Br Med J (Clin Res Ed). 1985 Jul 13;291(6488):97-104. doi: 10.1136/bmj.291.6488.97.
The main aim of the trial was to determine whether drug treatment of mild hypertension (phase V diastolic pressure 90-109 mm Hg) reduced the rates of stroke, of death due to hypertension, and of coronary events in men and women aged 35-64 years. Subsidiary aims were: to compare the course of blood pressure in two groups, one taking bendrofluazide and one taking propranolol, and to compare the incidence of suspected adverse reactions to these two drugs. The study was single blind and based almost entirely in general practices; 17 354 patients were recruited, and 85 572 patient years of observation have accrued. Patients were randomly allocated at entry to take bendrofluazide or propranolol or placebo tablets. The primary results were as follows. The stroke rate was reduced on active treatment: 60 strokes occurred in the treated group and 109 in the placebo group, giving rates of 1.4 and 2.6 per 1000 patient years of observation respectively (p less than 0.01 on sequential analysis). Treatment made no difference, however, to the overall rates of coronary events: 222 events occurred on active treatment and 234 in the placebo group (5.2 and 5.5 per 1000 patient years respectively). The incidence of all cardiovascular events was reduced on active treatment: 286 events occurred in the treated group and 352 in the placebo group, giving rates of 6.7 and 8.2 per 1000 patient years respectively (p less than 0.05 on sequential analysis). For mortality from all causes treatment made no difference to the rates. There were 248 deaths in the treated group and 253 in the placebo group (rates 5.8 and 5.9 per 1000 patient years respectively). Several post hoc analyses of subgroup results were also performed but they require very cautious interpretation. The all cause mortality was reduced in men on active treatment (157 deaths versus 181 in the placebo group; 7.1 and 8.2 per 1000 patient years respectively) but increased in women on active treatment (91 deaths versus 72; 4.4 and 3.5 per 1000 patient years respectively). The difference between the sexes in their response to treatment was significant (p = 0.05). Comparison of the two active drugs showed that the reduction in stroke rate on bendrofluazide was greater than that on propranolol (p = 0.002). The stroke rate was reduced in both smokers and non-smokers taking bendrofluazide but only in non-smokers taking propranolol. This difference between the responses to the two drugs was significant (p = 0.03).(ABSTRACT TRUNCATED AT 400 WORDS)
该试验的主要目的是确定药物治疗轻度高血压(V期舒张压90 - 109毫米汞柱)是否能降低35 - 64岁男性和女性的中风率、高血压导致的死亡率以及冠状动脉事件发生率。次要目的是:比较两组患者的血压变化过程,一组服用苄氟噻嗪,另一组服用普萘洛尔;比较这两种药物疑似不良反应的发生率。该研究为单盲试验,几乎完全在普通诊所进行;共招募了17354名患者,累积观察了85572患者年。患者在入组时被随机分配服用苄氟噻嗪、普萘洛尔或安慰剂片。主要结果如下。积极治疗可降低中风率:治疗组发生60例中风,安慰剂组发生109例,每1000患者年的发生率分别为1.4和2.6(序贯分析p值小于0.01)。然而,治疗对冠状动脉事件的总体发生率没有影响:积极治疗组发生222起事件,安慰剂组发生234起(每1000患者年分别为5.2和5.5)。积极治疗可降低所有心血管事件的发生率:治疗组发生286起事件,安慰剂组发生352起,每1000患者年的发生率分别为6.7和8.2(序贯分析p值小于0.05)。对于全因死亡率,治疗对发生率没有影响。治疗组有248例死亡,安慰剂组有253例(发生率分别为每1000患者年5.8和5.9)。还对亚组结果进行了多项事后分析,但这些分析需要非常谨慎地解读。积极治疗使男性的全因死亡率降低(157例死亡,安慰剂组为181例;每1000患者年分别为7.1和8.2),但使女性的全因死亡率升高(91例死亡,安慰剂组为72例;每1000患者年分别为4.4和3.5)。男女对治疗反应的差异具有显著性(p = 0.05)。两种活性药物的比较表明,苄氟噻嗪降低中风率的幅度大于普萘洛尔(p = 0.002)。服用苄氟噻嗪的吸烟者和非吸烟者中风率均降低,但服用普萘洛尔的仅非吸烟者中风率降低。两种药物反应的这种差异具有显著性(p = 0.03)。(摘要截选至400字)