Girerd X, Amery A, Birkenhager W, Bulpitt C, Cox J, De Leeuw P, De Cort P, Fagard R, Fletcher A, Forette F
Service de médecine interne et thérapeutique, hôpital Broussais, Paris.
Arch Mal Coeur Vaiss. 1992 Aug;85(8):1243-7.
Syst-Eur is a multicentre placebo-controlled outcome trial, designed by the European Working Party on High Blood Pressure in the Elderly (EWPHE), to investigate the effect of antihypertensive treatment on the incidence of stroke in elderly patients with isolated systolic hypertension (ISH). Eligible patients must be at least 60 years old and have a systolic blood pressure averaging 160-219 mmHg with a diastolic blood pressure less than 95 mmHg. The present paper in an interim report on the first 316 patients randomized into this trial. The placebo (N = 170) and active treatment (N = 146) groups were similar at randomization with respect to age (73 +/- 8 years; mean +/- standard deviation), sitting blood pressure (178 +/- 12/85 +/- 7 mmHg), percentage men (34%) and percentage of patients with cardiovascular complications (29%). After randomization blood pressure fell more (p < 0.001) on active treatment than in the placebo group (19 +/- 20/6 +/- 10 mmHg versus 7 +/- 19/1 +/- 10 mmHg for the sitting blood pressure). This first interim report on the Syst-Eur trial demonstrates that a multinational trial in elderly patients with ISH is feasible and that a significant blood pressure difference between the 2 treatment groups can be achieved and maintained. New centres are being recruited in order to randomize a total of 3,000 patients.
Syst-Eur研究是一项多中心、安慰剂对照的结局试验，由欧洲老年高血压工作组（EWPHE）设计，旨在研究抗高血压治疗对老年单纯收缩期高血压（ISH）患者中风发生率的影响。符合条件的患者年龄须至少60岁，收缩压平均为160 - 219 mmHg，舒张压低于95 mmHg。本文是关于随机纳入该试验的前316例患者的中期报告。安慰剂组（N = 170）和积极治疗组（N = 146）在随机分组时，在年龄（7（73±8岁；均值±标准差）、坐位血压（178±12/85±7 mmHg）、男性百分比（34%）以及有心血管并发症的患者百分比（29%）方面相似。随机分组后，积极治疗组的血压下降幅度更大（p < 0.001），高于安慰剂组（坐位血压分别为19±20/6±10 mmHg和7±19/1±10 mmHg）。这份关于Syst-Eur试验的首份中期报告表明，针对老年ISH患者开展多国试验是可行的，并且两个治疗组之间能够实现并维持显著的血压差异。目前正在招募新的中心，以便总共随机纳入3000例患者。
