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Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice

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No 1 (2025)
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FROM EDITOR

CLINICAL TRIALS

4-18 302
Abstract

   Introduction. Dementia is a heterogeneous class of diseases, the individual subtypes of which are distinguished based on etiological factors, the nature of disorders, the course of dementia, as well as laboratory instruments and neuroimaging. Among the diseases whose leading clinical syndrome is dementia, Alzheimer's disease (AD), vascular dementia, dementia with Lewy bodies, Pick's disease, Creutzfeldt-Jakob disease, Huntington's chorea, Parkinson's disease, the effects of traumatic brain injury, brain tumor, dementia with substance abuse and other diseases. Currently, there is no treatment that could significantly slow down or stop the effects of AD on the brain, and the search continues for ways to improve the treatment of AD. The search for effective and safety drugs for the treatment of AD is an extremely important task, which determines the urgency of developing new drugs for its treatment. Proper program planning and clinical trials are necessary to obtain reliable data on the efficacy and safety of drugs. Currently, there are no documents in the Russian Federation (RF) and the Eurasian Economic Union (EEU) regulating the conduct of clinical trials of drugs used to treat AD.

   Objective. The aim of this study was to analyze regulatory approaches to planning clinical research programs for drugs used for AD treatment abroad and to assess the possibility of extrapolation to RF clinical practice in the development of drugs for AD treatment.

   Discussion. The strategy for conducting clinical trials of drugs and the requirements for data volume and quality regarding efficacy and safety are presented. This article was prepared on the basis of recommendations approved by the RF for the planning and development of medicines, guidelines for the examination of drugs, EU regulatory requirements, and documents from the International Council for the Harmonization of Technical Requirements for the Registration of Medicines for Medical Use (ICH).

   Conclusion. An analysis of the Guidelines of the European Medicines Agency (EMA), which regulate the basic principles and key aspects of conducting preclinical and clinical trials on drugs for the treatment of AD, was carried out. The provisions of the EMA guidelines can be used as a basis for developing drug research programmes for treating diseases. It is advisable to develop a national guideline for the study of drugs for AD treatment in accordance with the regulatory legal acts in force in the RF.

19-27 237
Abstract

   Relevance. The number of international multicenter clinical trials and patient recruitment varies across countries, influenced by a variety of external factors such as the availability of experienced research centers, a sufficient patient pool, convenient logistics, the presence of competing studies, cost, political situation in the country, the timing of clinical trial approval by the regulator and ethics committee, the availability of a regulatory framework for clinical trials harmonized with ICH GCP, etc. At the same time, the speed of patient recruitment, along with the quality of data, remains one of the leading reasons for changes in the number of clinical trials in countries around the world. Clinical trials are usually conducted in cities where there is the necessary equipment to conduct the protocol, and the patient can get to the clinical center without special efforts. The authors emphasize that living close to a clinical center increases the motivation of patients to participate in a clinical trial. Many authors have also studied the relationship between patient recruitment and income.

   Objective. Calculate the quantitative impact of country, city (infrastructure), and income on patient recruitment.

   Materials and methods. The data were obtained for a period of 13 years from July 2008 to July 2021 during 4 international multicenter clinical trials of phases II–III. A retrospective analysis was conducted on the recruitment of patients depending on the influence of various factors — country, city (infrastructure) and income. Using the odds ratio method, a quantitative calibration of the influence of the selected factors was carried out.

   Conclusions. For the first time, the impact of external factors on patient recruitment in clinical studies was calibrated — country, city (infrastructure) and income. It was shown that the country, as an external factor, has a medium and weak impact on patient recruitment. Residence in the cities of Moscow, St. Petersburg and Kyiv has almost the same impact on patient recruitment as the country of residence. Clinical centers located in locations with high incomes of the population, as a rule, are characterized by lower patient recruitment.

QUALITY OF LIFE

28-34 274
Abstract

   Quality of life assessment is an important aspect of clinical medicine that allows a comprehensive evaluation of the patient's condition. This method is increasingly being used for comprehensive patient assessment and presents an opportunity to change the way diseases and patients are viewed by using information obtained directly from patients to analyze problems related to their disease and treatment. Quality of life assessment in osteopathy is considered an integral part of the patient-oriented approach, complementing the holistic nature of osteopathy, which considers mechanical, hydrodynamic, and neural functions in unity. The findings indicate a significant improvement in physical and psychological well-being after osteopathic treatment, emphasizing its effectiveness in improving quality of life.

NON-INTERVENTIONAL STUDY

35-38 240
Abstract

   Relevance. This work presents the diagnostic capabilities of the capnometry and spirometry methods in individuals with a mild form of COVID-19 infection.

   Objective. To assess changes in external respiration parameters in patients with a mild form of COVID-19 infection.

   Materials and methods. The results of examination of 2 groups of patients were analyzed. Group 1 included 30 subjects after a mild form of COVID-19 infection, 10 men and 20 women, average age 56.3 ± 4.2 years. The group was also divided into 10 people depending on the period after the infection: 3 months, 6 months and 9–10 months. Group 2 included 30 healthy volunteers: 16 men and 14 women, average age 45.6 ± 2.4 years.

   Results. Two groups of patients were examined: Group I — subjects who had COVID-19, Group II — 30 healthy volunteers. Capnometry revealed a statistically significant increase in the alveolar phase slope in subjects who had COVID-19 infection compared with the control group during quiet breathing and deep exhalation, and statistical differences in the Toulu index were also revealed. According to the spirometry data, no statistical difference was found in the FEV1, FVC, and FEV1/FVC ratio.

   Conclusion. The capnometry method revealed ventilation-perfusion disturbances for 10 months after mild COVID-19 infection. No changes in spirometric parameters were noted after mild COVID-19 infection. The capnometry method can be recommended to identify persistent disturbances in subjects who have had mild COVID-19.

INTERNAL MEDICINE

39-47 238
Abstract

   Introduction. Currently, meta-inflammation is considered a factor in the initiation and development of chronic heart failure (CHF) with preserved ejection fraction. A common comorbid condition in such patients is sarcopenic obesity (SO). The study of the level of CRP, as a marker of metaflammation, in patients with CHF and SO is a promising area for clinical medicine.

   The aim of the research. Determination of the level of C-reactive protein as a marker of meta-inflammation in patients with chronic heart failure and sarcopenic obesity.

   Materials and methods. A total of 298 patients underwent a SARC-F (SARCOPENIA-FAST) questionnaire, hand dynamometry, bioimpedance, and a 4-m walking speed test. Clinical status scales (SHOCKS) and a 6-min walking test (6MWT), approved by clinical guidelines and approved by the Ministry of Health of the Russian Federation, were used. The ejection fraction was studied, and the level of hsCRP was determined by the ELISA method (Cloud-clone, China). The patients were divided into 5 groups depending on their body composition — the presence of obesity and sarcopenia. Statistical processing was performed using the IBSS Statistics 25.0 package.

   Results. The level of hsCRP in the group of patients with sarcopenic obesity significantly differed from the indicator in the groups of patients without sarcopenia, without obesity and without disorders of body composition. The values were comparable in the groups of patients with sarcopenic obesity and those with reduced body weight and sarcopenia. An increase in the hsCRP marker was also found in the group of patients with sarcopenic obesity, compared with the indicators in the groups of patients with obesity or sarcopenia only. The functional status of the patients was lower, which highlights the contribution of metaflammation during the disease course.

   Conclusion. An increase in the level of the hsCRP marker in patients with sarcopenic obesity reflects a more severe course of CHF.

EPIDEMIOLOGY

48-52 226
Abstract

   Relevance. The quality of neonatal care for premature infants is improving, but the incidence of retinopathy of prematurity remains high. The results of treatment with angiogenesis inhibitors depend on the drug and antibacterial prophylaxis. The incidence of endophthalmitis after injections is 0.028 % — 0.029 %. Antibiotic prophylaxis should not be unjustified because of the risk of bacterial resistance. There is little data on the microflora of newborns, especially premature infants, in the scientific literature.

   Objective. To identify the main representatives of the conjunctival cavity microflora and its antibiotic resistance in premature infants born vaginally.

   Materials and methods. The material was collected using the eSwab system. Subsequent identification of microorganisms and determination of sensitivity to antibacterial drugs were carried out using the disk diffusion method, the double disk method, and the D-test. The results were calculated using the ADAGIO analyzer. The results were processed using IBM SPSS Statistics v27.

   Results. The conjunctival material was obtained from 22 premature newborns (44 eyes) born vaginally. The gestational age was 31–35 weeks, and the birth weight was 1385–2150 grams. 33 microbial cultures were isolated: S. epidermidis — 84.8 %; S. aureus — 9.1 %, Kl. pneumoniae — 3.0 %, E. faecalis — 3.0 %. The sterile cultures were 25.0 %. The total microflora had resistance in 42.4 % to aminoglycosides, 36.4 % to fluoroquinolones, 63.6 % to macrolides, 9.1 % to lincosamides and 60.6 % to cephalosporins. The MRS phenotype was detected in 70.97 %. MLS-B phenotype was detected in 9.68 %. Extended spectrum beta-lactamase (ESBL) 3.03 %.

   Conclusions. The most common representative of the microflora is S. epidermidis, which has high resistance to fluoroquinolones, aminoglycosides, macrolides, and cephalosporins.

EDUCATION

53-63 286
Abstract

   Relevance. Chronic obstructive pulmonary disease (COPD) is one of the most common causes of morbidity and mortality and, as a result, one of the most important health problems. In the coming decades, this disease will continue to be one of the leading causes of disability and mortality. This paper presents the results of the first and second stages of testing students of advanced training courses (ATs) on the basis of the Kazan State Medical Academy, a Branch Campus of the Russian Medical Academy of Continuous Professional Education. An assessment of their knowledge in the dynamics of the etiopathogenesis, diagnosis and pharmacotherapy of COPD was carried out.

   Objective. To assess the level of knowledge of physician on the etiopathogenesis, diagnosis and therapy of COPD and to determine the effectiveness of AT courses by comparing the results of a two-stage questionnaire of students before and after completing the courses.

   Methods. The article presents the results of the statistical analysis of two stages of testing of physicians of the Republic of Mari El according to the questionnaire of the ASCO-III study (full name of the project — Assessment of Senior Medical Students in the Field of COPD) to assess the level of basic knowledge on the issues of etiopathogenesis, diagnosis and treatment of COPD.

   Results. Thirty-seven physicians participated in the survey. The students showed significant positive results: the LCA (average level of completeness of the answer to the question) in the 1st stage was 60.7 %, in the second — 85.8 % (p < 0.001). The most difficult question was the choice of drugs for antibacterial therapy during exacerbations. So, in the 18th question, the LCA in the 1st stage was equal to 8.1 %, and at the end of the courses — 56.8 %. In the 19th issue, the LCA improved from 13.5 % to 70.3 %.

   Conclusions. The results of the study indicate a positive trend in the knowledge of doctors on COPD issues and demonstrate the high effectiveness and importance of "high-quality" AT courses.

EXPERT OPINIONS

64-68 245
Abstract

   The resolution of the Expert Council is devoted to the use of fluoroquinolones, in particular pazufloxacin, in the context of increasing antibiotic resistance. It is noted that fluoroquinolones, especially parenteral forms, remain an important tool for treating infections caused by resistant bacterial strains, such as ESBL-producing E. coli and K. pneumoniae. However, the growth of resistance to traditional fluoroquinolones (for example, ciprofloxacin and levofloxacin) requires a search for new solutions. Pazufloxacin, as a new representative of fluoroquinolones, has low cross-resistance, a broad spectrum of action, and high efficacy at low doses. The drug demonstrates minimal toxicity, including a low risk of neuro-, cardio- and phototoxicity, as well as no risk of tendinitis. Clinical studies have confirmed its effectiveness for treating respiratory tract infections, urinary tract infections, and other nosologies. Experts recommend the introduction of pazufloxacin into clinical practice, especially for patients at risk of developing cardiovascular complications and central nervous system lesions. It is also proposed to conduct post-registration studies to assess the effectiveness and safety of the drug in the Russian population and consider including it in the list of vital and essential drugs.



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ISSN 2588-0519 (Print)
ISSN 2618-8473 (Online)