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1、1,固定剂量联合用药与血压变异性,国家卫生部 全国合理用药监测网 孙忠实 2010,8，28，北海,药物降压治疗新潮流 New fashion of Antihypertension drugs trement,2,Global mortality from chronic diseases 人类死因第一位是心血管疾病,JAMA 2004; 291 (21): 2616-22,3,CAD Death Rate per 10,000 Person-years,160+,11.8,12.6,12.8,13.9,24.6,25.3,25.2,24.9,16.9,23.8,31.0,25.8,34.7
2、,43.8,38.1,80.6,37.4,48.3,100+,90-99,80-89,75-79,70-74,70,50%,Average reduction in events (%),60,50,40,30,20,10,0,Stroke,Myocardial,infarction,Heart failure,Blood Pressure Lowering Treatment Trialists Collaboration. Lancet. 2000;355:1955-1964.,循证表明 药物降压治疗获益显著,12,循证表明 SBP每降低10mmHgCV风险至少减少30%,13,血圧即使降
3、低2mmHg也能明显获益,14,降低每1mmHg都必须重视! 一定要把血圧降下来!,15,循证表明 单药治疗获益受限(DBP),16,不同种族年龄单药降圧不尽人意! (DBP),17,循证表明 单药治疗获益受限,18,ALLHAT Cumulative Percent Controlled (BP 140/90) at Five Years by Number of Drugs Prescribed,Cushman WC et al. J Clin Hypertens. 2002;4:393-404,19,循证表明 血压平均降低10/5mmHg各药所需剂量,20,为什么全球降圧达标不滿意?,2
4、1,世界各国高血压达标情况,JAMA 2003;290;199206,22,欧洲各国约70%患者血压不达标,23,我国防治高血压形势严峻 “三低一高”,低知晓率 30.2%;低治疗率 24.7%;低控制率 6.1%;目前,高血压患病率不断升高, 己达 18.8%,即全国有1.6亿之多;,24,循证表明 “Rule of TENS” (10mmHg法则 ),Rule :1 additional drug for every additional 10 mmHg reduction in SBP,25,循证表明 药物降压的成就与愿景,26,HOT研究证明欲达标必需联合用药药,27,28,ACE I
5、nhibitor/Ca-Blocker Combination,Benazepril 10 mg/ Amlodipine 2.5 mgAmlodipine 2.5 mgBenazepril 10 mgPlacebo,0%,50%,100%,62%,41%,38%,19%,Response Rate (%),Supine DBP 90 mm Hg or 10 mm Hg decrease,J Clin Pharmacol 1995;35:1060-6,29,Effect of Losartan or Losartan/HCTZ on Blood Pressure in African Ameri
6、can Patients,SiSBP SiDBP,Clin Ther. 2001;23:1193-1208.,* P 0.01 vs placebo P 0.01 vs losartan,30,单药与联用效果比较,31,循证表明 欲达到降压目标必需并用药物,32,33,单药与联用降压疗效比较,34,JNC-7指南的要点(2003) (美国高血压预防、检测、评估和治疗联合委员会第七份报告), 年龄在50岁以上者,较舒张压而言,收缩压大于140mmHg是更为重要的心血管疾病(CVD)危险因素。 当血压为115/175mmHg时即存在CVD的危险,血压每增加20/10mmHg,CVD的危险将增加1倍
7、。年龄为55岁的血压正常者,其在剩余生存期内发展为高血压的危险性为90%。 收缩压为120139mmHg及舒张压为8089mmHg的个体需要改善生活方式以预防CVD。 对于多数无并发症的高血压患者,应使用噻嗪类利尿剂治疗,可单独使用或与其他降压药联合使用。某些高危情况是治疗初始即须并用其他降压药(血管紧张素转换酶抑制剂、血管紧张素受体滞剂、受体阻滞剂、钙道阻滞剂)的强制性适应证。,35,JNC-7指南的要点(2003) (美国高血压预防、检测、评估和治疗联合委员会第七份报告), 多数高血压患者需要联用2种或2种以上的降压药,以达到降压目标(140/190mmHg,或合并有糖尿病或慢性肾脏疾病的
8、患者为130/180mmHg)。 若血压超过目标血压20/10mmHg,应在治疗初始即联合使用2种药物,其中之一通常为噻嗪类利尿剂。 临床医生处方的治疗药物只有在患者积极自觉地服药和建立健康的生活方式后,才能获得满意的血压控制,而这种服药积极性来源于患者对医生的信任和既往得到的良好治疗效果; 2/3以上患者需用2种或2种以上药物治疗!,36,ESH-ESC治疗指南(2007),37,为什么各国指南纷纷推荐联合用药?,Combination drug therapy of hypertension has become more widely used in order to achieve t
9、he lower blood pressure goals currently recommended, especially for patients with diabetes mellitus and chronic kidney disease. Especially fixed-dose combination products are used. Fully additive combinations are more effective in terms of BP reduction. In general, combining drugs from complementary
10、 classes is approximately five times more effective in lowering BP than increasing the dose of one drug. Journal of the American Society of Hypertension Volume 4 Issue 1, Pages 42-50 (January 2010),38,抗高血压药标准剂量 的1/2组合疗效更佳,39,四药标准剂量的1/4组合疗效更佳,Hypertension 2007; 49:272,40,Definition of Fixed Drug Comb
11、inations (FDCs),Fixed dose combinations drugs can be defined as two or more drugs in a single formulation,each drug having independent modes of action,the combination of which are synergistic or additive or complementary in their effect. “Free” combinations can be defined as two or more drugs in sep
12、arate formulations, each taken usually at the same time.,41,FDCs的发展,42,复方制剂并非新鲜事, 20世纪60年代我国就开始应用复方降压片、复方利血平氨苯蝶啶片（降压0号）;,43,美国新FDCsSingle pill,由三种药物组成: ARB(angiotensin receptor blocker) ACE( angiotensin-converting enzyme) CCB(calcium channel blocker),44,美国新FDCsSingle pill (Tetrapill),ACE inhibitors
13、Beta-adrenoceptor blockers Statins Low-dose ASAThe tetrapill (Mukherjee et al Circulation 2004),45,由Aspirin (75mg),Folic acid (0.8 mg), a cholesterol-lowering medication known as a statin (like Lipitor 40mg or Zocor 20mg),HCTZ( 12.5 mg) ,Atenolol (25 mg);an ACE-inhibitor (e.g., Enalapril, 2.5 mg) On
14、ly 1 or 2 per 100 patients may not tolerate the low-dose blood pressure-lowering drugs. Fatal or life-threatening risks would be less than 1 in 10,000. BMJ 2003; 326: 1419-24,A strategy to reduce cardiovascular disease by more than 80%Polypills(6种药组成),46,神奇丸Polypills获益突出,47,FDCs的优点,Fewer daily pills Low individual drug doses Faster results Better tolerability Convenience Improved compliance Lower cost,如美国南加州大学进行一项回顾性队列研究,对平均年龄76岁,女性占82.6%共2336例服用FDCs( Lotrel),3368例为Free-Combination组,随访1年;结果:FDCs组顺从性为63.4%,Free组为49.0%;经费比为3179:5236$;总支出平均降低12.5%,p0.003Am J Cardiovasc Drugs 2008;8:4550,
