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1、稳定型心绞痛是冠心病最常见的临床表现，不仅明显影响患者的生活和工作能力，而且有高度发生各种心、脑血管病的危险。,稳定型冠心病的药物治疗现状,抗心绞痛 硝酸酯类 阻滞剂 钙拮抗剂,改善病变进程 抗血小板药 他汀类 ACEI,ACTION:设计,ACTION:基础治疗情况,ACTION:终点事件,一级有效性终点,全因死亡 致残性脑卒中 心梗,一级安全性终点,1)全因死亡，任何心血管事件或介入操作(一级有效性终点 冠脉造影，PCI,CABG)2)任何血管事件或介入操作:CV 死亡急性MI顽固性心绞痛外周血管事件致残性卒中PCICABG3)任何心血管事件(一级有效性终点-非CV 死亡),二级有效性终点
2、,全因死亡心梗心衰致残性脑卒中顽固性心绞痛外周血管重建术,ACTION:分组,随机入组7,665名患者,7,661 名患者进入亚组分析,4名患者被排除,3,977 名患者基线高血压,3,684 名患者基线血压正常,1,975名患者拜新同组,2,002名安慰剂组,ACTION：血压升高患者终点事件,终点,0.0150.0270.008,危险度(95%CI),p,0.873(0.7680.993)0.896(0.8120.998)0.832(0.7260.954),0,0.5,1,1.5,2,一级终点一级终点和介入治疗任何CV原因导致的死亡,拜新同更优,安慰剂更优,ACTION:高血压亚组结果,O
3、verview of nifedipine GITS effects on composite endpoints,All patients,Hypertensive patients,Normotensive patients,Interaction between groups,Indicative implication,Primary efficacy,Not significant,Significant+ve benefit,Not significant,Significant,+ve benefit in hypertensives,Safety,Primary safety,
4、Not significant,Not significant,Not significant,Not significant,Any CV event,Not significant,Significant+ve benefit,Not significant,Significant,+ve benefit in hypertensives,+ve benefit in all patients,Death,any CV event or procedure,Significant+ve benefit,Not significant,Significant+ve benefit,Signi
5、ficant+ve benefit,Any vascularevent/procedure,Significant+ve benefit,Not significant,Endpoints,Significant+ve benefit,Significant+ve benefit,+ve benefit in all patients,临床意义(一),在已经实施降压治疗但血压依然升高的稳定性冠心病患者,硝苯地平控释片(拜新同)能进一步有效地降低血压，显示拜新同与其它类型降压药联合治疗的协同叠加作用，显著有益于冠心病患者的血压控制和达标。,EUROASPIRE and,冠心病合并高血压占冠心病患
6、者51%(37%-64%)。即使采用兼有降压作用的治疗冠心病药物，即-阻滞剂和ACEI，仍然有1/2以上患者血压未获得控制。血压控制达标率 EUROASPIRE(1995-1996):44%EUROASPIRE(1999-2000):45%,Boersma E,et al.J Hypertens 2003;21:1831-1840,ACTION(高血压亚组)基线时降压药使用情况,ACTION(高血压亚组)：血压控制达标率,Nifedipine GITS reduced add-on therapy in the hypertensive subgroup,*Including nifedipi
7、ne GITS,6,3,0,3,6,9,12,15,18,21,-blockers ACE inhibitors/ARBs Diuretics Any antihypertensive*,Nifedipine GITS,Placebo,Normotensive,Nifedipine GITS,Placebo,Hypertensive,Change in add-on therapy from baseline(%),临床意义(二),稳定性冠心病合并高血压具有较高的心血管危险,硝苯地平控释片(拜新同)治疗能有效地阻止或减轻这类患者的病情进展,并显著降低心脑血管病事件。这种治疗益处来自拜新同有效降
8、低血压和抗心绞痛的双重作用。,Mortality Due to CHD per Quartile of Usual Systolic and Diastolic BP:Seven Countries Study,van den Hoogen et al.N Engl J Med.2000;342:1-8.,United States,Northern Europe,Mediterranean Southern Europe,Inland Southern Europe,Serbia,Japan,Mortality From CHD(no./10,000 Person-Years),140,13
9、0,120,110,100,90,80,70,60,50,40,30,20,10,0,110,120,130,140,150,160,170,Systolic BP(mm Hg),140,130,120,110,100,90,80,70,60,50,40,30,20,10,0,65,70,75,80,85,95,100,Diastolic BP(mm Hg),90,动脉粥样硬化斑块,ACTION:入选对象,有心绞痛症状占93%,患者的血管病变阶段,Hypertensive patients were at high risk of CVD,ACTION:冠心病合并血压升高的心血管危险(安慰剂组
10、/100人年),高血压 血压正常 高血压/血压正常 心血管死亡 1.16 0.69 1.68 心肌梗死 1.56 1.21 1.29 心力衰竭 0.78 0.50 1.56 脑卒中 1.81 0.97 1.87 致残性脑卒中 0.77 0.26 2.96,BP-Lowering Treatment Trialists,Stroke,Systolic BP Difference Between Randomized Groups(mm Hg),Systolic BP Difference Between Randomized Groups(mm Hg),0.25,0.50,0.75,1.00,1
11、.25,1.50,CHD,.Blood Pressure Lowering Treatment Trialists Collaboration.Lancet.2003;362:1527-1535.,RR of Outcome Event,RR of Outcome Event,0.6,0.8,1,1.2,1.4,Favours nifedipine GITS,Favours placebo,Significant reductions in composite endpoints,NICOLE Study(Nisoldipine in Coronary Artery Disease in Le
12、uven),Clinical event(%)Nisoldipine(408)Placebo(411)p Death 2.9 3.4 NS CVA 1.0 1.7 NS AMI 3.9 3.2 NS CABG 5.1 10.0 0.01 Repeat PTCA 30.6 37.7 0.03 Total 44.6 52.7 0.02,Dens JA,et al.Heart 2003;89:887-892,临床意义(三),在稳定性冠心病合并高血压患者,硝苯地平控释片(拜新同)能显著降低需住院治疗的心力衰竭发生率,首次在前瞻性临床试验中显示这种治疗益处。,FavorsFirst Listed,Fav
13、orsSecond Listed,0.5,1.0,2.0,BP-Lowering Treatment TrialistsComparisons of Different Active Treatments,CA vs D/BB,1.33(1.21,1.47),1/0,0.93(0.86,1.01),CA vs D/BB,1/0,1.01(0.94,1.08),CA vs D/BB,1/0,ACE Inhibitor vs CA,0.82(0.73,0.92),1/1,1.12(1.01,1.25),ACE Inhibitor vs CA,1/1,0.96(0.88,1.05),ACE Inhi
14、bitor vs CA,1/1,Stroke,CHD,1.09(1.00,1.18),ACE Inhibitor vs D/BB,2/0,0.98(0.91,1.05),ACE Inhibitor vs D/BB,2/0,1.07(0.96,1.19),ACE Inhibitor vs D/BB,2/0,Blood Pressure Lowering Treatment Trialists Collaboration.Lancet.2003;362:1527-1535.,HF,BP-Lowering Treatment TrialistsComparisons of Active Treatm
15、ents and Control,Nifedipine GITS prevents new overt heart failure,38%,Heart failure significantly reduced in patients with CHDGreater reduction in hypertensive subgroupNifedipine GITS is the only CCB proven to prevent heart failure,为何在ACTION研究中血压不升高的稳定性冠心病患者主要终点未获得显著降低？,问题与答案？,大部分血压正常患者无降压效应,15,12,9
16、,6,3,0,3,6,Placebo,Nifedipine GITS,Normotensive,BP change from baseline(mmHg),Systolic BPDiastolic BP,Nifedipine GITS,Placebo,Hypertensive,Significant mean change in BP after 4 years,ACTION:拜新同治疗过程中血压改变,治疗前 治疗过程中 正常血压 122.3/74.6(9.2/7.2)1.9/0.5(14.7/9.3)合并高血压 151.3/84.8(14.0/8.6)14.5/7.0(18.2/10.0),
17、15,10,5,0,100-109,120-129,180-189,140-149,150-159,Systolic,Diastolic,10,5,0,Pretreatment blood pressure(mmHg),60-69,70-79,80-89,90-99,100-109,110-119,Decrease in blood pressure(treated-placebo)(mmHg),Law MR.BMJ 2003;326:1427,稳定型冠心病临床试验基线血压水平,SBP(mmHg),HOPEEUROPAQUIETPEACECAMELOTACTION(血压不高亚组),139/79
18、137/82123/74134/78129/78122/75,结 论,ACTION研究确立了硝苯地平控释片(拜新同)在稳定性冠心病患者中的治疗地位，尤其合并血压升高患者，为合理选择抗心绞痛治疗药物提供了证据。,Short acting sublingualor buccal nitrate prn,Beta blocker,Add dihydropyridinecalcium antagonist,Symptoms not controlled,Heart rate loweringcalcium antagonist eg diltiazem/verapamil,Level of evidence,Long acting nitrate ortransdermal nitrate,Immediate short term relief,Treatment aimed atrelief ofsymptoms,Intolerant(eg fatigue)or contraindication,Intolerantor ineffective,Symptoms not controlled after dose optimisation,1C,1A,1A,1A,1B,1C,Guidelines for the management of stable angina,
