[Staged treatment of a patient with malignant ischemic cerebral infarction]. / Sluchai etapnogo lecheniya patsienta so zlokachestvennym ishemicheskim infarktom mozga.

The authors discuss surgical decompression of the brain in patients with malignant ischemic cerebral infarcts. Successful staged treatment of a middle-aged patient with malignant ischemic stroke in the middle cerebral artery basin is presented.

[Multicenter experience of using Fortelyzin during staged reperfusion therapy of acute ischemic stroke in anterior circulation]. / Opyt mnogotsentrovogo primeneniya preparata Fortelizin pri provedenii etapnoi reperfuzionnoi terapii ostrogo ishemicheskogo insul'ta v karotidnoi sisteme.

OBJECTIVE: To evaluate the safety and efficacy of Fortelyzin in the performance of staged reperfusion therapy for acute ischemic stroke (intravenous thrombolytic therapy plus mechanical thrombectomy) in anterior circulation within the FORTA RF multicenter pilot study. MATERIAL AND METHODS: The study included 72 patients with acute ischemic stroke in anterior circulation, who underwent staged reperfusion therapy in four vascular centers of the Russian Federation from December 2019 to January 2023. RESULTS: The mean time from illness onset to hospitalization was 94.5 minutes in the Fortelyzin group and 97.2 min in the Actilyse group (p=0.78). The time from the moment of hospitalization to the admission of the patient to the X-ray operating room was significantly lower in the Fortelyzin group (p=0.002). The incidence of symptomatic hemorrhagic transformations in the Fortelyzin group was 6%, in the Actilyse group - 8% (p=0.75). A favorable functional outcome in the first group was observed in 47% of patients, in the control group in 42% (p=0.66). Mortality in both groups did not differ significantly and amounted to 22% and 25%, respectively. CONCLUSION: The first results of the FORTA RF multicenter study demonstrate the safety and efficacy of Fortelyzin in staged reperfusion therapy compared to Actilyse.

[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.

[Pathogenetic and clinical features of cerebral venous thrombosis]. / Patogeneticheskie i klinicheskie osobennosti tserebral'nykh venoznykh trombozov.

OBJECTIVE: To study the etiopathogenetic and clinical features of inpatients with venous thrombosis. MATERIAL AND METHODS: The analysis of 25 medical cases of patients with venous thrombosis was performed. RESULTS: Cerebral venous thrombosis most often developed in females (88%), the average age was 36 years. The most frequent localization of thrombosis was observed in the transverse sinus, as independently (40%) and in combination with thrombosis of other sinuses. Headache was the main clinical sign that could be a single feature or accompanied by other neurological symptoms. In 13 patients (86.6%), multiple polymorphisms in blood coagulation genes (more than 4 mutations) were identified. All patients were prescribed anticoagulant therapy. In all cases, there were positive dynamics of the patients' condition, in the form of a decrease in the intensity of headache or complete regression of cephalalgia, neurological symptoms regressed in 20 patients (80%), there was no fatal outcome. CONCLUSION: If central venous thrombosis is detected, especially in young people, an analysis for genetic polymorphism of the blood coagulation system and the folate cycle should be carried out. This will allow timely development of secondary prevention and reduce the risk of recurrent thrombosis.

[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.