机构：[1]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.首都医科大学宣武医院[2]Institute for Brain Disorders, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.[3]Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.首都医科大学附属天坛医院[4]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[5]Department of Neurology, Jiang'an County People's Hospital, Sichuan, China.[6]Department of Neurology, Liaocheng People's Hospital, Shandong, China.[7]Department of Neurology, Qinghe People's Hospital, Hebei, China.[8]Department of Neurology, Yanbian University Hospital (Yanbian Hospital), Yanji, China.[9]Department of Neurology, The First Affiliated Hospital of Soochow University, Suzhou, China.[10]Department of Neurology, Shandong Provincial Hospital Affiliated to Shandong First Medical University, Shandong, China.[11]Department of Neurology, The Second Affiliated Hospital, Harbin Medical University, Heilongjiang, China.[12]Department of Neurology, First Affiliated Hospital of Anhui University of Science and Technology (First People's Hospital of Huainan), Anhui, China.[13]Department of Neurology, The First People's Hospital of Yibin, Sichuan, China.[14]Department of Neurosurgery, Hengshui People's Hospital, Hebei, China.[15]Department of Neurology, Zhengzhou Central Hospital, Henan, China.[16]Department of Neurology, Zhoukou Central Hospital, Henan, China.[17]Department of Neurosurgery, The Third Hospital of Shijiazhuang, Hebei, China.[18]Department of Neurology, The First Hospital of Kunming Medical University, Yunnan, China.内科科室外科科室神经内科泌尿外科昆明医科大学附属第一医院[19]Department of Neurosurgery, Xuanwu Hospital, Capital Medical University, Beijing, China.首都医科大学宣武医院
Preclinical and clinical studies have suggested the neuroprotective effect of Panax notoginseng saponins (Xuesaitong soft capsules). However, robust evidence in patients with ischemic stroke is lacking.To assess the efficacy and safety of Xuesaitong soft capsules in patients with ischemic stroke.This multicenter, double-blind, placebo-controlled randomized clinical trial was conducted at 67 tertiary health centers in China from July 1, 2018, to June 30, 2020. Included patients were aged 18 to 75 years with a diagnosis of ischemic stroke and a National Institutes of Health Stroke Scale score between 4 and 15.Eligible patients were randomly assigned within 14 days after symptom onset to receive either treatment with Xuesaitong soft capsules (120 mg orally twice daily) or placebo (120 mg orally twice daily) for 3 months.The primary outcome was functional independence at 3 months, defined as a modified Rankin Scale score of 0 to 2.Among 3072 eligible patients with ischemic stroke who were randomized, 2966 (96.5%) were included in the modified intention-to-treat cohort (median [IQR] age, 62 [55-68] years; 1982 male [66.8%]). The number of patients who achieved functional independence at 3 months was 1328 (89.3%) in the Xuesaitong group and 1218 (82.4%) in the control group (odds ratio, 1.95; 95% CI, 1.56-2.44; P < .001). In the safety cohort, serious adverse events occurred in 15 of 1488 patients (1.0%) in the Xuesaitong group and 16 of 1482 (1.1%) in the control group (P = .85).In this randomized clinical trial, Xuesaitong soft capsules significantly increased the likelihood of functional independence at 3 months in patients with ischemic stroke, indicating that this may be a safe and effective alternative therapy to improve prognosis in this population.Chinese Clinical Trial Registry Identifier: ChiCTR1800016363.
基金：
Program of Research and Popularization of Appropriate Intervention Technology for the Stroke High Risk Group in China [GN-2017B0003]
第一作者机构：[1]Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, China.
推荐引用方式(GB/T 7714)：
Wu Longfei,Song Haiqing,Zhang Chi,et al.Efficacy and Safety of Panax notoginseng Saponins in the Treatment of Adults With Ischemic Stroke in China: A Randomized Clinical Trial[J].JAMA NETWORK OPEN.2023,6(6):doi:10.1001/jamanetworkopen.2023.17574.
APA：
Wu Longfei,Song Haiqing,Zhang Chi,Wang Anxin,Zhang Bowei...&Ji Xunming.(2023).Efficacy and Safety of Panax notoginseng Saponins in the Treatment of Adults With Ischemic Stroke in China: A Randomized Clinical Trial.JAMA NETWORK OPEN,6,(6)
MLA：
Wu Longfei,et al."Efficacy and Safety of Panax notoginseng Saponins in the Treatment of Adults With Ischemic Stroke in China: A Randomized Clinical Trial".JAMA NETWORK OPEN 6..6(2023)
医学