Clinical Outcome and Safety of Cerebrolysin® For Neurological Recovery after Traumatic Brain Injury and Stroke
Keywords:
Cerebrolysin, Functional neurorecovery, Severe Disability, Traumatic brain injuryAbstract
Background: Traumatic brain injury and stroke lead to a brain dysfunction and complex neurological sequelae despite aggressive surgical intervention and secondary brain injury prevention. However, alternative neuromodulation therapies can be a potential modality. Cerebrolysin is the drug which contains peptides derived from the brain of a pig that has potential neuroprotective properties and may help to protect and repair brain cells.
Objective: To compare the efficacy and safety of Cerebrolysin with usual care.
Methods: Randomized single blind study from December 2016 to May 2022. 68 Subjects including all the adult patients with severe disability (GOS of 2 and 3) after trauma or stroke. Patients were classified to receive cerebrolysin (n=32) and usual care (n=36). Cerebrolysin was administered intravenously in 30 mL dosage daily for 21 days. The 6-month NIHSS, Barthel Index and modified Rankin Scale were recorded. The outcome scales, safety and complications were compared between two study groups.
Results: Baseline characteristics were comparable between two groups. We found that NIHSS and modified Rankin Scale were significantly lower in those receiving cerebrolysin [6.40 ± 2.13 vs 10.02 ± 3.75 (p = 0.013) and 2.34 ± 0.11 vs 3.2 ± 0.46 (p=0.048)] and Barthel Index was significantly higher in those receiving cerebrolysin [77.23 ± 11.71 vs 68.82 ± 9.63 (p = 0.025)]. Cerebrolysin administration was associated with lower mortality rate, and no significant in seizure, cardiovascular complication, recurrent ischemic stroke and intracerebral hemorrhage.
Conclusion: Cerebrolysin administration is associated with improved functional neurorecovery and increased favorable outcome.
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