Verdecchia P
Minerva Med. 1986 Jun 23;77(26):1259-70.
After a brief introduction on the problems involved in the interpretation of long-term trials, the methods and the results of large clinical trials, on cardioprotection (defined as the ability of a drug to reduce mortality from all causes or fatal cardiovascular events) are reviewed, with the aim of providing useful clinical information for the treatment of the hypertensive patients. At the end of the review the author draws the following conclusions: The benefits of antihypertensive therapy reported in male patients suffering from severe hypertension are such that further controlled trials with placebo are not acceptable from an ethical point of view. The incidence of fatal and non fatal cardiovascular events is relatively low in mild uncomplicated hypertension but increases three-fold in the presence or organ involvement. A statistically significant reduction of mortality from all causes and of fatal cardiovascular events has been obtained in such patients by means of antihypertensive treatment in the Australian trial, contrary to the results of the MRC trial and the Oslo study. Furthermore, the HDFP trial has shown that mortality from all causes an fatal cardiovascular events are less frequent among patients in stepped care than among those in referred care. The EWPHE trial has demonstrated that antihypertensive treatment reduces non fatal complications and probably reduces mortality in elderly hypertensive patients. Diuretics, sympatholytics and beta-blockers have been used in the large trials on cardioprotection. When several trials prove the equivalence of drugs of different efficacy and safety, it is acceptable to extend the results obtained with such drugs to the therapeutic class they belong to. An example is represented by the results of the MRC and IPPPSH trials on cardioprotection with beta-blockers in male non-smokers suffering from mild-moderate hypertension.
在简要介绍了长期试验解读中涉及的问题、大型临床试验的方法和结果后，本文对心脏保护（定义为药物降低全因死亡率或致命心血管事件的能力）进行了综述，旨在为高血压患者的治疗提供有用的临床信息。综述结尾，作者得出以下结论：在患有严重高血压的男性患者中报告的降压治疗益处表明，从伦理角度来看，进一步进行安慰剂对照试验是不可接受的。在轻度单纯性高血压中，致命和非致命心血管事件的发生率相对较低，但在出现器官受累时会增加两倍。在澳大利亚的试验中，通过降压治疗，此类患者的全因死亡率和致命心血管事件有统计学意义的降低，这与医学研究委员会（MRC）试验和奥斯陆研究的结果相反。此外，高血压检测与随访计划（HDFP）试验表明，阶梯式护理患者的全因死亡率和致命心血管事件比转诊护理患者更少。欧洲工作组高血压老年人试验（EWPHE）表明，降压治疗可减少非致命并发症，并可能降低老年高血压患者的死亡率。利尿剂、交感神经阻滞剂和β受体阻滞剂已用于大型心脏保护试验。当多个试验证明不同疗效和安全性的药物等效时，将此类药物获得的结果推广到它们所属的治疗类别是可以接受的。医学研究委员会（MRC）和意大利高血压患者前瞻性预防研究（IPPPSH）试验对轻度至中度高血压男性非吸烟者使用β受体阻滞剂进行心脏保护的结果就是一个例子。
