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高血压患者心血管疾病预防随机试验的未来方向

Future directions for randomized trials of cardiovascular disease prevention in hypertensive patients.

作者信息

MacMahon S, Sharpe N

机构信息

Department of Medicine, University of Auckland, New Zealand.

出版信息

J Cardiovasc Pharmacol. 1990;16 Suppl 7:S96-9.

PMID:1708040
Abstract

Coronary artery disease (CAD) is the major cause of death in hypertensive patients in Western populations and further efforts are required to determine how best to reduce its incidence. Large-scale placebo-controlled trials of blood pressure reduction could resolve the uncertainty about the effects of antihypertensive treatment on CAD incidence, but at present, such trials could probably only be conducted in patients with mild hypertension (or normotension). If such patients were selected on the basis of clinically manifest vascular disease, the sample size necessary to detect plausible treatment effects may be practicable (i.e., several thousand patients). In moderately or severely hypertensive patients, "active-controlled" trials could be conducted to determine the relative effects of different anti-hypertensive drugs on CAD morbidity and mortality. However, because any difference between such regimens is likely to be modest in magnitude (and smaller than the difference between treatment and no treatment), the sample size required to detect such differences would be very large (i.e., tens of thousands). With somewhat smaller numbers of patients, it would be possible to conduct placebo-controlled trials to study the effects on CAD of other potentially cardioprotective interventions, such as cholesterol reduction and aspirin, both of which may offer effective means for CAD prevention in hypertensive patients.

摘要

冠状动脉疾病(CAD)是西方人群中高血压患者的主要死因,需要进一步努力来确定如何最好地降低其发病率。大规模的降压安慰剂对照试验可以解决关于降压治疗对CAD发病率影响的不确定性,但目前,此类试验可能只能在轻度高血压(或血压正常)患者中进行。如果根据临床表现的血管疾病来选择此类患者,检测合理治疗效果所需的样本量可能是可行的(即数千名患者)。在中度或重度高血压患者中,可以进行“活性药物对照”试验,以确定不同降压药物对CAD发病率和死亡率的相对影响。然而,由于此类治疗方案之间的任何差异可能在幅度上较小(且小于治疗与不治疗之间的差异),检测此类差异所需的样本量将非常大(即数万名患者)。对于数量稍少的患者,可以进行安慰剂对照试验,以研究其他潜在的心脏保护干预措施对CAD的影响,如降低胆固醇和使用阿司匹林,这两者都可能为高血压患者预防CAD提供有效手段。

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