[Results of an international multicenter, randomized, double-blind, placebo-controlled study assessing the efficacy and safety of sequential therapy with Mexidol and Mexidol FORTE 250 in patients with chronic brain ischemia (MEMO)]. / Rezul'taty mezhdunarodnogo mnogotsentrovogo randomizirovannogo dvoinogo slepogo platsebo-kontroliruemogo issledovaniya otsenki effektivnosti i bezopasnosti posledovatel'noi terapii patsientov s khronicheskoi ishemiei mozga preparatami Meksidol i Meksidol FORTE 250 (issledovanie MEMO).

OBJECTIVE: To assess the efficacy and safety of sequential therapy with Mexidol solution for intravenous and intramuscular administration, 50 mg/ml and Mexidol FORTE 250 film-coated tablets, 250 mg in patients with chronic brain ischemia (CBI). MATERIAL AND METHODS: An international multicenter, randomized, double-blind, placebo-controlled trial, conducted in 15 clinical centers located in Russian Federation and Republic of Uzbekistan, included 318 patients with CBI aged 40 to 90 years. The patients were randomized into 2 groups, the patients of the 1-st group received Mexidol intravenously 500 mg once daily for 14 days, followed by Mexidol FORTE 250 - 250 mg 3 times a day orally for 60 days; patients of the 2-nd group received a placebo in a similar mode. The primary endpoint was the mean value of difference by MoCA scale at the point of completing the therapy comparing to initial value. RESULTS: According to the results of the assessment of the primary endpoint, statistically significant changes in the MoCA scores at the stage of completion of study were revealed when comparing the dynamics between the 1-st and 2-nd groups (p<0.000001). The lower limit of the 95% confidence interval for the difference in the average of the main efficacy endpoint between the 1-st and 2-nd groups was 1.51, which allows to state a higher efficacy of the use of Mexidol. According to the estimates of secondary endpoints, a statistically significant advantage over placebo at the last visit achieved while evaluation by the following scales and tests: digit symbol substitution test, MFI-20 asthenia assessment scale, Beck anxiety scale, Vane questionnaire, Tinetti scale, SF-36 questionnaire (mental component of health), CGI scale. The comparable nature of the safety profile of Mexidol and Placebo was established. CONCLUSION: The validity and expediency of the use of Mexidol and Mexidol FORTE 250 in the treatment of patients with CBI has been demonstrated.

[Clinical features of asthenia in the context of adjustment disorders]. / Klinicheskie osobennosti astenii v ramkakh rasstroistv adaptatsii.

OBJECTIVE: To study asthenic symptoms in patients with adjustment disorders and to assess the efficacy of cytoflavin in their treatment. MATERIAL AND METHODS: The study included 100 patients, aged 20 to 43 years, with a diagnosis of adjustment disorder. Clinical, neurophysiological and parametric methods were used. An asthenic state scale, the Multidimensional Fatigue Inventory (MFI-20), a digital rating scale (a 10-point variant) and the Headache Impact Test (HIT-6), the Psychological Stress Measure (PSM-25), the Cognitive Emotion Regulation Questionnaire, the Test of Variables of Attention (TOVA) were administered. Cytoflavin was used in a dose of 2 tab. 2 times a day for 25 days for the treatment of patients from the study group. RESULTS: In the study group, 48.0% of patients had a pronounced degree of asthenia, and 52% had a moderate one. The clinical improvement was achieved in 73.0%. In the subgroup with moderate asthenia, the improvement was recorded in 88.5% of cases, in the subgroup of patients with severe asthenia in 56.3% of patients. There was a significant decrease in the severity of indicators on the scales of general asthenia, decreased activity and mental asthenia; a significant decrease in the integral indicator of mental tension, a significant improvement in the indicator of attention, a decrease in the frequency and intensity of headache. The improvement in the functional state of the brain in the form of a decrease in the power of the alpha rhythm in the anterior cerebral cortex was shown. CONCLUSION: The results of the study allow us to conclude that the use of cytoflavin is effective in the treatment of adjustment disorders.

[Features of cerebral venous hemodynamic in patients with hypertensive encephalopathy]. / Osobennosti tserebral'noi venoznoi gemodinamiki u bol'nykh s gipertonicheskoi entsefalopatiei.

OBJECTIVE: To study the characteristics of main clinical and diagnostic indicators of cerebral venous circulation and their dynamics in patients with hypertensive encephalopathy of various stages treated with cytoflavin. MATERIAL AND METHODS: Clinical and instrumental data of the examination of 105 patients with the established diagnosis of hypertensive encephalopathy of various stages were analyzed. Cerebral hemodynamics was investigated using transcranial duplex scanning of the veins and sinuses of the brain. Patients (n=85) with diagnostic signs of cerebral venous dysfunction were stratified into two groups by treatment regimen: main group (n=39) received standard antihypertensive therapy with cytoflavin (2 tablets 2 times a day from 1 to 30 days), the control group (n=46) received standard treatment. Control studies of cerebral hemodynamics were performed in both groups on the 30th and 60th day from the start of therapy. RESULTS AND: Conclusion. The patients who received cytoflavin in the treatment regimen showed a slight improvement on the 30th day and a significant improvement in venous cerebral circulation indicators on the 60th day (p<0,05), which made it possible to conclude that the drug is effective for improving cerebral venous hemodynamics, and to recommend it in the complex therapy of patients with hypertensive encephalopathy of various stages with existing venous cerebral disorders.

[Event-related potentials in moderate cognitive impairment in patients with chronic cerebral ischemia treated with cytoflavin].

Authors compared cognitive functions in 60 patients (main group) with different stages of discirculatory encephalopathy (DE), I, II and III stages. A comparison group included 10 age-matched normals without DE. All patients underwent a clinical-neurological investigation and performed neuropsychological tests (MMSE, the Clock drawing test, Burdon probe) and Spilberger-Khanin test. Cognitive evoked potentials, including P300, were recorded. Results revealed the decrease in performance on neuropsychological tests and P300 components that indicated the slowing of metabolic processes in the cerebral cells of patients with DE. In patients treated with cytoflavin, the activation of metabolic processes in the brain cells that indicated the protection of the cellular cluster clinically manifested itself in neurocognitive and electrophysiological improvements was observed.

[Dynamics of the symptoms of chronic ischemia during the treatment with cytoflavin].

Sixty patients with chronic brain ischemia (discirculatory encephalopathy, I and II stages) were enrolled in the study. Patients of the first group (n=30) were treated with cytoflavin and patients of the second group (n=30) received piracetam prescribed first as injections and then in pills. The treatment duration was 35 days. Standard neurological examination and psychometric assessment of patients and dopplerography of cerebral vessels were carried out. Cytoflavin was shown to have a positive effect on the neurological status. It decreases asthenic, cephalgia and vestibulo-cerebellar syndromes as well as neurological and emotional disturbances reducing the symptoms of depression and anxiety and improving cognitive functions and memory as well as quality of life of patients. The changes were significant compared to those in the group of patients treated with piracetam.