A retrospective, multi-center cohort study evaluating the severity- related effects of cerebrolysin treatment on clinical outcomes in traumatic brain injury.
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.
Department of Clinical Neurosciences, University of Medicine and Pharmacy "Iuliu Hatieganu", Victor Babeș Street No. 8, 400012 Cluj-Napoca, Romania. dafinm@ssnn.ro.
Dafin F
DF
Muresanu
Alexandru V
AV
Ciurea
Radu M
RM
Gorgan
Eva
E
Gheorghita
Stefan I
SI
Florian
Horatiu
H
Stan
Alin
A
Blaga
Nicolai
N
Ianovici
Stefan M
SM
Iencean
Dana
D
Turliuc
Horia B
HB
Davidescu
Cornel
C
Mihalache
Felix M
FM
Brehar
Anca S
AS
Mihaescu
Dinu C
DC
Mardare
Aurelian
A
Anghelescu
Carmen
C
Chiparus
Magdalena
M
Lapadat
Viorel
V
Pruna
Dumitru
D
Mohan
Constantin
C
Costea
Daniel
D
Costea
Claudiu
C
Palade
Narcisa
N
Bucur
Jesus
J
Figueroa
Anton
A
Alvarez
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000596:Amino Acids / Q000627:therapeutic use*; D000704:Analysis of Variance; D001930:Brain Injuries / Q000188:drug therapy*; D015331:Cohort Studies; D004185:Disability Evaluation; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009460:Neurologic Examination; D018696:Neuroprotective Agents / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D055815:Young Adult
D000596:Amino Acids; D018696:Neuroprotective Agents; C006952:cerebrolysin