治疗急性缺血性脑卒中的舌下含服依达拉奉-右旋糖酐：TASTE-SL 随机临床试验》。

IF 20.4 1区医学 Q1 CLINICAL NEUROLOGY

JAMA neurology Pub Date : 2024-02-19 DOI:10.1001/jamaneurol.2023.5716

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

{"title":"治疗急性缺血性脑卒中的舌下含服依达拉奉-右旋糖酐：TASTE-SL 随机临床试验》。","authors":"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","doi":"10.1001/jamaneurol.2023.5716","DOIUrl":null,"url":null,"abstract":"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 randomization.Results: Of 956 patients, 42 were excluded. A total of 914 patients (median [IQR] age, 64.0 [56.0-70.0] years; 608 male [66.5%]) were randomly allocated to the edaravone dexborneol group (450 [49.2%]) or placebo group (464 [50.8%]). The edaravone dexborneol group showed a significantly higher proportion of patients experiencing good functional outcomes on day 90 after randomization compared with the placebo group (290 [64.4%] vs 254 [54.7%]; risk difference, 9.70%; 95% CI, 3.37%-16.03%; odds ratio, 1.50; 95% CI, 1.15-1.95, P = .003). The rate of adverse events was similar between the 2 groups (89.8% [405 of 450] vs 90.1% [418 of 464]).Conclusion and relevance: Among patients with AIS within 48 hours, sublingual edaravone dexborneol could improve the proportion of those achieving a favorable functional outcome at 90 days compared with placebo.Trial registration: ClinicalTrials.gov Identifier: NCT04950920.","PeriodicalId":14677,"journal":{"name":"JAMA neurology","volume":" ","pages":""},"PeriodicalIF":20.4000,"publicationDate":"2024-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10877503/pdf/","citationCount":"0","resultStr":"{\"title\":\"Sublingual Edaravone Dexborneol for the Treatment of Acute Ischemic Stroke: The TASTE-SL Randomized Clinical Trial.\",\"authors\":\"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\",\"doi\":\"10.1001/jamaneurol.2023.5716\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"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 randomization.Results: Of 956 patients, 42 were excluded. A total of 914 patients (median [IQR] age, 64.0 [56.0-70.0] years; 608 male [66.5%]) were randomly allocated to the edaravone dexborneol group (450 [49.2%]) or placebo group (464 [50.8%]). The edaravone dexborneol group showed a significantly higher proportion of patients experiencing good functional outcomes on day 90 after randomization compared with the placebo group (290 [64.4%] vs 254 [54.7%]; risk difference, 9.70%; 95% CI, 3.37%-16.03%; odds ratio, 1.50; 95% CI, 1.15-1.95, P = .003). The rate of adverse events was similar between the 2 groups (89.8% [405 of 450] vs 90.1% [418 of 464]).Conclusion and relevance: Among patients with AIS within 48 hours, sublingual edaravone dexborneol could improve the proportion of those achieving a favorable functional outcome at 90 days compared with placebo.Trial registration: ClinicalTrials.gov Identifier: NCT04950920.\",\"PeriodicalId\":14677,\"journal\":{\"name\":\"JAMA neurology\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":20.4000,\"publicationDate\":\"2024-02-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10877503/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"JAMA neurology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1001/jamaneurol.2023.5716\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CLINICAL NEUROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"JAMA neurology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1001/jamaneurol.2023.5716","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CLINICAL NEUROLOGY","Score":null,"Total":0}

引用次数: 0

摘要

重要性：舌下含服依达拉奉-右旋波旁醇是一种多靶点脑细胞保护剂，由抗氧化和抗炎成分依达拉奉和右旋波旁醇组成，舌下含服后可通过口腔黏膜迅速扩散和吸收：研究舌下含服依达拉奉-右旋糖苷对急性缺血性脑卒中（AIS）患者 90 天功能预后的有效性和安全性：这是一项双盲、安慰剂对照、多中心、平行组、3期随机临床试验，于2021年6月28日至2022年8月10日进行，随访90天。参与者来自中国的 33 个中心。随机分配到治疗组的患者年龄在18至80岁之间，美国国立卫生研究院卒中量表评分在6至20分之间，上下肢运动障碍总分在2分或以上，48小时内有临床诊断的AIS症状，卒中前改良Rankin量表（mRS）评分在1分或以下。不符合资格标准或拒绝参与的患者被排除在外：按 1:1 的比例分配患者接受舌下含服依达拉奉-右旋龙胆紫（依达拉奉，30 毫克；右旋龙胆紫，6 毫克）或安慰剂（依达拉奉，0 毫克；右旋龙胆紫，60 微克），每天两次，共 14 天，并随访至 90 天：主要疗效指标为随机分组后第 90 天 mRS 评分为 1 分或 1 分以下的患者比例：在 956 例患者中，有 42 例被排除在外。共有914名患者（中位数[IQR]年龄为64.0[56.0-70.0]岁；608名男性[66.5%]）被随机分配到依达拉奉-右旋波旁醇组（450名[49.2%]）或安慰剂组（464名[50.8%]）。与安慰剂组相比，依达拉奉-右旋波旁醇组在随机分配后第 90 天获得良好功能结果的患者比例明显更高（290 [64.4%] vs 254 [54.7%]；风险差异，9.70%；95% CI，3.37%-16.03%；几率比，1.50；95% CI，1.15-1.95，P = .003）。两组的不良事件发生率相似（89.8% [450例中的405例] vs 90.1% [464例中的418例]）：结论和相关性：与安慰剂相比，在 48 小时内发生 AIS 的患者中，舌下含服依达拉奉-右旋波尼醇可提高 90 天后获得良好功能结果的患者比例：试验注册：ClinicalTrials.gov Identifier：试验注册：ClinicalTrials.gov Identifier：NCT04950920。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

查看原文本刊更多论文

Sublingual Edaravone Dexborneol for the Treatment of Acute Ischemic Stroke: The TASTE-SL Randomized Clinical Trial.

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 randomization.

Results: Of 956 patients, 42 were excluded. A total of 914 patients (median [IQR] age, 64.0 [56.0-70.0] years; 608 male [66.5%]) were randomly allocated to the edaravone dexborneol group (450 [49.2%]) or placebo group (464 [50.8%]). The edaravone dexborneol group showed a significantly higher proportion of patients experiencing good functional outcomes on day 90 after randomization compared with the placebo group (290 [64.4%] vs 254 [54.7%]; risk difference, 9.70%; 95% CI, 3.37%-16.03%; odds ratio, 1.50; 95% CI, 1.15-1.95, P = .003). The rate of adverse events was similar between the 2 groups (89.8% [405 of 450] vs 90.1% [418 of 464]).

Conclusion and relevance: Among patients with AIS within 48 hours, sublingual edaravone dexborneol could improve the proportion of those achieving a favorable functional outcome at 90 days compared with placebo.

Trial registration: ClinicalTrials.gov Identifier: NCT04950920.

求助全文

通过发布文献求助，成功后即可免费获取论文全文。去求助

来源期刊

JAMA neurology CLINICAL NEUROLOGY-

CiteScore

41.90

自引率

1.70%

发文量

250

期刊介绍： JAMA Neurology is an international peer-reviewed journal for physicians caring for people with neurologic disorders and those interested in the structure and function of the normal and diseased nervous system. The Archives of Neurology & Psychiatry began publication in 1919 and, in 1959, became 2 separate journals: Archives of Neurology and Archives of General Psychiatry. In 2013, their names changed to JAMA Neurology and JAMA Psychiatry, respectively. JAMA Neurology is a member of the JAMA Network, a consortium of peer-reviewed, general medical and specialty publications.