[New opportunities in the treatment of patients with multiple sclerosis (Resolution of the Council of Experts on April 23, 2022, Moscow, JSC «BIOCAD¼)]. / Novye vozmozhnosti v terapii patsientov s rasseyannym sklerozom¼ (Rezolyutsiya soveta ekspertov 23 aprelya 2022 goda, Moskva, AO «BIOKAD¼).

One of the target areas for the development of the Russian pharmaceutical industry at present is the development of next-in-class drugs medicines. These are original, patent-protected drugs that act on known biological targets, improved or modified in structure and mechanism of action compared to existing, successfully proven medicine. The article presents the results of an expert council on the management of patients with multiple sclerosis and the place of new original medicines of the JSC BIOCAD company (SamPEG-IFN-ß1a and divozilimab) in multiple sclerosis therapy algorithm.

[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.

[Cervical myelopathy in the hyperkinetic form of cerebral palsy: combination of botulinum therapy with surgical treatment]. / Tservikal'naia mielopatiia pri giperkineticheskoi forme detskogo tserebral'nogo paralicha: sochetanie botulinoterapii s khirurgicheskim lecheniem.

The article describes the case of cervical myelopathy with tetraparesis and sphincter disorders, as a complication of cervical dystonia in a patient with hyperkinetic form of cerebral palsy. Left-side laterocollis in combination with the same side laterocaput was noted. Myelopathy symptoms progressed gradually over one year. The main clinical problems were: the inability to conduct a qualitative MRI study due to hyperkinesis, which required anesthesia, and the high risk of perioperative complications and relapses of cervical myelopathy. Before the surgery, botulinum therapy of cervical dystonia with abobotulotoxin in the total dose 1000ED was administered that led to regression of hyperkinesis. Microsurgical decompression of the spinal canal with the installation of fixation system at the level of C7-Th1 vertebrae was performed. After surgery, the neck was fixed with a Philadelphia collar. There were no complications after surgery or displacement of the stabilizing structure. This case report indicates the possibility of development of cervical myelopathy in cervical dystonia and demonstrates the need of pre - and post-operative botulinum therapy of cervical dystonia to prevent possible complications and relapses in the postoperative period.

[S100B protein in the blood of children with autism spectrum disorders]. / Belok S100V v krovi detei s rasstroistvami autisticheskogo spektra.

AIM: To evaluate the plasma content of S100B protein in children with autism spectrum disorders (ASD). MATERIAL AND METHODS: Forty-five children with autism (item F84 of ICD-10), aged from 6 to 15 years, were examined. The control group (KG) consisted of 25 healthy children. The study included examination by specialists, an assessment of the severity of the disease using the Children's Rating Scale of Autism scale (CARS), evaluation of S100B in blood serum. RESULTS: The content of S100B in children with autism was significantly higher in comparison with KG. The level of S100B in children with ASD with abnormal development of brain structures (MRI) was significantly higher compared with KG and a group of children without signs of disturbance of brain structures. S100B levels were higher in children with severe ASD, and differed from controls in children with moderate ASD. CONCLUSION: The majority of children with ASD show signs of stress of neuroprotective mechanisms, and children with anomalies of brain structures have signs of hypoxia of the brain and damage of the blood-brain barrier.

[The effect of cellex on regenerative processes in cerebral parenchymal hemorrhage under experimental condition]. / Izuchenie vliianiia preparata tselleks na regeneratornye protsessy v tkani golovnogo mozga pri modelirovanii parenkhimatoznogo krovoizliianiia u zhivotnykh.

AIM: To study an effect of the protein-peptide preparation cellex on the cerebral tissue processes in case of parenchymal hemorrhage breed under experimental conditions. MATERIAL AND METHODS: The research involved the morphological examination of fragments of cerebral tissues of 57 rabbits of Chinchilla breed in artificially-provoked hemorrhagic stroke. Animals were divided into 2 groups: the first group received cellex once a day during 10 days, the second group received physiological solution in the same doses. The cerebral tissue was examined macroscopically and with histological, immunocytochemical and morphometric methods with subsequent data analysis. RESULTS AND CONCLUSION: A much more pronounced regression of the neurological deficit was observed in the group of animals which were administered cellex. There was a significant increase in volume of active movements in the limbs. No connective tissue changes were observed macroscopically in rabbits of the first group. Besides, the area of destruction decreased in size in comparison with initially diagnosed one. A decline in the rate of the formation of connective tissue was observed in damaged parts of the brain. The microscopic study of the first group showed that the degree of inflammatory and hemodynamic disturbances was much lower and necrosis foci were not detected, however small foci of neoangiogenesis were found.

[Growth factors and neurotrophic control in the 'motoneuron - muscular fiber' system in children with cerebral palsy]. / Rol' rostovykh faktorov i neirotroficheskogo kontrolia v sisteme 'motoneiron-myshechnoe volokno' pri detskom tserebral'nom paraliche.

The article deals with the role of neurotrophic and growth factors in the development and functioning of the nervous system. The authors present general information on neurotrophic control and its role in the interaction of motor neurons and innervated muscle fibers.