机构：[1]Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.首都医科大学附属天坛医院[2]China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.首都医科大学附属天坛医院[3]Center of Stroke, Beijing Institute for Brain Disorders, Capital Medical University, Beijing, China.[4]Department of Neurology, Liuyang Jili Hospital, Hunan, China.[5]Department of Interventional Neuroradiology, Langfang Changzheng Hospital, Hebei, China.[6]Department of Neurology, Traditional Chinese Medicine Hospital of Guangdong Province, Guangdong, China.广东省中医院[7]Department of Neurosurgery, Tianjin TEDA Hospital, Tianjin, China.[8]Department of Neurology, Tianjin Xiqing Hospital, Tianjin, China.[9]Department of Neurosurgery, Nanyang Nanshi Hospital, Henan, China.[10]Department of Neurology, Central Hospital of Wuhan, Hubei, China.[11]Department of Neurology, University of South China Affiliated Nanhua Hospital, Huna, China.[12]Department of Neurology, Jingjiang People's Hospital, Jiangsu, China.[13]Department of Neurology, Jilin Qianwei Hospital, Jilin, China.[14]Department of Neurology, Liaocheng Brain Hospital, Shandong, China.[15]Department of Neurology, Zibo Municipal Hospital, Shandong, China.[16]Department of Neurology, The Second People's Hospital of Nanning, Guangxi, China.[17]Department of Neurology, Jilin Province People's Hospital, Jilin, China.[18]Department of Neurology, Qingdao Central Hospital, Shandong, China.[19]Department of Neurology, Tangshan Fengrun District People's Hospital, Tangshan, China.[20]Department of Neurology, The Fourth Affiliated Hospital of China Medical University, Liaoning, China.[21]Department of Neurology, People's Hospital of Nanpi, Hebei, China.[22]Department of Neurology, The Affiliated Wuxi People's Hospital of Nanjing Medical University, Jiangsu, China.[23]Department of Neurology, The Affiliated Huai'an Hospital of Xuzhou Medical University and The Second People's Hospital of Huai'an, Jiangsu, China.[24]Department of Neurosurgery, Peking University BinHai Hospital, Tianjin, China.[25]Department of Neurology, Loudi Central Hospital, Hunan, China.[26]Department of Interventional Neuroradiology, The People's Hospital of Hunan Province, Hunan, China.[27]Department of Neurology, General Hospital of Fushun Mining Bureau of Liaoning Health Industry Group, Liaoning, China.[28]Department of Neurology, Shanghai Seventh People's Hospital, Shanghai, China.[29]Department of Neurology, Anyang District Hospital, Henan, China.[30]Department of Neurology, Shenzhen Hospital of Southern Medical University, Shenzhen, China.南方医科大学深圳医院深圳市康宁医院深圳医学信息中心[31]Department of Neurology, Meizhou People's Hospital, Guangdong, China.[32]Department of Interventional Neuroradiology, Liaocheng Third People's Hospital, Shandong, China.[33]Department of Neurology, General Hospital of Northern Theatre Command, Liaoning, China.[34]Department of Neurology, West China Hospital of Sichuan University, Sichuan, China.四川大学华西医院[35]Department of Neurology, Nanjing First Hospital, Nanjing Medical University, Jiangsu, China.[36]Department of Neurology, The First People's Hospital of Nanning City, Guangxi, China.[37]Department of Neurology, The Fourth Affiliated Hospital of Guangxi Medical University, Guangxi, China.[38]Department of Neurology, Yijishan Hospital of Wannan Medical College, Anhui, China.
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.To assess the efficacy and safety of NBP in patients with acute ischemic stroke receiving reperfusion therapy of intravenous thrombolysis and/or endovascular treatment.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.Within 6 hours after symptom onset, patients were randomized to receive NBP or placebo in a 1:1 ratio.The primary efficacy outcome was the proportion of patients with a favorable outcome based on 90-day modified Rankin Scale score (a global stroke disability scale ranging from 0 [no symptoms or completely recovered] to 6 [death]) thresholds of 0 to 2 points, depending on baseline stroke severity.Of 1216 enrolled patients, 827 (68.0%) were men, and the median (IQR) age was 66 (56-72) years. A total of 607 were randomly assigned to the butylphthalide group and 609 to the placebo group. A favorable functional outcome at 90 days occurred in 344 patients (56.7%) in the butylphthalide group and 268 patients (44.0%) in the placebo group (odds ratio, 1.70; 95% CI, 1.35-2.14; P < .001). Serious adverse events within 90 days occurred in 61 patients (10.1%) in the butylphthalide group and 73 patients (12.0%) in the placebo group.Among patients with acute ischemic stroke receiving intravenous thrombolysis and/or endovascular treatment, NBP was associated with a higher proportion of patients achieving a favorable functional outcome at 90 days compared with placebo.ClinicalTrials.gov Identifier: NCT03539445.
基金：
The study was supported by
grants from the National Key Technology Research
and Development Program of the Ministry of
Science and Technology of the People’s Republic
of China (grant 2016YFC1301501) and Shijiazhuang
Pharmaceutical Group dl-3-butylphthalide
Pharmaceutical.
第一作者机构：[1]Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.[2]China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.
共同第一作者：
通讯作者：
通讯机构：[1]Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.[2]China National Clinical Research Center for Neurological Diseases, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.[*1]Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, No. 119, South 4th RingWest Rd, Fengtai District, Beijing 100070, China.
推荐引用方式(GB/T 7714)：
Wang Anxin,Jia Baixue,Zhang Xuelei,et al.Efficacy and Safety of Butylphthalide in Patients With Acute Ischemic Stroke A Randomized Clinical Trial[J].JAMA NEUROLOGY.2023,80(8):851-859.doi:10.1001/jamaneurol.2023.1871.
APA：
Wang Anxin,Jia Baixue,Zhang Xuelei,Huo Xiaochuan,Chen Jianhuang...&Miao Zhongrong.(2023).Efficacy and Safety of Butylphthalide in Patients With Acute Ischemic Stroke A Randomized Clinical Trial.JAMA NEUROLOGY,80,(8)
MLA：
Wang Anxin,et al."Efficacy and Safety of Butylphthalide in Patients With Acute Ischemic Stroke A Randomized Clinical Trial".JAMA NEUROLOGY 80..8(2023):851-859
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