Safety and efficacy of glibenclamide combined with rtPA in acute cerebral ischemia with occlusion/stenosis of anterior circulation (SE-GRACE): a randomized, double-blind, placebo-controlled trial

doi:10.1016/j.eclinm.2023.102305

科研成果详情

题名	Safety and efficacy of glibenclamide combined with rtPA in acute cerebral ischemia with occlusion/stenosis of anterior circulation (SE-GRACE): a randomized, double-blind, placebo-controlled trial
作者	Huang, Kaibin 1; Zhao, Xiaolin 1; Zhao, Yunxiao 2; Yang, Guoshuai 4; Zhou, Saijun5; Yang, Zhi 8; Huang, Wenguo 7; Weng, Guohu 6; Chen, Pingyan 9; Duan, Chongyang 9; Lin, Zhenzhou 1; Wang, Shengnan 1; Liu, Xiangmin 2; Huang, Yunqiang 3; Zhang, Jiangshan 4; Zhang, Xu5; Li, Hao 8; Ye, Songsheng 7; Gu, Yong 6; Zhu, Minzhen 3; Chen, Weiying 2; Quan, Weiwei 5; Liu, Na 1; Chen, Quanfeng 1; Chang, Yuan 1; He, Jinzhao 3; Ji, Zhong 1; Wu, Yongming 1; Pan, Suyue 1
发表日期	2023-11
发表期刊	ECLINICALMEDICINE 影响因子和分区
语种	英语
原始文献类型	Article
关键词	Acute ischemic stroke Recombinant tissue plasminogen activator Glibenclamide Brain edema Neuroinflammation
其他关键词	HEALTH-CARE PROFESSIONALS ; HEMORRHAGIC TRANSFORMATION ; EARLY MANAGEMENT ; 2018 GUIDELINES ; STROKE ; GLYBURIDE ; EDEMA
摘要	Background Glibenclamide alleviates brain edema and improves neurological outcomes in experimental models of stroke. We aimed to assess whether glibenclamide improves functional outcomes in patients with acute ischemic stroke treated with recombinant tissue plasminogen activator (rtPA). Methods In this randomized, double-blind, placebo-controlled trial, patients with acute ischemic stroke were recruited to eight academic hospitals in China. Patients were eligible if they were aged 18-74 years, presented with a symptomatic anterior circulation occlusion with a deficit on the NIHSS of 4-25, and had been treated with rtPA within 4.5 h of symptom onset. We used web-based randomization (1:1) to allocate eligible participants to the glibenclamide or placebo group, stratified according to endovascular treatment and baseline stroke severity. Glibenclamide or placebo was taken orally or via tube feeding at a loading dose of 1.25 mg within 10 h after symptom onset, followed by 0.625 mg every 8 h for 5 days. The primary outcome was the proportion of patients with good outcomes (modified Rankin Scale of 0-2) at 90 days, assessed in all randomly assigned patients who had been correctly diagnosed and had begun study medication. The study is registered with ClinicalTrials.gov, NCT03284463, and is closed to new participants. Findings Between January 1, 2018, and May 28, 2022, 305 patients were randomly assigned, of whom 272 (142 received glibenclamide and 130 received placebo) were included in the primary efficacy analysis. 103 (73%) patients in the glibenclamide group and 94 (72%) in the placebo group had a good outcome (adjusted risk difference 0.002, 95% CI -0.098 to 0.103; p = 0.96). 12 (8%) patients allocated to glibenclamide and seven (5%) patients allocated to placebo died from any cause at 90 days (p = 0.35). The number and type of adverse events were similar between the two groups. There were no drug-related adverse events and no drug-related deaths.
资助项目	Initiative Project of Clinical Research of Southern Medical University [LC2016ZD001]; Clinical Research Program of Nanfang Hospital, Southern Medical University [2018CR025]
出版者	ELSEVIER
ISSN	2589-5370
EISSN	2589-5370
卷号	65
DOI	10.1016/j.eclinm.2023.102305
页数	10
WOS类目	Medicine, General & Internal
WOS研究方向	General & Internal Medicine
WOS记录号	WOS:001104329400001
收录类别	SCIE ; SCOPUS ; PUBMED
在线发表日期	2023-11
URL	查看原文
PubMed ID	37965431
SCOPUSEID	2-s2.0-85175318255
通讯作者地址	[Pan, Suyue]Department of Neurology,Nanfang Hospital,Southern Medical University,Guangzhou,510515,China ; [Wu, Yongming]Department of Neurology,Nanfang Hospital,Southern Medical University,Guangzhou,510515,China ; [Ji, Zhong]Department of Neurology,Nanfang Hospital,Southern Medical University,Guangzhou,510515,China ; [He, Jinzhao]Department of Neurology,Heyuan People's Hospital,Heyuan,517001,China
Scopus学科分类	Medicine (all)
引用统计
文献类型	期刊论文
条目标识符	https://kms.wmu.edu.cn/handle/3ETUA0LF/184016
专题	第一临床医学院（信息与工程学院）、附属第一医院_内科学_神经内科
通讯作者	He, Jinzhao; Ji, Zhong; Wu, Yongming; Pan, Suyue
作者单位	1.Department of Neurology,Nanfang Hospital,Southern Medical University,Guangzhou,China; 2.Department of Neurology,Huadu District People's Hospital of Guangzhou,Guangzhou,China; 3.Department of Neurology,Heyuan People's Hospital,Heyuan,China; 4.Department of Neurology,Central South University Xiangya School of Medicine Affiliated Haikou Hospital,Haikou,China; 5.Department of Neurology,The First Affiliated Hospital of Wenzhou Medical University,Wenzhou,China; 6.Department of Neurology,Hainan Hospital of Traditional Chinese Medicine,Haikou,China; 7.Department of Neurology,Guangdong Maoming Traditional Chinese Medicine Hospital,Maoming,China; 8.Department of Neurology,Maoming People's Hospital,Maoming,China; 9.Department of Biostatistics,School of Public Health,Southern Medical University,Guangzhou,China
推荐引用方式 GB/T 7714	Huang, Kaibin,Zhao, Xiaolin,Zhao, Yunxiao,et al. Safety and efficacy of glibenclamide combined with rtPA in acute cerebral ischemia with occlusion/stenosis of anterior circulation (SE-GRACE): a randomized, double-blind, placebo-controlled trial[J]. ECLINICALMEDICINE,2023,65.
APA	Huang, Kaibin., Zhao, Xiaolin., Zhao, Yunxiao., Yang, Guoshuai., Zhou, Saijun., ... & Pan, Suyue. (2023). Safety and efficacy of glibenclamide combined with rtPA in acute cerebral ischemia with occlusion/stenosis of anterior circulation (SE-GRACE): a randomized, double-blind, placebo-controlled trial. ECLINICALMEDICINE, 65.
MLA	Huang, Kaibin,et al."Safety and efficacy of glibenclamide combined with rtPA in acute cerebral ischemia with occlusion/stenosis of anterior circulation (SE-GRACE): a randomized, double-blind, placebo-controlled trial".ECLINICALMEDICINE 65(2023).