A long-term, complex, unitary appraisal regarding neurorestorative, including neurorehabilitative, outcomes in patients treated with Cerebrolysin®, following traumatic brain injury

Abstract

Cristina O Daia,1,2 Monica Haras,1,2 Tiberiu Spircu,1 Aurelian Anghelescu,1,2 Liliana Onose,3 Alexandru Vlad Ciurea,1,2 Anca Sanda Mihaescu,2 Gelu Onose1,21Carol Davila University of Medicine and Pharmacy, Bucharest, Romania; 2Bagdasar-Arseni Teaching Emergency Hospital, Bucharest, Romania; 3Metrorex – The Medical Service, Bucharest, RomaniaBackground: Neuroprotection is a modern therapeutic concept that has some useful outcomes discussed in the literature, including for traumatic brain injury (TBI).Scope and study design: This was a retrospective case-control study that was approved by the bioethics commission of the Bagdasar-Arseni Teaching Emergency Hospital, Bucharest, Romania. The aim of the study was to comparatively assess neurorestorative, including neurorehabilitative, outcomes obtained with or without Cerebrolysin®.Materials and methods: Nineteen cases treated with Cerebrolysin versus 28 who did not receive this drug were included in this study. All cases had a subacute or post-acute status after TBI and were hospitalized (only at their first admission) between January 2005 and December 2010 in the hospital's NeuroRehabilitation Clinic Division. Epidemiological, clinical, paraclinical, and functional parameters were evaluated, using the: Functional Independence Measure (FIMTM), Glasgow Outcome Score (GOS), and Modified Rankin Scale.Results: Patients in the Cerebrolysin group had, on average, higher (although not statistically significant) FIM evolution values (36.53) than the control group (29.64) (P=0.174, 95% confidence interval: -8.0 to 21.8). The effect size assessed on the GOS was 2.1%. Additionally, the mean FIM value at admission of the Cerebrolysin group (45.79) was lower than that of controls (61.50; P=0.076).Discussion and conclusion: The clinical/functional evolution, comparatively evaluated in the studied inpatients, and taking into account the small sample and effect sizes – including for GOS – suggest that Cerebrolysin, correctly indicated and administered, may perhaps contribute to some improvement of post-TBI patients' overall neurorestorative/rehabilitative outcomes; this given the short period (approximately 1 month) over which the medicine's action was evaluated, the lower FIM mean value at admission in the Cerebrolysin group, and respectively that, for severe central nervous system lesions – including after TBI – and consequent conditions, it cannot yet be concluded that any therapeutic approaches, such as Cerebrolysin, can significantly improve post-injury outcomes.Keywords: neuroprotection, Functional Independence Measure (FIM), brain trauma