养心定悸胶囊治疗室性期前收缩多中心随机双盲安慰剂对照研究  

Effects of Yangxin Dingji Capsule for Ventricular Premature Contractions:A Multicenter Randomized Double-blind Controlled Trial

作　　者：马晓昌[1] 张大武[1] 王安铸 袁慧[1] 华琦[2] 谢瑞芹 刘怡[4] 宋红莉[5] 王凤荣[6] 李树仁[7] 王振兴[8] 赵立志 林谦[10] 牛天福[11] 张立新[12] 樊民[13] 刘建和[14] 霍艳明[15] 杨新春[16] 陈可冀[1] MA Xiao-chang;ZHANG Da-wu;WANG An-zhu;YUAN Hui;HUA Qi;XIE Rui-qin;LIU Yi;SONG Hong-li;WANG Feng-rong;LI Shu-ren;WANG Zhen-xing;ZHAO Li-zhi;LIN Qian;NIU Tian-fu;ZHANG Li-xin;FAN Min;LIU Jian-he;HUO Yan-ming;YANG Xin-chun;CHEN Ke-ji(Department of Cardiology,Xiyuan Hospital of China Academy of Chinese Medical Sciences,National Clinical Research Center for Chinese Medicine Cardiology,Beijing,100091;Department of Cardiology,Xuanwu Hospital,Capital Medical University,Bejing,100053;Department of Cardiology,The Second Hospital of Hebei Medical University,Shijiazhuang,050000;Department of Cardiology,Xuzhou Central Hospital,Jiangsu,221009;Department of Cardiology,Baoding No.1 Hospital of Traditional Chinese Medicine,Hebei,071066;Department of Cardiology,Affiliated Hospital of Liaoning University of Chinese Medicine,Shenyang,110033;Department of Cardiology,Hebei General Hospital,Shjiazhuang,050057;Department of Cardiology,Jiangsu Province Hospital of Chinese Medicine,Nanjing,210004;Department of Cardiology,Hospital of Traditional Chinese Medicine Affiliated to Southwest Medical University,Sichuan,646099;Department of Cardiology,Dongfang Hospital,Bejing University of Chinese Medicine,Beijing,100078;Department of Cardiology,Shanxi Province Hospital of Chinese Medicine,Taiyuan,030012;Department of Cardiology,Bejing Luhe Hospital,Capital Medical University,Bejing,101199;Department of Cardiology,Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai,200437;Departmentof Cardiology,TheFirst Hospital of Hunan University of Chinese Medicine,Changsha,410021;Department of Cardiology,Wangjing Hospital of China Academy of Chinese Medical Sciences,Beijing,100102;Department of Cardiology,Beijing Chao-yang Hospital,CapitalMedicalUniversity,Bejing,100020)

机构地区：[1]中国中医科学院西苑医院心血管内科,国家中医心血管病临床医学研究中,北京100091 [2]首都医科大学宣武医院心血管内科,北京100053 [3]河北医科大学第二医院心血管内科,石家庄050000 [4]徐州市中心医院心血管内科,江苏221009 [5]保定市第一中医院心血管内科,河北071066 [6]辽宁中医药大学附属医院心血管内科,沈阳110033 [7]河北省人民医院心血管内科,石家庄050057 [8]江苏省中医院心血管内科,南京210004 [9]西南医科大学附属中医医院心血管内科,四川646099 [10]北京中医药大学东方医院心血管内科,北京100078 [11]山西省中医院心血管内科,太原030012 [12]首都医科大学附属北京河医院心血管内科,北京101199 [13]上海中医药大学附属岳阳中西医结合医院心血管内科,上海200437 [14]湖南中医药大学第一附属医院心血管内科,长沙410021 [15]中国中医科学院望京医院心血管内科,北京100102 [16]首都医科大学附属北京朝阳医院心血管内科,北京100020

出　　处：《中国中西医结合杂志》2022年第12期1428-1434,共7页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：中国中药协会上市后药物再评价项目(No.2017-617-03)。

摘　　要：目的 评价养心定悸胶囊治疗室性期前收缩(气阴两虚证)的有效性和安全性。方法 研究方案在中国临床试验注册中心注册(No.ChiCTR1900020720)。采用随机、双盲、安慰剂对照研究方法,在16家医院同期进行,筛选受试者330例,最终入组受试者240例,采用中心分层区组随机化方法,分为试验组(120例)和对照组(120例)。试验组口服养心定悸胶囊(8粒,2次/日);对照组口服养心定悸胶囊模拟剂。在试验期间不使用除β受体阻滞剂(不包括索他洛尔)外的抗心律失常药物。治疗周期8周。主要疗效指标:第8周室性早搏总有效率。次要疗效指标:(1)第4周室性早搏总有效率;(2)第8周室性早搏次数变化值;(3)第8周中医单项症状变化情况(消失率)。结果 用药4周时试验组与对照组的室性早搏总有效率差异无统计学意义(39.82%vs. 30.51%,P=0.1381),用药8周时,试验组患者室性早搏总有效率明显高于对照组(60.18%vs. 31.36%,P<0.0001)。用药8周时试验组室性早搏次数变化值高于对照组(2 808.33±6 952.62 vs.239.34±7 286.79,P=0.0003),心悸消失率、气短消失率和乏力消失率均高于对照组(50.00%vs.31.58%,P=0.0050;69.44%vs.50.00%,P=0.0160;74.44%vs. 57.14%,P=0.0160)。试验组女性用药8周时室性早搏有效率明显高于对照组(64.29%vs.27.78%,P<0.0001)。无论室性早搏次数的多少或者是否有合并疾病,试验组室性早搏有效率均较对照组增高(P<0.05,P<0.01)。两组安全性评价差异无统计学意义(P>0.05)。结论 养心定悸胶囊能有效减少室性期前收缩次数和改善相关症状,且安全性良好。Objective To evaluate the efficacy and safety of Yangxin Dingji Capsule(YXDJ) for ventricular premature contractions(VPCs,syndrome of qi-yin deficiency). Methods The protocol was registered in the Chinese Clinical Trial Registry(No.ChiCTR1900020720).A randomized,double-blind,placebo-controlled study was conducted in 16 hospitals.A total of 330 patients were screened,and 240 patients were finally enrolled.They were divided into an experimental group(120 cases)and a control group(120 cases)by central stratified block randomization.The experimental group received YXDJ(8 capsules at a time,twice a day),and the control group received YXDJ simulant.The treatment duration lasted for 8 weeks.Antiarrhythmic drugs other than β receptor blockers(excluding sotalol) were not used during the trial. Primary outcome involved total effective rate of VPCs at 8th week.Secondary outcomes involved total effective rate of VPCs in the 4th week,changes in the number of VPCs at 8th week,and changes of single Chinese medicine symptoms in the 8th week(disappearance rate). Results There was no significant difference in the total effective rate of VPCs between the two groups(39.82% vs. 30.51%,P=0.1381). At 8 weeks,the total effective rate of VPCs in the experimental group was significantly higher than that in the control group(60.18% vs. 31.36%,P<0.0001). At 8weeks,the experimental group showed a significantly higher change in the number of VPCs than the control group(2 808.33±6 952.62 vs. 239.34±7 286.79,P=0.0003). At 8 weeks,the disappearance rate of palpitations,shortness of breath and fatigue in the experimental group were higher than those in the control group(50.00%vs. 31.58%,P=0.0050;69.44% vs. 50.00%,P=0.0160;74.44% vs 57.14%,P=0.0160). In stratified analysis,the effective rate of VCPs at 8 weeks was significantly higher in the experimental group than in the control group(64.29% vs. 27.78%,P<0.0001).The effective rate of VPCs in the experimental group was significantly higher than that in the control group(P<0.05,P<0.01),regardles

关 键 词：室性期前收缩 室性早搏 养心定悸胶囊 中成药 随机对照试验 

分 类 号：R259[医药卫生—中西医结合]