体外反搏对冠心病近远期临床疗效的研究.pptx

单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,#,体外反搏对冠心病近远期临床疗效的研究,体外反搏对冠心病近远期临床疗效的研究,第1页,研 究 背 景,尽管体外反搏疗法对冠心病近期临床疗效作用已被确立并在临床上被应用，不过缺乏其对远期心血管事件影响资料，妨碍了该疗法在冠心病治疗领域中更广泛应用,2,体外反搏对冠心病近远期临床疗效的研究,第2页,研 究 目,评价体外反搏疗法对冠心病患者近期疗效和远期临床心血管事件发生率影响,3,体外反搏对冠心病近远期临床疗效的研究,第3页,研 究 对 象,病 例 来 源,本研究是一项前瞻性、分层随机、开放药品对照试验,于,1996,年,3,月,22,日在我院开始进行，从入组,3,个月后开始随访，随访至,年,4,月,27,日,4,体外反搏对冠心病近远期临床疗效的研究,第4页,研 究 设 计,观察指标,3,个月、,6,个月、,12,个月时心绞痛发作频率,心血管联合终点事件：冠心病死亡、非致命性心肌梗死、脑卒中,次要心血管事件：心绞痛住院、,冠脉血管重建术,5,体外反搏对冠心病近远期临床疗效的研究,第5页,研 究 对 象,纳 入 标 准,冠状动脉造影显示冠脉主要分支有一处以上,70,狭窄或闭塞性病变，或狭窄,50,伴有胸痛及或心肌缺血表现，或,急性心肌梗死后,3,个月伴有胸痛及或心肌缺血表现，或,冠心病,PCI,术后患者,(,预防再狭窄,),6,体外反搏对冠心病近远期临床疗效的研究,第6页,研 究 对 象,排 除 标 准,急性心肌梗死,12,周之内，或,显著主动脉瓣关闭不全，主动脉瘤及夹层动脉瘤，或,冠状动脉瘘或严重冠状动脉瘤，或,有症状充血性心力衰竭，或,心瓣膜病、先心病、心肌病伴显著血流动力学障碍，或,脑出血六个月内，出血性疾病或明确出血倾向，下肢感染、静脉炎、严重静脉曲张、深静脉栓塞，或,进展性恶性疾病,(,如肿瘤,),或预后差严重疾病，或,随机分组时收缩压,180mmHg,或舒张压,100mmHg,，或,影响反搏治疗严重心律失常，或,一年内曾接收过体外反搏治疗,7,体外反搏对冠心病近远期临床疗效的研究,第7页,干 预 措 施,在标准冠心病药品治疗基础上，患者随机分为药品组,(n=125),，药品,+,体外反搏组,(n=130),体外反搏：天天,1,小时，每七天反搏,6,天休息,1,天，共,36,天,8,体外反搏对冠心病近远期临床疗效的研究,第8页,受试者入组随访流程图,9,255,例,药品组,125,例,药品反博组,130,例,评定主要终点事件,随机,随机,中位随访时间,92,个月,体外反搏对冠心病近远期临床疗效的研究,第9页,统计学方法,使用,SAS,统计软件包预计主要心血管事件风险比。,全部数据资料由中山大学公共卫生学院统计学教研室进行统计分析。,10,体外反搏对冠心病近远期临床疗效的研究,第10页,结 果,-,基线特征,11,反搏组,(n=133),药品组(n=124),P,值,年纪,60.67,59.72,0.36,男性,103,97,0.75,血压,129.81/80.28,129.72/78.97,0.96,体重指数,23.637,23.62,0.96,心功效分级I/II/III/IV,74/55/0/0,89/29/2/0,0.08,既往心梗,/,心绞痛病史,58/122,65/105,0.24,既往,PCI,史,10,13,0.45,体外反搏对冠心病近远期临床疗效的研究,第11页,结 果,-,基线特征,12,反搏组,(n=133),药品组(n=124),P,值,高甘油三酯血症,44,51,0.25,高胆固醇血症,35,34,0.96,高血压病,68,52,0.08,糖尿病史,14,20,0.22,吸烟史,48,54,0.30,体外反搏对冠心病近远期临床疗效的研究,第12页,结 果,-,基线特征,13,反搏组,(n=133),药品组(n=124),P,值,硝酸酯类,96,85,0.30,-,受体阻滞剂,70,68,0.93,ACEI,83,82,0.77,钙拮抗剂,47,48,0.71,抗心律失常药品,6,9,0.38,阿司匹林,97,99,0.38,他汀类,1,1,0.98,地高辛,4,6,0.48,其它抗凝药,62,72,0.11,体外反搏对冠心病近远期临床疗效的研究,第13页,14,药品组,(n=125),随访三个月、六个月、十二个月时心绞痛发作频率,反搏组,(n=130),3,个月,6,个月,12,个月,P=0.0001,P=0.0002,P=0.0001,体外反搏对冠心病近远期临床疗效的研究,第14页,15,P=0.00098,P=0.052,P=0.24,P=0.015,体外反搏对冠心病近远期临床疗效的研究,第15页,16,P=0.47,P=0.04,体外反搏对冠心病近远期临床疗效的研究,第16页,结 论,冠心病患者给予标准药品治疗同时应用体外反搏治疗，可显著改进随访三个月、六个月与十二个月心绞痛症状，并可显著降低远期冠心病死亡、非致死性心梗、脑卒中发生联合终点,17,体外反搏对冠心病近远期临床疗效的研究,第17页,谢谢大家！,18,体外反搏对冠心病近远期临床疗效的研究,第18页,体外反搏对冠心病近远期临床疗效的研究,第19页,The Short-term and Long-term Effect of EECP on Coronary Heart Disease,Prof.Ma Hong M.D.,The 1,st,Affiliated Hospital of Sun Yat-Sen University,EECP Center of Cardiovascular Medicine,体外反搏对冠心病近远期临床疗效的研究,第20页,Backgrounds,Although Enhanced External Counterpulsation(EECP)has been applied in the clinical settings and its short-term therapeutic benefit documented,data of its long-term effect on cardiovascular events is lacking.Broader application of EECP for is therefore hindered.,21,体外反搏对冠心病近远期临床疗效的研究,第21页,Objectives,To investigate the short-term and long-term effect of EECP on coronary heart disease(CHD)patients.,22,体外反搏对冠心病近远期临床疗效的研究,第22页,Subjects,This is a prospective,randomized,open-label,medical Rx-controlled trial,Initiated in our center from Mar.22,nd,1996;follow-up begins 3 mo after inclusion;last follow-up Apr.27,th,23,体外反搏对冠心病近远期临床疗效的研究,第23页,Design,Outcomes:,Angina frequencies 3 months,6 months and 12 months after randomization,respectively,Composite Primary Cardiovascular Endpoints:Cardiac death,Non-fatal MI,Stroke,Secondary Endpoints:Hospitalization due to Angina,Coronary Revasc.,24,体外反搏对冠心病近远期临床疗效的研究,第24页,Inclusion Criteria,One or more,70%,stenotic or occlusive lesions on major branches during angiography,or one or more,50%stenotic or occlusive lesions with,chest pain and/or myocardial ischemia,OR,3 months after MI with residual chest pain and/or myocardial ischemia,OR,Post-PCI patients(for prevention of restenosis),25,体外反搏对冠心病近远期临床疗效的研究,第25页,Exclusion Criteria,12 weeks after MI,OR,Significant aortic regurgitation,aneurysm,or dissection,OR,Coronary fistula or aneurysm,OR,Symptomatic CHF,OR,Valvular heart disease,congenital heart disease,cardiomyopathy with significant hemodynamic compromise,OR,History of hemorrhagic stroke within 6 month,bleeding diathesis,local infection,phlebitis,varicoses,DVT of the lower extremities,OR,Progressive malignant diseases(e.g.cancer),OR,SBP,180mmHg,or DBP,100mmHg,OR,Severe arrhythmias that affects EECP implementation,OR,Previous EECP treatment within 1 year,26,体外反搏对冠心病近远期临床疗效的研究,第26页,Intervention,On top of standard pharmacological therapy,patients were randomized into Medical group,(n=125)and Medical+EECP group(n=130).,EECP protocol:1 hour daily,6 times a week,with a total of 36 hours,27,体外反搏对冠心病近远期临床疗效的研究,第27页,Flow Chart of Patient Registration,28,N=255,Med N=125,Med+EECP N=130,Observation of,Predetermined Events,Randomized,Medium F-U Time 92,mo,Randomized,体外反搏对冠心病近远期临床疗效的研究,第28页,Statistical Analysis,SAS software was applied for hazard ratios of major cardiac events.,All data was analyzed by the Dept.of Medical Statistics,Academy of Public Health,Sun Yat-Sen University,29,体外反搏对冠心病近远期临床疗效的研究,第29页,Results Baseline Characteristics,30,Med,+EECP,(n=133),Med,(n=124),P,Value,Age,60.67,59.72,0.36,Male,103,97,0.75,BP,129.81/80.28,129.72/78.97,0.96,BMI,23.637,23.62,0.96,Cardiac Function,NYHA I/II/III/IV,74/55/0/0,89/29/2/0,0.08,Prior MI/Angina,58/122,65/105,0.24,Prior,CABG,10,13,0.45,体外反搏对冠心病近远期临床疗效的研究,第30页,Results Baseline Characteristics,31,Med+EECP,(n=133),Med,(n=124),P,Value,TG,44,51,0.25,Chol,35,34,0.96,Hypertension,68,52,0.08,Diabetes,14,20,0.22,Smoking,48,54,0.30,体外反搏对冠心病近远期临床疗效的研究,第31页,Results Baseline Characteristics,32,Med+EECP,(n=133),Med,(n=124),P,Value,Nitrates,96,85,0.30,Beta blockers,70,68,0.93,ACEI,83,82,0.77,CCB,47,48,0.71,Anti-arrhythmics,6,9,0.38,Aspirin,97,99,0.38,Statins,1,1,0.98,Digoxin,4,6,0.48,Other Anticoagulants,62,72,0.11,体外反搏对冠心病近远期临床疗效的研究,第32页,33,Med,(n=125),Angina,Frequency,During 3mo,6mo,&12mo follow-up,Med+EECP,(n=130),3,mo,6,mo,12,mo,P=0.0001,P=0.0002,P=0.0001,体外反搏对冠心病近远期临床疗效的研究,第33页,34,P=0.00098,P=0.052,P=0.24,P=0.015,体外反搏对冠心病近远期临床疗效的研究,第34页,35,P=0.47,P=0.04,体外反搏对冠心病近远期临床疗效的研究,第35页,Conclusion,EECP,when applied in addition to standard medical therapy for the treatment of patients with stable coronary disease patients,significantly improves angina frequency at 3 month,6 month and 12 months of follow-up,and significantly reduces long-term composite endpoints of cardiac death,non-fatal MI and stroke.,36,体外反搏对冠心病近远期临床疗效的研究,第36页,