Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova最新文献

Objective: To study the effect of the combined drug Cytoflavin on the mechanisms of nonspecific inflammation in the treatment of diabetic polyneuropathy (DPN) with an assessment of the dynamics of the TNF-α index.

Material and methods: An open comparative prospective observation of patients with a history of DPN for more than 5 years and a high level of TNF-α was carried out. All patients underwent basic oral combined hypoglycemic therapy, the main group used the combined drug Cytoflavin 10 ml (per 200 ml 0.9% NaCl) for 10 days, followed by the transition to the enteral form of the drug, 2 tablets 2 times a day for 1 months The main indication for the appointment of Cytoflavin was the presence of comorbid pathology in the form of cerebrovascular disease in all studied patients. The severity of clinical symptoms of DPN, the quality of life (QOL) of patients, as well as the dynamics of the level of TNF-α as an indicator reflecting the process of inflammation were assessed.

Results: As a result of the treatment in the study group, there was an improvement in QoL, a decrease in the severity of sensory complaints and a decrease in the level of TNF-α, which may indicate a possible anti-inflammatory mechanism of the combined drug Cytoflavin.

Conclusion: Cytoflavin can inhibit inflammation and reduce the severity of sensitive disorders in patients with DPN.

Objective: To study the long-term results of surgical treatment of patients operated on for cerebral aneurysms and their impact on functional recovery, independence and cognitive functions in the long-term period.

Material and methods: A multivariate regression analysis of long-term results of surgical treatment of 324 patients for cerebral aneurysms was performed (on average after 3.5 years). Upon admission of the patient to the hospital for surgical intervention, a clinical diagnostic examination was performed to confirm the diagnosis and determine the volume, timing and type of intervention. In the late period, a clinical neurological study was performed, which included an assessment of the degree of disability with the Barthel index and a modified Rankin scale, cognitive functions with MMSE, and the mental sphere with HADS.

Results: The severity of the condition at admission, corresponding to grade III-IV according to the Hunt-Hess classification, was the risk factor for an unfavorable prognosis for the recovery of patients in the long-term period of cerebral aneurysm surgery. The severe condition of patients at the onset of the disease increases the risk of disability by 1.9 times (p<0.05) and the risk of dementia by 6 times (p<0.05). An independent risk factor for the development of cognitive impairment is the patient's age: with an increase in age by 1 year, the MMSE score decreases by 0.27 (p<0.05). The prevalence of hemorrhage according to the Fisher classification, corresponding to grade III, is a predictor of the development of angiospasm in 91% of cases. In patients with established angiospasm, the risk of developing dementia and pre-dementia cognitive impairment was 57.3% (p<0.05). The best predictions for recovery of cognitive functions in the long-term period were observed in patients who underwent simultaneous aneurysm clipping with extra-intracranial anastomosis (mean MMSE score 25) compared with patients who underwent only aneurysm clipping (mean score 20), endovascular intervention (average score 21) or microsurgical intervention followed by intrathecal fibrinolytic injection (mean MMSE score of 20) (p<0.05).

Conclusion: The predictors of unfavorable recovery of cognitive functions and the development of disability in the long-term period of surgical treatment of cerebral aneurysms were the severity of the condition at admission, corresponding to III-IV st. according to the Hunt-Hess classification, the age of the patient at the time of the intervention, the prevalence of hemorrhage according to Fisher, and the choice of surgical technique.

Objective: To evaluate the efficacy and safety of combination therapy for post-COVID asthenic syndrome with multicomponent bioregulatory drugs Traumeel S, Ubichinon compositum and Coenzyme compositum.

Material and methods: The study included 104 patients (averaged age 39.5 [30.8; 48] years) after COVID-19, clinically recovered from an acute infectious process, with asthenic syndrome lasting from 2 weeks to 6 months; the severity of asthenic syndrome on the asthenia VAS scale was at least 30 points. Before the start of the study, in addition to a physical examination, the patient's condition was assessed using the following questionnaires and scales: VAS for asthenia, subjective scale for assessing asthenia (MFI-20), L.D. Malkova, a questionnaire for the quality of life (EQ-5D), a questionnaire for identifying signs of autonomic disorders (Vayne A.M.). The patient's condition was monitored during follow-up visits 2 weeks, 1 month after the start of treatment and 1 month after the end of treatment. Patients of the main group received combination therapy, which included Traumeel S 1 tablet x 3 times a day, Ubichinone compositum and Coenzyme compositum 2.2 ml intramuscularly, alternating every other day, for 1 month (15 injections of each drug per course of treatment). Patients of the comparison group received eleutherococcus extract 100 mg during 30 days, 2 tablets x 2 times a day before mealsand vitamins B. The effectiveness of therapy was assessed by analysis of the asthenia severity (VAS scale), quality of life (EQ-5D questionnaire), patient satisfaction with treatment on a 5-point scale, which was carried out 1 month after the end of the course of treatment.

Results: As a result of the treatment was positive. The general asthenia severity, low activity and motivation significantly decreased in patients of both groups without significant differences. At the same time, in patients of the comparison group, there was no correlation between the quality of life and physical and mental asthenia, while in the main group there was an inverse correlation with the asthenia severity, which indicates an increase in the quality of life with a decrease in the severity of asthenia. One of the significant differences was the regression of headache and musculoskeletal pain in patients of the main group.

Conclusion: The advantage of combined therapy of post-COVID asthenic syndrome with bioregulation therapy Traumeel S, Ubichinone compositum and Coenzyme compositum was shown in comparison with one of the common treatment regimens, including eleutherococcus extract and combined preparations of B vitamins.

Objective: To investigate the therapeutic efficacy and tolerability of Mexicor as an adjuvant in the treatment of depression with SSRI antidepressants.

Material and methods: The study included 100 patients, aged 18-50 years, with verified depression of mild (n=32) or moderate (n=68) severity. Patients (n=50) of the main group, along with basic antidepressant therapy with SSRIs, received Mexicor at a dose of 600 mg/day, in the comparison group (n=50) - only SSRIs. Clinical-psychopathological, psychometric, using the HDRS-21 scale, CGI, HADS, fluency test of speech responses and the Stroop test, statistical research methods were used.

Results: The reduction of depressive symptoms on the HDRS-21 scale, starting from the fourth week, was statistically significantly superior to that in the comparison group (p<0.001), the reduction in the severity of the condition on the CGI scale in the main group was also significantly greater than in the comparison group (17.3% and 9.6% respectively, p<0.05). A significant improvement in speech fluency was found in the main group (p<0.05). Adverse events in the main group were significantly less common (p<0.001).

Conclusion: Administration of Mexicor together with SSRIs leads to improved efficacy and tolerability of antidepressant therapy, and in the future, Mexicor may be recommended as an adjuvant in SSRI therapy for depression.

Objective: To analyze mutations and polymorphisms in exons 2, 7, 8, 9, 10 and 11 of the glucocerebrosidase (GBA) gene in patients of the Krasnoyarsk region diagnosed with Parkinson's disease (PD).

Material and methods: Seventy-five patients with sporadic and familial forms of PD were examined. Genomic DNA was isolated from the whole blood of patients. The above mentioned exons of GBA were analyzed using Sanger sequencing.

Results: Various changes in the DNA structure of GBA were detected in 11 patients, thus, the overall frequency of variants was 14.7%, and the frequency of pathologically significant mutations (p.L444P, p.D409H, p.H255Q) was 5.3%.

Conclusion: The frequencies of variants in GBA, one of the most common high-risk factors for PD, in patients of the Krasnoyarsk region turned out to be quite high and comparable to that in patients in other populations of the world. Thus, screening for GBA mutations is relevant for PD patients living in the Krasnoyarsk region as part of genetic counseling at present, and in the future it may be necessary for personalized treatment.

Objective: To access the efficacy and safety of the first Russian botulinum toxin type A (Relatox) as a headache prophylaxis in adult with chronic migraine (CM).

Material and methods: The randomized, one-blind, multicenter, active-controlled, parallel-group trial study involved 209 patients with CM aged from 19 to 65 years. The patients were randomized to injections of the Russian botulinum toxin type A - Relatox (n=101) or onabotulinumtoxinA injections - Botox (n=108). The duration of the study was 16 weeks, which included five visits of patients every 4 weeks. Relatox and Botox were injected once into seven muscle groups of the head and neck at a dose of 155-195 units. Primary efficacy variable was mean change from baseline in frequency of headache days after 12 weeks. Secondary efficacy variables were mean changes from the baseline to week 12 in frequency of migraine days, acute headache pain medication intakes days; headache intensity; proportion of patients achieving ≥50% reduction from baseline in headache days, the proportion of the patients with medication overuse, the proportion of the patients with severe (≥60) Headache Impact Test-6 score and with a severe (≥21) MIDAS score.

Results: Analyses demonstrated a large mean decrease from baseline in frequency of headache days, without statistically significant between-group differences Relatox vs Botox at week 12 (-10.89 vs -10.06; p=0.365) and at other time points. Significant differences from baseline were also observed for all secondary efficacy variables at all time points without differences between the groups. The proportion of patients achieving ≥50% reduction from baseline in headache days was 75.0% and 70% in the Relatox and Botox groups, respectively (OR, CI 95% 1.58 [0.84; 3.02], p=0.155). Adverse events (AE) occurred in 15.8% of Relatox patients and 15.7% of Botox patients (p=1.000). No unexpected AE were identified.

Conclusion: The results demonstrate that the first Russian botulinum toxin type A (Relatox) is an effective prophylactic treatment for CM in adult patients. Relatox led to significant improvements from baseline in multiple measures of headache symptoms, headache-related disability and quality of life. For the first time, a comparative analysis of two botulinum toxin type A products in parallel groups showed no less (not inferior) efficacy and safety of Relatox relative to Botox in the treatment of CM in adults.

The term «salience» is most often used to describe «aberrant salience», which means assigning false significance to insignificant facts and details, that is inherent to patients with schizophrenia. Most often it is used in combination with «aberrant salience», which is understood as the assignment of false significance to insignificant facts and details. The term «adaptive salience» is less commonly used and means the «correct» assignment of the significance to important biological information. It is believed that in schizophrenia there is a decrease of adaptive salience in combination with an increase of aberrant salience. The concepts of aberrant and adaptive salience are a kind of link between the dopamine imbalance underlying the pathogenesis of schizophrenia and the diverse clinic of the disease. This article provides a review of the literature on methods for assessing, including quantitatively assessment, salience in schizophrenia. The comparison of these methods and their possible clinical and scientific application are provided.

Objective: To evaluate the efficacy and safety of the anti-CD20 monoclonal antibody divozilimab (DIV) used as an intravenous infusion at a dose of 500 mg for the treatment of patients with relapsing-remitting multiple sclerosis (RRMS) in comparison with the teriflunomide (TRF). The study of the efficacy and safety of the use of the drug DIV was carried out for 48 weeks of therapy.

Material and methods: The multicenter, randomized, double-blind and double-masked phase III clinical trial (CT) BCD-132-4/MIRANTIBUS included 338 adult patients with RRMS distributed in a 1:1 ratio into two groups: DIV 500 mg and TRF 14 mg. After screening, subjects were included in the main CT period, which consisted of two cycles of therapy over 48 weeks. The primary end point was «Mean annualized relapse rate 48 weeks after the last patient is randomized in the study».

Results: 321 subjects completed 48 weeks of therapy according to the study protocol. The analysis of the of efficacy data for the primary endpoint successively proved the hypothesis of superiority of the test drug DIV at a dose of 500 mg over the reference drug TRF. A rapid suppression of acute disease activity according to the brain MRI and clinical manifestations of the disease was shown after the first infusion of DIV in patients with RRMS. Thus, after 48 weeks of therapy in patients treated with DIV, there were no T1 gadolinium-enhancing lesions, while in the TRF group such lesions were observed in 20.7% (35/169) of subjects. Evaluation of the CUA per scan showed that the mean values for the estimated period were statistically significantly lower in the DIV drug group compared to the TRF group: the ratio of the adjusted per scan rates (DIV/TRF) was 0.125 [95% CI: 0.089; 0.177]. Over the 48 weeks of therapy, the proportion of subjects with relapses was 9.5% (n=16/169) in the DIV group and 19.5% (33/169) in the TRF group (p=0.0086). DIV has shown a favorable safety profile. Among the adverse reactions (AR), infusion reactions and deviations of laboratory data, such as a decrease in the number of leukocytes, neutrophils, and lymphocytes, were most often recorded. Identified AR were expected, had mild to moderate severity, and resolved without any negative consequences.

Conclusion: The results of the clinical study indicate the high efficacy and safety of DIV in comparison with TRF.

Objective: To study the efficacy of ocrelizumab (OCR) and natalizumab (NAT) using indicators of activity and progression in patients with highly active multiple sclerosis (HAMS) during the first year of therapy in real clinical practice.

Material and methods: The study included 110 patients with HAMS and 13 patients with rapidly progressive MS (RPMS), aged 19 to 60 years, who received monoclonal antibody (MAT) therapy for 12 months. Group 1 consisted of 77 patients receiving NAT therapy, group 2 of 46 patients receiving OCR therapy. To assess the efficacy of therapy, we used indicators of the average frequency of exacerbations per year, EDSS estimates, and MRI data.

Results: EDSS score at the time of initiation of MAT therapy was 2.4±1.0 in group 1 and 2.8±1.2 in group 2 (p=0.047); 12 months after the start of MAT therapy, EDSS score in group 1 decreased slightly (p=0.001), in group 2 it has not changed. The frequency of exacerbations per year after the start of MAT therapy was 0.04±0.2 in group 1 and 0.07±0.2 in group 2 (p<0.0001 in both groups). The number of foci accumulating gadolinium detected during the year was 3 in group 1, one in group 2 (p=0.629 between groups). Subgroups of patients who received line 1 DMT (n=22) or NAT (n=21) before the start of OCR therapy were considered separately. In both subgroups, a stable assessment of EDSS was noted, the average annual number of exacerbations did not differ (p=0.117). In patients with RPMS after a year of MAT therapy, EDSS scores were stable, the average annual frequency of exacerbations was 0.08±0.3 per year.

Conclusion: The administration of MAT therapy led to a statistically significant decrease in the number of exacerbations and stabilization of neurological deficits during the first year of follow-up. After 12 months of therapy, both groups experienced a dramatic decrease in the average annual number of exacerbations, no increase in disability, and positive dynamics according to MRI results. A similar level of OCR efficacy was found in patients who switched from DMT 1 line therapy and NAT.

Dihydroquercetin (DHQ) is a plant-derived polyphenol belonging to the group of flavonoids. In models associated with abnormal accumulation of β-amyloid in the brain (Alzheimer's disease and cerebral amyloid angiopathy), DHQ demonstrates the ability to disaggregate toxic forms of β-amyloid and prevent their formation. It is believed that this phenomenon underlies the protective effect of DHQ on brain neurons. However, pharmacokinetic data doubt the central mechanism of action of DHQ because this compound does not penetrate well into the brain. A hypothesis is put forward about the systemic nature of the neuroprotective action of DHQ, since this compound has multiple biological activities at the level of the whole organism. To characterize DHQ (and similar compounds), it is proposed to introduce the term «systemic neuroprotector».