Staessen J A, Thijs L, Celis H, Gasowski J, Wang J G, Fagard R H
Studiecoördinatiecentrum, Laboratorium Hypertensie, Campus Gasthuisberg, Herestraat 49, B-3000 Leuven, Belgium.
S Afr Med J. 2001 Dec;91(12):1060-8.
The Syst-Eur study investigated whether active antihypertensive treatment could reduce cardiovascular complications in elderly patients with isolated systolic hypertension.
Randomised, placebo-controlled, double-blind outcome trial.
Hypertension clinics or general practitioners' surgeries in 198 centres in 23 Western and Eastern European countries.
Patients aged > or = 60 years with sitting systolic blood pressure (BP) 160-219 mmHg and sitting diastolic BP < 95 mmHg during run-in phase.
Four thousand, six hundred and ninety-five patients were randomly assigned to active treatment (N = 2,398), i.e. nitrendipine, with the possible addition of enalapril and hydrochlorothiazide, or to matching placebos (N = 2,297). In the intention-to-treat analysis, the between-group difference in blood pressure (BP) amounted to 10.1/4.5 mmHg (P < 0.001). Active treatment reduced the incidence of fatal and non-fatal stroke (primary endpoint) by 42% (P = 0.003). On active treatment all cardiac endpoints decreased by 26% (P = 0.03) and all cardiovascular endpoints by 31% (P < 0.001). Cardiovascular mortality was slightly lower on active treatment (-27%, P = 0.07), but all-cause mortality was not influenced (-14%, P = 0.22). For total (P = 0.009) and cardiovascular mortality (P = 0.09), the benefit of antihypertensive treatment weakened with advancing age, and for total mortality it decreased with lower systolic BP at entry (P = 0.05). The benefits of active treatment were not independently related to sex or to the presence of cardiovascular complications at entry. The antihypertensive regimen was more effective in patients with diabetes than in those without diabetes at entry. Further analyses also suggested benefit in patients who were taking nitrendipine as the sole therapy. The per-protocol analysis largely confirmed the intention-to-treat results. Active treatment reduced all strokes by 44% (P = 0.004), all cardiac endpoints by 26% (P = 0.05) and all cardiovascular endpoints by 32% (P < 0.001). Total mortality was reduced by 26% (P = 0.05), but a similar reduction in cardiovascular mortality did not reach statistical significance in this analysis. Compared with placebo, active treatment also reduced the incidence of dementia by 50%.
Stepwise antihypertensive drug treatment, starting with the dihydropiridine calcium-channel blocker nitrendipine, improves prognosis in elderly patients with isolated systolic hypertension.
收缩期高血压欧洲试验（Syst-Eur研究）探讨了积极的抗高血压治疗是否能降低老年单纯收缩期高血压患者的心血管并发症。
随机、安慰剂对照、双盲结局试验。
23个西欧和东欧国家198个中心的高血压诊所或全科医生诊所。
年龄≥60岁，在导入期坐位收缩压（BP）为160 - 219 mmHg且坐位舒张压<95 mmHg的患者。
4695例患者被随机分配至积极治疗组（N = 2398），即硝苯地平，可能加用依那普利和氢氯噻嗪，或匹配的安慰剂组（N = 2297）。在意向性分析中，组间血压差异为10.1/4.5 mmHg（P < 0.001）。积极治疗使致死性和非致死性卒中（主要终点）的发生率降低了42%（P = 0.003）。积极治疗使所有心脏终点事件降低了26%（P = 0.03），所有心血管终点事件降低了31%（P < 0.001）。积极治疗组的心血管死亡率略低（-27%，P = 0.07），但全因死亡率未受影响（-14%，P = 0.22）。对于总死亡率（P = 0.009）和心血管死亡率（P = 0.09），抗高血压治疗的益处随年龄增长而减弱，对于总死亡率，其随入组时较低的收缩压而降低（P = 0.05）。积极治疗的益处与性别或入组时是否存在心血管并发症无独立相关性。抗高血压方案在入组时患有糖尿病的患者中比未患糖尿病的患者更有效。进一步分析还表明，仅使用硝苯地平治疗的患者也有益处。符合方案分析在很大程度上证实了意向性分析结果。积极治疗使所有卒中降低了44%（P = 0.004），所有心脏终点事件降低了26%（P = 0.05），所有心血管终点事件降低了32%（P < 0.001）。总死亡率降低了26%（P = 0.05），但在此分析中，心血管死亡率的类似降低未达到统计学显著性。与安慰剂相比，积极治疗还使痴呆的发生率降低了50%。
从二氢吡啶类钙通道阻滞剂硝苯地平开始的逐步抗高血压药物治疗可改善老年单纯收缩期高血压患者的预后。
