[Clinical results and prospects for the use of phenosanic acid in patients with focal epilepsy]. / Klinicheskie rezul'taty i perspektivy primeneniya fenozanovoi kisloty u vzroslykh patsientov s fokal'noi epilepsiei.

OBJECTIVE: To study the efficacy and safety of using a new original synthetic antioxidant - phenosanic acid as an adjunct therapy in patients with focal epilepsy. MATERIAL AND METHODS: A randomized, double-blind, placebo-controlled, parallel-group study evaluated the efficacy and safety of phenosanic acid as an adjunct therapy to basic antiepileptic drugs in 120 patients with focal epilepsy. Primary purpose: to study the dynamic of seizure frequency. Secondary purposes: to study the dynamic of seizure-free days, the dynamics of bilateral tonic-clonic seizures, the results of questionnaires and scales (General Dynamics Assessment, Visual Analogue Scale (VAS), Quality of Life in Epilepsy (QOLIE-31-P), European Quality of Life Questionnaire (EQ-5D), Hospital Anxiety and Depression Scale (HADS), Frontal Asstssment Battery (FAB), Mini-Mental State Examination (MMSE)). RESULTS: Phenosanic acid (Dibufelon) showed statistically significant benefit over placebo in the primary indicator of efficacy (reduction in the frequency of epileptic seizures by at least 50%) and in the secondary indicators. The drug was safe and well tolerated by the patients. CONCLUSION: The addition of phenosanic acid (Dibufelon) to base antiepileptic drugs seems to be perspective because of its positive effect on reducing the number of epileptic seizures, as well as on comorbid disorders in the emotional and cognitive spheres.

[Study of the effectiveness of neuroprotective therapy in restoring motor function in patients during the acute period of ischemic stroke]. / Issledovanie effektivnosti neiroprotektivnoi terapii pri vosstanovlenii dvigatel'noi funktsii u patsientov v ostrom periode ishemicheskogo insul'ta.

OBJECTIVE: The purpose of the work was to study the effect of neuroprotective therapy with Cellex on the features of recovery of movement disorders in patients in the acute period of ischemic stroke. MATERIAL AND METHODS: A single-center randomized study was conducted to assess the efficacy and safety of the use of neuroprotective therapy with Cellex in patients in the acute period of ischemic stroke. The study included 60 patients with a stroke duration of no more than 3 days in the middle cerebral artery area and vertebrobasillar area with moderate and severe central hemiparesis. Patients of the study group received 1 ml of Cellex. subcutaneously 1 time per day for 10 days. All patients received drug therapy and rehabilitation measures within the framework of the standard of care for patients with ischemic stroke. RESULTS: Against the background of the therapy, by the end of the study on days 14-21, the study and control groups showed a significant improvement according to clinical scales: NIHSS, mRS, RMI. The patients of the study group showed a more pronounced recovery of motor function, relative to the comparison group, according to motor scales: «A-D¼ FMA (54 [53; 62] and 42 [34; 51], p=0.03), «E-F¼ FMA (29 [28; 33] and 25 [18; 27], p=0.03), ARAT (47 [48; 57], 32 [24; 48], p=0.046). Among the patients of the study group, by the end of the study, the severity of mild stroke was 67%, relative to the comparison group 11% (χ21df=6.48; p=0.01). The use of neuroprotective therapy in the form of Cellex had a positive effect on both the prognostic score and the long-term assessment according to the SSS scale, due to the regression of motor disorders of the upper and lower extremities. CONCLUSION: The study has demonstrated the effectiveness of the use of neuroprotective therapy in the treatment of movement disorders in patients in the acute period of ischemic stroke. Therapy with Cellex helped to reduce the severity of stroke, and had a positive effect on the prognosis of the disease.

[Therapy of nonspecific lower back pain in patients with high cardiovascular risk]. / Terapiia nespetsificheskoi boli v nizhnei chasti spiny u patsientov s vysokim kardiovaskuliarnym riskom.

AIM: To evaluate the possibility of using symptomatic slow acting drugs for osteoarthritis (SYSADOA) in patients with nonspecific lower back pain and high cardiovascular risk. MATERIAL AND METHODS: The study registered as the observational program 'Possibilities of SYSADOA-therapy in patients with nonspecific lower back pain and high cardiovascular risk' was organized in outpatient clinics with sequential inclusion of patients (n=315) with lower back pain. All patients randomized into 5 main groups by method of envelopes were treated with different SYSADOA. The control group (group 6) included 63 patients without lower back pain syndrome. The duration of follow-up was 9 months. The results of the first 3 months of observation of group 1 treated with chondroitin sulfate (chondroguard) compared to the control group are presented. RESULTS: On the 21st day of therapy, the pain level decreased by more than 62% in group 1. There were no changes in the plasma hemostasis parameters (thrombin time, prothrombin index, activated partial thromboplastin time) and glomerular filtration rate, which was comparable with the control group. CONCLUSION: Chondroguard is safe for patients with comorbid osteoarthritis and high cardiovascular risk both in short and repeated long-term treatment.

[Disorders of arousal: the mechanism of occurrence, neurophysiological features]. / Parasomnii, sviazannye s narusheniem probuzhdeniia iz medlennogo sna: mekhanizm vozniknoveniia, neirofiziologicheskie osobennosti.

The article covers the current state of the problem of disorders of arousal (DOAs). The clinical features and diagnostics of the disease are described in detail. Separately, emphasis is placed on the mechanisms of the occurrence of DOAs and the characteristic changes in the central nervous system. The question of neurophysiological changes preceding the clinical manifestation of DOAs and the concept of local sleep as a physiological basis for the occurrence of DOAs are considered. Current therapeutic approaches in the treatment of these forms of parasomnias are reviewed.

[Diagnosis and treatment of cognitive impairment in patients with chronic cerebral ischemia: the results of observational Russian program DIAMANT]. / Diagnostika i lechenie kognitivnykh narushenii u patsientov s khronicheskoi ishemiei golovnogo mozga: rezul'taty Vserossiiskoi neinterventsionnoi nabliudatel'noi programmy DIAMANT.

AIM: To investigate the efficacy of divaza in outpatients with cognitive disorders and chronic brain ischemia (CBI). MATERIAL AND METHODS: The non-interventional observational program included the data of 2583 outpatients with CBI from 30 cities (8 federal okrugs of the Russian Federation) who were on outpatient neurological treatment and received divaza in a dose of 2 tablets three times a day from Oct 2016 to Jan 2017. Cognitive functions were evaluated using the MoCA scale before and after 3 months of treatment. RESULTS AND CONCLUSION: Cognitive disorders were identified in 90.7% of patients (<26 MoCA scores). After treatment, the mean MoCA score increased from 19.58±5.13 to 23.99±4.21 (p<0.0001), the number of patients with normal cognitive functions rate (≥26 scores) increased from 9.3 to 41.3%, the number of patients with marked cognitive impairment decreased. The drug was well-tolerated by old and very old patients, adverse events were observed rarely (0.6% of cases). The majority of doctors (88.4%) noticed the effect of divaza as significant improvement or improvement, and 89.6% of patients valued the effect to be excellent or good. The use of divaza, the drug with endothelioprotective and nootropic effects, is pathogenetically justified and promising in patients with cognitive disorders of vascular etiology.

[Results of a randomized double blind multicenter placebo-controlled, in parallel groups trial of the efficacy and safety of prolonged sequential therapy with mexidol in the acute and early recovery stages of hemispheric ischemic stroke (EPICA)]. / Rezul'taty randomizirovannogo dvoinogo slepogo mul'titsentrovogo platsebo-kontroliruemogo v parallel'nykh gruppakh issledovaniia éffektivnosti i bezopasnosti meksidola pri dlitel'noi posledovatel'noi terapii u patsientov v ostrom i rannem vosstanovitel'nom periodakh polusharnogo ishemicheskogo insul'ta (ÉPIKA).

AIM: To evaluate the efficacy and safety of prolonged sequential therapy with mexidol in the acute and early recovery stages of hemispheric ischemic stroke (IS). MATERIAL AND METHODS: A randomized double blind multicenter placebo-controlled, in parallel groups trial included 151 patients (62 men and 89 women) with hemispheric IS. Using a method of simple randomization, 150 patients (62 men and 88 women), aged 40-79 years, were randomized into two groups. Patients of Group I were treated with mexidol: 500 mg/day IV infusion for 10 days, followed by 125 mg tid (375 mg/day) PO for 8 weeks. Patients of Group II received the placebo according to the same scheme. The total duration of patients' participation in trial ranged from 67 to 71 days. RESULTS: By the end of treatment, the mean score on the modified Rankin scale (mRS) was lower in Group I compared to Group II (p=0.04). In Group I, the decrease in mRS mean score (Visit 1-5) was more prominent (p=0.023), percentage of patients with 0-2 scores by mRS scale (Visit 5) was higher (p=0.039), mean NIHSS score lower (p=0.035) in Visit 5 compared to group II. By the end of treatment, the decrease in mean NIHSS score in patients with diabetes mellitus was more prominent in Group I in comparison with Group II (p=0.038). In Group I, the dynamic of improvement of quality of life was more prominent and started from Visit 2 in general population and subpopulation of patients with diabetes mellitus. The share of patients with no problems with movement in space was higher in Group I (p=0.022). There were no statistically significant differences in frequency of side effects in patients of both groups. CONCLUSION: It is recommended to include mexidol in therapy of patients with IS in the acute and early rehabilitation stages.

[Anxiety-related blood pressure variability in patients with atrial fibrillation after cardioembolic stroke]. / Trevozhno-assotsiirovannaia variabel'nost' arterial'nogo davleniia u patsientov s fibrilliatsiei predserdii, perenesshikh kardioémbolicheskii insul't.

AIM: To investigate whether of anxiety-related blood pressure (BP) variability can be corrected in patients with atrial fibrillation (AF) who have experienced cardioembolic stroke (CES). SUBJECTS AND METHODS: The investigation enrolled 125 patients (mean age, 68.5±5.7 years) with AF, who had experienced CES. The patients were randomized into 2 groups by the envelope technique: 1) 63 patients received antihypertensive drugs and an anxiolytic (adaptol) (a study group); 2) 62 patients had antihypertensive drugs only (a comparison group). Effectiveness was evaluated 2 and 6 weeks later from the time course of changes in BP readings obtained by 24-hour Holter monitoring in relation to reactive anxiety (RA) and personal anxiety (PA) scores. The latter were determined using the Spielberger-Hanin Anxiety Self-Esteem scale. RESULTS: The patients with AF who had experienced CES were noted to have high BP variability associated with increased RA and PA scores. Group 1 showed statistically significant improvements in RA and PA 2 and 6 weeks after the start of treatment. The efficiency of anti-anxiety therapy (adaptol at a dose of 500 to 1500 mg/day) in combination with antihypertensive drugs is confirmed by the normalized circadian BP profile. CONCLUSION: The incorporation of an anxiolytic into pharmacotherapy regimens could improve BP, namely, to reduce and stabilize its circadian profile.

[Primary progressive multiple sclerosis: current issues of timely diagnosis]. / Pervichno-progressiruiushchii rasseiannyi skleroz: sovremennoe sostoianie problemy svoevremennoi postanovki diagnoza.

This article presents a review of international data on primary progressive multiple sclerosis (PPMS) and an analysis of factors influencing timely diagnosis of PPMS in a number of regions of the Russian Federation.

[Cerebrovascular risks and prediction of complications in patients with backache during therapy with nonsteroidal anti-inflammatory drugs].

AIM: To study the impact of therapy with nonsteroidal anti-inflammatory drugs (NSAIDs), such as diclofenac, meloxicam, etoricoxib, and nimesulide, on systolic and diastolic blood pressure (BP) changes in a short period (3 days), as well as the risk of acute transient ischemic attack, ischemic and hemorrhagic stroke, and acute cardiovascular events within 6 months after NSAID use. SUBJECTS AND METHODS: The follow-up included 66 patients (34 women and 32 men) who took NSAIDs for emergent low back pain. RESULTS: The findings may suggest that etoricoxib-based therapy is highly effective and relatively safe for the management of acute nonspecific backache in patients with comorbidity. The important feature is the established tendency towards BP destabilization in patients with chronic cerebrovascular diseases treated with NSAIDs (diclofenac, meloxicam, to a lesser extent, nimesulide). After completion of drug intake for 14 days or longer, acute cerebral circulatory disorder and acute cerebrovascular event developed within 4.5 months in 3 and 2 patients, respectively. CONCLUSION: Thus, the spectrum of possible adverse cardiovascular effects of NSAIDs is rather broad. It is advisable to identify two major groups of NSAID-associated complications: 1) destabilized hypertension; 2) cardiovascular and cerebrovascular events.

[Current pharmacotherapy of the autonomic nervous system disorders]. / Sovremennaya farmakokorrektsiya rasstroistv vegetativnoi nervnoi sistemy.

A state of the autonomic nervous system is known to play an important role in complex treatment of any somatic pathology. The drugs with complex anxiolytic, autonomic stabilizing and nootropic effects are used in treatment of autonomic disorders. These drugs stabilize as the general mental condition, including emotional state, as well as the autonomic condition of patients with somatic disorders. These notions are discussed in detail on the example of noofen and adaptol.

[Diagnosis and treatment of asthenic syndrome in elderly people after acute respiratory viral infection].

OBJECTIVE: To study the characteristics of asthenic syndrome in elderly people after acute respiratory viral infection. MATERIAL AND METHODS: We examined 87 patients with chronic cerebral ischemia and other comorbid disorders, aged from 63 to 78 years. Patients were randomized to two groups. Patients of the main group received mexidol (1 tablet (125 mg) 3 times a day during 3 weeks) along with standard treatment. Patients of the control group received standard treatment only. All patients underwent neuropsychological testing for the assessment of symptoms of asthenic syndrome. RESULTS AND CONCLUSION: A comparative analysis of the patient's condition in both groups has demonstrated a reduction in symptoms of asthenia, autonomic lability and cognitive deficit in patients treated with mexidol.

[Posture disorders in patients with multiple sclerosis]. / Osobennosti postural'nykh narushenii u bol'nykh rasseiannym sklerozom.

Impairment of stability in the vertical posture is one of the most common or, sometimes, a key symptom in patients with multiple sclerosis (MS). Reduction of postural control is often correlated with the severity of neurological deficit and is thought to be a leading factor that impacts on social and working activities of the patient with MS. We studied disturbances of postural control depending on the lesion of a functional system and evaluated the involvement of a corresponding system in the functions of postural control in 61 patients with confirmed MS. Patients were stratified into five groups according to lesion location: visual, motor, sensory, cerebellar or spine stem systems. The maximal impairment of static postural control corresponded to the maximal lesion of the sensory system. Compensatory mechanisms of the activation of central and neuromuscular.

[Preliminary results of the realization of the Federal program on improvement of medical care to stroke patients in the Samara region].

In the Samara oblast, cardiovascular diseases take the first place (53%) in the structure of total mortality. Due to the realization of the Federal program on improvement of medical care to patients with cardiovascular diseases, morbidity rates of acute blood circulation disorders decreased from 343 to 326 per 100 000, mortality rates decreased from 145,7 to 87,4 per 100 000 and percent of discharged patients who were independent in daily life increased from 50,8% in 2010 to 64,2% in 2012. Positive results of the organization of specialized care to stroke patients demand the implementation of this experience on the whole territory of the Samara oblast.

[Assessment of the risk of the transition of a monofocal clinically isolated syndrome to clinically definite multiple sclerosis].

We followed up 102 patients with a monofocal clinically isolated syndrome (CIS) during 8 years. Factors determining its transition to definite multiple sclerosis were singled out according to the data of anamnesis and MRI scans. Age of patients at the onset of CIS and the volume of demyelination measured by the first MRI were the most significant predictors of the transition of CIS to definite multiple sclerosis. A mathematical model based on logistic regression analysis for the estimation of the risk of this transition is suggested.

[The results of Russian multicenter open-label observational study of the efficacy and safety of мelaxen (melatonin) for the treatment of disordered sleep in patients with chronic cerebral ischemia].

The results of the multicenter open-label observational study of the efficacy and safety of the Melaxen (melatonin) for the treatment of disordered sleep in patients with chronic cerebral ischemia are presented. 2062 patients were studied with the use of subjective psychometric scales: subjective sleep characteristics scale, sleep apnea screening questionnaire, Epworth sleepiness scale, hospital anxiety and depression scale. Mean age of patients was 55.7±9.0 years, there were 74.1% females and 25.9% males. Melaxen was given in dosage of 3 mg. before sleep for 24 days. The use of Melaxen leads to the increase of subjective sleep quality by the subjective sleep characteristics scale from 19.7±3.1 points to и 22.7±3.4 points on day 14 and 22.7±3.4 on day 24 (differences are significant at p<0.0001). There was the decrease of the relative number of patients with frequent night awakenings, prolonged sleep latency, short night sleep, poor quality of morning awakening and multiple bothering dreams. Authors conclude that the use of Melaxen in dosage of 3 mg before sleep is effective and safe insomnia treatment in patients with chronic cerebral ischemia.

[Efficacy and tolerability of pantogam activ in patients with partial epilepsy].

Randomized double-blind, placebo-controlled study to determine efficacy and tolerability of pantogam activ as an add-on drug in patients with partial epilepsy was conducted. 20 patients received pantogam activ, 20 patients - placebo. Good tolerability and no advers event were detected in the dose of 1800 mg/d. The reduction in the frequency of epileptic seizures was achieved in 72,1% in the group receiving pantogam activ and in 16,7% in the group placebo. Significant improvement in long-term memory and manifestations of anxiety were found in patients using pantogam activ. Quality of life in scale QOLIE-31 improved after taking pantogam and did not change after placebo.

[Some problems in rehabilitating disabled people with multiple sclerosis in agencies for social protection].

The state social policy with regard to disable people in the Russian Federation is developed in accordance with international instruments which include the "Declaration on the Rights of People with Disabilities" adopted by the UN General Assembly, the ILO Convention (No159) "Vocational Rehabilitation and Employment of Disabled Persons", the "Standard Rules on the Equalization of Opportunities for Persons with Disabilities" adopted by the UN General Assembly, the World Program of Action Concerning Disabled Persons etc. All these instruments mainly focus on the issue of social rehabilitation of people with health disabilities in order to offer them "equal opportunities" in different areas of their life. The paper is devoted to research of some backbone arrangements of rehabilitation of people with multiple sclerosis (MS) and major lines of proficiency training and retraining of professionals on issues of social rehabilitation of people with health disabilities as well as methods of rehabilitation of MS patients.

[Epilepsy and pregnancy].

Course and outcome of 200 pregnancies, deliveries and post-partum periods of 127 women with the onset of epilepsy before or during pregnancy were compared to clinical form of the disease, frequency of seizures and antiepileptic therapy. In addition, 104 children born to 97 mothers with epilepsy, 85 children--from the moment of birth to 1 year old and others from 1 to 16 years old, were studied. The particular attention was focused on the early neonatal adaptation. It was shown that, along with the last weeks of pregnancy, the first 7 days period after the delivery was critical for epilepsy severity. The development of seizures at this period was related to sleep deprivation and marked hormonal changes. There were no significant changes between the body mass of newborns of mothers with epilepsy and those of healthy mothers. The period of neonatal adaptation in children of affected mothers was favorable in 46% of cases. Some peculiarities of a child's state (withdrawal syndrome, hepatitis A etc.) were mostly related to the treatment of a mother with high dosages of antiepileptic preparations, i.e. valproic acid. These disturbances vanished to the age of 1-3 years. In summary, the active supervision of women by an epileptologist during the pregnancy period allows to optimize the prognosis of the child's health and better course of epilepsy in the mother.