芪参益气滴丸对急性心肌梗死再灌注后心功能及生存质量的影响--一项多中心随机双盲安慰剂对照试验  

Qishenyiqi Dripping pills improves quality of life and cardiac function of patients with acute myocardial infarction after undergoing percutaneous coronary intervention:a multicenter,randomized double-blind and placebo-controlled trial

作　　者：招煦杰 廖鹏达[1,2] 毛帅 郭力恒 王肖龙[3] 张培影 吴旸[5] 王晓峰[6] 何汉康[7] 杨海玉[8] 吴同果 张敏州[1,2] Zhao Xujie;Liao Pengda;Mao Shuai;Guo Liheng;Wang Xiaolong;Zhang Peiying;Wu Yang;Wang Xiaofeng;He Hankang;Yang Haiyu;Wu Tongguo;Zhang Minzhou(Department of Critical Care Medicine,The Second Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510405,Guangdong,China;The Second Clinical College of Guangzhou University of Chinese Medicine,Guangzhou 510120,Guangdong,China;Department of Cardiology,Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200021,China;Department of Cardiology,Xuzhou Center Hospital,Xuzhou 221009,Jiangsu,China;Department of Cardiology,Dongfang Hospital Beijing University of Chinese Medicine,Beijing 100078,China;Department of Cardiology,Xinjiang Uyghur Autonomous Region Hospital of Traditional Chinese Medicine,Urumqi 830026,Xinjiang Uygur Autonomous Region,China;Department of Cardiology,Liuzhou Traditional Chinese Medical Hospital,Liuzhou 2852121,Guangxi Zhuang Autonomous Region,China;Department of Cardiology,Jiangmen Wuyi Traditional Chinese Medical Hospital,Jiangmen 529000,Guangdong,China;Department of Cardiology,Guangzhou Red Cross Hospital,Guangzhou 510220,Guangdong,China)

机构地区：[1]广州中医药大学第二附属医院重症医学科,广东广州510405 [2]广州中医药大学第二临床医学院,广东广州510120 [3]上海中医药大学附属曙光医院心内科,上海200021 [4]徐州市中心医院心内科,江苏徐州221009 [5]北京中医药大学东方医院心内科,北京100078 [6]新疆维吾尔自治区中医院心内科,新疆维吾尔自治区乌鲁木齐830026 [7]柳州市中医院心内科,广西壮族自治区柳州2852121 [8]江门五邑市中医院心内科,广东江门529000 [9]广州市红十字会医院心内科,广东广州510220

出　　处：《中国中西医结合急救杂志》2022年第5期524-528,共5页Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care

基　　金：广东省中医院陈可冀学术经验传承工作室(201461)。

摘　　要：目的评价芪参益气滴丸对急性ST段抬高型心肌梗死(STEMI)患者经皮冠脉介入治疗(PCI)后在心功能、主要心血管不良事件(MACE)、生活质量等的影响。方法采用多中心、双盲、安慰剂、随机对照前瞻性临床研究方法。选择广州中医药大学第二附属医院、上海中医药大学附属曙光医院、徐州市中心医院、北京中医药大学东方医院、新疆维吾尔自治区中医院、柳州市中医院、江门五邑市中医院、广州市红十字会医院共8家医院2013年8月至2015年3月收治的216例接受PCI的急性心肌梗死(AMI)患者作为研究对象。将患者以分中心为分层因素区组的随机分配方法分为中药治疗组(110例)及对照组(106例)。两组均接受西医常规治疗,对照组在此基础上给予安慰剂口服,中药治疗组给予芪参益气滴丸。两组均每次0.5 g,每日3次,疗程为6个月。通过比较两组STEMI患者治疗6个月后MACE事件、美国纽约心脏病协会(NYHA)心功能分级、心肌梗死多维度量表(MIDAS)评分、不良反应发生情况的差异,评价患者心功能及生存质量的情况。结果治疗前两组MIDAS 7个方面(安全性、躯体活动、情绪反应、依赖性、饮食、担心用药、不良反应)评分比较差异均无统计学意义(均P>0.05),治疗后中药治疗组躯体活动及不良反应评分均明显低于对照组〔躯体活动评分(分):9.26±8.10比10.31±6.71,不良反应评分(分):0.0(0.0,1.0)比0.0(0.0,1.7),均P<0.05〕;两组治疗后安全性、情绪反应、依赖性、饮食、担心用药方面评分和基础状况时NYHA心功能分级比较差异均无统计学意义(均P>0.05)。中药治疗组治疗后NYHA 1级患者比例较对照组明显增加〔73.6%(81/110)比58.5%(62/106),P<0.05〕,NYHA 2级和3级患者比例较对照组明显减少〔25.5%(28/110)比37.7%(40/106),0.9%(1/110)比3.8%(4/106),均P<0.05〕,MACE事件发生率较对照组降低〔10.9%(12/110)比16.0%(17/106)〕,但差异无统�Objective To evaluate the effects of Qishenyiqi Dripping pill(QSYQ)on the cardiac function,major adverse cardiovascular event(MACE)and quality of life in patients with acute ST segment elevation myocardial infarction(STEMI)after percutaneous coronary intervention(PCI).Methods A multicenter,double-blind,placebo,randomized controlled prospective clinical study was conducted.A total of 216 STEMI patients after PCI admitted to the 8 hospitals,as the Second Affiliated Hospital of Guangzhou University of Chinese Medicine(CM),Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine(TCM),Xuzhou Center Hospital,Dongfang Hospital Beijing University of CM,Xinjiang Uyghur Autonomous Region Hospital of TCM,Liuzhou TCM Hospital,Jiangmen Wuyi TCM Hospital,Guangzhou Red Cross Hospital,from August 2013 to March 2015 were enrolled in the study as the research objects.All included patients were randomly assigned to a TCM treatment group(n=110)and a control group(n=106)according to the method of sub-center as stratified factor block group.Both groups received basic conventional western medicine treatment.On this basis,patients in the control group would take identical placebo,while the TCM treatment group would receive QSYQ,usage:0.5 g each time,3 times a day,with the course of treatment for 6 months.The cardiac function and quality of life of STEMI patients were evaluated by comparing the differences of MACE scores,New York Heart Association(NYHA)cardiac function classification,myocardial infarction multidimensional assessment scale(MIDAS)scores and incidence of adverse reaction between the two groups after 6 months of treatment.Results There were no statistically significant differences in 7 dimensions(insecurity,physical activity,emotional reaction,dependency,diet,concerns over medication and adverse reaction)of MIDAS between two groups before treatment(all P>0.05).Compared with the control group,the patients in TCM treatment group were found to have a statistically significant lower score in physical a

关 键 词：芪参益气滴丸 急性心肌梗死 心功能 生存质量 

分 类 号：R542.22[医药卫生—心血管疾病]