马来酸桂哌齐特注射液对缺血性卒中急性期伴高血压患者血压的影响  

Effects of cinepazide maleate injection on blood pressure in patients with acute ischemic stroke and hypertension

作　　者：陈会生 杨弋[2] 倪俊[3] 陈国芳[4] 纪勇[5] 易飞[6] 张卓伯[7] 吴晋[8] 蔡学礼[9] 邵蓓[10] 王剑锋[11] 刘雅芳[12] 耿德勤 屈新辉[14] 李晓红[15] 魏琰[16] 韩树根 朱润秀 丁建平[19] 吕桦[20] 黄一宁[21] 黄勇华[22] 肖波[23] 龚涛[24] 俞晓飞[25] 崔丽英[3] Chen Huisheng;Yang Yi;Ni Jun;Chen Guofang;Ji Yong;Yi Fei;Zhang Zhuobo;Wu Jin;Cai Xueli;Shao Bei;Wang Jianfeng;Liu Yafang;Geng Deqin;Qu Xinhui;Li Xiaohong;Wei Yan;Han Shugen;Zhu Runxiu;Ding Jianping;Lyu Hua;Huang Yining;Huang Yonghua;Xiao Bo;Gong Tao;Yu Xiaofei;Cui Liying(Department of Neurology,General Hospital of Northern Theater Command,Shenyang 110016,China;Department of Neurology,the First Bethune Hospital of Jilin University,Changchun 130021,China;Department of Neurology,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100730,China;Department of Neurology,Xuzhou Central Hospital,Xuzhou 221009,China;Department of Neurology,Tianjin Huanhu Hospital,Tianjin 300350,China;Department of Neurology,JiangXi PingXiang People′s Hospital,Pingxiang 337055,China;Department of Neurology,the Fourth Affiliated Hospital of Harbin Medical University,Harbin 150001,China;Department of Neurology,the Second Affiliated Hospital of Nanjing Medical University,Nanjing 210011,China;Department of Neurology,Lishui Municipal Central Hospital,Lishui 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 435000,China;Department of Neurology,the Affiliated Hospital of Xuzhou Medical University,Xuzhou 221002,China;Department of Neurology,Jiangxi Provincial People′s Hospital,Nanchang 330006,China;Department of Neurology,Jinan Central Hospital,Jinan 250013,China;Department of Neurology,Hengshui People′s Hospital(Harrison International Peace Hospital),Hengshui 053000,China;Department of Neurology,Meihekou City Central Hospital,Meihekou 135014,China;Department of Neurology,Inner Mongolia People′s Hospital,Hohhot 010017,China;Department of Neurology,Xuanwu Hospital Capital Medical University,Beijing 100053,China;Department of Neurology,Shaanxi Provincial People′s Hospital,Xi′

机构地区：[1]北部战区总医院神经内科,沈阳110016 [2]吉林大学白求恩第一医院神经内科,长春130021 [3]中国医学科学院北京协和医学院北京协和医院神经内科,北京100730 [4]徐州市中心医院神经内科,徐州221009 [5]天津市环湖医院神经内科,天津300350 [6]江西省萍乡市人民医院神经内科,萍乡337055 [7]哈尔滨医科大学附属第四医院神经内科,哈尔滨150001 [8]南京医科大学第二附属医院神经内科,南京210011 [9]丽水市中心医院神经内科,丽水323000 [10]温州医科大学附属第一医院神经内科,温州325000 [11]大连市中心医院神经内科,大连116033 [12]湖北省黄石市中心医院神经内科,黄石435000 [13]徐州医科大学附属医院神经内科,徐州221002 [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,济南250013 [16]河北省衡水市人民医院(哈励逊国际和平医院)神经内科,衡水053000 [17]吉林省梅河口市中心医院神经内科,梅河口135014 [18]内蒙古自治区人民医院神经内科,呼和浩特010017 [19]首都医科大学宣武医院神经内科,北京100053 [20]陕西省人民医院神经内科,西安710068 [21]北京大学第一医院神经内科,北京100034 [22]解放军总医院第七医学中心神经内科,北京100700 [23]中南大学湘雅医院神经内科,长沙410008 [24]北京医院神经内科,北京100730 [25]上海中医药大学附属曙光医院神经内科,上海201203

出　　处：《中华内科杂志》2022年第8期916-920,共5页Chinese Journal of Internal Medicine

摘　　要：目的:分析马来酸桂哌齐特注射液对急性缺血性卒中(acute ischemic stroke,AIS)伴高血压患者血压的影响。方法:本研究是马来酸桂哌齐特注射液(桂哌齐特)治疗急性缺血性卒中随机、双盲、多中心、安慰剂平行对照的临床确证研究的一个亚组分析,该研究在中国开展,从2016年8月开始至2019年2月结束,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。主要终点指标为患者接受治疗期内(14 d)的血压均值及血压正常人群比例的变化。进一步,还探讨了既往合并高血压病史对结果的影响。结果:本分析纳入该大型临床研究中伴高血压的809例患者。患者接受治疗过程中,AIS患者血压均值、治疗结束后血压正常人群比例(60.5%比59.0%,P>0.05)在桂哌齐特组和安慰剂对照组间差异无统计学意义。结论:急性缺血性卒中患者应用马来酸桂哌齐特注射液治疗,不影响患者的临床血压管理。Objective To investigate the blood pressure change in patients with acute ischemic stroke(AIS)and hypertension treated with cinepazide maleate injection.Methods This was a subgroup analysis of post-marketing clinical confirmation study of cinepazide maleate injection for acute ischemic stroke:a randomized,double-blinded,multicenter,placebo-parallel controlled trial,which conducted in China from August 2016 to February 2019.Eligible patients fulfilled the inclusive criteria of acute anterior circulation ischemic stroke with National Institutes of Health Stroke Scale(NIHSS)scores of 7-25.The primary endpoints were mean blood pressure of AIS patients treated with cinepazide maleate or control,which were assessed during the treatment period(14 days),and the proportion of the patients with normal blood pressure was analyzed after the treatment period.Furthermore,a subgroup analysis was performed to investigate a possible effect of the history of hypertension on outcomes.Results This analysis included 809 patients with hypertension.There was no significant difference in patients blood pressure and the proportion of patients with normal blood pressure(60.5%vs.59.0%,P>0.05)between cinepazide maleate group and control group.Conclusion Administration of cinepazide maleate injection does not affect the management of clinical blood pressure in patients with AIS.

关 键 词：卒中 多中心研究 随机对照试验 血压 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] R544.1[医药卫生—临床医学]