F.A. KHABIROV^1,2, T.I. KHAYBULLIN^1,2, E.V. GRANATOV², S.R. SHAKIRZYANOVA²

¹Kazan State Medical Academy KSMA — Branch Campus of the FSBEI FPE RMACPE MOH Russia, 36 Butlerov Str., Kazan, Russian Federation, 420012

²Republic Clinical Neurology Center, 13 Vatutin Str., Kazan, Russian Federation, 420021 

Khabirov F.A. — D. Med. Sc., Professor, Head of the Department of Neurology and Manual Therapy, Chief Doctor of RCNC, tel. (843) 278-88-29, e-mail: [email protected]

Khaybullin T.I. — Cand. Med. Sc., Associate Professor of the Department of Neurology and Manual Therapy, neurologist, tel. (843) 278-88-29, e-mail: [email protected]

Granativ E.V. — Cand. Med. Sc., neurologist, tel. (843) 278-88-29, e-mail: [email protected]

Shakirzyanova S.R. — neurologist, tel. (843) 278-88-29, e-mail: [email protected]

Objective — to evaluate the efficacy and safety of Cerebrolysin (EVER Neuro Pharma GmbH, Austria) in the treatment of patients with multiple sclerosis (MS) at the stage of relapse regression.

Materials and methods. The study involved 40 patients with remitting MS (McDonald criteria 2010) in stage of MS relapse regression after pulse therapy with methylprednisolone 1000 mg/day №5. The patients were randomized into 2 groups: group 1 (G1, n=20; age 27.4±5.6 y.o.; disease duration — 29.9±11.1 months) received cerebrolysin 20 ml per 200 ml of 0.9% NaCl solution 1 times per day №10; Group 2 (G2, n=20; age — 26.6±4.9 y.o.; disease duration — 30.3±11.9 months) — only 200 ml of 0.9% NaCl solution by the same scheme. Prior and 3-4 weeks after the treatment all patients underwent clinical assessment of vital signs (EDSS), routine laboratory tests, tests of cognitive-motor functions (SDMT), functional capabilities of MS patients (MSFC), visual acuity (LCAT), a comprehensive neurophysiological examinations (CNE), and axion MRI.

Results and discussion. Clinical relapse of MS was categorized into groups as follows: optic neuritis (15% vs. 30%; p=0.26), stem dysfunction (15% vs. 25%; p=0.43), hemispheric dysfunction (50% vs. 35%; p=0.34), transverse myelitis (20% vs. 10%; p=0.38). 17 patients (85%) in G1 and 18 patients (90%) in G2 completed a full course of treatment. Both groups showed significant regression on EDSS (2.0 [1.75; 2.5] vs. 2.5 [1.75; 2.5]), while significant intergroup differences were not found (p = 0.665). G1 showed the more pronounced dynamics of improvement in MSFC and SDMT testing (p=0.038 and p=0.026, respectively). Significant intergroup differences in the dynamics of improvement VCAT values were not found (p=0.658). Also in G1 was revealed greater regression of total variance in the CNE compared to G2 (70.59% vs. 27.78%, p=0.028). According to the MRI data, cerebrolysin treatment was not associated with an increase of contrasted foci, which indicates the lack of inducing effect of the drug on the intrathecal inflammation in MS.

Conclusion. The positive role of cerebrolysin in the stimulation of remyelination process in MS has been confirmed by CNE and the selected treatment regimen has demonstrated its safety.

Key words: multiple sclerosis, relapse, demyelination, remyelination, cerebrolysin.