體外反搏對(duì)冠心病近遠(yuǎn)期臨床療效研究課件

1、體外反搏對(duì)冠心病 近遠(yuǎn)期臨床療效的研究馬 虹 教授 中國(guó) 廣州市 中山大學(xué)附屬第一醫(yī)院心血管醫(yī)學(xué)部體外反搏中心研 究 背 景盡管體外反搏療法對(duì)冠心病近期臨床療效的作用已被確立并在臨床上被應(yīng)用，但是缺乏其對(duì)遠(yuǎn)期心血管事件影響的資料，阻礙了該療法在冠心病治療領(lǐng)域中的更廣泛應(yīng)用2研 究 目 的評(píng)價(jià)體外反搏療法對(duì)冠心病患者的近期療效和遠(yuǎn)期臨床心血管事件發(fā)生率的影響3研 究 對(duì) 象病 例 來(lái) 源 本研究是一項(xiàng)前瞻性、分層隨機(jī)、開(kāi)放的藥物對(duì)照試驗(yàn) 于1996年3月22日在我院開(kāi)始進(jìn)行，從入組3個(gè)月后開(kāi)始隨訪，隨訪至2006年4月27日4研 究 設(shè) 計(jì)觀察指標(biāo)3個(gè)月、6個(gè)月、12個(gè)月時(shí)心絞痛發(fā)作頻率心血管聯(lián)

2、合終點(diǎn)事件：冠心病死亡、非致命性心肌梗死、腦卒中次要心血管事件：心絞痛住院、 冠脈血管重建術(shù)5研 究 對(duì) 象納 入 標(biāo) 準(zhǔn)冠狀動(dòng)脈造影顯示冠脈主要分支有一處以上70的狹窄或閉塞性病變，或狹窄50伴有胸痛及或心肌缺血表現(xiàn)，或急性心肌梗死后3個(gè)月伴有胸痛及或心肌缺血表現(xiàn)，或冠心病PCI術(shù)后患者(預(yù)防再狹窄) 6研 究 對(duì) 象排 除 標(biāo) 準(zhǔn)急性心肌梗死12周之內(nèi)，或顯著的主動(dòng)脈瓣關(guān)閉不全，主動(dòng)脈瘤及夾層動(dòng)脈瘤，或冠狀動(dòng)脈瘺或嚴(yán)重的冠狀動(dòng)脈瘤，或有癥狀的充血性心力衰竭，或心瓣膜病、先心病、心肌病伴明顯的血流動(dòng)力學(xué)障礙，或腦出血半年內(nèi)，出血性疾病或明確的出血傾向，下肢感染、靜脈炎、嚴(yán)重靜脈曲張、深靜脈栓

3、塞，或進(jìn)展性惡性疾病(如腫瘤)或預(yù)后差的嚴(yán)重疾病，或隨機(jī)分組時(shí)收縮壓180mmHg或舒張壓100mmHg ，或影響反搏治療的嚴(yán)重心律失常，或 一年內(nèi)曾接受過(guò)體外反搏治療 7干 預(yù) 措 施在標(biāo)準(zhǔn)的冠心病藥物治療基礎(chǔ)上，患者隨機(jī)分為藥物組(n=125)，藥物+體外反搏組(n=130)體外反搏：每天1小時(shí)，每周反搏6天休息1天，共36天8受試者入組隨訪流程圖9255例藥物組125例藥物反博組130例評(píng)估主要終點(diǎn)事件隨機(jī)隨機(jī)中位隨訪時(shí)間92個(gè)月統(tǒng)計(jì)學(xué)方法 使用SAS統(tǒng)計(jì)軟件包估計(jì)主要心血管事件的風(fēng)險(xiǎn)比。 全部數(shù)據(jù)資料由中山大學(xué)公共衛(wèi)生學(xué)院統(tǒng)計(jì)學(xué)教研室進(jìn)行統(tǒng)計(jì)分析。10結(jié) 果 - 基線特征11反搏組(n

4、=133)藥物組(n=124)P值年齡60.6759.720.36男性103970.75血壓129.81/80.28129.72/78.970.96體重指數(shù)23.63723.620.96心功能分級(jí)I/II/III/IV74/55/0/089/29/2/00.08既往心梗/心絞痛病史58/12265/1050.24既往PCI史10130.45結(jié) 果 - 基線特征12反搏組(n=133)藥物組(n=124)P值高甘油三酯血癥44510.25高膽固醇血癥35340.96高血壓病68520.08糖尿病史14200.22吸煙史48540.30結(jié) 果 - 基線特征13反搏組(n=133)藥物組(n=124

5、)P值硝酸酯類96850.30-受體阻滯劑70680.93ACEI83820.77鈣拮抗劑47480.71抗心律失常藥物690.38阿司匹林97990.38他汀類110.98地高辛460.48其他抗凝藥62720.1114藥物組(n=125)隨訪三個(gè)月、六個(gè)月、十二個(gè)月時(shí)心絞痛發(fā)作頻率反搏組(n=130)3個(gè)月6個(gè)月12個(gè)月P = 0.0001P = 0.0002P = 0.000115P = 0.00098P = 0.052P = 0.24P = 0.01516P = 0.47P = 0.04結(jié) 論冠心病患者給予標(biāo)準(zhǔn)藥物治療的同時(shí)應(yīng)用體外反搏治療，可顯著改善隨訪三個(gè)月、六個(gè)月與十二個(gè)月心絞痛

6、癥狀，并可顯著降低遠(yuǎn)期冠心病死亡、非致死性心梗、腦卒中發(fā)生的聯(lián)合終點(diǎn)17謝謝大家！18The 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 MedicineBackgroundsAlthough Enhanced External Counterpulsation (EECP) has been applied

7、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.21ObjectivesTo investigate the short-term and long-term effect of EECP on coronary heart disease (CHD) p

8、atients.22Subjects This is a prospective, randomized, open-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 200623DesignOutcomes:Angina frequencies 3 months, 6 months and 12 months after randomization, res

9、pectivelyComposite Primary Cardiovascular Endpoints: Cardiac death, Non-fatal MI, StrokeSecondary Endpoints: Hospitalization due to Angina, Coronary Revasc.24Inclusion CriteriaOne or more 70% stenotic or occlusive lesions on major branches during angiography, or one or more 50% stenotic or occlusive

10、 lesions with chest pain and/or myocardial ischemia, OR3 months after MI with residual chest pain and/or myocardial ischemia, ORPost-PCI patients (for prevention of restenosis)25Exclusion Criteria12 weeks after MI, ORSignificant aortic regurgitation, aneurysm, or dissection, ORCoronary fistula or an

11、eurysm, ORSymptomatic CHF, ORValvular heart disease, congenital heart disease, 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 dise

12、ases (e.g. cancer), ORSBP 180mmHg or DBP 100mmHg, ORSevere arrhythmias that affects EECP implementation, ORPrevious EECP treatment within 1 year26InterventionOn top of standard pharmacological therapy, patients were randomized into Medical group (n=125) and Medical + EECP group (n=130).EECP protocol

13、: 1 hour daily, 6 times a week, with a total of 36 hours27Flow Chart of Patient Registration28N=255Med N=125Med+EECP N=130Observation ofPredetermined EventsRandomizedMedium F-U Time 92 moRandomizedStatistical Analysis SAS software was applied for hazard ratios of major cardiac events. All data was a

14、nalyzed by the Dept. of Medical Statistics, Academy of Public Health, Sun Yat-Sen University29Results Baseline Characteristics30Med+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

15、MI/Angina58/12265/1050.24Prior CABG10130.45Results Baseline Characteristics31Med+EECP(n=133)Med(n=124)PValueTG44510.25Chol35340.96Hypertension68520.08Diabetes14200.22Smoking48540.30Results Baseline Characteristics32Med+EECP (n=133)Med(n=124)PValueNitrates96850.30Beta blockers70680.93ACEI83820.77CCB4

16、7480.71Anti-arrhythmics690.38Aspirin97990.38Statins110.98Digoxin460.48Other Anticoagulants62720.1133Med(n=125)AnginaFrequencyDuring 3mo, 6mo, & 12mo follow-upMed+ EECP(n=130)3 mo6 mo12 moP = 0.0001P = 0.0002P = 0.000134P = 0.00098P = 0.052P = 0.24P = 0.01535P = 0.47P = 0.04ConclusionEECP, when applied in addition to standard medical therapy for the treatme