Cutler J A, Furberg C D
Prev Med. 1985 Jul;14(4):499-518. doi: 10.1016/0091-7435(85)90010-6.
Thirteen controlled clinical trials (11 randomized) reporting morbidity and mortality results during 1960-1982 are summarized. Given the diverse design features, results are presented both for individual trials and for several combinations of similar studies, to provide more stable estimates of effects. Two of three trials in severe hypertension, while lacking enough events to evaluate effect on mortality, found significant reductions in "hypertensive" events, with the overall estimate being an 80% reduction. Similarly, combining six trials in less severe hypertension with untreated controls showed a 54% reduction in such events. The favorable trend in all-causes mortality from these trial results, whether viewed separately or in combination, was not significant. However, the findings from a large randomized trial with community controls, the Hypertension Detection and Follow-up Program, indicated significant reduction of all-causes mortality, the magnitude of which was consistent with the other trials. Outcomes of hypertensive participants in the Multiple Risk Factor Intervention Trial raised questions about mortality benefits in certain subgroups. These and other issues about patient benefit are further addressed with trial data and reference to the 1984 Report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure. We note also 1) that evidence for reduction of coronary heart disease death or nonfatal myocardial infarction with antihypertensive drug treatment is weak, perhaps due to inadequate power to detect such a difference, and that data are limited regarding effects on quality of life. Nevertheless, the overall trial results provide strong support for drug treatment of severe hypertension, and for most individuals with less severe hypertension, when nonpharmacologic treatment will not suffice.
本文总结了1960年至1982年间报告发病率和死亡率结果的13项对照临床试验(11项随机试验)。考虑到设计特点的多样性,本文分别给出了各个试验以及相似研究的几种组合的结果,以便更稳定地估计治疗效果。三项重度高血压试验中的两项,虽然缺乏足够的事件来评估对死亡率的影响,但发现“高血压”事件显著减少,总体估计减少了80%。同样,将六项轻度高血压试验与未治疗的对照组相结合,此类事件减少了54%。无论单独还是综合来看,这些试验结果中全因死亡率的有利趋势并不显著。然而,一项以社区为对照的大型随机试验——高血压检测与随访计划——的结果表明全因死亡率显著降低,其降低幅度与其他试验一致。多重危险因素干预试验中高血压参与者的结果引发了关于某些亚组死亡率获益的问题。本文利用试验数据并参考1984年全国高血压检测、评估与治疗联合委员会的报告,进一步探讨了这些以及其他关于患者获益的问题。我们还注意到:1)抗高血压药物治疗降低冠心病死亡或非致命性心肌梗死的证据不足,可能是由于检测这种差异的能力不足,而且关于对生活质量影响的数据有限。尽管如此,总体试验结果为重度高血压的药物治疗提供了有力支持,对于大多数轻度高血压患者,当非药物治疗不足时也是如此。