Efficacy and Safety of Butylphthalide for Neurological Recovery After Cardiac Arrest: A Pilot Randomized Controlled Trial

ABSTRACT Background and Aims Butylphthalide (NBP) is a neuroprotective agent that ameliorates cerebral ischemia‐hypoxia and reperfusion injury. However, evidence regarding whether NBP can improve neurological prognosis in patients with cardiac arrest (CA) remains limited. The present study aims to evaluate the efficacy and safety of butylphthalide treatment in improving neurological function in patients with cardiac arrest. Methods This research constituted a single‐center, randomized, double‐blind, placebo‐controlled trial. Those meeting the inclusion criteria were randomly allocated to either the NBP group or the Placebo group at a 1:1 ratio. The primary outcome was the proportion of patients with a Cerebral Performance Category (CPC) score of 1 or 2 in each group at 90 days after randomization. Results A total of 70 patients were included in the final analysis, of whom 34 were in the placebo group and 36 in the NBP group. No statistically significant differences were observed in baseline characteristics between the two groups ( p > 0.05). Similarly, no statistically significant differences were noted between the two groups in the proportion of patients with CPC scores of 1 or 2 at 90 days, in‐hospital mortality, or Glasgow Coma Scale (GCS) scores at discharge ( p > 0.05). However, compared with the placebo group, the NBP group exhibited significantly lower levels of brain injury biomarkers, including neuron‐specific enolase (NSE), glial fibrillary acidic protein (GFAP), and ubiquitin C‐terminal hydrolase L1 (UCHL1), after 14 days of treatment ( p < 0.001). Additionally, no statistically significant differences were found between the two groups in terms of safety outcomes ( p > 0.05). Conclusion Although butylphthalide treatment significantly reduced levels of brain injury biomarkers in patients with cardiac arrest, it did not significantly improve their 90‐day neurological prognosis.