祛风通玄法治疗急性期中小量脑出血的多中心随机对照临床研究  

Low-and moderate-volume intracerebral hemorrhage at acute stage treated by Qufeng Tongxuan method:a multicenter,randomized,controlled study

作　　者：杨燕 刘天助 徐厚平 刘平 陈丽 杨思进 白雪 顾应江 喻银全 黄敬东[3] 吴波 雷励[5] 袁江 于周[7] 卓开全 潘道林 李健 陈霄 罗琴 赵必乐 Yang Yan;Liu Tianzhu;Xu Houping;Liu Ping;Chen Li;Yang Sijin;Bai Xue;Gu Yingjiang;Yu Yinquan;Huang Jingdong;Wu Bo;Lei Li;Yuan Jiang;Yu Zhou;Zhuo Kaiquan;Pan Daolin;Li Jian;Chen Xiao;Luo Qin;Zhao Bile(Department of Cardio-Encephalopathy,Affiliated Hospital of Traditional Chinese Medicine,Southwest Medical University,Luzhou 646000,China;Department of Neurology,Bazhong Hospital of Traditional Chinese Medicine,Bazhong 636000,China;Department of Surgery,Leshan Hospital of Traditional Chinese Medicine,Leshan 614000,China;Department of Neurosurgery,Yanjiang District Hospital of Traditional Chinese Medicine,Ziyang 641300,China;Department of Encephalopathy,Beibei Hospital of Traditional Chinese Medicine,Chongqing 400700,China;Department of Neurology,Xuyong People's Hospital,Luzhou 646400,China;Department of Neurology,Liangshanzhou First People's Hospital,Liangshanzhou615000,China;Departmentof Encephalopathy,Suining Hospital of Traditional Chinese Medicine,Suining 629000,China;Unit Three,Department Internal Medicine,Luxian Hospital of Traditional Chinese Medicine,Luzhou 646100,China;Department of Internal Medicine,Hejiang Hospital of Traditional Chinese Medicine,Luzhou 646200,China;Nineth Departments of Encephalopathy,Xi'an Encephalopathy Hospital of Traditional Chinese Medicine,Xi'an 710000,China;Department of Cardio-Encephalopathy,Xuyong Hospital of Traditional Chinese Medicine,Luzhou 646000,China;Department of Internal Medicine,Langzhong Hospital of Traditional Chinese Medicine,Langzhong 637400,China)

机构地区：[1]西南医科大学附属中医医院心脑病科,泸州646000 [2]巴中市中医院神经内科,巴中636000 [3]乐山市中医医院外科,乐山614000 [4]资阳市雁江区中医医院神经外科,资阳641300 [5]重庆市北碚区中医院脑病科,重庆400700 [6]叙永县人民医院神经内科,泸州646400 [7]凉山州第一人民医院神经内科,凉山州615000 [8]遂宁市中医医院脑病科,遂宁629000 [9]泸县中医医院内三科,泸州646100 [10]合江县中医医院内科,泸州646200 [11]西安中医脑病医院脑病九科,西安710000 [12]叙永县中医医院心脑病科,泸州646000 [13]阆中市中医医院内科,阆中637400

出　　处：《中华神经医学杂志》2023年第3期240-247,共8页Chinese Journal of Neuromedicine

基　　金：四川省中医药管理局中西医结合方案治疗脑出血的临床循证研究(2020ZD002);四川省科技厅重大科技专项项目(2022ZDZX0022);国家中医药管理局中医药创新团队及人才支持计划项目(ZYYCXTD-C-202207);四川省中医药管理局中医药防治心脑血管疾病创新团队(2022C007);四川省中医药管理局重点项目(2021ZD015)。

摘　　要：目的探讨祛风通玄法治疗急性期中小量脑出血患者的临床疗效及安全性。方法前瞻性纳入16家医院自2019年9月至2022年4月收治的基底节区和(或)丘脑中小量脑出血患者, 采用多中心、随机、双盲、安慰剂对照研究设计, 使用SAS软件将患者通过区组随机方法分为试验组和对照组, 对照组患者采用西医常规治疗方案治疗, 试验组患者在西医常规治疗方案的基础上使用祛风通玄法(麝香化瘀醒脑颗粒联合蛭龙活血通瘀颗粒序贯疗法)治疗, 分别在治疗前、治疗第7、14、30、90天采用美国国立卫生研究院卒中量表(NIHSS)评估患者的神经功能, 治疗前、治疗第180天采用改良Rankin量表(mRS)评估患者的预后, 治疗前、治疗第7、14天患者均行颅脑CT检查以计算血肿体积, 比较2组患者治疗前、治疗第14天的凝血功能、肝肾功能变化情况, 记录2组患者治疗期间发生的不良反应。结果治疗前、治疗第7、14、30天试验组和对照组患者NIHSS评分的差异无统计学意义(P>0.05);治疗第90天试验组患者NIHSS评分低于对照组, 差异有统计学意义(P<0.05);试验组患者治疗前、治疗第7、14、30、90天的NIHSS评分逐渐下降, 差异均有统计学意义(P<0.05)。治疗前2组患者mRS评分的差异无统计学意义(P>0.05);治疗第180天试验组患者的mRS评分低于对照组, 差异有统计学意义(P<0.05)。治疗前、治疗第7、14天2组患者血肿体积的差异均无统计学意义(P>0.05);2组患者治疗前、治疗第7、14天的血肿体积逐渐下降, 差异均有统计学意义(P<0.05);试验组患者治疗第14天与治疗前血肿体积差值[6.42(4.10, 11.73)]高于对照组患者治疗第14天与治疗前血肿体积差值[4.00(1.25, 10.58)], 差异有统计学意义(P<0.05)。治疗前、治疗第14天试验组与对照组肝肾功、凝血功能指标的差异均无统计学意义(P>0.05)。对照组患者发生不良反应12例(10.34%), 试验组患�Objective To verify the clinical efficacy and safety of Qufeng Tongxuan method in treating low-and moderate-volume intracerebral hemorrhage at acute stage.M.ethodsSA prospective,multicenter,randomized,double-blind,placebo-controlled study was performed;patients with low-and moderate-volume intracerebral hemorrhage at the basal ganglia and/or thalamus accepted treatment in 16 hospitals from September 2019 to April 2022 were enrolled.These patients were divided into experimental and control groups with a block randomized method by SAS software.Patients in control group were given conventional western medicine treatment;those in experimental group accepted Qufeng Tongxuan method(sequential therapy of Shexiang Huayu Xingnao granules and Zhilong Huoxue Tongyu granules)besides conventional western medicine treatment.NIHSS was used to assess neurological function before treatment and on 7^(th),14^(th),30^(th),and 90^(th) d of treatment.Prognoses of these patients were assessed by modified Rankin scale(mRS)before treatment and on 180^(th)d of treatment.Brain CT was performed before treatment and on 7^(th) and 14^(th)d of treatment to calculate the hematoma volume.Before treatment and on 14^(th)d of treatment,changes of coagulation function,liver and kidney functions of the 2 groups were compared.Adverse reactions during treatment in the 2 groups were recorded.Results No significant differences in NIHSS scores were noted between the 2 groups before treatment,on 7^(th),14^(th),and 30^(th)d of treatment(P>0.05);NIHSS scores in experimental group on 90^(th)d of treatment were signficantly lower than those in control group(P<0.05);NIHSS scores in experimental group decreased gradually before treatment and on 7^(th),14^(th),30^(th)and 90^(th)d of treatment,with statistical significances(P<0.05).No significant differences in mRS scores were noted between the 2 groups before treatment(P>0.05);mRS scores in experimental group on 180^(th) d of treatment were signfciantly lower than those in control group(P<0.05).No significant dif

关 键 词：脑出血 中西医结合 临床研究 安全性评价 

分 类 号：R277.7[医药卫生—中医学]