Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice最新文献

{"title":"Focus on lomefloxacin: effectiveness and safety","authors":"A. L. Khokhlov, J. V. Rybachkova","doi":"10.37489/2588-0519-2024-2-43-50","DOIUrl":"https://doi.org/10.37489/2588-0519-2024-2-43-50","url":null,"abstract":"The results of clinical studies on the use of lomefloxacin for various diseases are presented.The purpose of this study was to analyze the effectiveness and safety of lomefloxacin based on the results of clinical studies published in the scientific literature. Extensive clinical experience with the use of fluoroquinolones in millions of patients indicates their high effectiveness in treating infections of various origins and localities. Lomefloxacin, a difluorinate representative of the fluoroquinolone group, is a bactericidal agent with a wide spectrum of antimicrobial activity against gram-negative and gram-positive microorganisms. The most important property of lomefloxacin is its high bioavailability — more than 98 % when administered orally.The effectiveness of oral lomefloxacin against respiratory tract, urinary tract, obstetric, and gynecological infections, joint infections, skin infections, and mouth, ears, nose, throat, and eyes infections has been studied. Moreover, lomefloxacin has been used as an otic solution to treat otitis media and in the form of an ophthalmic solution to treat eye infections.In studies conducted in Western countries, 72 to 94 % of patients with respiratory tract infections treated with lomefloxacin (400 mg once daily) experienced improvement in clinical symptoms: the causative bacteria were eliminated in 80 to 90 % of cases. Lomefloxacin was well tolerated, and most adverse effects were mild to moderate and reversible. The most common adverse events were gastrointestinal symptoms (nausea, diarrhea, pain/discomfort). In addition, headache, dizziness, transient insomnia, skin hypersensitivity reactions, including photosensitivity, were reported in fewer patients.Based on extensive clinical experience with the use of lomefloxacin, it can be argued that the drug has established itself as a drug with proven effectiveness and a known safety profile.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141681192","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}

{"title":"Monitoring and safety assessment of drug-drug interactions in elderly patients","authors":"A. Sharaeva, A. Zurdinova, A. T. Satybaldieva","doi":"10.37489/2588-0519-2024-2-51-64","DOIUrl":"https://doi.org/10.37489/2588-0519-2024-2-51-64","url":null,"abstract":"Most elderly patients have polymorbidity, have more frequent illnesses, and greater medical care needs. Each of the existing diseases requires constant drug therapy, thus increasing the risk of developing adverse drug reactions from the medications taken. It is also necessary to consider that elderly patients are more susceptible to the occurrence of serious adverse drug reactions and drug-drug interactions.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141683278","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}

{"title":"Evaluation of the effectiveness of the Program for Providing Certain Categories of Citizens with Necessary Medicines based on a sociological survey of physicians’ opinions","authors":"E. Eliseeva, E. S. Maneeva, O. V. Perelomova, A. V. Tyrtyshnikova, D. V. Savitskaya","doi":"10.37489/2588-0519-2024-2-91-103","DOIUrl":"https://doi.org/10.37489/2588-0519-2024-2-91-103","url":null,"abstract":"The opinions of physicians regarding the effectiveness of the Program for Providing Certain Categories of Citizens with Necessary Medicines (Program) are the leading component of feedback conducted to create an idea of the activities of the benefit segment.Objectives. Based on a sociological survey of physicians involved in prescribing treatment to beneficiary patients, recommendations for increasing the effectiveness of pharmacotherapy included in the program.Materials and methods. Based on a sociological survey of physicians involved in prescribing treatment to beneficiary patients, recommendations for increasing the effectiveness of pharmacotherapy included in the program.Results. The questionnaire was developed and assessed quantitative indicators based on the answers of the surveyed specialists, and recommendations for increasing the effectiveness of pharmacotherapy in the Program.Conclusions. A sociological survey of physicians involved in prescribing pharmacotherapy to patients in the Program, conducted using a Questionnaire, is a highly informative method that makes it possible to meaningfully study the main problems of Preferential Medicinal Providing and offer recommendations for increasing the effectiveness of pharmacotherapy in the Program.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141683426","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}

{"title":"Ineffectiveness of carbapenems in real-world clinical practice according to therapeutic drug monitoring data and Roszdravnadzor AIS reports","authors":"O. V. Zhukova, N. N. Chesnokova, O. A. Vorobeva, I. E. Pogodin, I. Shirokova","doi":"10.37489/2588-0519-2024-2-65-71","DOIUrl":"https://doi.org/10.37489/2588-0519-2024-2-65-71","url":null,"abstract":"Relevance. The use of carbapenems is associated with significant variability in pharmacokinetics/pharmacodynamics (FC/PD) parameters, particularly in critically ill patients. The combination of variability in these parameters and standardized dosing regimens can lead to irrational dosing, excessively high or low doses, and consequently less effective treatment and resistance. Optimal management of these factors is essential for combating the development of resistance, particularly for reserve antibiotics.The aim of this study was to evaluate the achievement of the target levels of carbapenems (imipenem/cilastatin) in plasma concentrations in patients with burn injury based on therapeutic drug monitoring and to analyze spontaneous reports registered in the AIS Roszdravnadzor database regarding the effectiveness of therapy.Methods. The analysis included patients receiving antibiotic therapy with imipenem/cilastatin in the burn unit for adults at the University Hospital of the Volga Region Research Medical University for burn trauma who were hospitalized from 01.03.2023 to 30.06.2023. The study was conducted without correcting the trade name of imipenem/cilastatin. Therapeutic drug monitoring was performed after the 4th administration of imipenem/cilastatin. Blood was drawn at 3 h (1st sample), 5 h (2nd sample), and 8 h (3rd sample) after infusion in a clotting activator tube. The analysis was performed using a liquid chromatograph \"LC-20 Prominance\" (Shimadzu, Japan) in reversed-phase mode with a matrix photodiode detector for UV and visible spectra. Data processing was performed using the LCsolution program. Spontaneous reports regarding the use of carbapenems recorded in the AIS of Roszdravnadzor from January 2020 to November 2023 were also analyzed as the object of the study.Results. The results of the study of carbapenems (imipenem/cilastatin) concentration level achievement in the plasma of patients with burn injury showed that the effective imipenem concentration exceeding the MPC value in relation to the isolated Gram-negative pathogen was found only in 1 out of 5 patients included in the study. Two patients showed dynamically changing IPC values during treatment, indicating the necessity of therapeutic drug monitoring, as well as the probability of failure to achieve target concentrations and optimal FC/FD values. In another two patients, imipenem concentrations were insufficient to maintain optimal FC/PD values, indicating that the antimicrobial regimen was ineffective. An analysis of spontaneous reports registered in the AIS of Roszdravnadzor regarding identified cases of the ineffectiveness of carbapenems (imipenem/cilastatin, meropenem) revealed 5,2% of reports regarding meropenem and 1.4% regarding imipenem/cilastatin in the total structure of reports.Conclusion. The implementation of therapeutic drug monitoring procedures can reduce therapy ineffectiveness and antibiotic resistance through personalized antimicrobial dosing.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141680790","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}

{"title":"Pharmaceutical care for patients with headaches: pharmacists' statements and pharmacy practice","authors":"O. V. Reshetko, A. I. Grishin","doi":"10.37489/2588-0519-2024-2-104-115","DOIUrl":"https://doi.org/10.37489/2588-0519-2024-2-104-115","url":null,"abstract":"Relevance. According to the World Health Organization, headaches are one of the most common symptoms of nervous system diseases. Pharmacists play an important role in communicating with headache patients, as well as in rationally directing self-treatment.Aim. Using the questionnaire and patient’s simulation method, comparing the results of these studies, to evaluate the quality of pharmaceutical care for patients with headaches.Material and methods. An anonymous survey was conducted among 153 pharmacists. Three different trained simulated patients (SP) allegedly suffering from headaches visited 101 pharmacies. The results were recorded visually and on a voice recorder. The commercial segment of the Russian pharmaceutical market for analgesics was analyzed.Results. The leaders in sales in ATC-subgroups were the following INN: Ibuprofen, Paracetamol+Naproxen+Caffeine+Drotaverine+ Pheniramine. Corresponding trade names are most often recommended based on the results of questionnaires and simulated patient methodology (SPM). Prescription drugs (13.1 %/14.9 % in SPM) that shouldn’t be recommended in the pharmacy and combination drugs (87.6 %/91.1 % in SPM) were frequently mentioned. A similar number of INN (20/23) and trade names (52/53) were named. The average number of trade names recommended by one pharmacist was higher in the SPM. In SPM the patient was asked very few questions and almost no information about the drug was specified.Conclusion. The real involvement of pharmacists in the provision of pharmaceutical care to patients with cephalgia appears to be much lower, in contrast to the stated results of the questionnaire. In real pharmacy practice, the approach to interaction with a patient with headache and counselling is formal and requires standardization: the development of protocols, standards and algorithms for interaction with patients with headache based on clinical guidelines.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141681196","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}

{"title":"Medical and biological research data","authors":"A. F. Martsinkevich","doi":"10.37489/2588-0519-2024-2-80-90","DOIUrl":"https://doi.org/10.37489/2588-0519-2024-2-80-90","url":null,"abstract":"This paper discusses the importance of properly organizing data for effective statistical analysis. The main problems that arise when recording research results due to the heterogeneity of information and the imperfections of standard approaches, as well as ways to address and prevent them, are presented. Simple principles for creating a research database, validating, and ensuring its integrity are proposed.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141681042","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}

{"title":"Study of the functional residual capacity of the lungs caused by nitrogen leaching during multiple respirations and the diffusion capacity of the lungs in patients with bronchial asthma and chronic obstructive pulmonary disease","authors":"A. I. Mikhailovicheva, V. V. Smirnov, N. S. Nosenko","doi":"10.37489/2588-0519-2024-2-124-131","DOIUrl":"https://doi.org/10.37489/2588-0519-2024-2-124-131","url":null,"abstract":"Relevance. This article discusses the use of nitrogen depletion and lung diffusivity measurements to assess functional lung capacity (FLC) in patients with bronchial asthma (BA) and chronic obstructive pulmonary disease (COPD).Relevance. This article discusses the use of nitrogen depletion and lung diffusivity measurements to assess functional lung capacity (FLC) in patients with bronchial asthma (BA) and chronic obstructive pulmonary disease (COPD).The purpose. Comparative assessment of FRC values measured using diffusion tests and nitrogen-leaching methods during multiple respirations.Material and methods. An observational cross-sectional study was conducted. The examination results of the two groups were compared. Group 1: included 30 patients with BA of 3–4 severity — 13 men (43.4 %) and 17 women (56.6 %); the average age was 50.6±4.3 years at the stage of subsiding exacerbation. Group 2: included 30 patients with moderate COPD — 13 men (43.4 %) and 17 women (56.6 %), average age was 50.6±4.3 years. The functional residual capacity of the lungs was determined using the multiple-breath nitrogen washout method, whereas the diffusion capacity of the lungs. The statistical analysis and visualization of the obtained data were performed using the statistical computing environment R 4.3.0 (R Foundation for Statistical Computing, Vienna, Austria). Differences were considered statistically significant at a p<0.05. The Bland — Altman method was used to assess the consistency of the FRC measurements obtained from the two methods.Results. Two groups of patients were examined: first group — 30 patients with BA of 3–4 severity; second group — 30 patients with COPD. When statistically analyzed between the two methods, no significant differences were observed in the FRC values using the nitrogen washout method and lung diffusivity. The Bland-Altman method produced similar statistical results.Conclusion. Measurement of FRC in patients with asthma and COPD can be performed using both lung diffusivity and multibreath nitrogen washout methods.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141682419","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}

{"title":"Pharmacotherapy with alpha-1 adrenergic blockers and lipid spectrum correction in patients with urinary disorders","authors":"V. V. Danilov, E. Eliseeva, V. V. Danilov, I. Volnykh, A. V. Tyrtyshnikova, M. M. Piskun, V. V. Danilov","doi":"10.37489/2588-0519-2024-2-72-79","DOIUrl":"https://doi.org/10.37489/2588-0519-2024-2-72-79","url":null,"abstract":"The study was based on treatment outcomes in a group of 130 patients aged 18–81 years. Subgroups were formed according to gender and age criteria, which included 56 men and 74 women, and were also divided into subgroups under 65 years of age and after 65. Treatment lasting continuously from 11 to 18 months was carried out in the form of combination therapy with the prescription of α1‑blockers (terazosin, doxazosin) in combination with vitamin-like drugs (levocarnitine, alpha-lipoic acid) in dosages according to the official instructions for the drug. The work involved systems for tabular assessment of the clinical symptoms of urinary disorders, as well as instrumental, laboratory, and statistical methods (Mann — Whitney test, Spearman's rank correlation coefficient).Results. Against the background of the prescribed treatment, HDL levels significantly changed from 1.3 to 1.38 mmol/L, as well as VLDL from 0.88 to 0.72 mmol/L in the general observation group. In some indicators, particularly total cholesterol, low-density lipoprotein, and triglycerides, no dynamics were noted. In the men subgroup, the indicators of both HDL and VLDL changed significantly and reliably from 1.2 to 1.29 mmol/L and, accordingly, from 0.79 to 0.65 mmol/L. In the 65-yearold subgroup, VLDL levels significantly decreased from 0.88 to 0.76 mmol/L and triglyceride levels from 1.9 to 1.65 mmol/L, respectively. In the subgroup of patients aged >65 years, there was a significant increase in HDL from 1.29 to 1.46 mmol/L.Conclusion. Long-term combination therapy over 11 months, including alpha1 inhibitors in combination with vitamin-like drugs, significantly changed the lipid spectrum. The best outcomes of pharmacotherapy were observed in the male subgroup and in patients aged >65 years.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141681039","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}

{"title":"Possibility analysis of antiepileptic drugs import substitution in the Russian Federation","authors":"E. Bochanova, S. D. Gusev, D. A. Zhuravlev, A. V. Ignatyuk, L. A. Luneva, V. S. Chavyr, N. A. Shnayder","doi":"10.37489/2588-0519-2024-2-116-123","DOIUrl":"https://doi.org/10.37489/2588-0519-2024-2-116-123","url":null,"abstract":"Relevance. Epilepsy is a common chronic disease of the nervous system that can be treated rationally, ensuring the possibility of remission in most patients. The availability of antiepileptic drugs (AEDs) for patients with epilepsy is an important characteristic for achieving a long and quality life. Domestic AED production in the Russian Federation guarantees accessible medicinal assistance.Objective. Assessment of the AED import substitution level in the Russian Federation.Methods. The assessment is based on an analysis of the State Register of Medicines (SRM), the list of vital and essential drugs (VED) for 2023, and the clinical recommendations of the Ministry of Health of the Russian Federation “Epilepsy and status epilepticus in adults and children”.Results. Currently, the SRM registers 27 international non-proprietary names of AEDs, 101 trade names, mainly in the form of oral dosage forms, and 1,355 nomenclature items. All AEDs are prescription drugs. Generally, 70.6% of AED manufacturers are domestic. In 2020, the share of manufacturers from the Russian Federation increased by 20%. However, only 14.2% of the substances are directly produced in the Russian Federation. A high 100% level of import substitution is available only for firstgeneration antiepileptic drugs, and for third-generation drugs it remains at 43%. Import substitution of antiepileptic drug substances stays significantly low — 75% — 47.5% — 14% for antiepileptic drugs of I — II — III generations, respectively.Conclusion. The level of import substitution of modern AEDs for generations II–III should be increased to improve the efficiency and safety of epilepsy therapy.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141680338","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}

{"title":"Trends in clinical pharmacology as represented by international and specialized journals","authors":"A. Kolbin, K. S. Radaeva, A. S. Motrinchuk, I. R. Svechkareva","doi":"10.37489/2588-0519-2024-2-33-42","DOIUrl":"https://doi.org/10.37489/2588-0519-2024-2-33-42","url":null,"abstract":"Relevance. Clinical pharmacology is a rapidly evolving field of medicine. The advent of modern technologies has led. The continued evolution of clinical pharmacology, as reflected in publications in specialized medical journals.The aim of this study was to determine how new trends in clinical pharmacology were reflected in the publications of the leading clinical pharmacology journals in Russia during the period from 2015-2021, to conduct a comparative analysis of trends with international journals from 2015-2021.Materials and methods. Original articles published in leading Russian journals were analyzed and categorized into relevant key areas of interest, drug modalities, and therapeutic areas based on the content of the publications independently by three authors. Publications in which authors expressed divergent opinions were discussed until consensus was reached using a modified Delphi method. A comparative analysis was then performed with the results of a similar analysis published in journal “Clinical Pharmacology and Therapeutics”.Results. Most Russian journals and publications have focused on real-world data. The topics most frequently covered in international journals were pharmacometrics, machine learning, and pharmacogenetics. In third place were real-world data. The leading therapeutic areas represented in publications in both Russian and international journals were cardiology, oncology, and infectious diseases. Most publications have focused on various aspects of small molecule use.Conclusions. The novel trends in clinical pharmacology are reflected in the scientific articles published in specialized journals. The principal trends observed in Russian publications are consistent with international tendencies.","PeriodicalId":326764,"journal":{"name":"Kachestvennaya Klinicheskaya Praktika = Good Clinical Practice","volume":null,"pages":null},"PeriodicalIF":0.0,"publicationDate":"2024-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141686766","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}