葛酮通络胶囊对缺血性脑卒中恢复期病人中医证候改善的多中心随机对照临床研究  

A Multicentre Randomized Controlled Trial on TCM Syndrome Improvement of Patients with Convalescence of Ischemic Stroke by Getong Tongluo Capsule

作　　者：赵倩煜 刘运海 张金涛[4] 唐荣华[5] 刘路然 曹绪政[7] 吕国雄[8] 张继华[9] 魏洪涛 杨淼[11] 李虹霖 徐彬[13] 朱文宗[14] 张梅[15] 马丽平 韦玲[17] 钟池[18] 王宏[19] 陈志刚[1,2] ZHAO Qianyu;LIU Yunhai;ZHANG Jintao;TANG Ronghua;LIU Luran;CAO Xuzheng;LYU Guoxiong;ZHANG Jihua;WEI Hongtao;YANG Miao;LI Honglin;XU Bin;ZHU Wenzong;ZHANG Mei;MA Liping;WEI Ling;ZHONG Chi;WANG Hong;CHEN Zhigang(Dongfang Hospital Beijing University of Chinese Medicine,Beijing 100078,China,Beijing University of Chinese Medicine,Beijing 100029,China)

机构地区：[1]北京中医药大学东方医院,北京100078 [2]北京中医药大学,北京100029 [3]中南大学湘雅医院 [4]中国人民解放军第八十八医院 [5]华中科技大学同济医学院附属同济医院 [6]哈尔滨医科大学附属第四医院 [7]中国人民解放军第二一一医院 [8]江西中医药大学附属医院 [9]绥化市第一医院 [10]甘肃省第二人民医院 [11]亳州市人民医院 [12]黑龙江中医药大学附属第二医院 [13]浙江省新华医院 [14]温州市中医院 [15]淮南市第一人民医院 [16]忻州市人民医院 [17]山西中医学院第三中医院 [18]潍坊市人民医院 [19]石河子大学医学院第一附属医院

出　　处：《中西医结合心脑血管病杂志》2021年第23期4039-4043,4049,共6页Chinese Journal of Integrative Medicine on Cardio-Cerebrovascular Disease

基　　金：广州市临床医学研究与转化中心试点建设项目(No.20160402003)。

摘　　要：目的评价葛酮通络胶囊对缺血性脑卒中恢复期病人中医证候改善的临床疗效。方法采用随机、双盲双模拟、阳性药与安慰剂平行对照、多中心研究。筛选纳入受试者477例,按照2∶1∶1比例随机分配到试验组(葛酮通络胶囊+银杏叶提取物片模拟剂)、阳性对照组[银杏叶提取物片(金纳多)+葛酮通络胶囊模拟剂]、安慰剂组(葛酮通络胶囊模拟剂+银杏叶提取物片模拟剂)。基础用药为阿司匹林肠溶片,共治疗12周。观察治疗前及治疗4周、8周、12周时3组病人中医证候积分变化,评价试验用药的临床疗效。结果治疗12周,试验组和阳性对照组中医证候总有效率71.70%、72.73%,均高于安慰剂组(47.79%,P<0.05),且试验组与阳性对照组中医证候总有效率比较,差异无统计学意义(P>0.05)。治疗12周,试验组在改善病人头痛、肢体疼痛方面均优于阳性对照组与安慰剂组(P<0.05)。试验组与阳性对照组治疗12周,在改善病人肢体不遂症状方面均优于安慰剂组(P<0.05),且试验组与阳性对照组比较,差异无统计学意义(P>0.05)。结论葛酮通络胶囊对缺血性脑卒中恢复期病人的中医证候有改善作用,能提高病人的生活质量。且在改善病人头痛及肢体疼痛方面优于金纳多。Objective To evaluate the efficacy of Getong Tongluo capsule on traditional Chinese medicine(TCM)syndrome of convalescence patients with ischemic stroke.Methods A randomized,double-blind,double-simulated,positive-placebo parallel control,multicenter study was conducted.A total of 477 patients were randomly divided into treatment group,positive medicine control group,and placebo group according to a 2∶1∶1 ratio,and all patients were given Aspirin Enteric-coated Tablets for 12 weeks.Getong Tongluo Capsule and Ginaton(ginkgo biloba extract,GBE)matching placebo were applied in the treatment group,while positive medicine-Ginaton and Getong Tongluo matching placebo were applied in the positive medicine control group,two kinds of matching placebo were applied in the placebo group for 12 weeks.The validity observation was the index of TCM syndrome.The symptom scores were recorded at baseline and at 4,8,and 12 weeks of treatment.The changes in symptom scores were compared between three groups to evaluate the efficacy.Results After 12 weeks treatment,the TCM syndrome efficacy of the treatment group was 71.70%that in the positive medicine control group was 72.73%,and that in the placebo group was 47.79%,that in the treatment group and the positive medicine control group were superior to the placebo group(P<0.05),and there were no difference between the treatment group and the positive medicine control group(P>0.05).The treatment group was superior to the positive medicine control group and the placebo group in improving headache and limb pain(P<0.05)after 12 weeks treatment.Besides,the treatment group and the positive medicine control group were superior to the placebo group in improving limb dysfunction at the end of the trial(P<0.05),and there were no difference between the treatment group and the positive medicine control group(P>0.05).Conclusion Getong Tongluo Capsule can significantly improve the TCM syndrome of convalescence patients with ischemic stroke,and quality of life.Getong Tongluo Capsules was more effecti

关 键 词：缺血性脑卒中 恢复期 葛酮通络胶囊 银杏叶提取物片 中医证候 随机对照试验 

分 类 号：R28[医药卫生—中药学]