Sublingual Edaravone Dexborneol for the Treatment of Acute Ischemic Stroke

作者：Yu Fu, Anxin Wang, Renhong Tang, Shuya Li, Xue Tian, Xue Xia, Jinsheng Ren, Shibao Yang, Rong Chen, Shunwei Zhu, Xiaofei Feng, Jinliang Yao, Yan Wei, Xueshuang Dong, Yun Ling, Fei Yi, Qian Deng, Cunju Guo, Yi Sui, Shugen Han, Guoqiang Wen, Chuanling Li, Aiqin Dong, Xin Sun, Zhimin Wang, Xueying Shi, Bo Liu, Dongsheng Fan · 发表于：JAMA Neurology · 年份：2024 · DOI：10.1001/jamaneurol.2023.5716 · 被引用次数：100 · 研究领域：Acute Ischemic Stroke Management、Neuroinflammation and Neurodegeneration Mechanisms、Medicinal Plants and Bioactive Compounds

Importance: Sublingual edaravone dexborneol, which can rapidly diffuse and be absorbed through the oral mucosa after sublingual exposure, is a multitarget brain cytoprotection composed of antioxidant and anti-inflammatory ingredients edaravone and dexborneol. Objective: To investigate the efficacy and safety of sublingual edaravone dexborneol on 90-day functional outcome in patients with acute ischemic stroke (AIS). Design, Setting, and Participants: This was a double-blind, placebo-controlled, multicenter, parallel-group, phase 3 randomized clinical trial conducted from June 28, 2021, to August 10, 2022, with 90-day follow-up. Participants were recruited from 33 centers in China. Patients randomly assigned to treatment groups were aged 18 to 80 years and had a National Institutes of Health Stroke Scale score between 6 and 20, a total motor deficit score of the upper and lower limbs of 2 or greater, a clinically diagnosed AIS symptom within 48 hours, and a modified Rankin Scale (mRS) score of 1 or less before stroke. Patients who did not meet the eligibility criteria or declined to participate were excluded. Intervention: Patients were assigned, in a 1:1 ratio, to receive sublingual edaravone dexborneol (edaravone, 30 mg; dexborneol, 6 mg) or placebo (edaravone, 0 mg; dexborneol, 60 μg) twice daily for 14 days and were followed up until 90 days. Main Outcomes and Measures: The primary efficacy outcome was the proportion of patients with mRS score of 1 or less on day 90 after ...