[Clinico-psychological profile and life quality of patients with post-COVID syndrome]. / Kliniko-psikhologicheskii profil' i kachestvo zhizni patsientov s postkovidnym sindromom.

OBJECTIVE: To study clinico-psychological profile and life quality of patients with post-COVID syndrome. MATERIAL AND METHODS: We examined 162 patients aged 24-60 years with confirmed SARS-CoV-2 infection which having symptoms that served as the basis for the diagnosis of post-COVID syndrome. Patients underwent general neurological and somatic examination with allocation of the corresponding neurological syndromes. The intensity and quality of pain were assessed using the McGill Pain questionnaire. The level of psychosocial stress was determined by the Holmes-Ray questionnaire, the identification and severity of asthenia - by the MFI-20 asthenia scale. The level of reactive and personal anxiety was studied according to the Spielberger-Khanin questionnaire, depression - according to the Beck scale. The assessment of life quality was carried out using the Russian version of SF-36 questionnaire. To correct the identified disorders, Mexidol was used according to the scheme: 500 mg once daily intravenously for 14 days, followed by Mexidol FORTE 250 750 mg per day orally (250 mg 3 times a day) for 2 months. RESULTS: The course of treatment with Mexidol in patients with post-COVID syndrome led to decrease in the severity of subjective and objective symptoms, asthenic, anxiety and depressive disorders, and improved the life quality of patients. CONCLUSION: The high efficacy and safety of sequential therapy with Mexidol (injections followed by tablets of Mexidol FORTE 250) has been shown.

[Efficacy, tolerability and safety of the treatment with teberif: the results of a 2-year randomized clinical trial of treatment naïve patients with remitting multiple sclerosis, who have not received DMT, after switching from other interferon ß-1a]. / Éffektivnost', perenosimost' i bezopasnost' terapii preparatom teberif: rezul'taty dvukhletnego klinicheskogo issledovaniia u patsientov s remittiruiushchim rasseiannym sklerozom, ranee ne poluchavshikh PITRS, i pri perekliuchenii s drugogo interferona ß-1a.

OBJECTIVES: To evaluate efficacy, safety, and tolerability of the treatment with teberif/interferon ß-1a, to analyze safety, tolerability and dynamics of key efficacy variables after switching from referent drug rebif to biosimilar teberif in patients with remitting multiple sclerosis (RMS). MATERIAL AND METHODS: During the main period of the international multicenter randomized study patients were randomized to receive treatment with teberif for 52 weeks, or rebif for 52 weeks, or placebo for 16 weeks to evaluate efficacy and safety of treatment. After the main study period, patients were group-independently switched to take open-label teberif treatment during the next 48 weeks. RESULTS AND CONCLUSION: The analysis of multiple evaluation parameters of the efficiency during the 1st study period (blinded) and the 2nd study period (open-label) has shown that teberif and rebif demonstrate equivalent efficacy and stable 2-year efficacy of teberif was proven. There were no significant differences between teberif and rebif for all safety, and tolerability parameters. Switching from rebif to teberif didn't influence treatment efficacy. The 2-year study results confirmed a biosimilar teberif's benign tolerability and expected safety profile to other interferons ß-1a in patients with RMS.

[Dose-dependent effects of cortexin in chronic cerebral ischemia (results of a multicenter randomized controlled study)]. / Dozozavisimoe deistvie korteksina pri khronicheskoi ishemii mozga (rezul'taty mnogotsentrovogo randomizirovannogo kontroliruemogo issledovaniia).

AIM: To study an effect of cortexin on neurological symptoms and oxidative stress as part of the ischemic cascade in chronic cerebral ischemia (CCI), I-II stages. MATERIAL AND METHODS: The multicenter randomized controlled study included 189 patients with CCI, 42 (22.2%) men and 147 (77.8%) women, mean age 64.3±0.5 years. Patients were randomized into three groups. Group 1 received intramuscular injection of 20 mg of cortexin, group 2 received 10 mg of cortexin; group 3 received basic treatment only. The duration of treatment was 10 days, the treatment course was repeated after 6 months. The patients were examined at baseline and during treatment (in total 5 times). Along with clinical and neurological examinations, some scales and tests ('Fedin Outpatient scale of chronic brain ischemia', MFI-20, Spiegel sleep scale, the Zung self-rating depression scale, Spielberger's inventory, the clock-drawing test, the 5-word test) were used. The severity of oxidation stress was assessed by the content of reduced SH-groups and total superoxide dismutase activity. RESULTS AND CONCLUSION: A dose-dependent effect of cortexin on the severity of neurological disorders, asthenia, sleep disturbance was shown. Antidepressant and anxiolytic effects were insignificant and were determined after repeated courses of the drug. The laboratory data confirmed the antioxidant effect regardless of the dose of cortexin. The safety and good tolerability of the drug were shown.

[A comparative placebo-controlled clinical study on the efficacy and safety of interferon beta-1a for subcutaneous injections in patients with remitting multiple sclerosis: results of the first year of observations]. / Sravnitel'noe platsebo-kontroliruemoe klinicheskoe issledovanie éffektivnosti i bezopasnosti preparatov interferona beta-1a dlia podkozhnogo vvedeniia u patsientov s remittiruiushchim rasseiannym sklerozom: rezul'taty pervogo goda nabliudeniia.

AIM: To prove the equivalent efficacy of teberif (BCD-033, interferon beta-1) and rebif (interferon beta-1a) in patients with remitting multiple sclerosis (RMS). MATERIAL AND METHODS: A multicenter double blind placebo-controlled comparative randomized III phase study included 163 patients with RMS. Patients were randomized into three equal groups (teberif, rebif or placebo). RESULTS AND CONCLUSION: After 52 weeks, the equivalent efficacy of teberif and the brand drug rebif was shown. The result of assessment of the primary endpoint, which was combined unique active (CUA) lesion (the total of MRI T1-weighted lesions and new or newly enlarging T2-weighted lesions, without double counting of lesions with both activities), showed no significant differences (0.727±1.042 and 0.652±1.059 (p=0.7354, t-Student test) in the teberif and rebif groups, respectively. No between-group differences were found for other MRI indices and clinical parameters related with relapses. Teberif was shown to have a favorable safety and tolerability profile comparable to that of rebif. The results suggest the therapeutic equivalency of the drugs and form the basis for using the bioanalogue of interferon-beta 1 in patients with RMS.

[A study of the efficacy and safety of L-carnitine in patients with ischemic stroke in the early rehabilitation period]. / Issledovanie bezopasnosti i éffektivnosti L-karnitina u bol'nykh v rannem vosstanovitel'nom periode ishemicheskogo insul'ta.

AIM: To evaluate the efficacy and safety of L-carnitine injections in patients with ischemic stroke (IS) in the rehabilitation period. MATERIAL AND METHODS: Sixty patients in the early rehabilitation period of IS were stratified into two groups. Patients of group 1 received elcar, the 100 mg/ml solution for intravenous and intramuscular injection, in dose of 500 mg intramuscular 2 times a day during 7 days, with the second course after 10 days, in the complex treatment of the 2nd stage of poststroke rehabilitation. Patients of group 2 received conventional therapy. Treatment efficacy was assessed at end points: 1st visit (the 1 st day of treatment), 2nd visit (the 7-10th day), 3rd visit (28-30th day).The following scales were used: NIHSS, the Barthel index, MFI-20, HADS, the Visual Analogue Scale. RESULTS AND CONCLUSION: L-carnitine significantly improved the quality of life of the patients. The frequency of complaints of cerebral and somatic character decreased significantly which was combined with a reduction in the severity of neurological deficit on the NIHSS. Moreover, the decreased levels of general asthenia and psychoemotional defect were observed that resulted in the reduction of the percentage of patients who needed help according to the Barthel index.

[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.

[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.