Amery A, Berthaux P, Birkenhäger W, Boel A, Brixko P, Bulpitt C, Clement D, Deruyttere M, de Schaepdryver A, Dollery C, Fagard R, Forette F, Henry J F, Hellemans J, Laaser U, Lund-Johansen P, MacFarlane J, Maling T, Mutsers A, Nissinen A, Ohn O H, Pelemans J, Suchettkaye A I, Tuomilehto J, Willems J
Acta Cardiol. 1978;33(2):113-34.
Three hundred forty nine hypertensive patients above the age of 60 have entered the double-blind multicentre trial of the European Working Party on High blood pressure in the Elderly (EWPHE). After stratification and randomisation half were treated with one or two capsules containing 25 mg hydrochlorothiazide and 50 mg triamterene and if blood pressure control was insufficient methyldopa was added up to 2 g daily; the other half received matching placebo. No significant differences between the groups were present prior to randomisation. A significant blood pressure difference of 25/10 mm Hg was obtained between the groups and maintained during two years of follow-up. No major disturbances in serum potassium or serum sodium were noted with the present drug combination. However, during the initial phase an increase in serum creatinine and serum uric acid was noted in the actively treated group, which was maintained for two years. Also glucose tolerance was impaired after 2 years in the actively treated group. A favourable influence on prognosis by active treatment can be expected on the basis of the blood pressure reduction and in the absence of major electrolytes disturbances. But this benefit must be proven by observed statistical differences in terminating events between the groups. Therefore the patients are being followed for a longer period of time and more patients are admitted into the trial.
349名60岁以上的高血压患者参加了欧洲老年高血压工作组(EWPHE)的双盲多中心试验。经过分层和随机分组,一半患者服用含25毫克氢氯噻嗪和50毫克氨苯蝶啶的一粒或两粒胶囊,若血压控制不佳,则加用甲基多巴,每日剂量可达2克;另一半患者服用匹配的安慰剂。随机分组前两组之间无显著差异。两组之间出现了25/10毫米汞柱的显著血压差异,并在两年的随访期间得以维持。目前的药物组合未发现血清钾或血清钠有重大紊乱。然而,在初始阶段,积极治疗组的血清肌酐和血清尿酸有所升高,并持续了两年。积极治疗组在2年后糖耐量也受到了损害。基于血压降低且无重大电解质紊乱,预计积极治疗对预后有有利影响。但这种益处必须通过观察两组之间终止事件的统计学差异来证实。因此,患者正在接受更长时间的随访,并且有更多患者被纳入该试验。