Efficacy and Safety of Butylphthalide in Patients With Acute Ischemic Stroke

作者：Anxin Wang, Baixue Jia, Xuelei Zhang, Xiaochuan Huo, Jianhuang Chen, Liqiang Gui, Yefeng Cai, Zaiyu Guo, Yuqing Han, Zhaolong Peng, Ping Jing, Yongjun Chen, Yan Liu, Yong Yang, Fengyun Wang, Zengqiang Sun, Tong Li, Hongxia Sun, Haicheng Yuan, Hongmin Shao, Lianbo Gao, Peipei Zhang, Feng Wang, Xiangyang Cao, Wanchao Shi, Changmao Li, Jianwen Yang, Hong Zhang, Feng Wang, Jianzhong Deng, Yanjie Liu, Weisheng Deng, Cunfeng Song, Dawei Chen, Li He, Hong-Dong Zhao, Xianfeng Li, Hong Yang, Zhiming Zhou, Yilong Wang, Zhongrong Miao, BAST Investigators, Shuncong Tang, Baojun Wang, Xing Fang, Weiming Sun, Di Li, Shugai Liu, Zhiqiang Peng, Chuanqing Yu, Lizhi Wang, Xiaosong Huang, Yongjun Li, Haidong Lv, Xiangdong Xie, Heyun Yang, Chaomao Li, Zhonglun Chen, Zanhua Liu, Wenli Xing, Delin Lin, Lijun Wang, Liyan Zhang, Weiping Ju, Chunlei Yu, Jingyu Zhang, Yingting Zuo, Yijun Zhang, Xiaoli Zhang, Xue Tian, Dapeng Mo, Xiaoqing Li, Guojuan Chen, Haibo Wu, Duan Qu, David Wang, Zeguang Ren, Hao Li, Anding Xu, Meng Zhang, Qin Xu · 发表于：JAMA Neurology · 年份：2023 · DOI：10.1001/jamaneurol.2023.1871 · 被引用次数：145 · 研究领域：Neurological Disease Mechanisms and Treatments、Cerebrovascular and Carotid Artery Diseases、Neurological Disorders and Treatments

Importance: DL-3-n-butylphthalide (NBP) is a drug for treating acute ischemic stroke and may play a neuroprotective role by acting on multiple active targets. The efficacy of NBP in patients with acute ischemic stroke receiving reperfusion therapy remains unknown. Objective: To assess the efficacy and safety of NBP in patients with acute ischemic stroke receiving reperfusion therapy of intravenous thrombolysis and/or endovascular treatment. Design, Setting, and Participants: This multicenter, double-blind, placebo-controlled, parallel randomized clinical trial was conducted in 59 centers in China with 90-day follow-up. Of 1236 patients with acute ischemic stroke, 1216 patients 18 years and older diagnosed with acute ischemic stroke with a National Institutes of Health Stroke Scale score ranging from 4 to 25 who could start the trial drug within 6 hours from symptom onset and received either intravenous recombinant tissue plasminogen activator (rt-PA) or endovascular treatment or intravenous rt-PA bridging to endovascular treatment were enrolled, after excluding 20 patients who declined to participate or did not meet eligibility criteria. Data were collected from July 1, 2018, to May 22, 2022. Interventions: Within 6 hours after symptom onset, patients were randomized to receive NBP or placebo in a 1:1 ratio. Main Outcomes and Measures: The primary efficacy outcome was the proportion of patients with a favorable outcome based on 90-day modified Rankin Scale score (a global str...