Zanchetti A
Institute of Clinical Medicine and Therapeutics, University of Milan, Italy.
Blood Press Suppl. 1994;1:1-4.
All major randomized trials that have tested the effectiveness of antihypertensive therapy have exclusively or almost exclusively been based on mortality and morbidity data (fatal and non-fatal strokes, fatal and non-fatal myocardial infarctions, sudden cardiac deaths, cardiovascular mortality, mortality by any cause). Thus, trials based on the monitoring of events have succeeded in ascertaining the achievement of the most important goals of treatment of any morbid condition--the prolongation of life and prevention of incapacitating morbid events. However, a clear distinction has to be made between cardiovascular events, as measured in any randomized trial of antihypertensive therapy, and the underlying vascular lesions, which have never been measured in large randomized therapeutic trials. Therefore, the results of therapeutic trials based on events cannot be applied towards the conclusion that antihypertensive therapy has similar effects on the underlying disease. Indeed, the mechanisms responsible for the precipitation of events are often different from the mechanisms leading to disease. Both the prevention of cardiovascular events and prevention of organ damage or disease are essential goals of antihypertensive therapy. As the mechanisms leading to vascular injury and to events are, to a significant extent, different, the achievement of the two goals has to be evaluated through trials that use, separately or conjointly, different criteria--either cardiovascular events, or one or more measures of cardiovascular injury. Trials based on cardiovascular injury are now possible due to the relatively large number of quantitatively precise and reproducible techniques for evaluating organ damage accompanying hypertension.(ABSTRACT TRUNCATED AT 250 WORDS)
所有检验抗高血压治疗效果的主要随机试验都完全或几乎完全基于死亡率和发病率数据(致命和非致命性中风、致命和非致命性心肌梗死、心源性猝死、心血管死亡率、任何原因导致的死亡率)。因此,基于事件监测的试验成功地确定了治疗任何疾病最重要目标的达成情况——延长生命和预防致残性疾病事件。然而,在抗高血压治疗的任何随机试验中所测量的心血管事件与从未在大型随机治疗试验中测量过的潜在血管病变之间必须明确区分。因此,基于事件的治疗试验结果不能用于得出抗高血压治疗对潜在疾病有相似效果的结论。事实上,引发事件的机制往往与导致疾病的机制不同。预防心血管事件和预防器官损害或疾病都是抗高血压治疗的重要目标。由于导致血管损伤和事件的机制在很大程度上不同,必须通过分别或联合使用不同标准——心血管事件或一种或多种心血管损伤测量指标的试验来评估这两个目标的达成情况。由于有相对大量用于评估高血压伴发器官损害的定量精确且可重复的技术,基于心血管损伤的试验现在成为可能。(摘要截短于250词)