近日，首都医科大学王拥军团队比较了依达拉奉右莰醇片与安慰剂对接受血管内血栓切除术（TASTE-2）的急性缺血性卒中患者功能结局的影响。该研究于2026年1月7日发表在《英国医学杂志》上。

为了评估评估依达拉奉右莰醇（一种由抗氧化和抗炎成分组成的多靶点脑细胞保护剂）改善急性缺血性脑卒中血管内取栓患者功能结局的有效性和安全性，研究组进行了一项多中心、双盲、随机对照试验。2022年3月至2023年5月期间，在中国106家医院招募1362例症状发作24小时内临床诊断为急性缺血性卒中的患者，年龄18-80岁，美国国立卫生研究院卒中量表（NIHSS）评分为6-25分，阿尔伯塔卒中计划早期计算机断层扫描评分（ASPECTS）为6-10分，证实前循环大血管闭塞，计划血管内血栓切除术。

患者在接受血管内血栓切除术之前，以1:1的比例随机分配至两组：依达拉奉右莰醇组（37.5毫克，其中含依达拉奉30毫克、右莰醇7.5毫克，共690例患者）或安慰剂组（672例患者），并在术后每日两次持续用药10-14天。主要结局为测量90天的功能独立性，定义为0-2的修正兰金量表评分（范围0（无症状）至6（死亡））和严重不良事件。

每组均有1例患者在90天失访。意向治疗分析纳入的1360例患者中，689例依达拉奉右莰醇组中379例（55.0%）患者和671例安慰剂组中333例（49.6%）患者在第90天实现功能独立(风险比1.11,95%置信区间（CI） 1.00 ~ 1.23；P = 0.05；风险差5.4%,95% CI 0.1% ~ 10.7%)。在亚组分析中，入院时不匹配的患者（定义为NIHSS评分≥10和ASPECTS≥9或NIHSS评分≥20和≥7）更有可能实现功能独立(55.5%（178/321）对42.9% (134/312)；风险比1.29,1.10 ~ 1.52；风险差13.0%,5.6% ~ 20.3%；P为相互作用=0.003)。两组严重不良事件发生率相似，分别为27.2%（188/690）和25.7% (173/672)；风险比1.06,0.89 ~ 1.26；风险差异为1.5%，3.2%至6.2%:P=0.53)。

研究结果表明，在症状发作24小时内接受血管内血栓切除术的急性缺血性卒中患者中，与安慰剂相比，接受依达拉奉右莰醇片治疗的患者更有可能在90天内实现功能独立，而不会增加安全性问题。这种影响似乎主要是由入院时存在不匹配的亚组驱动的，这表明在这一人群中进行专门的试验可能是有必要的。

附：英文原文

Title: Edaravone dexborneol versus placebo on functional outcomes in patients with acute ischaemic stroke undergoing endovascular thrombectomy (TASTE-2): randomised controlled trial

Author: Chunjuan Wang, Hongqiu Gu, Xiaochuan Huo, Baoshi Yuan, Shuo Li, Jie Xu, Yong Jiang, Jing Jing, Xiaoxi Yao, Zhiliang Li, Faqing Long, Zhengfei Ma, Xianbo Zhuang, Lihua Xu, Yu Jin, Wenguo Huang, Yongqiang Zhang, Jun Wen, Anxin Wang, Yuesong Pan, Wanxing Ye, Weiran Yu, Aichun Cheng, Meng Wang, Qiang Dong, Anding Xu, Ning Wang, Yi Yang, Xia Meng, Liping Liu, Xingquan Zhao, Hao Li, Zhongrong Miao, Zixiao Li, Yongjun Wang

Issue&Volume: 2026/01/07

Abstract:

Objective To assess the efficacy and safety of edaravone dexborneol, a multitarget brain cytoprotectant composed of antioxidant and anti-inflammatory ingredients, in improving functional outcomes among patients with acute ischaemic stroke undergoing endovascular thrombectomy.

Design Multicentre, double blind, randomised, placebo controlled trial.

Setting 106 hospitals in China between March 2022 and May 2023.

Participants 1362 patients with clinically diagnosed acute ischaemic stroke within 24 hours of symptom onset, aged 18-80 years, with a National Institutes of Health Stroke Scale (NIHSS) score of 6-25 and an Alberta Stroke Program Early Computed Tomography Score (ASPECTS) of 6-10, confirmed large vessel occlusion in the anterior circulation, and planned endovascular thrombectomy.

Interventions Patients were randomly allocated in a 1:1 ratio to receive edaravone dexborneol 37.5 mg (edaravone, 30 mg; (+)dexborneol, 7.5 mg; 690 patients) or placebo (672 patients) before endovascular thrombectomy and continued the regimen twice daily for a consecutive period of 10-14 days.

Main outcome measures Functional independence at 90 days, defined as a modified Rankin Scale score (range 0 (no symptoms) to 6 (death)) of 0-2, and serious adverse events.

Results One patient from each group was lost to follow-up at 90 days. Of the 1360 patients included in the intention-to-treat analysis, 379 (55.0%) of 689 patients in the edaravone dexborneol group and 333 (49.6%) of 671 patients in the placebo group achieved functional independence on day 90 (risk ratio 1.11, 95% confidence interval (CI) 1.00 to 1.23; P=0.05; risk difference 5.4%, 95% CI 0.1% to 10.7%). Patients with mismatch at admission (defined as NIHSS score ≥10 and ASPECTS ≥9 or NIHSS score ≥20 and ≥7) were more likely to achieve functional independence in the subgroup analysis (55.5% (178/321) versus 42.9% (134/312); risk ratio 1.29, 1.10 to 1.52; risk difference 13.0%, 5.6% to 20.3%; P for interaction=0.003). The rates of serious adverse events were similar in the two groups (27.2% (188/690) versus 25.7% (173/672); risk ratio 1.06, 0.89 to 1.26; risk difference 1.5%, 3.2% to 6.2%: P=0.53).

Conclusions Among patients with acute ischaemic stroke within 24 hours of symptom onset who underwent endovascular thrombectomy, those treated with edaravone dexborneol, compared with placebo, were more likely to achieve functional independence at 90 days without increased safety concerns. This effect seemed to be primarily driven by the subgroup with mismatch present at admission, suggesting that dedicated trials in this population may be warranted.

DOI: 10.1136/bmj-2025-086850

Source: https://www.bmj.com/content/392/bmj-2025-086850