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欧洲老年高血压工作组试验的死亡率和发病率结果。

Mortality and morbidity results from the European Working Party on High Blood Pressure in the Elderly trial.

作者信息

Amery A, Birkenhäger W, Brixko P, Bulpitt C, Clement D, Deruyttere M, De Schaepdryver A, Dollery C, Fagard R, Forette F

出版信息

Lancet. 1985 Jun 15;1(8442):1349-54. doi: 10.1016/s0140-6736(85)91783-0.

Abstract

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.

摘要

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。

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