Vol 24, No 6 (2018)

Articles

ASSESSMENT OF MORBIDITY AND EFFECTIVENESS OF MEDICAL REHABILITATION OF CHILDREN WITH CHRONIC DISEASES OF THE RESPIRATORY SYSTEM IN CLINIC

Polunina V.V., Dubrovskaya M.I., Lobov A.N., Plotnikov V.P., Pavlova S.V.

Abstract

The data obtained in the study of incidence in children, reflect the results of the children’s clinic. Analysis of the incidence was carried out according to the analysis of medical records. In the structure of general and chronic morbidity in children, the leading places belong to respiratory diseases, among which chronic diseases of adenoids and tonsils prevail (67.7%). Therefore, prevention and timely effective treatment of diseases of the respiratory system will reduce the overall incidence, and, consequently, improve the performance of a children’s clinic. To determine the role of medical rehabilitation, a group of children aged 3 to 14 years with chronic respiratory diseases was recruited in the amount of 127 children (68 boys and 59 girls). In the main group (n=78), treatment without exacerbation included 3 courses of comprehensive medical rehabilitation, including physiotherapy, reflexology, and physical therapy; in the control (n=49) treatment was carried out only in the period of exacerbation. The total duration of observation in both groups was 12 months. The effectiveness of treatment was assessed by the dynamics of the frequency and duration of colds and exacerbations of chronic diseases during the year. In the main group, the average frequency of colds for the year decreased by 2 times (p<0.05) and the average duration of colds decreased by 1.5 times (p<0.05), while in the control group these indicators remained almost unchanged. Analysis of the data showed that comprehensive rehabilitation using non-drug methods can significantly improve the health of children with chronic respiratory diseases.
Medical Journal of the Russian Federation. 2018;24(6):284-288
pages 284-288 views

REGULATORY ADAPTIVE STATUS IN DETERMING THE EFFECTIVENESS OF ZOFENOPRIL AND LISINOPRIL IN PATIENTS WITH CHRONIC HEART FAILURE WITH PRESERVED LEFT VENTRICULAR EJECTION FRACTION

Nedvetskaya S.N., Shubitidze I.Z., Tregubov V.G., Pokrovsky V.M.

Abstract

Goal. Сompare the effectiveness of combination therapy with zofenopril and lisinopril in patients with preserved ejection fraction (CHFpEF) of the left ventricle (LV) in the presence of hypertension disease (HD), considering its impact on the regulatory adaptive status (RAS). Material and methods. 69 patients with CHFpEF in the presence of HD III stage who were randomized into two groups for treatment with zofenopril (17,9±5,9 mg/day, n=35) or lisinopril (14,2±4,3 mg/day, n=34). As part of combination pharmacotherapy, patients were included nebivolol (6,5±1,8 mg/day and 5,8±1,7 mg/day), and acetylsalicylic acid when required (100 mg/day, n=7 and 100 mg/day, n=8), atorvastatin (16,5±4,7 mg/day, n=12 and 15,7±4,8 mg/day, n=14), respectively. Initially and after six months, the following was done: a quantitative evaluation of the RAS (by cardio-respiratory synchronism test), echocardiography, treadmill test, six-minute walking test, determination of the N-terminal precursor of the natriuretic brain peptide level in blood plasma, holter monitoring of blood electrocardiograms, all-day monitoring of pressure, subjective evaluation of quality of life. Results. Both schemes of combined therapy comparatively controlled arterial hypertension, improved functional and structural state of the heart, reduced neurohumoral activity. Compared with lisinopril, the use of zofenopril more positively influenced on RAS, increased exercise tolerance and improved quality of life. Conclusion. The use of zofenopril, in comparison with lisinopril, in patients with CHFpEF LV on the background HD of III stage is preferable due to a more positive effect on RAS.
Medical Journal of the Russian Federation. 2018;24(6):289-294
pages 289-294 views

CHANGES OF ANGIOGENIC FACTORS AND MARKERS OF ENDOTHELIAL DYSFUNCTION IN CHILDREN AND ADOLESCENTS OF WILSON-KONOVALOV DISEASE

Batyrova A.S., Vasilyeva E.M., Bakanov M.I., Surkov A.N.

Abstract

Although angiogenesis is an integral part of tumor progression, it has also been observed in different inflammatory, fibrotic, and ischemic diseases. Angiogenesis is a multifactorial process and its changes bring essential information about the status of complex pathology. Aim: evaluate the role of angiogenesis and endothelial dysfunction factors in Wilson-Konovalov disease (WKD) in children and adolescents. Methods: 19 children and adolescents with WKD were included in the study. VEGF-A, angiotensin (ANG), soluble receptors of VEGF-A (sVEGF-R1 и sVEGF-R2) and trombomodulin have been investigated in serum by enzyme immunoassay using special kits (BCM Diagnostics, USA). Other endothelial dysfunction markers as von Willebrand factor (vWf) was determined in blood plasma by immunoturbidimetry (Siemens, Germany), plasminogen (PLG) was investigated due to extended coagulation. Results: it was founded marked decreasing of VEGF-A and increasing concentration of sVEGF-R1, sVEGF-R2 in blood plasma of WKD children and adolescence by comparison of reference group. ANG did not change. Comparing the ratio of levels VEGF-A+ANG/sVEGF-R1+sVEGF-R2 (in children with WKD 16,7±1,9 and in reference group 23,0±1,6, р<0,05), we have revealed the deficiency of pro-angiogenic factors that can be helpful in characterizing of angiogenic activity. At the same time, the level of TM and the percentage of PLG and vWf increased. Conclusion: it was revealed correlation between studied markers and liver damage, concomitant diseases and the presence of chronic infection, as well as a number of other parameters.
Medical Journal of the Russian Federation. 2018;24(6):295-298
pages 295-298 views

STUDY OF COMPARATIVE PHARMACOKINETICS AND BIOEQUIVALENCE OF DRUGS AMLODIPINE + VALSARTAN AND EXFORGE®

Khokhlov A.L., Miroshnikov A.E., Khokhlov A.A., Pozdnyakov N.O., Voronina E.A., Gerasimchuk S.A., Rybachkova Y.V., Manko K.S., Dubovik E.G.

Abstract

Objective: Drug Amlodipine+Valsartan is safe and effective for comprehensive treatment of arterial hypertension patients taken combined therapy by prescription. The development of new fix drug combination amlodipine and valsartan will provide in the near future a significant reduction in the cost of treatment. The aim of this work was investigation of bioequivalence for a generic drug Amlodipine+Valsartan, film-coated tablets, 10 mg+160 mg (Polpharma SA, Poland) and Exforge®, film-coated tablets, 10 mg+160 mg (Novartis Pharma AG, Switzerland). Materials and methods: 58 healthy volunteers were enrolled in open label, randomized, two sequence, two treatment cross-over study. Drugs were administered in two periods with a 21-day washout period in-between. Blood samples were collected over a 72-hour period. Amlodipine and Valsartan were measured in plasma using an automated LC-MS/MS assay. Pharmacokinetic parameters were calculated by non-compartmental analyses approach to evaluate AUC0-t, AUC0-∞ and Cmax. ANOVA was performed on the ln-transformed data and the 90% Confidence Interval (CI) was determined. Bioequivalence will be concluded if the 90% CI falls within 80-125% for AUC0-t and Cmax. Results: 53 volunteers completed the study and were considered for the pharmacokinetic and statistical analyses. Descriptive safety data analyses were performed on all 58 subjects. 90%-CI for corrected GMEAN of test and reference ratio was 94.76-105.24% for AUC0-t and 92.78-108.79% for Cmax in the case of amlodipine; 94.93-119.61% for AUC0-t and 90.41-116.03% for Cmax in the case of valsartan. So all pharmacokinetic parameters met the acceptance criteria as the 90% CI were within 80.00-125.00%. Conclusion: This study showed that Amlodipine+Valsartan, film-coated tablets, 10 mg+160 mg (Polpharma SA, Poland) is bioequivalent to reference product Exforge®, film-coated tablets, 10 mg+160 mg (Novartis Pharma AG, Switzerland).
Medical Journal of the Russian Federation. 2018;24(6):299-305
pages 299-305 views

ASSESSMENT OF ACTUAL TERMS OF REGISTRATION EXAMINATION OF MEDICINES FOR 2011-2018

Olefir Y.V., Koshechkin K.A., Romanov B.K.

Abstract

The key issue in discussing the possibility of entering the pharmaceutical market of the Russian Federation are aspects of the fulfillment of state registration expertise procedures. Estimation of the timing of its implementation suggests a change in the efficiency of the entire system for regulating the circulation of medicines. A reduction in the total actual period from the receipt of the first application for registration of a drug to the receipt of a positive opinion from 340 to 311 calendar days on average was established. At the same time, the number of negative opinions decreased from 52% to 7%. On the basis of the obtained data, it was concluded that there is a general tendency to accelerate the release of new drugs to the market.
Medical Journal of the Russian Federation. 2018;24(6):306-309
pages 306-309 views

ABNORMALITY IN LEARNING ON THE MODEL OF PARKINSON-LIKE SYNDROME: THE CORRECTABILITY BY THYMUS PEPTIDES

Korolev A.G., Novoseletskaya A.V., Kiseleva N.M.

Abstract

In recent times the question of the bidirectional interactions of the neuroendocrine and immune systems is studied quite actively, its mechanisms offer the opportunity to allow for optimization the therapy of several diseases, including Parkinson’s disease. The purpose of this work is to study the influence of peptide drugs derived from the body’s immune system, the thymus, for the avoidance test conditioning, both in health and in the model of Parkinson-like syndrome. The work was performed on 80 male Wistar rats weighing 300-350 g. The injection of thymosin fraction 5 and thymalin to animals corrects clinical traits and behavioral dysfunctions caused by the singular injection of the neurotoxin. It also facilitates conditioned active evasion response in rats, which is especially noticeable at the early stages of memory footprint formation.
Medical Journal of the Russian Federation. 2018;24(6):310-315
pages 310-315 views

ABILITY TO PREVENT AND TREAT THE CARDIOVASCULAR SYSTEM DAMAGES, CAUSED BY THE USE OF ANTI-CANCER DRUGS

Ibragimova A.A., Emelina E.I., Gendlin G.E., Nikitin I.G.

Abstract

This review presents modern strategies for the prevention and treatment of cardiotoxicity induced by the most commonly used anticancer drugs such as anthracycline antibiotics, monoclonal antibodies, tyrosine kinase inhibitors. There are a large number of conflicting data on ways to overcome the cardiotoxicity of anticancer drugs. The creation of a complex of diagnostic measures will allow to identify the earliest signs of heart damage during chemotherapy and to develop timely preventive measures to prevent cardiotoxicity, improve the quality of life and prognosis of patients. Currently, a large number of small publications on the prevalence, prediction and prevention of cardiotoxicity in cancer patients, including the primary and secondary prevention of cardiotoxicity, are available. Beta-blockers and inhibitors of angiotensin-converting enzyme most often use as cardioprotective agents. There is evidence of poor tolerability of treatment with these drugs for young patients. Most drugs reduce blood pressure, which can adversely affect the health of patients without associated hypertension. Coordinated work between cardiologists and oncologists is needed to create common terminology, to define cardiovascular events and create registers, meta-analyzes, generally accepted recommendations, guidelines for the management of patients at risk of developing cardiotoxicity. This review used published articles the Scopus, Pubmed database, articles from The New England Journal of Medicine, Annals of Oncology, and periodicals of the Russian Federation over the past 10 years, as well as publications from previous years.
Medical Journal of the Russian Federation. 2018;24(6):316-323
pages 316-323 views

NONCLINICAL STUDIES OF BIOTECHNOLOGY DERIVED MEDICINAL PRODUCTS - THEORY AND PRACTICE SPECIFICITY

Samsonov M.Y., Dmitrieva A.A., Konopleva G.E., Shipaeva E.V., Barbashov S.F., Lavrovsky Y.V.

Abstract

Nonclinical studies of biotechnology-derived medicinal products are discussed in the article in terms of new original fusion protein RPH-104 - high potency IL-1β signal pathway antagonist. Specificity of biotherapeutics is connected to complexity of molecules. Efficacy, pharmacokinetic and toxicity nonclinical studies of the biotherapeutics are conducted using relevant species taking into consideration potent immunogenicity. Cytotoxic reactions risk assessment is also important. Accurate nonclinical studies planning can help to obtain sufficient information about potential target organs for toxicity, reversibility of toxic effects and determine safety parameters. According to ethical principles in vivo studies can be optimized using modern in silico analysis, computer modelling and in vitro testing.
Medical Journal of the Russian Federation. 2018;24(6):324-331
pages 324-331 views

ISOLATED SYNOVIAL TUBERCULOSIS OF THE KNEE JOINT

Khomenko V.A., Semenova L.A., Shekhter A.B., Lyalina V.V., Savitsky P.P.

Abstract

We present a clinical observation of a patient with tuberculosis of the synovium without X-ray signs of tuberculosis of the lungs and bone tissue which confirms possibility of an isolated tuberculosis synovitis. The case demonstrates the necessity of synovial fluid assessment for early diagnostics of tuberculous inflammation in the joint. Diagnostic arthroscopy and synovial biopsy reveal specific changes. Early diagnostics of isolated tuberculosis synovitis can contribute to the timely treatment and prevent the adjacent bones involvement.
Medical Journal of the Russian Federation. 2018;24(6):332-336
pages 332-336 views

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