the regions of the Russian Federation. Methods. At the first stage, the indicators of population, cardiovascular and overall mortality in 2012–2018 were analyzed for 84 subjects of the Russian Federation. The time period of the analysis is determined by the timing of the implementation of the Federal project "Combating Cardiovascular Diseases". Next, we analyzed the frequency of prescribing lipid-lowering therapy in high doses in 84 regions of the Russian Federation in 2014– 2018, according to IMS Health for 2 market segments (preferential and hospital). The number of patients receiving high-dose statins (HDS) (atorvastatin 40 and 80 mg, rosuvastatin 20 and 40 mg) was calculated based on sales volumes in natural terms. Results. Based on the analysis of cardiovascular mortality, all 84 regions of the Russian Federation were divided into 3 groups: high, medium and moderate mortality. In the high-mortality group, HDS consumption per patient averaged 4.45 patients per 100,000 population, in the moderate-mortality group, 19.39 patients, and in the moderate-mortality group, 21.51 patients. Conclusions. The results of the study showed that there is a relationship between the frequency of HDS use and cardiovascular mortality in the regions of the Russian Federation. These results may indicate the effectiveness of lipid-lowering therapy in real practice.
A. I. Listratov, , A. I. Kochetkov,
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; https://doi.org/10.37489/2588-0519-2022-2-55-68

Intracerebral hemorrhage (ICH), which is a form of hemorrhagic stroke, is an extremely serious disease. This pathology is characterized by very high levels of disability and mortality. Despite the improvement in the treatment of those diseases that can lead to ICH, its frequency is currently increasing, which is largely due to the use of drugs, in which case the term «drug-induced intracerebral hemorrhage» (DI ICH) is used. One of the main reasons for drug-induced ICH is an increase in the frequency of prescribing anticoagulant therapy for the prevention of ischemic stroke in atrial fibrillation, as well as dual antithrombotic therapy. In addition to anticoagulants, thrombolytic drugs can lead to the development of this pathology. According to the literature, an increase in the risk of developing ICH is also associated with therapy with antidepressants from the group of selective serotonin reuptake inhibitors, as well as high doses of statins. Risk factors for this adverse reaction are age, smoking, hypertension, and thrombocytopenia. Treatment of DI ICH is an extremely difficult task and includes the withdrawal of the culprit medication, antihypertensive therapy, correction of intracranial hypertension, and, in some cases, the administration of antidotes. The main method of prevention is the use of antiplatelet drugs and other drugs, the use of which is associated with an increased risk of developing DI ICH, in strict accordance with modern protocols and recommendations.
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; https://doi.org/10.37489/2588-0519-2022-1-64-71

Введение. Пандемия COVID-19 внесла коррективы в привычный образ жизни молодых людей. Дистанционное обучение в вузе, продолжительное нахождение дома, ограничение социальных контактов приводят к снижению физической активности, изменению пищевого поведения, психологическим проблемам. Всё это лишь небольшая часть негативного влияния сложившейся эпидемиологической ситуации на здоровье молодёжи. Цель и методы. С целью оценки влияния пандемии COVID-19 на образ жизни молодых людей, проведён сравнительный анализ различных аспектов образа жизни 208 студентов-медиков до пандемии в 2019 году и 100 студентов-медиков в период пандемии COVID-19 в 2021 году. Для сбора информации использовалась специально разработанная анкета, включающая вопросы о питании, физической активности, вредных привычках, психологическом статусе молодых людей, а также выполнялось измерение антропометрических показателей (рост, масса тела, окружность талии) и артериального давления. Результаты. Среди студентов-медиков в период пандемии COVID-19 выявлено нарушение характера и режима питания, снижение физической активности и рост психологических проблем в виде стресса и депрессии, что может способствовать увеличению массы тела молодых людей и повышению распространённости вредных привычек (употребления алкоголя, курения). Заключение. Сложная эпидемиологическая ситуация с новой коронавирусной инфекцией оказывает негативные воздействия на образ жизни молодёжи. В настоящее время, несмотря на активную борьбу с COVID-19, не следует забывать о своевременном мониторинге и модификации образа жизни молодёжи, что, в свою очередь, является залогом успешной профилактики самых распространённых неинфекционных заболеваний, смертность от которых продолжает занимать лидирующие позиции во всём мире.
, A. I. Listratov, A. I. Kochetkov, S. A. Bliznyuk, A. G. Komarova,
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; https://doi.org/10.37489/2588-0519-2022-1-53-63

Pulmonary arterial hypertension is a condition characterized by an increase in mean pressure in the pulmonary artery. This pathology is associated with high mortality, and specific therapy for pulmonary arterial hypertension does not affect the cause of the disease and is extremely expensive. In this regard, it is especially important to study the modifiable etiological factors of pulmonary arterial hypertension. One such factor is drugs. One of the leading groups of drugs-inductors is anorexigenic drugs. It was the representatives of this group, such as aminorex, who were the first inducers of pulmonary hypertension. Moreover, this adverse reaction was so significant that it led to the withdrawal of these drugs. Currently, the leading role in the context of drug-induced pulmonary hypertension is played by such drugs as anticancer, antiviral drugs, and interferons. These drugs lead to pulmonary hypertension through various pathophysiological mechanisms. The leading measures to prevent this pathology are to limit the use of culprit medications, reduce the spread of HIV infection, since several groups of drugs can be used to treat HIV-infected patients, leading to the development of pulmonary hypertension.
O. I. Ivakhnenko, E. V. Derkach, V. S. Krysanova, A. D. Ermolaeva, K. A. Kokushkin
Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice; https://doi.org/10.37489/2588-0519-2022-1-30-40

По данным Международного общества по удержанию мочи, симптомы ГМП имеются у 17 % взрослого населения Европы. Распространённость гиперактивного мочевого пузыря в России неизвестна, но считается сопоставимой с таковой в европейских странах. Согласно российским клиническим рекомендациям, основа терапии ГМП — медикаментозное лечение М-холиноблокаторами и препаратами из группы бета-3-адренорецепторов. По результатам метаанализа Wang J et al. (2018) продемонстрирована сопоставимая эффективность и безопасность мирабегрона и солифенацина. При этом, по данным Chapple CR et al. (2017) и Yeowell G et al. (2018), применение мирабегрона ассоциировано с большей приверженностью к терапии и длительностью применения препарата до необходимости смены терапии. С экономической точки зрения большая приверженность к лекарственной терапии по сравнению с солифенацином ассоциируется с меньшими затратами на 1 пациента с ГМП в год при использовании мирабегрона на консервативном этапе лечения. Результаты проведённого анализа структуры и объёмов оказания различных видов медицинской помощи пациентам с ГМП на территории Московской области демонстрируют необходимость расширения подходов к оказанию лекарственной помощи данной группе пациентов. В настоящее время основная доля затрат приходится на оперативное лечение пациентов с ГМП, что делает актуальным расширение возможностей лекарственной терапии, в том числе в рамках льготного лекарственного обеспечения.
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