Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: a multicenter, randomized, double-blind, placebo-controlled trial(Open Access)
机构:[1]Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, No1 Shuaifuyuan Wangfujing Dongcheng District, Beijing 100730,China[2]General Hospital of Northern Theater Command, Shenyang, China[3]Xuzhou Central Hospital, Xuzhou, China[4]Tianjin Huanhu Hospital, Tianjin,China[5]Pingxiang People’s Hospital, Pingxiang, China[6]Fourth Affiliated Hospital of Harbin Medical University, Harbin, China[7]First Bethune Hospital of Jilin University, Changchun, China[8]Second Affiliated Hospital of Nanjing Medical University, Nanjing, China[9]Lishui Municipal Central Hospital, Lishui,China[10]First Affiliated Hospital of Wenzhou Medical University, Wenzhou,China[11]Dalian Municipal Central Hospital, Dalian, China[12]Huangshi Central Hospital, Huangshi, China[13]Affiliated Hospital of Xuzhou Medical University, Xuzhou, China[14]Jiangxi Provincial People’s Hospital affiliated to Nanchang University, Nanchang, China[15]Jinan Central Hospital, Jinan, China[16]Hengshui People’s Hospital (Harrison International Peace Hospital), Hengshui, China[17]Xuan Wu Hospital, Capital Medical University, Beijing,China首都医科大学宣武医院神经内科[18]Shaanxi Provincial People’s Hospital, Xi’an, China[19]Peking University First Hospital, Beijing, China[20]Seventh Medical Center of the Chinese PLA General Hospital, Beijing, China[21]Xiangya Hospital Central South University, Changsha, China[22]Beijing Hospital, Beijing, China[23]Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China[24]Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China[25]General Hospital of Northern Theater Command, Shenyang,China Guofang Chen, Xuzhou Central Hospital, Xuzhou, China[26]Tianjin Huanhu Hospital, Tianjin, China[27]Pingxiang People’s Hospital, Pingxiang, China[28]Fourth Affiliated Hospital of Harbin Medical University, Harbin, China[29]First Bethune Hospital of Jilin University, Changchun, China[30]Second Affiliated Hospital of Nanjing Medical University, Nanjing,China[31]Lishui Municipal Central Hospital, Lishui, China[32]First Affiliated Hospital of Wenzhou Medical University, Wenzhou,China[33]Dalian Municipal Central Hospital, Dalian, China[34]Huangshi Central Hospital, Huangshi, China[35]Affiliated Hospital of Xuzhou Medical University, Xuzhou, China[36]Jiangxi Provincial People’s Hospital affiliated to Nanchang University, Nanchang, China[37]Jinan Central Hospital, Jinan, China[38]Hengshui People’s Hospital (Harrison International Peace Hospital), Hengshui, China[39]Xuan Wu Hospital, Capital Medical University, Beijing, China首都医科大学宣武医院神经内科[40]Shaanxi Provincial People’s Hospital, Xi’an, China[41]Peking University First Hospital, Beijing, China[42]Seventh Medical Center of the Chinese PLA General Hospital, Beijing, China[43]Xiangya Hospital Central South University, Changsha, China[44]Beijing Hospital, Beijing, China[45]Inner Mongolia Baogang Hospital, Baotou, China[46]Meihekou Central Hospital, Meihekou, China[47]Hunan Provincial People’s Hospital, Hunan, China[48]Zhongshan Hospital Affiliated to Xiamen University, Xiamen, China[49]The Second Hospital of Hebei Medical University, Shijiazhuang,China[50]Inner Mongolia People’s Hospital, Baotou, China[51]Tianjin Union Medical Center, Nankai University Affiliated Hospital, Tianjin, China[52]Liuzhou Workers’ Hospital, Liuzhou, China[53]First Hospital of Nanchang, Nanchang, China[54]Yichang Central People’s Hospital, Yichang, China[55]Yanbian University Hospital, Yanji, China[56]Cangzhou Hospital of Integrated Traditional Chinese and Western Medicine, Cangzhou, China[57]Affiliated Hospital of Hangzhou Normal University (Hangzhou Second People’s Hospital), Hangzhou, China[58]Handan Central Hospital, Handan, China[59]First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China[60]Second Hospital of Shanxi Medical University, Taiyuan, China[61]Tianjin First Central Hospital, Tianjin, China[62]Chenzhou No 1 People’s Hospital, Chenzhou, China[63]Jilin Province People’s Hospital, Changchun, China[64]The Second People’s Hospital of Huai’an, Huai’an, China[65]The First People’s Hospital of Yueyang, Yueyang, China[66]Dongguan People’s Hospital, Dongguan, China[67]Affiliated Hospital of Nantong University, Nantong, China[68]Third Affiliated Hospital of Southern Medical University, Guangzhou, China[69]First Affiliated Hospital of Xiamen University, Xiamen, China[70]General Hospital of Ningxia Medical University, Yinchuan, China[71]Baotou Central Hospital, Baotou, China[72]Affiliated Hospital of Chengde Medical College, Chengde, China[73]Brain Hospital of Jilin Province, Changchun, China[74]Peking University Shougang Hospital, Beijing, China[75]Jiangsu Taizhou People’s Hospital, Taizhou, China[76]Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou, China[77]Tonghua Central Hospital, Tonghua, China[78]Shanghai Shuguang Hospital, Shanghai, China[79]Siping Hospital of China Medical University, Siping, China[80]People’s Hospital of Quzhou, Quzhou, China[81]General Hospital of Xuzhou Mining Group (The Second Affiliated Hospital of Xuzhou Medical University), Xuzhou, China[82]Chinese People’s Liberation Army General Hospital, Beijing,China[83]China Rehabilitation Research Center, Beijing, China[84]Zhejiang Hospital, Hangzhou, China[85]Hainan General Hospital, Haikou, China[86]University of South China Second Hospital, Hengyang, China
BACKGROUND: Ischemic stroke is a leading cause of morbidity and mortality. Thrombolytic therapy improves disability and survival rates; however, to be effective, it must be given within 4.5 h of onset. Moreover, thrombolytic therapy is frequently contraindicated. Therefore, alternative therapeutic options are required. In China, cinepazide maleate injection has been shown to improve the cerebral collateral circulation and further reduce disability in stroke patients; however, very few studies investigating this therapy have been conducted to date. Therefore, this study aimed to further confirm the efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke. METHODS: Patients with acute ischemic stroke were administered an intravenous infusion of 320 mg cinepazide maleate or placebo once daily for 14 days. All patients were also administered basic therapy (citicoline sodium). The primary efficacy endpoint was the proportion of patients with a modified Rankin scale (mRS) ≤2 on day 90. Secondary efficacy endpoints included Barthel Index ≥95. Safety was evaluated by recording all adverse events (AEs), monitoring laboratory parameters and vital signs, and electrocardiogram. RESULTS: In total, 937 patients with an acute ischemic stroke were included, with a mean (standard deviation, SD) National Institutes of Health Stroke Scale score of 8.8 (2.4) and a mean (SD) stroke onset of 30.9 (11.4) hours prior. Following treatment for 90 days, the proportion of patients with an mRS score ≤ 2 was significantly higher in the cinepazide maleate group than in the control group (60.9% vs. 50.1%; p = 0.0004). Moreover, the proportion of patients with a Barthel Index of ≥95 on day 90 was also significantly higher in the cinepazide maleate group than in the control group (53.4% vs. 46.7%; p = 0.0230). There were no statistically significant differences in safety parameters between the cinepazide maleate and control groups. CONCLUSIONS: The results of this study show that cinepazide maleate injection is superior to placebo in improving neurological function and activities of daily living, reducing disability, and promoting functional recovery in patients with acute ischemic stroke. Cinepazide maleate injection was safe and well tolerated with no unexpected AEs reported. TRIAL REGISTRATION: Chinese Clinical Trial Registry CTR20160292 and ChiCTR1900023827 . Retrospectively registered June 13, 2019.
第一作者机构:[1]Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, No1 Shuaifuyuan Wangfujing Dongcheng District, Beijing 100730,China
推荐引用方式(GB/T 7714):
Jun Ni,Huisheng Chen,Guofang Chen,et al.Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: a multicenter, randomized, double-blind, placebo-controlled trial(Open Access)[J].BMC NEUROLOGY.2020,20(1):doi:10.1186/s12883-020-01844-8.
APA:
Jun Ni,Huisheng Chen,Guofang Chen,Yong Ji,Fei Yi...&the study collaboration group.(2020).Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: a multicenter, randomized, double-blind, placebo-controlled trial(Open Access).BMC NEUROLOGY,20,(1)
MLA:
Jun Ni,et al."Efficacy and safety of cinepazide maleate injection in patients with acute ischemic stroke: a multicenter, randomized, double-blind, placebo-controlled trial(Open Access)".BMC NEUROLOGY 20..1(2020)