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1、体外反搏对冠心病 近远期临床疗效的研究,马 虹 教授 中国 广州市 中山大学附属第一医院心血管医学部体外反搏中心,研 究 背 景,尽管体外反搏疗法对冠心病近期临床疗效的作用已被确立并在临床上被应用，但是缺乏其对远期心血管事件影响的资料，阻碍了该疗法在冠心病治疗领域中的更广泛应用,2,研 究 目 的,评价体外反搏疗法对冠心病患者的近期疗效和远期临床心血管事件发生率的影响,3,研 究 对 象病 例 来 源,本研究是一项前瞻性、分层随机、开放的药物对照试验 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2006年4月27日,4,研 究 设 计,观察指标3个月、6个月、12个月时
2、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,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的狭窄或闭塞性病变，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,研 究 对 象排 除 标 准,急性心肌梗死12周之内，或显著的主动脉瓣关闭不全，主动脉瘤及夹层动脉瘤，或冠状动脉瘘或严重的冠状动脉瘤，或有症状的充血性心力衰竭，或心瓣膜病、先心病、心肌病伴明显的血流动力学障碍，或脑出血半年内，出血性疾病或明确的出血倾向，下肢感染、
3、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)或预后差的严重疾病，或随机分组时收缩压180mmHg或舒张压100mmHg，或影响反搏治疗的严重心律失常，或 一年内曾接受过体外反搏治疗,7,干 预 措 施,在标准的冠心病药物治疗基础上，患者随机分为药物组(n=125)，药物+体外反搏组(n=130)体外反搏：每天1小时，每周反搏6天休息1天，共36天,8,受试者入组随访流程图,9,255例,药物组125例,药物反博组130例,评估主要终点事件,随机,随机,中位随访时间92个月,统计学方法,使用SAS统计软件包估计主要心血管事件的风险比。全部数据资料由中山大学公共卫生学院统计学教研室
4、进行统计分析。,10,结 果-基线特征,11,结 果-基线特征,12,结 果-基线特征,13,14,药物组(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=0.0001,15,P=0.00098,P=0.052,P=0.24,P=0.015,16,P=0.47,P=0.04,结 论,冠心病患者给予标准药物治疗的同时应用体外反搏治疗，可显著改善随访三个月、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、脑卒中发生的联合终点,17,谢谢大家！,18,The Short-term
5、 and Long-term Effect of EECP on Coronary Heart Disease,Prof.Ma Hong M.D.The 1st Affiliated Hospital of Sun Yat-Sen UniversityEECP Center of Cardiovascular Medicine,Backgrounds,Although Enhanced External Counterpulsation(EECP)has been applied in the clinical settings and its short-term therapeutic b
6、enefit documented,data of its long-term effect on cardiovascular events is lacking.Broader application of EECP for is therefore hindered.,21,Objectives,To investigate the short-term and long-term effect of EECP on coronary heart disease(CHD)patients.,22,Subjects,This is a prospective,randomized,open
7、-label,medical Rx-controlled trial Initiated in our center from Mar.22nd 1996;follow-up begins 3 mo after inclusion;last follow-up Apr.27th 2006,23,Design,Outcomes:Angina frequencies 3 months,6 months and 12 months after randomization,respectivelyComposite Primary Cardiovascular Endpoints:Cardiac de
8、ath,Non-fatal MI,StrokeSecondary Endpoints:Hospitalization due to Angina,Coronary Revasc.,24,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,OR3 months afte
9、r MI with residual chest pain and/or myocardial ischemia,ORPost-PCI patients(for prevention of restenosis),25,Exclusion Criteria,12 weeks after MI,ORSignificant aortic regurgitation,aneurysm,or dissection,ORCoronary fistula or aneurysm,ORSymptomatic CHF,ORValvular heart disease,congenital heart dise
10、ase,cardiomyopathy with significant hemodynamic compromise,ORHistory of hemorrhagic stroke within 6 month,bleeding diathesis,local infection,phlebitis,varicoses,DVT of the lower extremities,ORProgressive malignant diseases(e.g.cancer),ORSBP 180mmHg or DBP 100mmHg,ORSevere arrhythmias that affects EE
11、CP implementation,ORPrevious EECP treatment within 1 year,26,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,Flow Chart of Patient Registratio
12、n,28,N=255,Med N=125,Med+EECP N=130,Observation ofPredetermined Events,Randomized,Medium F-U Time 92 mo,Randomized,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 Univ
13、ersity,29,Results Baseline Characteristics,30,Results Baseline Characteristics,31,Results Baseline Characteristics,32,33,Med(n=125),AnginaFrequencyDuring 3mo,6mo,&12mo follow-up,Med+EECP(n=130),3 mo,6 mo,12 mo,P=0.0001,P=0.0002,P=0.0001,34,P=0.00098,P=0.052,P=0.24,P=0.015,35,P=0.47,P=0.04,Conclusion
14、,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,Thank you!,37,
