[Intravenous thrombolytic therapy of ischemic stroke with the drug Revelisa in real clinical practice: results of the IVT-AIS-R study]. / Vnutrivennaya tromboliticheskaya terapiya ishemicheskogo insul'ta preparatom Reveliza v real'noi klinicheskoi praktike: rezul'taty issledovaniya IVT-AIS-R.

OBJECTIVE: Evaluation of the safety and effectiveness of thrombolytic therapy (TLT) with the drug Revelisa (alteplase) in patients with ischemic stroke (AI) in real clinical practice. MATERIAL AND METHODS: An open prospective multicenter non-interventional register study was conducted, which included 550 patients with AI - 259 (47.1%) women and 291 (52.9%) men; average age 67.7±12.6 years. All included patients underwent TLT with the drug Revelisa within 4.5 hours from the onset of the disease and, according to the protocol of reperfusion therapy of AI, clinical, instrumental and laboratory examinations were performed. Symptomatic hemorrhagic transformation (GT) was determined in accordance with the criteria of the ECASS 3 study. RESULTS: The majority of patients (95.8%) suffered from hypertension, 69.6% had chronic heart failure, 53.8% had coronary heart disease, 38.7% had various cardiac arrhythmias, 20.7% of patients suffered from type 2 diabetes mellitus. A day after TLT, an improvement of 4 points or more on the NIHSS scale was noted in 45% of patients. The average dynamics index on the NIHSS stroke scale after a day was -3.2±4.7 and -4.4±6.1 per 7 females (p<0.0001). GT of the lesion of the brain developed in 10.9% of cases, symptomatic GT was diagnosed in 12 (2.3%) patients. The hospital mortality rate was 12.7%. The proportion of patients with good functional recovery (0-2 points on the modified Rankin scale (mRS)) at discharge, on days 30 and 90 was 44.7%, 59.2% and 68.5%, respectively. CONCLUSION: Performing TLT with the drug Revelisa in patients with AI leads to a statistically significant regression of neurological symptoms. A significant proportion of patients achieve a favorable clinical outcome upon discharge from the hospital and in the long term. The obtained data on the efficacy and safety profile correlate with previously published register studies of alteplase in AI.

[Nonimmunogenic staphylokinase in the treatment of acute ischemic stroke (FRIDA trial results)]. / Neimmunogennaya stafilokinaza ­ novyi tromboliticheskii preparat v lechenii ishemicheskogo insul'ta (rezul'taty issledovaniya FRIDA).

AIM OF THE STUDY: To investigate the efficacy and safety of non-immunogenic staphylokinase (NS) compared with alteplase (A) in patients with acute ischemic stroke (AIS) within 4.5 h after symptom onset. MATERIAL AND METHODS: 336 patients with IS within 4.5 h after symptom onset were included in a randomized, open-label, multicenter, parallel-group, non-inferiority comparative trial of NS vs A (168 patients in each group). NS was administered as an intravenous bolus in a dose of 10 mg, regardless of body weight, over 10 s, A was administered as a bolus infusion in a dose of 0.9 mg/kg, maximum 90 mg over 1 hour. The primary efficacy endpoint was a favorable outcome, defined as a modified Rankin scale (mRS) score of 0-1 on day 90. Safety endpoints included all-cause mortality on day 90, symptomatic intracranial haemorrhage, and other serious adverse events (SAEs). RESULTS: At day 90, 84 (50%) patients reached the primary endpoint (mRS 0-1) in the NS group, 68 (41%) patients - in the A group (p=0.10, OR=1.47, 95% CI=0.93-2.32). The difference between groups NS and A was 9.5% (95% CI= -1.7-20.7) and the lower limit of the 95% CI did not cross the margin of non-inferiority (pnon-inferiority<0.0001). There were no significant differences in the frequency of deaths between the groups: on day 90, 17 (10%) patients in the NS group and 24 (14%) in the A group had died (p=0.32). There was a trend towards significant differences in the frequency of symptomatic intracranial haemorrhage: NS group - 5 (3%) patients, A group - 13 (8%) patients (p=0.087, OR=0.37, 95% CI=0.1-1.13). There were significant differences in the number of patients with SAEs: in the NS group - 22 (13%) patients, in the A group - 37 (22%) patients (p=0.044, OR=0.53, 95% CI=0.28-0.98). CONCLUSION: The presented results of the FRIDA trial are the first in the world to use a drug based on NS in patients with IS. It has been shown that a single bolus (within 10 s) administration of NS at a standard dose of 10 mg, regardless of body weight, allows to conduct fast, effective and safe thrombolytic therapy in patients with IS within 4.5 h after symptom onset. In further clinical tials of NS, it is planned to expand the therapeutic window beyond 4.5 h after symptom onset in patients with IS.

[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.

[Intravenous thrombolytic therapy with Revelisa of ischemic stroke in real-world clinical practice: interim results of an open-label, prospective, multicenter, non-interventional study IVT-AIS-R]. / Vnutrivennaya tromboliticheskaya terapiya ishemicheskogo insul'ta preparatom Reveliza v real'noi klinicheskoi praktike: promezhutochnye rezul'taty issledovaniya IVT-AIS-R.

OBJECTIVE: To assess the safety and efficacy of Revelisa in patients with ischemic stroke in real-world clinical practice. MATERIAL AND METHODS: The interim analysis of an open-label, prospective, multicenter, non-interventional study IVT-AIS-R included 223 patients (50.2% women and 49.8% men, mean age 66.6 (13.5) years) with ischemic stroke who were admitted to the study sites since July 2019 and who, in the absence of contraindications, underwent thrombolytic therapy (TLT) with Revelisa within the first 4.5 hours from the onset of stroke. Data were collected as a continuous sample. According to the reperfusion therapy protocol for ischemic stroke, all patients included in the study underwent clinical examination, investigations and laboratory tests before TLT and within the first days after it. Symptomatic hemorrhagic transformation was determined in accordance with the ECASS 3 criteria. RESULTS: Most of the patients (96%) had hypertension, 74% of patients had chronic heart failure, 57.4% had coronary artery disease, of which 8.5% were patients with a previous myocardial infarction. Various cardiac arrhythmias were observed in 33.2% of cases, 21.5% of patients had type 2 diabetes, 18.4% had a history of previous acute cerebrovascular accidents. Hemorrhagic transformation (HT) of a cerebral lesion developed in 7.1% of cases, with the frequency of symptomatic HT being 3.1% (7 patients). The hospital mortality rate was 13.9%. The median NIHSS score was 4 points (p<0.0001) on day 7 versus baseline. The proportion of patients with good functional recovery (the modified Rankin scale score 0-2) at discharge was 48.2%. CONCLUSION: The data obtained with the use of Revelisa in patients with ischemic stroke in real-world clinical practice allow drawing conclusions about a comparable safety and efficacy profile to that in previously published registry studies of alteplase.

[The efficacy and safety of Mexidol Forte 250 as part of long-term sequential therapy in patients with carotid stroke]. / Éffektivnost' i bezopasnost' preparata Meksidol Forte 250 v ramkakh dlitel'noi posledovatel'noi terapii u bol'nykh s ishemicheskim insul'tom v karotidnoi sisteme.

AIM: To evaluate an effect of long-term sequential therapy with mexidol and mexidol forte on the functional outcome of patients with carotid ischemic stroke. MATERIAL AND METHODS: The study included 50 patients with newly developed carotid stroke, hospitalized in the stroke unit on the first day from the onset of the disease. Patients of the main group (n=25) received mexidol in a dose of 500 mg intravenously once a day for 14 days, then mexidol forte 250 in tabs 250 mg 3 times a day for 60 days. Patients of the comparison group (n=25) received standard basic therapy. The significance of intergroup differences was assessed using the Mann-Whitney test, Fisher's exact test, and relative risk (OR) calculation. Differences were considered significant at a level of p<0,05. RESULTS: After 14 days of therapy, both groups of patients showed a positive trend compared to baseline. At the same time, patients of the mexidol group had a higher MoCA score (U=173,5, p=0,006), a lower score when performing tasks on dynamic praxis (U=214,0, p=0,028) and optical spatial disturbances (U=170,5, p=0,003), better memorization strength (181,5, p = 0,006) and better performance on abstraction MOCA subtest (U=200,5, p=0,014). By the 74th day, the absence of moderate cognitive impairment (MoCA> 26 points) was diagnosed in 17 patients (68%) of the main group and 14 patients (56%) of the comparison group. No significant differences were found. Moreover, patients of the main group had a significantly lower NIHSS score (U=124,0, p<0,001) and a lower degree of disability: a total mRS score 0-2 was achieved in 19 (76%) patients of the main group and only in 12 (48%) patients of the comparison group (OR=3,34, F=0,07, p<0,05). Also, patients receiving long-term sequential therapy with mexidol and mexidol forte 250 had milder spatial disorders than patients of the comparison group. CONCLUSION: Consecutive treatment with mexidol and mexidol forte 250 in the acute and early recovery periods of ischemic stroke positively affects the regression of local neurological symptoms, increases the likelihood of achieving independence in everyday life by 3,34 times, and reduces the severity of optical-spatial, neurodynamic and memory impairments.

[Mexidol in the rehabilitation of patients in the acute ischemic stroke]. / Meksidol v reabilitatsii bol'nykh v ostrom periode ishemicheskogo insul'ta.

UNLABELLED: Research objective - studying of results of a comprehensive neuro-rehabilitation patients in the acute ischemic stroke (according to the Samara regional vascular centre). MATERIAL AND METHODS: A review of the work of RVC on the main indicators for 2014, detailed analysis of 20 patients in the acute period of ischemic stroke, in which treatment was used the drug mexidol with the dynamics on standardized assessment scales (NIHSS, Rankin, Rivermead, MoCA, HADS). RESULTS AND DISCUSSION: The use of «Mexidol¼ in the treatment of stroke leads to a significant statistically and clinically significant improvement in cognitive, motor, sensory functions, reduction of fatigue, anxiety, improved adaptation to physical loads.

[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.