Title:A Retrospective, Multi-Center Cohort Study Evaluating the Severity- Related Effects of Cerebrolysin Treatment on Clinical Outcomes in Traumatic Brain Injury
VOLUME: 14 ISSUE: 5
Author(s):Dafin F. Muresanu, Alexandru V. Ciurea, Radu M. Gorgan, Eva Gheorghita, Stefan I. Florian, Horatiu Stan, Alin Blaga, Nicolai Ianovici, Stefan M. Iencean, Dana Turliuc, Horia B. Davidescu, Cornel Mihalache, Felix M. Brehar, Anca . S. Mihăescu, Dinu C. Mardare, Aurelian Anghelescu, Carmen Chiparus, Magdalena Lapadat, Viorel Pruna, Dumitru Mohan, Constantin Costea, Daniel Costea, Claudiu Palade, Narcisa Bucur, Jesus Figueroa and Anton Alvarez
Affiliation:Department of Clinical Neurosciences, University of Medicine and Pharmacy “Iuliu Hatieganu”, Victor Babeș Street No. 8, 400012 Cluj-Napoca, Romania.
Keywords:Cerebrolysin, disability, functional recovery, neuroprotection, clinical outcome, traumatic brain injury.
Abstract:Traumatic brain injury (TBI) is a leading cause of death and disability for which there is currently no effective
drug therapy available. Because drugs targeting a single TBI pathological pathway have failed to show clinical efficacy to
date, pleiotropic agents with effects on multiple mechanisms of secondary brain damage could represent an effective
option to improve brain recovery and clinical outcome in TBI patients. In this multicenter retrospective study, we
investigated severity-related efficacy and safety of the add-on therapy with two concentrations (20 ml/day or 30 ml/day)
of Cerebrolysin (EVER Neuro Pharma, Austria) in TBI patients. Adjunctive treatment with Cerrebrolysin started within
48 hours after TBI and clinical outcomes were ranked according to the Glasgow Outcome Scale and the Modified Rankin
Disability Score at 10 and 30 days post-TBI. Analyses of efficacy were performed separately for subgroups of patients
with mild, moderate or severe TBI according to Glasgow Coma Scale scores at admission. Compared to standard medical
care alone (control group), both doses of Cerebrolysin were associated with improved clinical outcome scores at 10 days
post-TBI in mild patients and at 10 and 30 days in moderate and severe cases. A dose-dependent effect of Cerebrolysin on
TBI recovery was supported by the dose-related differences and the significant correlations with treatment duration
observed for outcome measures. The safety and tolerability of Cerebrolysin in TBI patients was very good. In conclusion,
the results of this large retrospective study revealed that early Cerebrolysin treatment is safe and is associated to improved
TBI outcome.
