阿替洛尔用于短暂性脑缺血发作或非致残性缺血性卒中后二级预防的试验。荷兰短暂性脑缺血发作试验研究组。

Trial of secondary prevention with atenolol after transient ischemic attack or nondisabling ischemic stroke. The Dutch TIA Trial Study Group.

出版信息

Stroke. 1993 Apr;24(4):543-8. doi: 10.1161/01.str.24.4.543.

DOI:10.1161/01.str.24.4.543

Abstract

BACKGROUND AND PURPOSE

beta-Blockers prevent vascular events in patients after myocardial infarction and lower blood pressure, the main risk factor for stroke. Hence, we assessed the effects of atenolol on the occurrence of death from vascular causes, stroke, or myocardial infarction and on blood pressure in patients after a transient ischemic attack or nondisabling ischemic stroke.

METHODS

In a double-blind, placebo-controlled randomized clinical trial we studied the occurrence of the outcome event death from vascular causes, nonfatal stroke, or nonfatal myocardial infarction and the outcome event fatal or nonfatal stroke as well as blood pressure on follow-up. A total of 1,473 aspirin-treated patients with transient ischemic attack or nondisabling ischemic stroke were randomized to 50 mg atenolol daily or placebo. The mean follow-up was 2.6 years.

RESULTS

Patients on atenolol had a risk of 97/732 (13.3%) for the combined outcome event versus a risk of 95/741 (12.8%) for those on placebo (adjusted hazard ratio, 1.00; 95% confidence interval, 0.76-1.33). The adjusted hazard ratio for fatal or nonfatal stroke was 0.82 (95% confidence interval, 0.57-1.19). More patients on beta-blocker (153) reported adverse effects than on placebo (103). At the first follow-up visit after randomization (median at 4 months) systolic blood pressure in the atenolol group had dropped by 8.0 mm Hg compared with 2.2 mm Hg in the placebo group (difference, 5.8 mm Hg; 95% confidence interval, 2.9-8.6 mm Hg). For diastolic blood pressure this difference was 2.9 mm Hg (95% confidence interval, 1.5-4.4 mm Hg).

CONCLUSIONS

Our data neither confirm nor rule out that atenolol prevents important vascular events in patients after transient ischemic attack or nondisabling ischemic stroke, given the modest effect on blood pressure, the restrictions in patient selection, and the limited number of patient-years.

摘要

背景与目的

β受体阻滞剂可预防心肌梗死后患者发生血管事件，并降低血压，而血压是中风的主要危险因素。因此，我们评估了阿替洛尔对短暂性脑缺血发作或非致残性缺血性中风患者血管性死亡、中风或心肌梗死发生率以及血压的影响。

方法

在一项双盲、安慰剂对照的随机临床试验中，我们研究了随访时血管性死亡、非致命性中风或非致命性心肌梗死等结局事件的发生情况，以及致命或非致命性中风这一结局事件和血压情况。共有1473例接受阿司匹林治疗的短暂性脑缺血发作或非致残性缺血性中风患者被随机分为每日服用50毫克阿替洛尔组或安慰剂组。平均随访时间为2.6年。

结果

服用阿替洛尔的患者发生联合结局事件的风险为97/732（13.3%），而服用安慰剂的患者为95/741（12.8%）（调整后风险比为1.00；95%置信区间为0.76 - 1.33）。致命或非致命性中风的调整后风险比为0.82（95%置信区间为0.57 - 1.19）。报告有不良反应的β受体阻滞剂组患者（153例）多于安慰剂组（103例）。随机分组后的首次随访（中位数为4个月）时，阿替洛尔组的收缩压下降了8.0毫米汞柱，而安慰剂组下降了2.2毫米汞柱（差值为5.8毫米汞柱；95%置信区间为2.9 - 8.6毫米汞柱）。舒张压的差值为2.9毫米汞柱（95%置信区间为1.5 - 4.4毫米汞柱）。