090731-04 (络活喜)循证医学和最新指南的启示PPT.ppt

各位老师，大家好！感谢大家百忙中参加辉瑞公司产品介绍会议。 欧洲迄今最大规模的里程碑高血压研究ASCOT（Anglo-Scandinavian Cardiac Outcome Trial: 盎格鲁-斯堪的那维亚心脏终点研究）在2004年11月因显著的心血管获益而提前结束，研究的最终结果已经于2005年9月4日在ESC会议上公布，并引起各国与会专家的极大关注和热烈反响。 今天，就请允许我给各位老师对ASCOT研究的背景、结果和临床意义做一个简单的介绍 19257名患者随机接受氨氯地平治疗、必要时加用培哚普利以使血压达标（以氨氯地平为基础的降压治疗方案），或接受阿替洛尔治疗、必要时加用苄氟噻嗪钾（以阿替洛尔为基础的降压治疗方案）。随机化采用计算机优化盲法分配。采用开放治疗、盲法终点评估（PROBE）15设计。 在随机分组后6周、3个月、6个月及其后每6个月各随访一次，每年进行一次空腹血糖、血脂测定及尿常规（血，糖和蛋白）分析。 总胆固醇小于等于6.5mmol/L的患者随机接受阿托伐他汀或安慰剂治疗－血脂分支。这部分结果已经在2002年底发表。 ASCOT病人就是每日所见的常规病人。入选ASCOT的病人可被视作具有中度心血管危险。常见的危险因素包括年龄55岁、男性、吸烟、高脂血症（超过50%的高血压病人血脂升高）、冠心病家族史。在临床实践中，象年龄、男性、冠心病家族史这样的危险因素常被忽略。实际上，日常临床所见的大多数中年至老年高血压病人均有资格被称为“ASCOT病人”。 需要注意的是基于络活喜的降压治疗所获得的益处，在预先设定的15个终点中有10个终点其 p值小于 0.05 。没有终点有利于甚至倾向于基于阿替洛尔的降压治疗组。这是基于络活喜的降压治疗的出色结果。 In September 2002, the Data Safety Monitoring Board (DSMB) recommended that the double-blind cholesterol-lowering study arm be terminated on the grounds that atorvastatin demonstrated a highly significant reduction in the primary end point as well as a significant reduction in the secondary end point of stroke. The Steering Committee endorsed the recommendation of the DSMB, and the lipid arm was closed after a median follow-up period of 3.3 years. Slide Summary In their study published in 2002, Fogari and colleagues reported that combination therapy had more favorable effects on blood pressure in diabetic, hypertensive patients with microalbuminuria than monotherapy with amlodipine besylate or fosinopril at any time during the 4-year trial. Background The aim of the study was to compare the long-term effects of amlodipine beylate and fosinopril monotherapies with those of combination therapy using the two agents. Hypertensive patients with type 2 diabetes and microalbuminuria (n=453) were randomized to one of the following regimens: amlodipine besylate (5 to 15 mg/day), fosinopril (10 to 30 mg/day) or amlodipine besylate/fosinopril (5/10 to 15/30 mg/day) for a 3-month titration period. Nonresponder patients or those with side effec