[The use of monoclonal antibodies in the treatment of patients with high-active multiple sclerosis in real clinical practice]. / Primenenie monoklonal'nykh antitel v lechenii bol'nykh vysokoaktivnym rasseyannym sklerozom v real'noi klinicheskoi praktike.

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.

[Cases of pregnancy in patients with aggressive multiple sclerosis treated with natalizumab]. / Sluchai beremennosti u patsientok s agressivnym rasseiannym sklerozom na fone priema natalizumaba.

The authors consider the issues concerning planning of pregnancy in patients with multiple sclerosis receiving pathogenetic and immunomodulatory therapy and provide descriptions of cases of pregnancy in patients with aggressively multiple sclerosis occurred during the treatment with natalizumab.

[A retrospective analysis of using zonisamide and retention in monotherapy among patients with epilepsy in routine clinical practice]. / Retrospektivnyi analiz primeneniia i uderzhaniia na monoterapii zonisamidom bol'nykh épilepsiei v usloviiakh povsednevnoi klinicheskoi praktiki.

INTRODUCTION: Zonisamide is one of the first antiepileptic drugs of new generation with a wide spectrum of action. It is successfully used in treatment of epilepsy for 30 years. The study aims at analyzing the results of the multicenter Russian trial on the efficacy and tolerability of zonisamide and retention in monotherapy. MATERIAL AND METHODS: The analysis included 92 patients with focal epilepsy, aged 18-78 years, from 20 epileptology centers in different regions of Russia. The patients were treated with zonisamide in initial and subsequent treatment. RESULTS AND CONCLUSION: The efficacy (the reduction of seizure frequency by >50%) was achieved in 81 (91%) out of 89 patients (95% CI 83.6-95.7%). Fifty-two patients received zonisamide for more than one year. The efficacy was achieved in 50 (96.2%) (95% CI 88.2-99.2%), including 39 (79.6%) patients with remission out of 49 patients with assessment of seizure free periods (95% CI was 66.8-89% for the frequency of remissions). The adverse effects were recorded in 27 (29.3%) patients. Seven (7.6%) patients were withdrawn due to these effects. The maximal duration of observation period was 50 month. Mean time of retention in treatment was 42.4 month (95% CI 38.7-46.2 month). The total frequency of retention in treatment was 82.1% (95% CI 73.1-91%) during the whole observation period.

[Psychotic disorders in multiple sclerosis]. / Psikhoticheskie narusheniia pri rasseiannom skleroze.

Nowadays there is no definite answer to questions: either multiple sclerosis (MS) patients with psychotic disorders have two independent diseases (multiple sclerosis and schizophrenia) or psychotic episodes are associated with organic damage of brain substances. The authors describe two cases of patients with MS with psychotic disorders which could help to clarify the problem.

[The efficacy of systemic thrombolysis in patients with cardioembolic stroke]. / Éffektivnost' sistemnoi tromboliticheskoi terapii u bol'nykh s kardioémbolicheskim insul'tom.

AIM: To compare the efficacy and safety of systemic thrombolytic therapy (STLT) in patients with cardioembolic stroke (CE) versus other pathogenic subtypes of ischemic stroke (IS). MATERIAL AND METHODS: The study included 147 patients, 62 women and 85 men (mean age - 62.9±0.8 years) including 37 patients (25.2%) with CE subtype of IS (group 1) and 110 patients with other pathogenetic subtypes of IS (group 2). NIHSS and Rankin scale were used to assess patient's neurological status. RESULTS: One hundred and twenty-six patients were discharged, 21 (14.3%) died. In 11 patients, the cause of death was the development of symptomatic hemorrhagic transformation (SHT). There were no significant differences in the lethality between groups 1 and 2. Tolerability to STLT in these groups did not differ as well. As a result of treatment, the condition of patients surviving to the end of the hospital stay improved, which was reflected in a significant decrease in the NIHSS scores, despite the higher NIHSS scores in group 1. CONCLUSION: The results confirm the efficacy of STLT in patients with CE IS and indicate the increase in the frequency of favorable functional recovery in these patients.

[The efficacy of cocarnit in diabetic neuropathy]. / Éffektivnost' preparata kokarnit pri diabeticheskoi neiropatii.

AIM: To study the efficacy of the complex therapy, including cocarnit (group B vitamins, triphosadenine and nicotinamide), of diabetic neuropathy. MATERIAL AND METHODS: Forty-one patients with diabetes mellitus type 2 and distal symmetric sensorimotor polyneuropathy were examined. Patients were divided into 2 groups. Patients of the main group (n=26) received complex therapy, including cocarnit, and patients of the comparison group (n=15) received standard treatment. RESULTS AND CONCLUSION: The positive dynamics based on the VAS (р=0.0001), TSS (р=0.0001), NSS (р=0.001), NDS (р=0.0431), SF-36 (р=0.0008), electroneuromyographic results and glycated hemoglobin levels was observed in the main group. In patients of the comparison group, the positive dynamics was instable; the scores of clinical scales did not reach statistical significance. The results suggest the use of cocarnit in the complex treatment of patients with diabetic neuropathy.

[Restoring of the speech functions in patients with aphasia in the early rehabilitation period of ischemic stroke]. / Vosstanovlenie rechevykh funktsii u bol'nykh s afaziei v rannem reabilitatsionnom periode ishemicheskogo insul'ta.

AIM: To study the efficacy of combined therapy including daily sessions and two 10-day injections of the drug cellex in patients with aphasia in the early rehabilitation period of ischemic stroke (II). MATERIAL AND METHODS: Forty patients in the early rehabilitation period of II in the basin of the left middle cerebral artery with moderate to severe aphasia were studied. Twenty patients received combined therapy, including daily sessions with a speech therapist-aphasiologist within 10 days using the improved method, then a self-study using educational materials and two 10-day injections of cellex. Other 20 patients received only speech therapy. To assess the efficacy of therapy, the automated "Program of examination of patients with aphasia", Goodglass-Kaplan scale, modified Rankin scale were used. RESULTS: There was a significant improvement of speech functions, communicative abilities and functional recovery (p<0.01) in patients of both groups. However, a significantly greater level of rehabilitation (p<0.05) was noted in patients treated with combined therapy included two courses of cellex. CONCLUSION: The results allow to recommend the inclusion of cellex in the complex rehabilitation of patients with post-stroke speech disorders.

[Diabetic asymmetric proximal neuropathy]. / Diabeticheskaia asimmetrichnaia proksimal'naia neiropatiia.

AIM: To study the prevalence, clinical features and treatment of diabetic asymmetric proximal neuropathy (DAPN). MATERIAL AND METHODS: Four hundred and forty-five patients with diabetes mellitus (DM), 257 women and 188 men, mean age 47.6±0.5 years, including 163 patients with DM type I and 282 with DM type II, were examined. RESULTS AND CONCLUSION: Distal symmetric sensory motor polyneuropathy was found in 62% of the patients, autonomic neuropathy in 25.6%, somatic mononeuropathy in 28.5%, DAPN in 7.9%. DAPN was more frequent in patients with DM type II (9.6), with poor control of glycemia and DM duration more than 5 years. Pain and paresthesia in a zone of innervation of several roots and nerves, amyotrophy that spread beyond the definite myotome were key symptoms of DAPN. The efficacy of double therapy of neuropathic pain (pregabalin and duloxetine) and vitamin B complex was shown. A role of glucocorticoids and normal human immunoglobulin in treatment of DAPN is discussed.

[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.

[Systemic thrombolytic therapy of ischemic stroke in diabetes mellitus type 2 and hyperglycemia]. / Sistemnaya tromboliticheskaya terapiya ishemicheskogo insul'ta pri sakharnom diabete i giperglikemii.

AIM: Systemic thrombolytic therapy (STLT) is an available method of treatment of ischemic stroke (II) with proven efficacy. The efficacy and safety of STLT in certain groups of patients, in particular with diabetes mellitus type 2 (T2DM), are being discussed. To compare the efficacy and safety of STLC in II patients with T2DM, hyperglycemia and normoglycemia. MATERIAL AND METHODS: Eighty-six patients were examined, including 23 with T2DM (7 newly diagnosed), 27 with hyperglycemia at stroke onset and 36 with normoglycemia. Cardioembolic subtype of II was diagnosed in 35%, atherothrombotic in 29%, lacunar in 7%. In other patients, the subtype was unknown. STLT was administered to all patients 153.8±4.7 min after stroke onset. RESULTS: At admission, the NIHSS severity of II and the level disability assessed by the Rankin scale did not differ in the three groups. A significantly lower regression was observed in patients with T2DM (p<0.01) in the 28th day. The fatality was higher in this group compared to the patients with normoglycemia (p<0.05). The frequency of symptomatic hemorrhagic transformation (SHT) was higher (56.5%) as well. After treatment, status of surviving patients in all groups has improved to the end of hospitalization, which was reflected in a significant decrease in NIHSS compared to baseline (p<0.01). CONCLUSION: The data indicate an increased risk of SGT after STLC in patients with T2DM. Significant positive changes in the surviving patients with T2DM confirm the feasibility of STLC in patients with T2DM.

[New possibilities of monotherapy of symptomatic and cryptogenic partial epilepsy].

This literature review is devoted to the use of the antiepileptic drug zonisamide in the initial monotherapy of symptomatic and cryptogenic partial epilepsy. The review is based on the results of the trials, level of evidence A, that demonstrate the efficacy and tolerability of zonisamide comparable to those of carbamazepine. The possible advantages of zonisamide in different clinical situations and characteristics of its use related to molecule structure, pharmacokinetics, mechanisms of drug action are discussed.