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基于β受体阻滞剂氧烯洛尔进行治疗的随机试验中的心血管风险及危险因素:国际高血压前瞻性一级预防研究(IPPPSH)。IPPPSH协作组

Cardiovascular risk and risk factors in a randomized trial of treatment based on the beta-blocker oxprenolol: the International Prospective Primary Prevention Study in Hypertension (IPPPSH). The IPPPSH Collaborative Group.

出版信息

J Hypertens. 1985 Aug;3(4):379-92. doi: 10.1097/00004872-198508000-00011.

DOI:10.1097/00004872-198508000-00011
PMID:2864374
Abstract

Myocardial infarction, sudden cardiac death, cerebrovascular accidents, blood pressure control and treatment tolerability were studied in a randomized double-blind trial conducted in 6357 men and women aged 40-64 years with uncomplicated essential hypertension (diastolic blood pressures 100-125 mmHg). At the start of the trial 3185 patients received treatment based on a beta-blocker (oxprenolol), while in the remaining 3172 placebo replaced oxprenolol. Supplementary drugs, excluding beta-blockers, were used as necessary in both treatment groups, with the aim of reducing diastolic pressure to 95 mmHg or less. Patients were followed for 3-5 years, a total of 25 651 patient years at risk. In most respects the two groups fared equally well; sudden death (relative risk [RR] 1.08; 95% confidence interval [Cl] 0.68 and 1.72), myocardial infarction (RR 0.83; Cl 0.59 and 1.16) and cerebrovascular accident (RR 0.97; Cl 0.64 and 1.47) rates were similar. Beta-blocker based therapy was associated with significantly lower average blood pressures, earlier ECG normalization, less hypokalaemia and fewer withdrawals from double-blind treatment for uncontrolled hypertension. Doctor-elicited and patient-assessed unwanted effects demonstrated overall good tolerability. In smokers the cardiac event rate was doubled. We propose that beta-blocker treatment effects depend on smoking status, with a significant interaction benefiting non-smoking men. Lower blood pressures during treatment were associated with substantially lower rates for cardiac as well as cerebrovascular events. Proportional hazards analysis also underlines the importance of other cardiovascular risk factors. The IPPPSH stresses the need for a comprehensive approach to the management of blood pressure and other risk factors in hypertensive patients.

摘要

在一项针对6357名年龄在40 - 64岁、患有单纯原发性高血压(舒张压为100 - 125 mmHg)的男性和女性进行的随机双盲试验中,对心肌梗死、心源性猝死、脑血管意外、血压控制及治疗耐受性进行了研究。试验开始时,3185名患者接受基于β受体阻滞剂(氧烯洛尔)的治疗,而其余3172名患者则用安慰剂替代氧烯洛尔。两个治疗组均根据需要使用除β受体阻滞剂之外的补充药物,目的是将舒张压降至95 mmHg或更低。对患者进行了3至5年的随访,共有25651患者年处于风险中。在大多数方面,两组情况相当;猝死(相对风险[RR] 1.08;95%置信区间[CI] 0.68和1.72)、心肌梗死(RR 0.83;CI 0.59和1.16)和脑血管意外(RR 0.97;CI 0.64和1.47)发生率相似。基于β受体阻滞剂的治疗与显著更低的平均血压、更早的心电图正常化、更少的低钾血症以及因高血压控制不佳而退出双盲治疗的情况减少相关。医生引发的和患者评估的不良事件总体耐受性良好。在吸烟者中,心脏事件发生率翻倍。我们认为β受体阻滞剂的治疗效果取决于吸烟状态,对不吸烟男性有显著的交互有益作用。治疗期间较低的血压与心脏及脑血管事件的大幅降低发生率相关。比例风险分析也强调了其他心血管危险因素的重要性。IPPPSH强调对高血压患者的血压及其他危险因素管理需要采取综合方法。

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