体外反搏对冠心病近远期临床疗效研究培训 参考ppt课件

体外反搏对冠心病体外反搏对冠心病 近远期临床疗效的研究近远期临床疗效的研究马马 虹虹 教授教授 中国中国 广州市广州市 中山大学附属第一医院中山大学附属第一医院心血管医学部体外反搏中心心血管医学部体外反搏中心体外反搏对冠心病 近远期临床疗效的研究马 虹 教授研研 究究 背背 景景尽管体外反搏疗法对冠心病近期临床疗效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碍了该疗法在冠心病治疗领域中的更广泛应用应用2研 究 背 景尽管体外反搏疗法对冠心病近期临床疗效的作研研 究究 目目 的的评价体外反搏疗法对冠心病患者的近期疗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效和远期临床心血管事件发生率的影响3研 究 目 的评价体外反搏疗法对冠心病患者的近期疗效和研研 究究 对对 象象病病 例例 来来 源源 本研究是一项前瞻性、分层随机、开放的药物对本研究是一项前瞻性、分层随机、开放的药物对照试验照试验 于于19961996年年3 3月月2222日在我院开始进行，从入组日在我院开始进行，从入组3 3个月个月后开始随访，随访至后开始随访，随访至20062006年年4 4月月2727日日4研 究 对 象病 例 来 源 本研究是一项前瞻性、分研研 究究 设设 计计观察指标观察指标3 3个月、个月、6 6个月、个月、1212个月时心绞痛发作频率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、脑卒中死、脑卒中次要心血管事件：心绞痛住院、次要心血管事件：心绞痛住院、冠脉血管重建术冠脉血管重建术5研 究 设 计观察指标5研研 究究 对对 象象纳纳 入入 标标 准准冠状动脉造影显示冠脉主要分支有一处以上冠状动脉造影显示冠脉主要分支有一处以上7070的狭窄或的狭窄或闭塞性病变，或狭窄闭塞性病变，或狭窄5050伴有胸痛及或心肌缺血表现，伴有胸痛及或心肌缺血表现，或或急性心肌梗死后急性心肌梗死后3 3个月伴有胸痛及或心肌缺血表现，或个月伴有胸痛及或心肌缺血表现，或冠心病冠心病PCIPCI术后患者术后患者(预防再狭窄预防再狭窄)6研 究 对 象纳 入 标 准冠状动脉造影显示冠脉主要研研 究究 对对 象象排排 除除 标标 准准急性心肌梗死急性心肌梗死1212周之内，或周之内，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、静脉炎、严脑出血半年内，出血性疾病或明确的出血倾向，下肢感染、静脉炎、严重静脉曲张、深静脉栓塞，或重静脉曲张、深静脉栓塞，或进展性恶性疾病进展性恶性疾病(如肿瘤如肿瘤)或预后差的严重疾病，或或预后差的严重疾病，或随机分组时收缩压随机分组时收缩压180mmHg180mmHg或舒张压或舒张压100mmHg100mmHg ，或，或影响反搏治疗的严重心律失常，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一年内曾接受过体外反搏治疗 7研 究 对 象排 除 标 准急性心肌梗死12周之内，干干 预预 措措 施施在标准的冠心病药物治疗基础上，患者随在标准的冠心病药物治疗基础上，患者随机分为药物组机分为药物组(n=125)(n=125)，药物，药物+体外反搏组体外反搏组(n=130)(n=130)体外反搏：每天体外反搏：每天1 1小时，每周反搏小时，每周反搏6 6天休息天休息1 1天，共天，共3636天天8干 预 措 施在标准的冠心病药物治疗基础上，患者随机分受试者入组随访流程图255255例例药物组药物组125125例例药物反博组药物反博组130130例例评估主要终点事件评估主要终点事件随机随机随机随机中位随访时间中位随访时间92个月个月9受试者入组随访流程图255例药物组125例药物反博组130统计学方法统计学方法 使用使用SASSAS统计软件包估计主要心血管事件的统计软件包估计主要心血管事件的风险比。风险比。全部数据资料由中山大学公共卫生学院统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。计学教研室进行统计分析。10统计学方法 使用SAS统计软件包估计主要心血管事件结结 果果 -基线特征基线特征反搏反搏组(n=133)药物物组(n=124)P值年年龄60.6759.720.36男性男性103970.75血血压129.81/80.28129.72/78.970.96体重指数体重指数23.63723.620.96心功能分心功能分级I/II/III/IV74/55/0/089/29/2/00.08既往心梗既往心梗/心心绞痛病史痛病史58/12265/1050.24既往既往PCI史史10130.4511结 果-基线特征反搏组(n=133)药物组(n=124结结 果果 -基线特征基线特征反搏反搏组(n=133)药物物组(n=124)P值高甘油三高甘油三酯血症血症44510.25高胆固醇血症高胆固醇血症35340.96高血高血压病病68520.08糖尿病史糖尿病史14200.22吸烟史吸烟史48540.3012结 果-基线特征反搏组(n=133)药物组(n=124结结 果果 -基线特征基线特征反搏反搏组(n=133)药物物组(n=124)P值硝酸硝酸酯类96850.30-受体阻滞受体阻滞剂70680.93ACEI83820.77钙拮抗拮抗剂47480.71抗心律失常抗心律失常药物物690.38阿司匹林阿司匹林97990.38他汀他汀类110.98地高辛地高辛460.48其他抗凝其他抗凝药62720.1113结 果-基线特征反搏组(n=133)药物组(n=124药物组(n=125)随访三个月、六个月、十随访三个月、六个月、十二个月时心绞痛发作频率二个月时心绞痛发作频率反搏组(n=130)3个月个月6个月个月12个月个月P=0.0001P=0.0002P=0.000114药物组(n=125)随访三个月、六个月、十二个月时心绞痛发作P=0.00098P=0.052P=0.24P=0.01515P=0.00098P=0.052P=0.24P P=0.47P=0.0416P=0.47P=0.0416结结 论论冠心病患者给予标准药物治疗的同时应用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、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卒中发生的联合终点17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，可谢谢大家！谢谢大家！18谢谢大家！181919The Short-term and Long-term Effect of EECP on Coronary Heart DiseaseProf.Ma Hong M.D.The 1st Affiliated Hospital of Sun Yat-Sen UniversityEECP Center of Cardiovascular Medicine20The Short-term and Long-term EBackgroundsBackgroundsAlthough Enhanced External Although Enhanced External Counterpulsation(EECP)has been Counterpulsation(EECP)has been applied in the clinical settings and applied in the clinical settings and its short-term therapeutic benefit its short-term therapeutic benefit documented,data of its long-term documented,data of its long-term effect on cardiovascular events is effect on cardiovascular events is lacking.Broader application of EECP lacking.Broader application of EECP for is therefore hindered.for is therefore hindered.2121BackgroundsAlthough Enhanced EObjectivesObjectivesTo investigate the short-term and To investigate the short-term and long-term effect of EECP on coronary long-term effect of EECP on coronary heart disease(CHD)patients.heart disease(CHD)patients.2222ObjectivesTo investigate the sSubjectsSubjects This is a prospective,randomized,open-This is a prospective,randomized,open-label,medical Rx-controlled triallabel,medical Rx-controlled trial Initiated in our center from Mar.22Initiated in our center from Mar.22ndnd 1996;follow-up begins 3 mo after 1996;follow-up begins 3 mo after inclusion;last follow-up Apr.27inclusion;last follow-up Apr.27thth 2006 20062323Subjects This is a prospectiveDesignDesignOutcomes:Outcomes:Angina frequencies 3 months,6 months and 12 Angina frequencies 3 months,6 months and 12 months after randomization,respectivelymonths after randomization,respectivelyComposite Primary Cardiovascular Endpoints:Composite Primary Cardiovascular Endpoints:Cardiac death,Non-fatal MI,StrokeCardiac death,Non-fatal MI,StrokeSecondary Endpoints:Hospitalization due to Secondary Endpoints:Hospitalization due to Angina,Coronary Revasc.Angina,Coronary Revasc.2424DesignOutcomes:2424Inclusion CriteriaInclusion CriteriaOne or more One or more 70%70%stenotic or occlusive lesions on stenotic or occlusive lesions on major branches during angiography,or one or more major branches during angiography,or one or more 50%stenotic or occlusive lesions with50%stenotic or occlusive lesions with chest pain chest pain and/or myocardial ischemia,ORand/or myocardial ischemia,OR3 months after MI with residual chest pain and/or 3 months after MI with residual chest pain and/or myocardial ischemia,ORmyocardial ischemia,ORPost-PCI patients(for prevention of restenosis)Post-PCI patients(for prevention of restenosis)2525Inclusion CriteriaOne or more Exclusion CriteriaExclusion Criteria12 weeks after MI,OR12 weeks after MI,ORSignificant aortic regurgitation,aneurysm,or dissection,ORSignificant aortic regurgitation,aneurysm,or dissection,ORCoronary fistula or aneurysm,ORCoronary fistula or aneurysm,ORSymptomatic CHF,ORSymptomatic CHF,ORValvular heart disease,congenital heart disease,Valvular heart disease,congenital heart disease,cardiomyopathy with significant hemodynamic compromise,ORcardiomyopathy with significant hemodynamic compromise,ORHistory of hemorrhagic stroke within 6 month,bleeding History of hemorrhagic stroke within 6 month,bleeding diathesis,local infection,phlebitis,varicoses,DVT of the diathesis,local infection,phlebitis,varicoses,DVT of the lower extremities,ORlower extremities,ORProgressive malignant diseases(e.g.cancer),ORProgressive malignant diseases(e.g.cancer),ORSBP SBP 180mmHg180mmHg or DBP or DBP 100mmHg,OR100mmHg,ORSevere arrhythmias that affects EECP implementation,ORSevere arrhythmias that affects EECP implementation,ORPrevious EECP treatment within 1 yearPrevious EECP treatment within 1 year2626Exclusion Criteria12 weeks aftInterventionInterventionOn top of standard pharmacological On top of standard pharmacological therapy,patients were randomized therapy,patients were randomized into Medical groupinto Medical group (n=125)and(n=125)and Medical+EECP group(n=130).Medical+EECP group(n=130).EECP protocol:1 hour daily,6 times EECP protocol:1 hour daily,6 times a week,with a total of 36 hoursa week,with a total of 36 hours2727InterventionOn top of standardFlow Chart of Patient Registration28N=255Med N=125Med+EECP N=130Observation ofPredetermined EventsRandomizedMedium F-U Time 92 moRandomized28Flow Chart of Patient RegistraStatistical AnalysisStatistical Analysis SAS software was applied for hazard SAS software was applied for hazard ratios of major cardiac events.ratios of major cardiac events.All data was analyzed by the Dept.of Medical Statistics,Academy of Public Health,Sun Yat-Sen University2929Statistical Analysis SAS Results Baseline Results Baseline CharacteristicsCharacteristics30Med+EECP(n=133)Med(n=124)P ValueAge60.6759.720.36Male103970.75BP129.81/80.28129.72/78.970.96BMI23.63723.620.96Cardiac Function NYHA I/II/III/IV74/55/0/089/29/2/00.08Prior MI/Angina58/12265/1050.24Prior CABG10130.4530Results Baseline CharacterisResults Baseline Results Baseline CharacteristicsCharacteristics31Med+EECP(n=133)Med(n=124)PValueTG44510.25Chol35340.96Hypertension68520.08Diabetes14200.22Smoking48540.3031Results Baseline CharacterisResults Baseline Results Baseline CharacteristicsCharacteristics32Med+EECP(n=133)Med(n=124)PValueNitrates96850.30Beta blockers70680.93ACEI83820.77CCB47480.71Anti-arrhythmics690.38Aspirin97990.38Statins110.98Digoxin460.48Other Anticoagulants62720.1132Results Baseline Characteris33Med(n=125)AnginaFrequencyDuring 3mo,6mo,&12mo follow-upMed+EECP(n=130)3 mo6 mo12 moP=0.0001P=0.0002P=0.00013333MedAnginaMed+EECP3 mo6 mo1234P=0.00098P=0.052P=0.24P=0.0153434P=0.00098P=0.052P=0.2435P=0.47P=0.043535P=0.47P=0.0435ConclusionConclusionEECP,when applied in addition to EECP,when applied in addition to standard medical therapy for the standard medical therapy for the treatment of patients with stable treatment of patients with stable coronary disease patients,coronary disease patients,significantly improves angina significantly improves angina frequency at 3 month,6 month and 12 frequency at 3 month,6 month and 12 months of follow-up,and months of follow-up,and significantly reduces long-term significantly reduces long-term composite endpoints of cardiac death,composite endpoints of cardiac death,non-fatal MI and stroke.non-fatal MI and stroke.3636ConclusionEECP,when applied iThank you!Thank you!3737Thank you!3737 素材和资料部分来自素材和资料部分来自网络，如有帮助请下载网络，如有帮助请下载!素材和资料部分来自网络，如有帮助请下载!