Cutler J A, MacMahon S W, Furberg C D
Prevention and Demonstration Research Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland 20892.
Hypertension. 1989 May;13(5 Suppl):I36-44. doi: 10.1161/01.hyp.13.5_suppl.i36.
We reviewed the designs and major results of 17 large-scale, controlled, clinical trials that reported the effects of drug treatment for hypertension on morbidity or mortality. Seven trials conducted in study populations with more-severe hypertension (diastolic blood pressures 100-120 mm Hg or higher), including the more-severe stratum of the Veterans Administration Trial, showed large reductions in stroke, other "hypertensive" events, and, in one trial, total mortality. Of 11 trials in populations with less-severe hypertension (diastolic blood pressures predominantly below 105 mm Hg), including the less-severe stratum of the Veterans Administration Trial, nine met the criteria for pooling of results. Among the aggregate 43,000 patients in the nine trials who were followed up for an average of 5.6 years, mean diastolic blood pressure reduction was 5.8 mm Hg, and a significant 11% reduction in total mortality was observed. This benefit was largely attributable to a 38% reduction in fatal strokes; nonfatal strokes were similarly reduced. Coronary heart disease mortality was 8% lower in drug treatment than in control groups, but this difference was not significant. A similar result was observed for combined coronary mortality and nonfatal myocardial infarction. A possible explanation for the inconclusive result regarding coronary end points was an adverse trend, observed in several trials, in a subgroup with baseline resting electrocardiographic abnormalities. Because all the trials except the propranolol arm of the Medical Research Council trial used drug regimens based on thiazide-like diuretic agents, and because there are now several new drug classes proposed as initial therapy, additional large-scale clinical trials may need to be considered.
我们回顾了17项大规模、对照临床试验的设计和主要结果，这些试验报告了药物治疗高血压对发病率或死亡率的影响。在患有更严重高血压（舒张压100 - 120毫米汞柱或更高）的研究人群中进行的7项试验，包括退伍军人管理局试验中病情更严重的那一层，显示中风、其他“高血压”事件大幅减少，并且在一项试验中总死亡率也有所降低。在患有不太严重高血压（舒张压主要低于105毫米汞柱）的人群中进行的11项试验，包括退伍军人管理局试验中病情不太严重的那一层，其中9项符合结果汇总标准。在这9项试验中总计43,000名平均随访5.6年的患者中，平均舒张压降低了5.8毫米汞柱，总死亡率显著降低了11%。这一益处主要归因于致命性中风减少了38%；非致命性中风也有类似程度的减少。药物治疗组的冠心病死亡率比对照组低8%，但这一差异不显著。对于冠心病死亡率与非致命性心肌梗死合并情况也观察到了类似结果。关于冠心病终点结果不明确的一个可能解释是，在几项试验中，在基线静息心电图异常的亚组中观察到了不利趋势。由于除医学研究委员会试验中普萘洛尔组外的所有试验都使用了基于噻嗪类利尿剂的药物方案，并且由于现在有几种新药类别被提议作为初始治疗药物，可能需要考虑进行更多大规模临床试验。
