马来酸桂哌齐特注射液明显促进急性缺血性脑卒中患者的早期功能恢复:一项多中心、随机、双盲、安慰剂对照Ⅳ期临床研究  

Cinepazide maleate injection reduced the disability rate for acute ischemic stroke patients:a multicenter,randomized,double-blind,parallel-group,placebo-controlled phaseⅣclinical trial

作　　者：倪俊[1] 陈会生 陈国芳[3] 纪勇[4] 易飞[5] 张卓伯[6] 杨弋[7] 吴晋[8] 蔡学礼[9] 邵蓓[10] 王剑锋[11] 刘雅芳[12] 耿德勤[13] 屈新辉[14] 李晓红[15] 魏琰[16] 丁建平[17] 吕桦[18] 黄一宁[19] 黄勇华[20] 肖波[21] 龚涛[22] 崔丽英[1] Ni Jun;Chen Huisheng;Chen Guofang;Ji Yong;Yi Fei;Zhang Zhuobo;Yang Yi;Wu Jin;Cai Xueli;Shao Bei;Wang Jianfeng;Liu Yafang;Geng Deqin;Qu Xinhui;Li Xiaohong;Wei Yan;Ding Jianping;Lyu Hua;Huang Yining;Huang Yonghua;Xiao Bo;Gong Tao;Cui Liying(Department of Neurology,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences,Beijing 100730,China;Department of Neurology,General Hospital of Northern Theater Command,Shenyang 110016,China;Department of Neurology,Xuzhou Central Hospital,Xuzhou 221009,China;Department of Neurology,Tianjin Huanhu Hospital,Tianjin 300350,China;Department of Neurology,Pingxiang People's Hospital,Pingxiang,Jiangxi 337055,China;Department of Neurology,the Fourth Affiliated Hospital of Harbin Medical University,Harbin 150001,China;Department of Neurology,First Bethune Hospital of Jilin University,Changchun 130021,China;Department of Neurology,Second Affiliated Hospital of Nanjing Medical University,Nanjing 210011,China;Department of Neurology,Lishui Municipal Central Hospital,Lishui,Zhejiang 323000,China;Department of Neurology,the First Affiliated Hospital of Wenzhou Medical University,Wenzhou 325000,China;Department of Neurology,Dalian Municipal Central Hospital,Dalian 116033,China;Department of Neurology,Huangshi Central Hospital,Huangshi,Hubei 435000,China;Department of Neurology,Affiliated Hospital of Xuzhou Medical University,Xuzhou 221006,China;Department of Neurology,Jiangxi Provincial People's Hospital affiliated to Nanchang University,Nanchang 330006,China;Department of Neurology,Jinan Central Hospital,Jinan 250013,China;Department of Neurology,Hengshui People's Hospital(Harrison International Peace Hospital),Hengshui,Hebei100191,China;Department of Neurology,Xuan Wu Hospital,Capital Medical University,Beijing 100053,China;Department of Neurology,Shaanxi Provincial People's Hospital,Xi'an 710068,China;Department of Neurology,Peking University First Hospital,Beijing 100034,China;Department of Neurology,Seventh Medical Center of the Chinese People's Liberation Army General

机构地区：[1]中国医学科学院北京协和医院神经内科,100730 [2]北部战区总医院神经内科,110016 [3]徐州市中心医院神经内科,221009 [4]天津市环湖医院神经内科,300350 [5]萍乡市人民医院神经内科,江西萍乡337055 [6]哈尔滨医科大学附属第四医院神经内科,150001 [7]吉林大学第一医院神经内科,长春130021 [8]南京医科大学第二附属医院神经内科,210011 [9]丽水市中心医院神经内科,浙江丽水323000 [10]温州医科大学附属第一医院神经内科,325000 [11]大连市中心医院神经内科,116033 [12]黄石市中心医院神经内科,湖北黄石435000 [13]徐州医学院附属医院神经内科,221006 [14]江西省人民医院神经内科,南昌330006 [15]济南市中心医院神经内科,250013 [16]衡水市人民医院(哈励逊国际和平医院)神经内科,河北衡水100191 [17]首都医科大学宣武医院神经内科,北京100053 [18]陕西省人民医院神经内科,西安710068 [19]北京大学第一医院神经内科,100034 [20]解放军总医院第七医学中心神经内科,北京100007 [21]中南大学湘雅医院神经内科,长沙410008 [22]北京医院神经内科,100730

出　　处：《中华神经科杂志》2020年第10期790-797,共8页Chinese Journal of Neurology

摘　　要：目的评估马来酸桂哌齐特注射液治疗急性缺血性脑卒中的早期有效性和安全性。方法本研究为多中心、随机、双盲、安慰剂对照Ⅳ期临床研究,由北京协和医院牵头,全国65家国家临床试验机构的神经内科专业组共同完成。于2016年8月至2019年2月连续入组发病时间≤48 h,美国国立卫生研究院卒中量表(NIHSS)评分为7~25分的急性前循环非心源性脑梗死患者,其中937例(治疗组466例,对照组471例)进入最终全分析集进行分析。以用药后14 d改良Rankin量表(mRS)评分≤1分比例和Barthel指数为疗效终点,安全性终点指标包括用药后14 d的生命体征、实验室检查指标和心电图结果。结果共入组946例患者,其中937例纳入最终分析。多因素Logistic回归分析显示,治疗组用药后14 d mRS≤1分受试者比例高于对照组[分别为102/466(21.89%)和76/471(16.14%)],两组间差异具有统计学意义(OR=0.677,95%CI 0.484~0.948,P=0.023);治疗组病后14 d Barthel指数≥95受试者比例高于对照组[分别为125/466(26.82%)和91/471(19.32%)],两组间差异具有统计学意义(OR=0.632,95%CI 0.459~0.869,P=0.005)。两组间不良事件发生率相似。结论马来酸桂哌齐特注射液治疗急性缺血性脑卒中,早期即可显著改善患者残障程度和日常生活能力,且安全性良好。Objective To assess the efficacy and safety of cinepazide maleate injection in the treatment of patients with acute ischemic stroke.Methods A multicenter, randomized, double-blind, placebo-controlled phase Ⅳ clinical trial, led by Peking Union Medical College Hospital, was conducted in 65 Hospitals in China. The efficacy of cinepazide maleate injection in patients with acute anterior circulation cerebral infarction with onset time of ≤48 hours, 7≤National Institute of Health stroke scale (NIHSS) score ≤25 was assessed from August 2016 to February 2019, using the proportion of modified Rankin scale (mRS) score≤1 and Barthel index (BI) score≤95 on day 14 as efficacy endpoint. The patients were divided into treatment group who were treated with cinepazide maleate injection and control group who were treated with placebo.Results A total 937 patients were involved in the final efficacy analysis (466 in treatment group and 471 in control group). The proportion of subjects with mRS score≤1 on day 14 after treatment were higher in the treatment group than that in the control group (102/466(21.89%) vs 76/471(16.14%)). Logistic regression analysis showed that patients treated with cinepazide maleate were significantly more likely to have a favorable outcome (mRS score≤1) than patients treated with placebo on day 14 (OR=0.677, 95% CI 0.484-0.948, P=0.023), and patients treated with cinepazide maleate were more likely to reach independence in activities of daily living (Barthel Index ≥95) than those treated with placebo on day 14 (125/466(26.82%) vs 91/471(19.32%);OR=0.632, 95% CI 0.459-0.869, P=0.005). The rate of adverse events was similar between the treatment and control groups.Conclusion The 14-day treatment with cinepazide maleate injection could reduce the degree of disability whereas did not increase the risk of adverse events.

关 键 词：脑梗塞 多中心研究 随机对照试验 疗效比较研究 马来酸桂哌齐特 安慰剂 

分 类 号：R743.3[医药卫生—神经病学与精神病学]