Affiliation:
1. National Medical Research Center for Therapy and Preventive Medicine;
Yevdokimov Moscow State University of Medicine and Dentistry
2. National Medical Research Center for Therapy and Preventive Medicine
Abstract
Introduction. Given due regard to the urgency of the issue of pharmaceutical support in neurorehabilitation after stroke, an open multicenter study was designed and conducted.Aim. To evaluate the efficacy and safety of therapy with Brainmax®, which is an original combination of two drugs: ethylmethylhydroxypyridine succinate (EMHPS) (100 mg/ml) and meldonium dihydrate (100 mg/ml) in the form of a solution for intravenous and intramuscular injections in patients with ischemic stroke in the acute and early recovery period.Materials and methods. The study included 60 patients aged 18 to 80 years with the first ischemic stroke in the carotid or vertebrobasilar system, meeting the inclusion/exclusion criteria. The total duration of therapy was 24 days. The efficacy of therapy was assessed using the following tools: modified Rankin Scale (mRS), National Institutes of Health Stroke Scale (NIHSS), Rivermead Mobility Index (RMI), Montreal Cognitive Assessment scale (MoCA).Results. All patients showed improvement of their general condition by the end of therapy. The vast majority of patients noted that they had fewer difficulties with movement, self-care and daily activities as compared to the first visit. There was also a significant improvement in the total scores on the NIHSS scale, the Rivermead Mobility Index, and the Montreal Cognitive Assessment Scale (p < 0.05) by the end of therapy. The proportion of patients with reported adverse events (AEs) accounted for 3.33%. All AEs were transient and did not require cessation of the therapy. No serious side effects were recorded in any of the groups.Conclusions. The study showed significant improvement of the key symptoms of ischemic stroke: regression of neurological deficit, functional and cognitive impairment. On top of that, it was noted that the incidence of adverse events associated with the use of Brainmax® was low, which did not lead to cessation of therapy. No serious side effects were recorded in any of the groups.
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