心速宁胶囊治疗痰热扰心证室性早搏多中心随机对照研究  

Multi-center Randomized Controlled Trial of Xinsuning Capsule in the Treatment of Ventricular Premature Beat with Phlegm-heat Disturbing Xin Syndrome

作　　者：宋欣丽 杨新春 鲁娜 吴旸[4] 汪少开 毛静远[6] 孙艳玲 孙刚[7] 吴焕林[8] 王小青 陆峰[10] 万贤明 张林[12] 李冬玉 刘亚荣[14] 黄培元 谢桂香[16] 高东升 冯伟 陈守强[19] 鲁卫星 SONG Xin-li;YANG Xin-chun;LU Na;WU Yang;WANG Shao-kai;MAO Jing-yuan;SUN Yan-ling;SUN Gang;WU Huan-lin;WANG Xiao-qing;LU Feng;WAN Xian-ming;ZHANG Lin;LI Dong-yu;LIU Ya-rong;HUANG Pei-yuan;XIE Gui-xiang;GAO Dong-sheng;FENG Wei;CHEN Shou-qiang;LU Wei-xing(Department of Cardiology,Beijing University of Chinese Medicine,Third Affiliated Hospital,Beijing,100029;Heart Center of Beijing Chao-Yang Hospital,Capital Medical University,Beijing,100020;Health Care Department,Jinan Zhangqiu District People's Hospital,Jinan,250200;Department of Cardiology,Dong Fang Hospital,Beijing University of Chinese Medicine,Beijing,100078;Internal Medicine Department,Mudanjiang Hospital of Traditional Chinese Medicine,Heilongjiang,150070;Department of Cardiology,First Teaching Hospital of Tianjin University of TCM,Tianjin,300193;Department of Cardiology,The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine,Guiyang,550001;Department of Cardiovascular,Guangdong Hospital of Traditional Chinese Medicine,Guangzhou,510120;Geriatric Department,Nanyang Hospital of Traditional Chinese Medicine,Henan,473003;Department of Cardiology,Shandong Hospital of Traditional Chinese Medicine,Jinan,250011;Department of Cardiology,Hengyang Hospital of Traditional Chinese Medicine,Hunan,421001;Department of Cardiology,Taian Hospital of Traditional Chinese Medicine,Shandong,271000;Department of Cardiovascular,Zhengzhou Hospital of Traditional Chinese Medicine,Zhengzhou,450007;Department of Cardiology,The Second Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine,Shaanxi,712000;Heart Disease Division,Qinzhou Hospital of Traditional Chinese Medicine,Guangxi,535000;Department of Cardiology,Taizhou Hospital of Traditional Chinese Medicine,Jiangsu,225300;Internal Medicine Department,Luoyang Second Hospital of Traditional Chinese Medicine,Henan,471000;Department of Cardiology,Tangshan Hospital of Traditional Chinese Medicine,Hebei,064400;Department of Cardiology,The Second Affiliated Hospital of Shandong University of Trad

机构地区：[1]北京中医药大学第三附属医院心内科,北京100029 [2]首都医科大学附属北京朝阳医院心脏中心,北京100020 [3]济南市章丘区人民医院医保科,济南250200 [4]北京中医药大学东方医院心内科,北京100078 [5]牡丹江市中医医院内科,黑龙江150070 [6]天津中医药大学第一附属医院心内科,天津300193 [7]贵阳中医学院第一附属医院心内科,贵阳550001 [8]广东省中医院心血管科,广州510120 [9]南阳市中医院老年病科,河南473003 [10]山东中医药大学附属医院心内科,济南250011 [11]衡阳市中医医院心内科,湖南421001 [12]泰安市中医医院心内科,山东271000 [13]郑州市中医院心血管科,郑州450007 [14]陕西中医学院第二附属医院心内科,陕西712000 [15]钦州市中医医院心病科,广西535000 [16]泰州市中医院心内科,江苏225300 [17]洛阳市第二中医院内科,河南471000 [18]唐山市中医医院心内科,河北064400 [19]山东中医药大学第二附属医院心内科,济南250001

出　　处：《中国中西医结合杂志》2022年第4期438-443,共6页Chinese Journal of Integrated Traditional and Western Medicine

摘　　要：目的评价心速宁胶囊治疗室性早搏(痰热扰心证)有效性和安全性。方法本试验已于中国临床试验注册中心注册(No.ChiCTR-TRC-14004180)。采用分层区组随机方法,将861例痰热扰心证室性早搏患者随机分为试验组(343例)、阳性对照组(345例)和安慰剂组(173例)。试验组给予心速宁胶囊加盐酸美西律片模拟剂,阳性对照组盐酸美西律片加心速宁胶囊模拟剂,安慰剂组心速宁胶囊模拟剂加盐酸美西律片模拟剂。3组疗程均为4周。观察治疗14、28天室性早搏24小时动态心电图(holter)疗效、中医证候疗效积分以及不良反应发生情况。结果与安慰剂组[27.27%(45/165)]比较,试验组[65.85%(216/328)]及阳性对照组[63.10%(212/336)]holter总有效率升高(Z=8.1727,7.4809,P<0.01)。与阳性对照组及安慰剂组比较,试验组中医证候积分治疗14、28天与治疗前差值更多(P<0.05)。治疗14天,与安慰剂组比较,试验组口干症状改善更明显(Z=1.1731,P<0.05)。治疗28天,与阳性对照组、安慰剂组比较,试验组口干、口苦症状改善更明显(P<0.05)。与安慰剂组比较,试验组治疗28天多梦症状改善更明显(Z=2.5085,P<0.0167)。3组间不良反应发生情况比较,差异无统计学意义(P=0.4280)。结论心速宁胶囊可有效改善痰热扰心证室性早搏患者holter总有效率、中医证候积分以及口干、口苦、失眠等症状方面,安全性好。Objective To evaluate the efficacy and safety of Xinsuning Capsule(XSNC)in the treatment of ventricular premature beats(VPB)with syndrome of phlegm heat disturbing the Xin.Methods This study was registered in the Chinese Clinical Trial Registry(No.ChiCTR-TRC-14004180).Totally 861 patients with Phlegm-heat disturbing Xin syndrome were randomly assigned to experimental group(343 cases),positive control group(345 cases)and placebo group(173 cases).The experimental group was given XSNC plus Mexilol hydrochloride tablet simulation agent,the positive control group was given Mexilol hydrochloride tablet plus XSNC simulation agent,the placebo group was given XSNC simulation agent plus Mexilol hydrochloride tablet simulation agent.The treatment course of 3 groups was 4 weeks.The curative effect of 24 hour dynamic electrocardiogram(holter),Chinese Medicine(CM)syndrome curative effect score and the occurrence of adverse reactions after 14 and 28 days of treatment were observed.Results Compared with placebo group[27.27%(45/165)],the holter total effective rate of experimental group[65.85%(216/328)]and positive control group[63.10%(212/336)]was increased(Z=8.1727,7.4809,P<0.01).Compared with positive control group and placebo group,the difference of CM syndrome score between 14 and 28 days of treatment and before treatment was larger in experimental group(P<0.05).After 14 days of treatment,dry mouth symptoms improved more in the experimental group than in the placebo group(Z=1.1731,P<0.05).After 28 days of treatment,compared with positive control group and placebo group,the symptoms of dry and bitter mouth symptoms in experimental group improved more significantly(P<0.05).Compared with placebo group,the improvement of dreamful sleeping symptoms was more significant in the experimental group after 28 days of treatment(Z=2.5085,P<0.0167).There was no significant difference in the incidence of adverse reactions among the 3 groups(P=0.4280).Conclusion XSNC has significant efficacy and good safety in improving holter total effecti

关 键 词：室性早搏 痰热扰心证 心速宁胶囊 

分 类 号：R259[医药卫生—中西医结合]