Amery A, Birkenhäger W, Brixko P, Bulpitt C, Clement D, Deruyttere M, De Schaepdryver A, Dollery C, Fagard R, Forette F
Lancet. 1985 Jun 15;1(8442):1349-54. doi: 10.1016/s0140-6736(85)91783-0.
A double-blind randomised placebo-controlled trial of antihypertensive treatment was conducted in patients over the age of 60. Entry criteria included both a sitting diastolic blood pressure on placebo treatment in the range 90-119 mm Hg and a systolic pressure in the range 160-239 mm Hg. 840 patients were randomised either to active treatment (hydrochlorothiazide + triamterene) or to matching placebo. If the blood pressure remained raised, methyldopa was added to the active regimen and matching placebo in the placebo group. An overall intention-to-treat analysis, combining the double-blind part of the trial and all subsequent follow-up, revealed a non-significant change in total mortality rate (-9%, p = 0.41) but a significant reduction in cardiovascular mortality rate (-27%, p = 0.037). The latter was due to a reduction in cardiac mortality (-38%, p = 0.036) and a non-significant decrease in cerebrovascular mortality (-32%, p = 0.16). In the double-blind part of the trial, total mortality rate was not significantly reduced (-26%, p = 0.077). Cardiovascular mortality was reduced in the actively treated group (-38%, p = 0.023), owing to a reduction in cardiac deaths (-47%, p = 0.048) and a non-significant decrease in cerebrovascular mortality (-43%, p = 0.15). Deaths from myocardial infarction were reduced (-60%, p = 0.043). Study-terminating morbid cardiovascular events were significantly reduced by active treatment (-60%, p = 0.0064). Non-terminating cerebrovascular events were reduced (-52%, p = 0.026), but the non-terminating cardiac events were not (+3%, p = 0.98). In the patients randomised to active treatment there were 29 fewer cardiovascular events and 14 fewer cardiovascular deaths per 1000 patient years during the double-blind part of the trial.
对60岁以上患者进行了一项双盲随机安慰剂对照降压治疗试验。入选标准包括安慰剂治疗时坐位舒张压在90 - 119毫米汞柱之间且收缩压在160 - 239毫米汞柱之间。840名患者被随机分为接受活性治疗组（氢氯噻嗪 + 氨苯蝶啶）或匹配安慰剂组。如果血压仍居高不下，则在活性治疗方案中添加甲基多巴，安慰剂组添加匹配安慰剂。一项综合试验双盲部分及所有后续随访的总体意向性分析显示，总死亡率无显著变化（-9%，p = 0.41），但心血管死亡率显著降低（-27%，p = 0.037）。后者归因于心脏死亡率降低（-38%，p = 0.036）以及脑血管死亡率无显著下降（-32%，p = 0.16）。在试验的双盲部分，总死亡率未显著降低（-26%，p = 0.077）。活性治疗组心血管死亡率降低（-38%，p = 0.023），这归因于心脏死亡减少（-47%，p = 0.048）以及脑血管死亡率无显著下降（-43%，p = 0.15）。心肌梗死死亡人数减少（-60%，p = 0.043）。活性治疗使导致研究终止的严重心血管事件显著减少（-60%，p = 0.0064）。非致死性脑血管事件减少（-52%，p = 0.026），但非致死性心脏事件未减少（+3%，p = 0.98）。在试验双盲部分，每1000患者年中，随机接受活性治疗的患者心血管事件减少29例，心血管死亡减少14例。
