Effectiveness of butylphthalide on cerebral autoregulation in ischemic stroke patients with large artery atherosclerosis (EBCAS study): A randomized, controlled, multicenter trial.

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.

• Authors: Zhen-Ni Guo, Bing-Hong Yue, Lei Fan, Jie Liu, Yuanyuan Zhu, Yuanqi Zhao, Jingxin Zhong, Zhan Lou, Xing-Liang Liu, Reziya Abuduxukuer, Peng Zhang, Yang Qu, Ziduo Shen, Baoyang Shi, Ke-Jia Zhang, Jia Liu, Junlei Chang, Hang Jin, Xin Sun, Yi Yang
• Journal: Journal of cerebral blood flow and metabolism : official journal of the International Society of Cerebral Blood Flow and Metabolism (J Cereb Blood Flow Metab) Vol. 43 Issue 10 Pg. 1702-1712 (10 2023) ISSN: 1559-7016 [Electronic] United States
• PMID: 37021629 (Publication Type: Randomized Controlled Trial, Multicenter Study, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• 3-n-butylphthalide

Topics

• Humans
• Ischemic Stroke
• Atherosclerosis
• Arteries
• Homeostasis
• Stroke (drug therapy)
• Treatment Outcome
• Brain Ischemia (drug therapy)