Significant Positive Dynamics Research Articles

Peculiarities of morphofunctional changes of the eye and lamina cribrosa in myopia of various degrees: final report

Background. Myopia is the most common visual defect. Complicated myopia is one of the main causes of disability due to eye diseases. In case of myopia, the axial length increases, and all membranes are loosened. Lamina cribrosa (LC) undergoes special changes. Clinical assessment of the LC parameters has high diagnostic significance. LC defects, changes in its thickness and depth of location can be well visualized using modern research methods, and therefore, allow us to study these parameters in detail in the norm and with the development of eye pathology. The correlation between the optic disc deformation and LC deformation and its pores remains unknown. It is only known that the severity of the lesion will depend on the degree of damage to the nerve and ganglion fibers and the degree of change in the LC structure. The purpose: to study the features of morphofunctional changes in the eye and lamina cribrosa in myopia of various degrees based on the analysis of morphological and morphometric parameters. Mate­rials and methods. The study consisted of experimental and clinical parts. During the experiment, 42 animals (rabbits) (84 eyes) were studied. A comprehensive diagnostic examination of 120 people (230 eyes) was conducted. The control group included 20 patients without myopia (40 eyes). All patients were of working age, from 18 to 45 years. Patients in the main group received a vitamin complex containing carotenoids, lutein, zeaxanthin and omega-3 fatty acids, as well as vitamin B preparation. The control group did not receive treatment. Results. When studying the optic disc parameters in patients with different degrees of myopia, the most significant changes occurred in the indicators of GLV, nerve head, optic disc area. The parameters of MD and PSD perimetry differed significantly in all groups. Based on the developed markers, with the help of optical coherence tomography, it was possible to assess the general morphology and position of the LC in patients by measuring its depth and insertion in different meridians. After treatment of patients, statistically significant positive dynamics was revealed, taking into account changes in the indicators of Humphrey perimetry — MD and PSD, as well as a tendency to improve visual acuity, the absence of significant changes in the anterior-posterior segment of the eye, intraocular pressure, average refraction in the main group during the entire treatment period without significant statistical changes. The experimental study on the effect of low doses of atropine revealed the appearance of functionally active fibroblasts with the accumulation of the ground substance and thickening of the bundles of collagen fibers of the sclera and the walls of the LC pores, which is accompanied by thickening of both the sclera and the LC when using 0.5 and 0.01% atropine sulfate solution compared to the control group. Conclusions. LC defects, changes in its thickness and depth of location are well visualized using optical coherence tomography. With the experimental use of 0.01% atropine sulfate, strengthening of the sclera and LC with preservation of the morphofunctional state of the receptor apparatus of the eye was proven, which allows us to consider it advisable to use the selected concentration of the drug in the future in patients with myopia.

Effectiveness of anti-IL-5Rα-therapy in patients with T2-inflammatory airway diseases in real clinical practice

Introduction. There is insufficient data on effectiveness and safety of targeted drugs aimed at T2 inflammation in real-life practice.Aim. To evaluate benralizumab effectiveness in patients with T2-inflammatory airway diseases in real-life clinical practice and to identify predictors of a positive response to therapy.Materials and methods. Patients' data from Sverdlovsk region registry with non-allergic eosinophilic (n = 32) and mixed (n = 6) severe asthma received benralizumab were analyzed. Reduction in proportion of patients requiring systemic GCS and proportion of patients with a good response to therapy according to BARS were the main endpoints. Dynamics in ACT score, basic therapy, asthma exacerbations frequency, emergency calls and hospitalizations, FEV1 and eosinophil blood count, scores in AQLQ, SNOT-22 and VAS were also evaluated. Control visits were conducted at baseline, after 4 and 12 months of benralizumab administration. Analysis of good response predictors to benralizumab was performed.Results. Over 12 months of benralizumab therapy, the proportion of patients requiring systemic GCS decreased by 81.8%. According to BARS, a good response to therapy was demonstrated by 69.6% of patients (n = 16), satisfactory - 21.7% (n = 5), and insufficient - 8.7% (n = 2). Significant positive dynamics were observed in asthma control level, therapy volume (doses of inhaled GCS, intake of LABA, SABA), frequency of asthma exacerbations and hospitalizations, FEV1 and eosinophil blood count, AQLQ, SNOT-22 and VAS questionnaires. Patients with insufficient response to benralizumab had high initial blood eosinophilia.Conclusions. In real clinical practice, benralizumab improves asthma control, reduces frequency of asthma exacerbations even in discontinuation of SGCS and reduction of basic therapy, improves lung function, quality of life, and reduces nasal symptoms in patients with concomitant inflammatory nasal diseases. A possible predictor of insufficient response to benralizumab was high initial eosinophilia (>2330 cells/μl).

Sensitivity of the hospital anxiety and depression scale HADS in stroke patients

Introduction. The validated Hospital Anxiety and Depression Scale HADS is recommended for screening symptoms of anxiety and depression in the routine practice of somatic doctors; it is also recommended by experts for use in rehabilitation medicine and frequently used in scientific research to assess the emotional state of stroke patients. At the same time, the literature provides various contradictory data on the sensitivity of this scale for stroke patients. Aim. To evaluate the detectability of emotional disorders in stroke patients using the HADS scale in comparison with the author’s computer program for studying the actual emotional state of the patient. Materials and methods. 60 stroke patients underwent inpatient rehabilitation in the National Medical Research Center for Rehabilitation and Balneology were randomly divided into 2 groups. 30 patients of Group 1 received a basic rehabilitation complex (aimed at correcting motor disorders); 30 patients of Group 2 received a basic rehabilitation complex in combination with a course of cognitive behavioral psychotherapy (CBT). To assess the emotional state at the beginning and at the end of rehabilitation, the HADS scale and the author’s computer program were used to study the actual emotional state of the patient. Statistical analysis was carried out using the Statistica-10 program. Results. The study groups were comparable in gender, age and clinical parameters. Initially, in patients of both groups, the median values of anxiety and depression on the HADS Scale corresponded to the norm, while the median values of the author’s methodology corresponded to a low level of comfort, the presence of fatigue, high levels of anxiety and depression. At the end of rehabilitation, according to the HADS Scale, significant positive dynamics was revealed in both groups, both for depression and anxiety (p 0.05), without significant intergroup differences. Whereas with the help of the author’s methodology, significant intergroup differences (p 0.05) were revealed, indicating a better positive dynamics of the emotional state in group 2, additionally receiving CBT. Conclusion. In comparison with the author’s program in stroke patients, the HADS scale is significantly less sensitive in the diagnosis of anxiety and depression, and does not reflect the established intergroup difference in the dynamics of emotional state after the use of the basic complex and its combination with CBT.

Efficacy and safety of the biosimilar etanercept in the treatment of patients with rheumatoid arthritis and spondyloarthritis

Objective: to evaluate the efficacy and safety of the biosimilar etanercept (ETC, Altebrel) in patients with rheumatoid arthritis (RA) and spondyloarthritis (SpA) in clinical practice.Material and methods. The study included 20 patients with a confirmed diagnosis of RA and 8 with SpA: 5 with axial SpA with radiological signs of sacroiliitis (r-axSpA), 3 with peripheral psoriatic arthritis (PsA). The mean age of the patients with RA was 47.7±12.3 years, and the mean age of SpA patients was 40.4±15.9 years. Patients with RA had moderate or high disease activity: mean DAS28-ESR index 5.2±1.0, median CDAI – 22.5 [15.5; 35.0], SDAI – 31.9 [24.4; 38.6], CRP level – 11 [0.9; 32.5] mg/L. Patients with r-axSpA had high activity and functional impairment, the median BASDAI was 5.5 [3.5; 8.0], BASFI – 6 [4; 6], CRP level – 17.5 [12.5; 27] mg/L. In PsA, the average DAS28 was 6.25±0.71. All patients were prescribed Altebrel at a dose of 50 mg subcutaneously weekly against a background of disease-modifying antirheumatic drugs. Patients were examined at baseline and then after 3 and 6 months of treatment.Results and discussion. During treatment with the biosimilar ETC, all patients with RA showed a decrease in inflammatory activity markers: after 3 and 6 months of therapy, the mean DAS28-ESR value decreased to 3.5±1.2 and 2.3±0.7 (p <0.001) the median SDAI value to 19.6 [6.9; 32.5] and 8.4 [4.7; 15.6] (p<0.001), CDAI value to 9.5 [4; 13.0] and 4.5 [3.0; 7.5] (p <0.001), the CRP level – to 5.0 [0.7; 21.9] and 5.0 [2.0; 10.9] mg/L (p<0.001), respectively. Patients with SpA showed a decrease in disease activity and an improvement in functional status: the median BASDAI decreased to 1.0 [0; 2.5] and 0 [0; 1.5], BASFI to 0 [0; 1] and 0 [0; 0], CRP level to 4.5 [2.5; 6.5] and 2.0 [2.0; 2.5] mg/L, respectively. In patients with PsA, DAS28 decreased on average to 2.92±0.12 after 3 months, and after 6 months the values were 1.74 and 2.29 in 2 patients.All patients completed the study and no adverse events were observed during treatment. According to EULAR criteria, a good response was achieved in 40% of patients with RA after 3 months, and in 80% after 6 months, and a satisfactory response in 20%. Patients with r-axSpA showed statistically significant positive dynamics of BASDAI and BASFI indices as well as normalization of laboratory activity parameters.Conclusion. The results of the study demonstrate the high efficacy of Altebrel in rheumatic diseases, including RA and SpA.

Comprehensive Medical and Psychological Rehabilitation in War Trauma (clinical case)

The purpose of the work was to analyze a clinical case of the course of war trauma and presents the experience of providing comprehensive medical and psychological clinical rehabilitation to a patient who suffered as a result of a terrorist attack. Patient D., 65 years old, sustained a mine-blast injury (MBI) to the right upper limb extremity during shelling. The optimal restoration of the functions of the upper injured limb and the patient's health (physical, somatic, mental) was carried out according to the algorithm of comprehensive medical and psychological clinical rehabilitation. As a result of the course of comprehensive medical and psychological clinical rehabilitation, significant positive dynamics was observed, including a decrease in edematous, painful, and inflammatory syndromes. The range of motion in the right upper limb and cervical-thoracic spine increased. Supination and pronation of the right hand became clearer and less painful (from 8 to 2 points), movement in the fingers of the right hand increased and became more steady, a clear pulsation appeared in the area of the skin defect on the right forearm, regression of pain in the elbow and shoulder joints on the right was noted, and the patient began to walk without a mobilization bandage. The course helped to reduce anxiety (from -1.82 to 0.85), asthenic symptoms (from 0.48 to 3.71), obsessive-phobic symptoms (from -1.96 to 1.74), and autonomic disorders (from -0.83 to 2.03). Low cortisol levels (61 nmol/l) in against acute stress indicated the development of post-traumatic stress disorder. Upon completion of the rehabilitation course, cortisol levels rose to a healthy level (246 nmol/l), indicating the effectiveness of the process of restoring the psychophysiological state and adapting to a stressful situation. War trauma is a complex and severe condition that requires an integrated approach to treatment and rehabilitation, covering not only physical but also psychological and social aspects of patients' health.

Quality of Life Indices in Patients with Coronary Heart Disease with Stable Angina Pectoris Accompanied by Non-alcoholic Steatohepatitis after Complex Treatment Supplemented with Ezetimibe and Ursodeoxycholic Acid

Introduction. Coronary heart disease (CHD) is often complicated by the presence of concomitant diseases, especially non-alcoholic fatty liver disease (NAFLD). According to the data from numerous studies, it is known that the number of cardiovascular complications in patients with NAFLD is increasing. This negatively affects the clinical course of both diseases, worsens the quality of life of patients and increases the percentage of cardiovascular mortality among the population. The aim of the study. To evaluate the quality of life indicators in patients with coronary heart disease with stable angina pectoris in combination with nonalcoholic steatohepatitis after complex therapy including ezetimibe and ursodeoxycholic acid. Materials and methods. The study involved 145 patients with a verified diagnosis of coronary heart disease, stable angina pectoris II functional class combined with nonalcoholic steatohepatitis (NASH) and 100 patients with coronary heart disease without NASH. There were 140 men (57.0 %), and 105 women (43.0 %). The average age of patients is 55.3 ± 6.3 years. Results. A decrease in the number of angina attacks and the need to use nitroglycerin per week was registered in patients with coronary artery disease in combination with NASH under the influence of the treatment, which was more pronounced in the group with the addition of ezetimibe and ursodeoxycholic acid (UDCA). According to the Medical Outcomes Study 36-Item Short-Form Health Status (SF-36) questionnaire after treatment, a tendency to improve most of its indicators was revealed, which was more clearly observed in patients in the group with the addition of ezetimibe and UDCA. Also, according to the EuroQoL-5D (EQ-5D) questionnaire, significant positive dynamics of the quality of life were found for all indicators, which were more reliably increased in the group with the addition of ezetimibe and UDCA. According to the Seattle Angina Questionnaire (SAQ), after treatment, reliable positive changes on 4 scales were observed in patients in the group with the addition of ezetimibe and UDCA. Conclusion. The inclusion of ezetimibe and ursodeoxycholic acid in the basic therapy has a positive effect on the clinical course of coronary heart disease in combination with non-alcoholic steatohepatitis, the quality of life of patients and the patient's attitude to his disease.

ДОЛГОСРОЧНАЯ ЭФФЕКТИВНОСТЬ УСИЛЕННОЙ НАРУЖНОЙ КОНТРПУЛЬСАЦИИ У ПАЦИЕНТОВ ХРОНИЧЕСКОЙ СЕРДЕЧНОЙ НЕДОСТАТОЧНОСТЬЮ ИШЕМИЧЕСКОГО ГЕНЕЗА

Aim. To study the long-term effect of complex therapy with the addition of enhanced external counterpulsation (EECP) on exercise tolerance, quality of life and systolic heart function in patients with ischemic chronic heart failure (CHF). Material and methods. Patients with ischemic CHF NYHA class II-III (n=20) included in the study. Patients, in addition to optimal medical therapy, were treated with EECP (35 hours, the standard protocol, 1 course every 6 months). The duration of observation was 5 years. Baseline, 12, 24, 36, 48 and 60 months performed assessment of NT-proBNP level, clinical status, exercise tolerance (6-minute walk test – 6MWT), quality of life (Minnesota Living with Heart Failure Questionnaire – MLHFQ), left ventricular ejection fraction (LVEF) according to echocardiography. The composite primary endpoint (CPE) included adverse cardiovascular events, new cases of atrial fibrillation (AF), diabetes mellitus (DM), decreased renal function, and hospitalizations due to CHF. Results. During the observation period (60 months), significant stable positive dynamics were noted in exercise tolerance (6MWT distance increased by 59.3%), clinical status, LVEF, NT-proBNP level, quality of life (MLHFQ). The incidence of myocardial infarction was 5%, revascularization – 15%, new cases of AF – 5%, decreased renal function – 10%, hospitalizations for CHF – 35%. There were no cases of strokes, deaths or new cases of diabetes. The prevalence of CPE was 70% over a 5-year period. Conclusion. A stable positive effect of EECP treatment of patients with ischemic heart failure on functional status and clinical outcomes has been demonstrated.

Direct comparative study of anti-IgE and anti-IL4Rα therapy effectiveness in patients with severe allergic and mixed bronchial asthma

Introduction. There is insufficiency of direct comparative studies of genetically engineered biological drugs (GEBD) for severe bronchial asthma (SA) treatment in scientific databases.Aim. To compare omalizumab and dupilumab effectiveness in patients with allergic and mixed SA in real clinical practice.Materials and methods. The direct comparative study included SA patients with an allergic component from regional registry of Sverdlovsk region. The data of patients with allergic (n = 68) and mixed (n = 27) SA treated with omalizumab (n = 62) and dupilumab (n = 33) were analyzed. Therapy effectiveness was determined for 12 months in general group No. 1, allergic asthma group No. 2 and mixed asthma group No. 3 according to the following indicators: asthma control level (ACT), proportion of patients with uncontrolled asthma, need for systemic glucocorticosteroids (SGCS) and short‐acting beta agonists (SABA), basic therapy volume, asthma exacerbations number, emergency calls and hospitalizations, forced expiratory volume in the first second (FEV ), assessment of life quality (AQLQ and SNOT-22). Control evaluation visits were conducted before therapy start, after 4 and 12 months of biologics taking.Results. In general, during the 12 months of targeted therapy in patients receiving omalizumab statistically significant positive dynamics was observed in 12 of the 13 evaluated indicators; in patients receiving dupilumab – in 9 indicators. When analyzing such indicators as, ACT, taking SGCS, exacerbations of SA, FEV , statistically significant positive dynamics was revealed for all 4 indicators in patients receiving omalizumab in group No. 2 and in patients receiving dupilumab in group No. 3.Conclusions. Patients with allergic component of SA respond equally well to therapy with omalizumab and dupilumab. At the same time, a tendency towards the advantage of omalizumab in patients with allergic asthma, and dupilumab in patients with a mixed phenotype of the disease was revealed.

Боль в спине. Результаты неинтервенционного исследования применения препарата Амбениум® парентерал в условиях реальной клинической практики

Aim: to estimate efficacy, tolerability, and safety of Ambenium® parenteral [phenylbutazone sodium 400 mg and lidocaine hydrochloride 4 mg] used for treatment of patients with low back pain. Methods. A total of 100 patients with low back pain (LBP), who received a single intramuscular injection of Ambenium® parenteral, were included in the study. The follow-up period was 3 days. The change in pain severity on VAS (mm) was selected as a primary outcome measure for efficacy. The pain syndrome severity was estimated before administration of the drug (visit 1) and 4, 6, 8 and 12 h after the drug administration, as well as during visits 2 (day 2) and 3 (day 4). The McGill Pain Questionnaire, muscle syndrome index (MSI), Roland-Morris Disability Questionnaire pain estimates were used as the secondary diagnostic criteria. The percentage of patients with the positive response relative to baseline (the decrease in pain severity on VAS by more than 50%) was also determined. Results. The dynamics of the primary efficacy measure (pain severity on VAS) was as follows: 7.4 ± 0.92 cm (mean ± standard deviation) during visit 1, 5.6 ± 1.49 cm after 2 h, 4.6 ± 1.74 cm after 4 h, 3.0 ± 1.79 cm after 8 h; the VAS score was 2.3 ± 1.70 cm after 12 h (р<0.001). The share of patients who responded to therapy (with the decrease in pain severity on VAS by more than 50% relative to baseline) was 84% [95% CI: 75.0 – 91.0] 24 h after the first administration, 94% during visit 3 [95% CI: 87.0 – 98.0], р<0.001. The secondary efficacy criteria (muscle syndrome index and McGill Pain Questionnaire score) showed significant positive dynamics (р<0.001). No systemic adverse events were reported. Conclusion. The study showed that a single intramuscular injection of Ambenium® parenteral was an efficient, well-tolerated and safe treatment option for low back pain. Administration of a single drug dose makes it possible to ensure a significant clinical effect reflected in the pain severity decrease and restoration of the patient’s motor activity.

Evaluation of the Clinical Effectiveness of the Drug Laennec in Complex Rehabilitation of Patients with Post-COVID Syndrome: a Randomized Trial

INTRODUCTION. The development of post-COVID syndrome is accompanied by an increase in markers of systemic inflammation, a violation of the detoxification function of the liver, caused by both direct viral damage to hepatocytes and an increased iatrogenic load on the hepatobiliary system due to polypharmacy. AIM. Studying the use of the drug Laennec in the rehabilitation period as a hepatoprotector and immunomodulator in patients with post-COVID syndrome. MATERIALS AND METHODS. The study included 40 patients with post-COVID syndrome aged 30 to 60 years, with steatosis and steatohepatitis (increased levels of liver transaminases). The clinical effectiveness of Laennec was assessed based on the dynamics of pro-inflammatory biomarkers, liver metabolism indicators, as well as functional tests and psychological questionnaires. RESULTS. The inclusion of Laennec in the rehabilitation program for patients with post-COVID syndrome leads to a more pronounced improvement in lipid metabolism parameters, correction of liver metabolism parameters, a decrease in the level of pro-inflammatory biomarkers, and an improvement in the quality of life of patients than in the control group. DISCUSSION. Significantly significant positive dynamics in the severity of complaints of general weakness and sleep disturbance, as well as indicators of memory impairment and impaired concentration in the main group could indicate the achievement of anabolic, neurotrophic and bioenergetic effects of the Laennec drug. A significantly significant decrease in the level of liver transaminases in the main group indicates the hepatoprotective effect of the drug Laennec, due to the amino acids, vitamins and microelements included in the drug, which support the reactions of phases 1 and 2 of liver detoxification. Normalization of elevated pro-inflammatory markers (ferritin, IL-6, CRP) in patients of the main group may indicate the presence of anti-inflammatory and immunoregulatory effects of the Laennec drug. CONCLUSIONS. A course prescription of the drug Laennec for the purpose of correcting pro-inflammatory markers and hepatoprotection can be recommended for use in complex non-drug rehabilitation to increase its clinical effectiveness, as well as improve subjective indicators of the quality of life of patients with post-COVID syndrome.

ДОЛГОСРОЧНЫЕ СОСУДИСТЫЕ ЭФФЕКТЫ УСИЛЕННОЙ НАРУЖНОЙ КОНТРПУЛЬСАЦИИ У ПАЦИЕНТОВ С ИШЕМИЧЕСКОЙ БОЛЕЗНЬЮ СЕРДЦА, ОСЛОЖНЕННОЙ СЕРДЕЧНОЙ НЕДОСТАТОЧНОСТЬЮ

Aim. To study the long-term effect of complex therapy with the addition of enhanced external counterpulsation (EECP) on the structural and functional parameters of the cardiovascular system in patients with ischemic chronic heart failure (CHF). Material and methods. Patients with ischemic CHF NYHA class II-III (n=59; median age 64.8 [57.6; 71.2] years; 81.4% men), receiving EECP in addition to optimal medical treatment (35-hour course every 6 months; compression pressure 220-280 mmHg) had an assessment of exercise tolerance (distance in the 6-minute walk test; 6MWT), structural and functional state of large vessels and microvasculature (computer video capillaroscopy of the periungual bed, photoplethysmography, applanation tonometry), assessment of echocardiographic parameters (volume dimensions, systolic and diastolic functions of the left ventricle) at baseline, after 12, 24 and 36 months. The follow-up period was 36 months. Results. Significant stable positive dynamics of tolerance to physical activity (the distance in the 6MHT increased by 59.4%) was found. Functional parameters of the heart (LVEF from 40.6 [34.6; 43.2] to 49.2 [43.0; 52.7] %, p=0.003; NT-proBNP from 246 [167; 341] to 120 [93; 148] pg/ml), large (occlusion index by phase shift) and small (occlusion index by amplitude, percentage of perfused capillaries, percentage of capillary restoration) vessels significantly improved already in the first year of observation, while structural parameters (volume dimensions; indexed LV myocardial mass from 94.3 [79.4; 97.4] to 121 [109; 134] g/m2, p=0.010; radial augmentation index, stiffness index, occlusion index) began to change significantly by 2-3-years. Conclusion. A stable positive effect of EECP treatment in patients with ischemic heart failure on the structural and functional parameters of the heart and blood vessels has been demonstrated. At the same time, the rate of improvement in functional indicators was much faster than that of structural parameters.

The first clinical experience with selective DNA plasmasorption using the NucleoCapture Device in the treatment of systemic lupus erythematosus

Systemic lupus erythematosus (SLE) is a systemic autoimmune disease of unknown etiology characterized by the overproduction of autoantibodies against various components of the nucleus of the patient's own cells with the development of immunoinflammatory tissue damage. In recent years, more and more data have accumulated on the involvement of neutrophils in the development of the clinical symptoms of SLE, and DNA-containing structures and neutrophil extracellular traps (NETs) playing an important role in this process. Effective neutralization of NETs in SLE can be achieved by removing circulating proteins and molecules associated with NETs from the bloodstream by selective plasma sorption of DNA using the NucleoCapture Device.This article describes the case of a patient who underwent three plasma sorption sessions aiming to suppress the activity of SLE. During the therapy, significant positive dynamics were achieved: the SLEDAI-2K index decreased from 32 to 12 points, the number of leukocytes in the blood normalized, renal function improved, and the immunological activity of the disease decreased.

Efficacy and safety of the type I interferon receptor inhibitor anifrolumab in patients with systemic lupus erythematosus (results of a 6-month study)

Objective: to evaluate the efficacy and safety of the type I interferon (IFN) receptor inhibitor anifrolumab (AFM, Safnelo®) in patients with systemic lupus erythematosus (SLE) in real-life clinical practice over an observation period of 6 months.Material and methods. The prospective 6-month study included 21 patients with SLE fulfilling the 2012 SLICC criteria, predominantly women (n=17,81%), median age – 31 [27; 46] years, disease duration – 9 [6.0; 11.0] years. Standard laboratory values and immunological markers of SLE were examined in all patients. The SLEDAI-2K index was used to determine the activity of SLE, and the severity of the mucocutaneous syndrome was assessed using the Cutaneous Lupus Disease Area and Severity Index (CLASI) index. Organ damage was assessed using the SLICC/ACR Damage Index (DI). After 6 months, the achievement of low activity was assessed according to the Lupus Low Disease Activity State (LLDAS) indexResults and discussion. At the time of inclusion in the study, the mean SLEDAI-2K activity index for the group was 8 [6.0; 10.0] points, the median CLASI index – 8.6±8.2 points, 81% of patients had skin and mucosal lesions, 66% had non-erosive polyarthritis, and high immunological activity was observed in all cases. Various irreversible organ damage was observed in 86 of patients. The average DI was 2.2±1.5 points. At the start of AFM therapy, all patients received glucocorticoids (GCs) at a mean dose of 10.7±5.6 mg/day, 52% of patients received a dose above 10 mg/day, 76% of patients continued to take hydroxychloroquine, and 33% of patients took immunosuppressants. Significant positive dynamics were observed with AFM therapy. The average CLASI index for the group after 3 months of treatment was 1.2±4.1 points, after 6 months – 0.3±1.2 points (p<0.0001). The SLEDAI-2K index fell significantly in the group on average from 8 [6.0; 10.0] to 2 [2.0; 4.0] points from the 3rd month of treatment (p<0.0001) and remained at the same level after 6 months. At month 6 of treatment, 13 (62%) of 21 patients met the LLDAS criteria for low disease activity. After the 3rd month of treatment, a significant decrease in antibodies against dsDNA was observed, which persisted for 6 months after the start of treatment. In the group as a whole, there were no significant changes in complement fractions values during the observation period. There was no increase in irreversible organ damage (DI – mean 2.2±1.5 points). The mean daily dose of GCs was significantly reduced from 10.7±5.6 mg/day to 7.5±4.0 mg/day (p<0.01) by the 3rd month and to 5.2±2.1 (p<0.001) by the 6th month of treatment. No infusion reactions were observed in any case. Adverse events occurred in 9 (42%) out of 21 patients, mainly herpes infections of varying severity, mainly after the 1st to 3rd infusions. In one case, severe herpes zoster was observed, so the drug was discontinued.Conclusion. At a dose of 300 mg intravenously monthly AFM is a highly effective drug with a relatively good safety profile in patients with active SLE in whom autoantibodies are present and who do not respond adequately to standard therapy.

Effectiveness of ademetionine in patients with intrahepatic cholestasis syndrome in the drug induced liver damage

Objective — to investigate the effectiveness and safety of the generic ademetionine drug, Hepamethion lyophilizate for solution for injection (by the «Arterium» corporation) in comparison with the original drug ademetionine in patients with intrahepatic cholestasis syndrome against the background of drug induced liver damage (DILI) at the treatment of COVID­­ 19. Materials and methods. The examination involved 60 patients with DILI. Patients of the main group (13 men and 17 women, the mean age 54.6±18.2 and 48.7±19.2 for men and women, respectively) were administered the generic ademetionine drug Hepamethion 1000 mg a day intravenously for ten days. Patients of the comparison group (14 men and 16 women, the mean age 55.4±18.6 and 50.3±18.6 for men and women, respectively) received the original preparation of ademetionine 1000 mg intravenously also for 10 days. The groups were matching in terms of gender, age, and biochemical parameters (p >0.05). Visits and assessment of complaints and biochemical indicators were carried out according to the approved study design. Results. The dynamic examination of patients in both groups in 10 days after the therapy start demonstrated a significant decrease in the laboratory indicators and skin manifestations of jaundice (p <0.05). The significant positive dynamics of intrahepatic cholestasis was determined in both groups. Conclusions. The results of the use of ademetionine give reason to positively evaluate its effectiveness in patients with intrahepatic cholestasis syndrome against the background of drug induced liver damage in the treatment of COVID 19. The studied preparation of ademetionine is comparable to the reference one.

Clinical Effects and Functional State of the Endothelium in Patients with Arterial Hypertension with a Suboptimal Level of K+ in the Dynamics of Treatment with a Potassium-Magnesium Mineral Complex

Today, electrolyte dysbalance plays an important role in the formation and progression of cardiovascular diseases. The risk of development cardiovascular events also depends on potassium and magnesium deficiency. However, the issue of risks and clinical consequences of suboptimal serum potassium remains poorly understood. The objective: to analyze the influence of the mineral complex on the clinical status, serum levels of potassium and magnesium and the functional state of the endothelium, heart rhythm and parameters of the blood lipid spectrum in patients with arterial hypertension (AH) of the 2nd grade. Materials and methods. 60 patients from 43 to 65 years old with grade 2 AH, II stage took part in the study. Patients (36 men and 24 women) were divided into two groups of 30 persons each. Patients of the 1st group received antihypertensive therapy (perindopril 5–10 mg/day or valsartan 80–120 mg/day + hydrochlorothiazide 12.5 mg) and atorvastatin 20 mg/day. Patients of the 2nd group, in addition to the above-mentioned therapy, were prescribed a mineral complex of natural potassium and magnesium, 1 sachet per day for 3 months. Endothelial function was examined for all participants, the peak blood flow index was determined, arterial blood pressure (ABP) and electrocardiogram (ECG) were monitored daily. Results. In patients of the 2nd group, gradual increased levels of K+ and Mg+ in the blood plasma were determined: the median level of K+ increased by 25.9%, and the median Mg+ concentration – by 16.4% (р˂0.01). Endothelium-dependent vasodilatation after three months of potassium-magnesium citrate use became 2.17 times higher than the initial indicator and 1.94 times higher than in the 1st group (p<0.05). In the 2nd group of patients who additionally took the mineral complex, statistically significant positive dynamics of the blood pressure level were found: after 3 months, the median daily systolic blood pressure (SBP) decreased to 133.56 mm Hg. (LQ=131.64; HQ=135.29) (p<0.01). A significant decrease in the medians of both day and night SBP and diastolic blood pressure was also determined (p<0.01). At the same time, compared to the initial values, the number of ectopic arrhythmias decreased: supraventricular extrasystoles – by 47%, single and paired ventricular extrasystoles – by 37.5% and 47.1%, respectively (p<0.01). Positive dynamics of lipid indicators were found in the patients of the 2nd group. Conclusions. Prescribing a mineral complex to patients with AH and a suboptimal level of K+ who receive therapy including a thiazide diuretic has a complex positive effect: it increases the effectiveness of antihypertensive and hypolipidemic therapy, improves the functional state of the endothelium and vasodilatation, reduces the number of heart rhythm disorders and prevents the occurrence of hypokalemia and hypomagnesemia.

Clinical, Metabolic and Neurohumoral Effects of L-arginine in Patients with Coronary Heart Disease in Combination with Arterial Hypertension

The objective: to analyze the impact of complex therapy using L-arginine, ubiquinone (coenzyme Q10), L-carnitine, lycopene, plant extracts and folic acid on the functional state of the endothelium, tolerance to physical activity, indicators of oxidative stress, lipid metabolism and clinical status patients with stable angina pectoris of the III functional class (FC) in comorbidity with arterial hypertension (AH) of the II grade, stage 2. Materials and methods. 100 patients with stable angina pectoris III FC and AH II grade, stage 2 aged 55–68 years participated in the study. The patients were divided into two groups: 50 patients of the 1st group received standard therapy – RAAS blocker, amlodipine, bisoprolol, acetylsalicylic acid and atorvastatin; 50 patients of the 2nd group in addition to standard therapy received a multi-component product of complex action, which includes L-arginine, ubiquinone (coenzyme Q10), Lcarnitine, lycopene, a number of plant extracts and folic acid, in a dose of 1 sachet per day. At the beginning and at the end of the study endothelial functions were assessed, daily blood pressure (BP) was monitored, physical exercise testing was performed, the weekly number of angina attacks and nitroglycerin tablet taking were recorded, oxidative status parameters were studied, quality of life was assessed, and the results were statistically processed. Results. The use of complex action preparation, which includes L-arginine, ubiquinone (coenzyme Q10), L-carnitine, lycopene, plant extracts and folic acid, as adjuvant therapy demonstrated a decrease in the level of indicators of lipid peroxidation (LPO) and an increase levels of antioxidant protection parameters. In the patients of the 2nd group a statistically significant positive dynamics of the blood pressure level was found: the median of daily systolic blood pressure (SBP) decreased to 131.78 mm (p<0.01). A significant decrease in median daytime and nighttime SBP and diastolic blood pressure (DBP) was also determined (p<0.01). The use of a multicomponent preparation of complex action led to a significant decreased of total cholesterol (CHL) by 14.5%, TG by 10.37% and low-density lipoprotein cholesterol by 12.5%. There was also an increased level of high-density lipoprotein cholesterol by 6.48% (р<0.05 for all indicators). The patients of the 2nd group demonstrated a significant increase in tolerance to physical excesses: an increase in the double product by 21.4% and the total amount of the done work by 78.4% compared to the initial values (р<0.05 for both indicators). After 2 months of treatment the difference between the groups in terms of the decrease in the weekly number of angina attacks was statistically significant (р<0.05). This positive trend was accompanied by a decrease in the median number of nitroglycerin tablets taken per week in the 2nd group from 5.4 to 3.0 (р<0.05). In the patients of the 2nd group after 2 months of observation a statistically significant improvement in quality of life indicators according to the “Seattle Angina Questionnaire” was determined (р<0.05). Conclusions. Although all study participants received identical standard antihypertensive and lipid-lowering therapy, adjuvant use of a multicomponent complex of L-arginine, ubiquinone (coenzyme Q10), L-carnitine, lycopene, plant extracts, and folic acid for 2 months demonstrated a reduction in the impact of oxidative stress with parallel restoration of antioxidant mechanisms, improvement in vascular reactivity in patients and daily control of blood pressure, contributed to the correction of the lipid profile with increased tolerance to physical exercise and, as a result of the above-mentioned effects, had a significant positive impact on the quality of life of patients.

Study of the effect of a drug from the macromycetes Ganoderma lucidum on the phagocytic activity of peripheral blood neutrophils in patients with year-round allergic rhinitis

Modern complex therapy of patients with persistent (year-round, chronic) allergic rhinitis (AR), based on the use of antihistamines and intranasal glucocorticosteroids, in many cases is not effective enough, since drug therapy acts only on individual links in the pathogenesis, without preventing the progression of the allergic disease. At the same time, the quantitative and reserve capabilities of neutrophil granulocytes are depleted, which increases the level of antigenic load in patients with AR. The aim of this study is to investigate the phagocytic activity of neutrophils in patients with AR who received basic therapy and patients who received basic therapy and a course of the drug from the macromycetes Ganoderma lucidum "Astmagan". We examined 40 patients of both sexes with AR, the duration of the disease ranged from 6 months to 2 years. Patients were divided into 2 equal groups: The 1st group consisted of patients who received basic therapy (oral Loratadine and intranasal Nasonex). The 2nd group consisted of patients who received basic therapy and a course of "Astmagan". The treatment course lasted 90 days. The control group consisted of 25 healthy individuals. After the treatment, patients in both groups showed a statistically significant positive dynamics of phagocytic system activity: in group 1, the phagocytic index (FI) increased by 30 % (p=0.001), in the second group this indicator reached the normal level. Also, in patients of group 1, the phagocytic number (PN) increased by 35 % (p=0.0001), but did not reach the normal level.
 According to the results of comparative evaluation, a greater efficacy of the treatment complex with the additional use of "Astmagan" was established, which is manifested in the restoration of phagocytic activity of peripheral blood neutrophils, the effect persists for 6 months after treatment.

Experience of pyridoxin and glutamic acid use in effective correction of the main asthenia manifestations

Introduction. Asthenia manifestation treatment is an urgent problem due to its high frequency in outpatients.Аim. To evaluate in a controlled randomized clinical trial the efficacy and tolerability of the course use of a combination of pyridoxine and glutamic acid in patients with asthenic complaints.Materials and methods. 50 outpatients with main asthenia manifestations were included in the study if they complied inclusion criteria and signed the informed consent. After randomization, in group 1 a combined supplement with 2.5 mg of pyridoxin and 100 mg of glutamic acid (Metabovit® Life Energy, MNPK “BIOTIKI”) was added to therapy 1 tablet a day sublingually, in group 2 patients received basic therapy for chronic diseases only. The duration of observation was 21 days. Before and after the end of the study all patients underwent neuropsychological examination, which included the questionnaires: Multidimensional Fatigue Inventory (MFI-20), a Reader stress test (adopted by O.Kopina), a questionnaire on the level of life exhaustion (The Maastricht Questionnaire), a “Schulte tables” test with working efficiency evaluation.Results. In the group of patients receiving Metabovit® Life Energy 1 tablet a day, in comparison with the control group (p < 0.001) the overall score on the MFI-20 self-questionnaire decreased and amounted to 29 [26; 30]; Δ MFI-20 was equal to -22 [-27; -16]; the results reached normative values for most participants; improved time the performance of the “Schulte tables” test decreased by more than 9 seconds; stress levels decreased by almost 30% in men and 20% in women; the indicator of life exhaustion decreased by 60%. In patients in the control group, no significant changes in the studied indicators were detected by the end of the follow-up.Conclusion. In the group of patients who received the biologically active food supplement Metabovit® Life Energy, there was a significant positive dynamics and regression of most of the symptoms of asthenia, in comparison with the control group.

Dynamics of the course of Duchenne muscular dystrophy in patients taking ataluren and concomitant drug and non-drug therapy

Background. Duchenne muscular dystrophy is a hereditary, X-linked, progressive, disabling disease. One of the possible pathogenetic methods for treating this disease is the drug ataluren, which acts at the stage of protein translation in the ribosome and makes it possible to read information from mRNA, despite the presence of a premature stop codon in it, and, as a result, synthesize the dystrophin protein.Aim. To evaluate the dynamics of the course of Duchenne muscular dystrophy in patients receiving appropriate drug and non-drug therapy and patients receiving pathogenetic therapy with ataluren.Materials and methods. We examined 38 patients with genetically confirmed Duchenne muscular dystrophy. Of these, 11 patients with a genetically confirmed nonsense mutation receiving pathogenetic therapy with ataluren and 27 patients in the comparison group with other mutations in the dystrophin gene. 6‑minute walk test and timed function tests was done at baseline and during follow-up. Ataluren side effects were assessed.Results. Statistically significant positive dynamics were revealed during follow-up at 12 month when assessing the distance of a 6‑minute walk test and tests for getting up from the floor and running 10 meters in groups taking ataluren and receiving standard drug therapy with the initial initiation of a course of regular physical exercise. The control group was characterized by negative dynamics in speed tests.Conclusion. Thus, when taking ataluren in the standard recommended dosage, patients with Duchenne muscular dystrophy with a nonsense mutation shows a decrease in the rate of disease progression and an improvement in speed and endurance. The initial prescription of regular non-weightbearing aerobic exercise on the early ambulatory stage is also characterized by an increase in motor skills.

Clinical efficacy and safety of Picamilon in patients with progressive chronic cerebral ischemia

To study the efficacy and safety of the drug Picamilon with various therapy regimens in patients with stage II chronic cerebral ischemia (CCI). An open cohort clinical study involved 50 patients diagnosed with stage II CCI aged 51 to 69 years (average age 62.2±8.98 years). Patients received Picamilon first parenterally 200 mg (100 mg/ml, 2 ml) intravenously for 10 days, then orally in 50 mg tablets 3 times a day for 60 days. The total duration of therapy in the group was 70 days. The study included 3 visits (before treatment, after completion of the course, 1.5 months after completion of treatment). The dynamics of cognitive status according to the Montreal Cognitive Assessment Scale, vegetative disorders according to the A.M. Vane scale, neurological disorders according to the A.I. Fedin scale, and sleep quality according to the Ya. I. Levin scale were compared. The state of cerebral blood flow and endothelium was studied before and after treatment: dopplerography of cranial vessels, assessment of the level of methylated forms of arginine (ADMA, MMA, SDMA) and their ratios. The registration of adverse events against the background of therapy and the tolerability of treatment by patients was also carried out. Against the background of Picamilon treatment, a significant positive dynamics of the MoCA scale results was observed in the general sample of patients, increasing in the delayed period (20.9, 24.6 and 25.9, p<0.0001 and p=0.0006); sleep normalization was observed in 55% of patients by Visit 2 and in 81% of patients by Visit 3 (p<0.0001 and p=0.0025). Improvement of neurological functions is noted in 84% of patients, the score on the Fedin A.I. scale significantly decreases after treatment from 17.4±9.34 to 8.06±6.84 (p<0.0001) and to 5.31±5.71 in the delayed period (p=0.0002). Normalization of vegetative status was observed in 38% of patients with stage II CCI, and in 60% of cases there was a decrease in the severity of vegetative dystonia syndrome (p=0.0001). Picamilon therapy has high efficacy in assessing clinical outcomes (100%), good tolerability in 98% of patients and is characterized by a favorable safety profile (in 92% of patients). Picamilon significantly affects the parameters of cerebral hemodynamics: increases the linear velocity of blood flow, reduces the thickness of the intima-media complex and the resistance index. It affects markers of NO metabolism and endothelial function: significantly reduces elevated levels of ADMA and ADMA/MMA and (ADMA+SDMA)/MMA ratios. The use of Picamilon is effective in patients with stage II CCI in the form of step therapy contributes to a significant regression of neurological deficit, cognitive impairment, improvement of sleep quality and autonomic function; improves vascular endothelial function, reduces the risk of cardiovascular complications. Picamilon is a pathogenetic therapy agent that prevents the progression of CCI.