Effectiveness of butylphthalide on cerebral autoregulation in ischemic stroke patients with large artery atherosclerosis (EBCAS study): A randomized, controlled, multicenter trial
Zhen‐Ni Guo, Bing-Hong Yue, Lei Fan, Jie Liu, Yuanyuan Zhu, Yuanqi Zhao, Jingxin Zhong, Zhan Lou, Xingliang Liu, Reziya Abuduxukuer, Peng Zhang, Yang Qu, Zi‐Duo Shen, Baoyang Shi, Kejia Zhang, Jia Liu, Junlei Chang, Hang Jin, Xin Sun, Yi Yang
Abstract
Finding appropriate drugs to improve cerebral autoregulation (CA) in patients with acute ischemic stroke (AIS) is necessary to improve prognosis. We aimed to investigate the effect of butylphthalide on CA in patients with AIS. In this randomized controlled trial, 99 patients were 2:1 randomized to butylphthalide or placebo group. The butylphthalide group received intravenous infusion with a preconfigured butylphthalide-sodium chloride solution for 14 days and an oral butylphthalide capsule for additional 76 days. The placebo group synchronously received an intravenous infusion of 100 mL 0.9% saline and an oral butylphthalide simulation capsule. The transfer function parameter, phase difference (PD), and gain were used to quantify CA. The primary outcomes were CA levels on the affected side on day 14 and day 90. Eighty patients completed the follow-up (52 in the butylphthalide group and 28 in the placebo group). The PD of the affected side on 14 days or discharge and on 90 days was higher in the butylphthalide group than in the placebo group. The differences in safety outcomes were not significant. Therefore, butylphthalide treatment for 90 days can significantly improve CA in patients with AIS. Trial registration: ClinicalTrial.gov: NCT03413202