[Characteristics and dynamics of pathological changes in visual evoked potentials in multiple sclerosis]. / Kharakteristika i dinamika patologicheskikh izmenenii zritel'nykh vyzvannykh potentsialov pri rasseyannom skleroze.

OBJECTIVE: Clarification of the characteristics and dynamics of changes in the main indicators of visual evoked potentials (VEP) for a reverse chess pattern in patients with multiple sclerosis (MS) at various stages of the disease and severity of disability. MATERIAL AND METHODS: The study of VEP was carried out on 477 subjects, 120 of which were healthy volunteers and 357 patients with MS, including those with clinically isolated syndrome (CIS; 22.7%), remitting course (RT; 55.7%), primary progressive course (PPT; 8.4%), secondary progressive course (VPT; 13.2%). Disability was assessed using the Expanded Disability Status Scale (EDSS). RESULTS: A high sensitivity of VEP in the detection of demyelinating damage to the visual pathways, including subclinical, was noted already at the initial stages of MS, which increases with the progression of the disease from 77.8 to 97.8%. There was a significant increase in latency (r=0.42, p<0.05) and a decrease in amplitude (r= -0.26, p<0.05) of the P100 peak as the EDSS score increased. In patients with MS, 5 patterns of VEP were identified depending on the level and severity of damage to the visual pathways, where pattern 1 is normative VEP, pattern 5 is the absence of VEP recording in case of a pronounced axonal-demyelinating lesion of the visual pathways (prechiasmal/postchiasmal levels). Patterns 1 and 2 are most typical for CIS (22.2 and 53.1%) or RT (20.1 and 26.6%). Patterns 3 and 4 are typical for APT (70 and 20%) and VPT (48.9 and 21.3%), pattern 5 - for VPT (19.1%). Patterns 3-5 predominated in patients with higher EDSS (r=0.54, p<0.05). CONCLUSION: The classification of VEP changes into patterns makes it possible to identify the dissemination of a focal lesion in the projections of the visual pathways, which increases the diagnostic efficiency of the study and makes it possible to assess the severity of MS.

[Differential diagnosis of multiple sclerosis in children]. / Differentsial'naya diagnostika rasseyannogo skleroza u patsientov detskogo vozrasta.

At the onset, multiple sclerosis (MS) in children is characterized by a phase of active inflammation with extensive demyelination of the white matter of the CNS, which often mimics this nosology with a whole spectrum of inflammatory demyelinating diseases such as ADEM, anti-MOG encephalitis, ONMSD. In order to formalize the diagnostic process, the International Pediatric Multiple Sclerosis Study Group (IPMSSG) proposed diagnostic criteria for the main immune-mediated demyelinating diseases of the CNS in children, which, in theory, should simplify the diagnostic search. However, in practice, the range of nosologies in the course of differential diagnosis is much wider and often it is not possible to establish an unambiguous diagnosis in the early stages. The authors analyze their own clinical observations based on a sample of 100 pediatric patients with a referral diagnosis of «MS?¼ and describe a clinical case of the onset of highly active MS with an assessment of the dynamics of the clinical and paraclinical course of the disease.

[Comparison of the efficacy of Cellex and Cortexin in patients in the early recovery period of ischemic stroke]. / Sravnenie effektivnosti preparatov Tselleks i Korteksin u patsientov v rannem vosstanovitel'nom periode ishemicheskogo insul'ta.

OBJECTIVE: To compare the efficacy of Cellex and Cortexin in patients in the early recovery period of ischemic stroke (ERPIS) receiving basic therapy (BT). MATERIAL AND METHODS: Forty patients were randomized into the cellex group (n=20) and the cortexin group 2 (n=20). Cellex was administered in a dose of 0.1 mg daily SC for 10 days and cortexin in a dose of 10 mg per 2 ml of 0.9% NaCl solution IM daily for 10 days. The efficacy of treatment was assessed with NIHSS, Bartel's index (BI), MMSE, the Rivermead Mobility Index (RMI), the Frontal Assessment Battery (FAB), Beck's depression scale (BDS). RESULTS: A more pronounced positive dynamics of NIHSS: 3 [2; 4.5] vs. 5 [2; 7] (p=0.03) and MMSE scores: 24 [21.5; 25] vs. 22 [20; 23] (p=0.04) was noted in the cellex group. Also, in this group, a more significant trend towards regression of depressive disorders (BDS) was revealed: 17.5 [14.5; 21] vs. 14 [13; 16] (p=0.064). The dynamics of RMI and FAB scores did not differ significantly between the groups. CONCLUSION: The use of cellex in comparison with cortexin is more effective in terms of the dynamics of regression of neurological and neurocognitive dysfunctions in patients with ERPIS.

[The results of an open comparative retrospective trial of the course of multiple sclerosis during treatment with infibeta and other interferon-beta bioanalogues and glatiramer acetate]. / Rezul'taty otkrytogo sravnitel'nogo retrospektivnogo issledovaniia osobennostei rasseiannogo skleroza na fone terapii preparatom infibeta i drugimi bioanalogami interferonov beta i glatiramera atsetatom.

AIM: To evaluate the efficacy and safety of the interferon beta-1b bioanalogue 'infibeta' in the treatment of multiple sclerosis (MS) in comparison with other interferon beta bioanalogues and the generic drug glatiramer acetate. MATERIAL AND METHODS: The data of 500 patients with MS treated with different disease-modifying drugs were analyzed. Patients of group 1 (n=95) received infibeta; group 2 (n=108) interferon beta-1b; group 3 (n=83) genfaxon-44; group 4 (n=109) sinnovex; group 5 (n=105) aksoglatiran FS. RESULTS: In all groups, there was a significant decrease in the AARR and an increase in the EDSS score (p<0,05) after 12 and 24 months of treatment (p<0,05) with the best indicators in groups 1-3. After 12 months of treatment, the number of patients without signs of MRI activity was higher in groups 1-3 (48-61%) than in groups 4 and 5 (47, 43%, respectively) (p>0,05). After 24 months of treatment, the number of patients without signs of MRI activity decreased to 41-46% in groups 1-3, and more significantly in group 4 (27%). The percentage of NEDA-3 achieving patients did not significantly differ in the groups (23-32%) after 12 months of treatment. After 24 months of treatment the NEDA-3 declined more in group 4 (19%), least of all in groups 1 and 2 (27, 25%, respectively) (p>0,05). In most cases, the observed adverse events were mild or moderate. Flu-like syndrome was observed rarely in groups 1 and 4 (p<0,05). Injection reactions were observed most commonly in groups 3 and 5 (p<0,05). CONCLUSION: Infibeta, while retaining all the advantages of high-dose interferon beta, has the best tolerability profile, which makes it one of the optimal first line disease-modifying therapy for treatment of patients with MS.

[Evaluation of efficiency and safety of adding neuromultivit to basic therapy of vertebrogenic radiculopathy]. / Éffektivnost' i bezopasnost' neiromul'tivita pri vertebrogennykh radikulopatiiakh.

AIM: To evaluate the efficacy and safety of neuromultivit (valiant, Russia) as add-on to the basic therapy of vertebrogenic radiculopathy (VR) L5-S1. MATERIAL AND METHODS: The open clinical trial included 100 patients with VR L5-S1 randomized into 2 groups. In group 1, patients received neuromultivit and basic therapy; in group 2 only basic therapy. Treatment efficacy was assessed by the dynamics of regression of pain intensity on the visual analogue scale (VAS), McGill pain questionnaire (MGPQ), Aberdeen back pain scale (ABPS), the Quebec Back Pain Disability Scale (QBPDS), the dynamics of neurologic symptoms, the need for additional treatment with NSAID. Safety was assessed by evaluation of vital functions, laboratory tests, ECG, registration of adverse events (AE). RESULTS: In both groups, a significant positive changes on VAS, MGPQ, ABPS, QBPDS were observed. Nevertheless, the positive effect of therapy was more pronounced in group 1 p<0.05). The AE spectrum between two groups did not differ significantly (p<0.05). CONCLUSION: Addition of neuromultivit to basic therapy increased the efficacy of treatment of VR L5-S1.

[Comparative, placebo-controlled clinical study of efficacy and safety of glatiramer acetate 20 mg in patients with relapsing-remitting multiple sclerosis: results of the first year of the study]. / Sravnitel'noe platsebo-kontroliruemoe klinicheskoe issledovanie effektivnosti i bezopasnosti preparatov glatiramera atsetata 20 mg u patsientov s remittiruyushchim rasseyannym sklerozom: rezul'taty pervogo goda nablyudeniya.

The article presents the results of international multicenter randomized double-blind, active and placebo-controlled, comparative phase 3 trial. The goal of the study was to demonstrate non-inferiority of BCD-063 (glatiramer acetate, manufactured by JSC «BIOCAD¼, Russia) to copaxone-Teva (Teva Pharmaceutical Enterprise Co., Ltd., Israel) in patients with relapsing-remitting multiple sclerosis. METHODS: 158 patients with relapsing-remitting multiple sclerosis were randomly assigned into 3 groups: BCD-063, copaxone-Teva and placebo, at a ratio of 2:2:1, respectively. RESULTS AND CONCLUSION: Efficacy analysis after 48 weeks of therapy demonstrated no differences between BCD-063 group and copaxone-Teva group in both MRI parameters and frequency of relapses. The mean (SD) of number of MRI-confirmed relapses per patient per year (the primary endpoint) in BCD-063 group was 0.098361 (0.351422), in copaxone-Teva group - 0.098361 (0, 351 422) and in placebo group - 0.178571 (0.390021). There were also no differences between the groups for all other efficacy parameters (EDSS and MSFC). Both investigational BCD-063 and copaxone-Teva demonstrated a favorable safety profile. The data obtained from the present study confirm the therapeutic equivalence of BCD-063 (CJSC BIOCAD, Russia) and copaxone-Teva, that is important for further implementation of glatiramer acetate generic in the clinical practice of multiple sclerosis therapy.

[Effect of cerebrolysin on remyelination processes in multiple sclerosis patients in stage of relapse regression]. / Primenenie tserebrolizina u bol'nykh rasseyannym sklerozom v stadii regressa obostreniya.

AIM: To evaluate the efficacy and safety of Cerebrolysin (EVER Neuro Pharma GmbH, Austria) in the treatment of patients with multiple sclerosis (MS) in stage of relapse regression. MATERIAL AND METHODS: The study involved 40 patients with remitting MS (McDonald criteria 2010) in stage of MS relapse regression after pulse therapy with methylprednisolone 1000 mg/day 5. Patients randomized into 2 groups: group 1 (G1, n=20) received cerebrolysin 20 ml per 200 ml of 0.9% NaCl solution 1 times per day 10; Group 2 (G2, n=20) - only 200 ml 0.9% NaCl solution on analogical scheme. All patients before and 3-4 weeks after the treatment were carried out assessment of vital signs, routine laboratory tests, tests of cognitive-motor functions (SDMT), visual acuity (LCAT), a comprehensive neurophysiological examinations (CNE). 4 patients in the G1 with presence of previously identified G+ lesions (G+L) were conducted MRI of brain after 3-4 weeks after treatment. RESULTS: In G1 the average age of the patients was 27.35 (5.65) years, the ratio of M/F - 40/60%, the duration of the disease 29.9 (11.01) months, the EDSS in relapse stage - 3.5 [2.0; 4.5] points. The average age of patients in G2 was 26.65 (4.93) years, the ratio of M/F - 35/65%, the duration of the disease - 30.25 (11.98) months, the EDSS in relapse stage - 3.0 [1.5; 4.5] points. Clinical relapse of MS was categorized into groups as follows: optic neuritis (15% vs. 30%; p=0.26), stem dysfunction (15% vs. 25%; p=0.43), hemispheric dysfunction (50% vs. 35%; p=0.34), transverse myelitis (20% vs. 10%; p=0.38). 17 patients (85%) in G1 and 18 patients (90%) in G2 completed a full course of treatment. In both groups showed significant regression estimation EDSS (2.0 [1.75; 2.5] vs. 2.5 [1.75; 2.5]), while significant intergroup differences were not found (p=0.665). In G1 was noted more pronounced dynamics of performance improved in testing MSFC and SDMT (p=0.038 and p=0.026, respectively). Significant intergroup differences in the dynamics of improvement VCAT values were not found (p=0.658). Also in G1 was revealed greater regression of total variance in the CNE than G2 (70.59% vs. 27.78%, p=0.028), while in almost all cases the previously identified neurophysiological abnormalities are not completely regressed. In addition to G1 was marked a tendency to reduce of progressive deterioration of CNE indicators (10% vs. 30%; p=0.228). On MRI cerebrolysin treatment was not associated with an increase of G+L (G+L number before treatment in 4 patients - 14, after treatment - 12), which indicates a potential anti-inducing effect of the drug on the intrathecal inflammation in MS. CONCLUSION: Cerebrolysin positive role in the stimulation of remyelination process in MS has been confirmed by CNE and the selected treatment regimen has demonstrated its safety. Effect of the drug appear to be due to its composition: so according to a group of authors found that investigated the drug contained fragments of tubulin, actin and myelin basic protein, all of which is necessary to ensure non-specific trophic regenerated CNS myelin sheath.

[Clinical, neurophysiological and neuroimaging study of tremor in multiple sclerosis]. / Klinicheskoe, neirofiziologicheskoe i neirovizualizatsionnoe izuchenie tremora pri rasseiannom skleroze.

OBJECTIVE: To identify clinical types of tremor in multiple sclerosis (MS) and clarify their pathophysiological mechanisms. MATERIAL AND METHODS: We examined 124 patients with MS, including 58 patients with tremor, using clinical (digital spiralography), neurophysiological (tremor electromyography, visual and sensory evoked potentials, transcranial magnetic stimulation with tremor resetting, long latency reflexes, electroencephalography) and neuroimaging (MRI, morphometry) methods. RESULTS AND CONCLUSION: Five main variants of tremor were identified: distal postural and postural-intention (variant 1), distal intention (variant 2), proximal and distal intention and postural-intention (variant 3), Holmes (variant 4), axial (variant 5). Postural tremor (variants 1, 3) and rest tremor (variant 4) are caused by the central oscillators. Intention tremor (variants 2, 3), postural-intention tremor (variant 4), axial (variant 5) are caused by the pathology of cerebellar feedback loops. Clarification of mechanisms for the development of tremor in MS allowed to develop a scheme of differential treatment.

[Biosimilar of interferon-beta 1b in the treatment of multiple sclerosis and the own experience in the use of ronbetal].

The results of using ronbetal, the Russian biosimilar of interferon-beta 1b, in the treatment of multiple sclerosis (MS) are presented. The study included outpatients followed up from February 2008 to March 2012. All patients were assessed neurologically with additional evaluation using the EDSS; a number of exacerbations and their outcomes, disease progression, tolerability of the drug were recorded. No significant differences in the efficacy of ronbetal and betaferon were found. The frequency of exacerbations and MS progression were comparable for both drugs. The same was with the tolerability, with the exception of higher frequency of the flu-like syndrome at the beginning of treatment with ronbetal. A single-step substitution of betaferon for ronbetal often caused the discontinuation of treatment by patients because they were not fully informed about the new drug, need to use a new dose titration scheme and were anxious about side-effects.