RESUMO
AIM: To evaluate the efficacy and safety of Brainmax in comparison with ethylmethylhydroxypyridine succinate and trimethylhydrazinium propionate in patients with ischemic stroke in the acute and early recovery period. MATERIALS AND METHODS: An open multicenter randomized study included 180 patients aged 1880 years (mean age 60.917.66 years, men 47.8%) with ischemic stroke in the acute and early recovery period (NIHSS from 3 to 15 points). Patients were randomized to receive Brainmax, ethylmethylhydroxypyridine succinate and trimethylhydrazinium propionate in an equal ratio (n=60). The drugs were administered intravenously for 10 days, followed by a transition to intramuscular injection for 14 days. Efficacy was assessed using the following scales: Modified Rankin Scale, NIHSS, Rivermead Mobility Index, Montreal Cognitive Assessment Scale (MoCA). Safety assessment was carried out according to the presence and structure of adverse events. RESULTS: The mean Modified Rankin Scale score for Visits 3 (day 10) and 5 (day 25) for the group treated with Brainmax was 2.410.85 and 1.440.91 points, for the group EMHPS 2.870.68 and 2.180.85 points, and for the group receiving trimethylhydrazinium propionate 2.870.50 and 2.550.70 points respectively, which reflects the best functional outcome in the Brainmax group (p0.05). Comparison of cognitive function indicators also showed statistically significant differences between the groups of drugs Brainmax and ethylmethylhydroxypyridine succinate. Evaluation according to the MoCA test showed that the use of Brainmax is 20% more effective in restoring cognitive functions (compared to monodrugs). CONCLUSION: The present study confirms the superiority of combination therapy with Brainmax over monotherapy with each of the components.
