[A neuroprotective approach to optimizing treatment and correction activities in children with autism spectrum disorders]. / Neiroprotektivnyi podkhod k optimizatsii lechebno-korrektsionnykh meropriiatii u detei s rasstroistvami autisticheskogo spektra.

AIM: To study neuroprotective properties of heat shock proteins and neurotrophins in children with autism spectrum disorders (ASD). MATERIAL AND METHODS: Sixty-eight children with ASD (ICD-10 F84), aged from 5 to 12 years, were examined. General clinical examination and evaluation of brain-derived neurotrophic factor (BDNF), nerve growth factor (NGF), heat shock proteins (Hsp27, Hsp70) in the blood serum were performed. RESULTS AND CONCLUSION: There was a decrease in NGF, BDNF, Hsp27, Hsp70 in the total group and in boys with severe ASD. These changes reflect the deterioration of neuroprotective processes in the brain in children with ASD that demands further research and development of treatment procedures.

[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.

[Clinical and morphologic efficacy of a complex antioxidant and energy correction therapy of different duration in brain infarction: results of a multicenter randomized trial].

AIM: To compare clinical and morphological results of treatment of ischemic stroke in three groups of patients which differed by the forms and duration of an antioxidant therapy. MATERIAL AND METHODS: A randomized clinical trial was performed in 8 vascular centers of the Russian Federation in 2010-2014. It included 373 patients with ischemic stroke in the carotid territory. Patients were randomized into 3 groups to receive different regimens of antioxidant therapy as an adjunct to standard therapy: control group (ascorbic acid; 132 patients); cytoflavin (20 ml per day for 10 days; 133 patients); cytoflavin (the dose was decreased to 10 ml per day from 11th to 20th day) (108 patients). Patient's condition was assessed in 1, 10 and 21 day by a complex of clinical, laboratory and instrumental methods. RESULTS AND CONCLUSION: The analysis of CT in 1th and 21th day revealed a significant 1,5-1,7- fold decrease in the cerebral ischemic lesion in both groups treated with cytoflavin with no significant morphologic changes in the ascorbic acid group. The percentage of patients with ischemic lesion, increased during days 1-21, was 2-fold higher in the ascorbic acid group compared to cytoflavin groups. Morphologic changes were correlated with clinical variables and outcome. In patients with ≥14 points on NIH scale on admission, prolonged 20 day cytoflavin therapy was associated with a more prominent improvement of neurologic, functional and cognitive status compared to 10-day cytoflavin infusion. No differences in clinical variables were observed in patients with mild symptoms (<14 points on NIH scale on admission) receiving cytoflavin for 10 and 20 days.

[Performance evaluation of integrated cytoprotective therapy of different duration in patients with cerebral infarction].

The paper reviews the preliminary results of a multicenter randomized clinical research. The aim of the study was to determine the optimal duration of different types of energy-correction therapy. 99 case report forms of patients with cerebral infarction were reviewed with their prior envelope randomization into three groups. Patients in the first group (experimental group), consisting of 32 patients, as part of combined therapy received ascorbic acid (5% solution twice a day in a recommended dosage of 20 ml/day for 20 days); the second group (37 patients) received 10 ml of cytoflavin intravenously by drop infusion twice a day for 10 days; the third group received cytoflavin for 20 days (from day 1 to day 10 - 20 ml a day, from day 11 to day 20 - 10 ml a day). The average NIH scale score on admission was 14.9 ± 2.6. Prescription of cytoflavin came with average 1.7 - 1.8 time regression (p < 0.05) of the volumes of cerebral ischemia in the of cases of the 10- and 20-day courses of treatment, while there were no significant morphologic changes in the ascorbic acid group. These results correlated with the best dynamics and outcomes of the neurological and performance status of patients receiving cytoflavin. Despite the lack of significant general differences in the clinical and morphological data of the second and third groups, the patients with underlying grave medical condition in the 20-day cytoflavin group (with NIH score of 14-20 points on admission) tended to have improved neurologic status parameters in comparison with the experimental group and the 10-day cytoflavin group. These results attest to the advantages of personalized antioxidant energy-correction therapy.

[Efficacy of antioxidant energocorreсtion in brain infarction (results of a multicenter randomized trial)].

OBJECTIVE: To determine the optimal duration of energy corrective treatment of ischemic stroke (II) with cytoflavin or ascorbic acid. MATERIAL AND METHODS: A multicenter randomized clinical trial included 185 patients, aged 40-75 years. Patients were randomized into 3 groups: the control group (n=64) received ascorbic acid; cytoflavin group 1 (n=72) was treated for 10 days and cytoflavin group 2 (n=49) for 20 days. In all groups, mean NIHSS score was 13, 42.2% of patients scored ≥14 and on admission, 42.2% of patients had consciousness impairment of different severity. RESULTS: Cytoflavin treatment was more efficient than ascorbic acid that can be explained by different pharmacologic mechanisms. Treatment with cytoflavin for 10 days resulted in a significant decrease of ischemia zone volume by 25.2%, treatment with cytoflavin for 20 days - by 29.0%, which was associated with better outcomes in neurologic and functional status. Ascorbic acid demonstrated no effect on morphologic parameters. Prolonged treatment with cytoflavin in critically ill patients led to significant improvement in clinical and morphologic variables compared to the 10-day course. In patients with less severe condition comparable results were obtained. CONCLUSION: Our data justify the need for personalized integrated antioxidant and energy correction therapy.

[Modern methods of energy homeostasis correction in elderly patients].

In the multicenter randomized clinical-instrumental prospective study 185 patients aged 55-75 years (mean age 68 years) with 94 men and 91 women with cerebral infarction were included. All the patients were hospitalized in the period from 6 to 24 hours from the time of the debut of clinical symptoms, 42,2% of patients scored 14 and above on NIH scale on admission. Patients were randomized into 3 groups: 1st group consisted of 64 patients treated as an antioxidant by 5% solution of ascorbic acid 2 times a day the recommended dose (20 ml/day) for 20 days; 2nd group consisted of 72 patients who received energy monitor Cytoflavin in a daily dose of 20 ml (10.0 ml/drip 2 times a day for 10 days); 3rd group consisted of 49 patients with Cytoflavin therapy extended to 20 days, moreover from 11th to 20th day the dose was 10 ml/day. Cytoflavin treatment was more efficient than ascorbic acid, which can be explained by different pharmacologic mechanisms. Treatment with Cytoflavin for 10 days resulted in a significant decrease of ischemia zone volume by 25% in average, treatment with Cytoflavin for 20 days--by 29%, which manifested in better outcomes in neurologic and functional status. Ascorbic acid demonstrated no effect on morphologic parameters. Patients having at the time of admission 18-20 points according to the NIH and treated with Cytoflavin for 20 days demonstrated significant trend towards improvement of the parameters of the neurological status.