阿托伐他汀联合厄贝沙坦治疗急性缺血性脑卒中的随机安慰剂对照试验。
A randomized placebo controlled trial of early treatment of acute ischemic stroke with atorvastatin and irbesartan.
机构信息
Western Australian Centre for Health and Ageing, University of Western Australia, Perth, WA, Australia.
出版信息
Int J Stroke. 2012 Feb;7(2):104-11. doi: 10.1111/j.1747-4949.2011.00653.x. Epub 2011 Nov 2.
BACKGROUND
Cholesterol and blood pressure lowering therapies are effective in the secondary prevention of ischemic stroke.
AIM
To determine whether 30 days of treatment with atorvastatin, or irbesartan, initiated within 96 h of symptom onset improves recovery from acute ischemic stroke.
METHODS
Eighty-one patients with acute ischemic stroke participated in this double-blind, placebo-controlled, randomized trial of atorvastatin (80 mg) vs. placebo, and/or irbesartan (150 mg) vs. placebo. Fifty-two patients (randomized 53 ± 22 h after onset of symptoms) completed the 30-day primary outcome follow-up.
RESULTS
The primary outcome, maximal brain infarct size at days 3 and 30 measured by perfusion computed tomography, was not significantly altered by random assignment to irbesartan (1088 (IQR 216, 2594) mm² at day 3, compared with 398 (144, 2053) mm² among the placebo group, P= 0.79 controlling for baseline values; and 822 (159, 1717) mm² at day 30, cf 280 (76, 1330) mm²; P=0.63); or atorvastatin (454 (107, 1765) mm² cf 825 (265, 2509) mm² at day 3; P= 0.33; and 462 (43, 1399) mm² cf 280 (128, 1559) mm² at day 30, P= 0.79). There were no other significant differences among the treatment groups with the exception of: • high sensitivity C-reactive protein concentrations, which were lower in the irbesartan treatment group at day 30 (mean difference 12.6 mg/L; 95% CI: -25.1, - 0.1; P= 0.048); and • the mean cerebral blood flow in the affected cerebral hemisphere at 30 days after stroke, which was significantly reduced by random assignment to irbesartan compared with placebo in both the affected cerebral hemisphere (-7.5 mL/100 mL/min (95% CI: -1.7 to - 13.4, P= 0.01)) and in the unaffected hemisphere (- 7.3 mL/100 mL/min (95% CI: - 1.3, -13.4; P= 0.02)). Atorvastatin therapy was well tolerated, but irbesartan therapy was associated with an increased rate of withdrawal from therapy (n=10 (29%), compared with n=3 (9%) who withdrew from placebo, P= 0.04).
CONCLUSIONS
Treatment with atorvastatin and irbesartan, initiated on day 3 after acute ischemic stroke, did not appear to substantially modify infarct growth.
背景
胆固醇和血压降低疗法在缺血性中风的二级预防中有效。
目的
确定阿托伐他汀或厄贝沙坦在症状发作后 96 小时内开始治疗 30 天是否能改善急性缺血性中风的恢复。
方法
81 例急性缺血性中风患者参与了这项阿托伐他汀（80mg）与安慰剂、厄贝沙坦（150mg）与安慰剂的双盲、安慰剂对照、随机试验。52 例患者（症状发作后随机分组 53±22 小时）完成了 30 天的主要结局随访。
结果
主要结局为灌注 CT 测量的第 3 天和第 30 天最大脑梗死面积，随机分配至厄贝沙坦组（第 3 天为 1088（IQR 216，2594）mm²，安慰剂组为 398（144，2053）mm²，P=0.79 时基线值校正；第 30 天为 822（159，1717）mm²，安慰剂组为 280（76，1330）mm²；P=0.63）或阿托伐他汀组（第 3 天为 454（107，1765）mm²，安慰剂组为 825（265，2509）mm²，P=0.33；第 30 天为 462（43，1399）mm²，安慰剂组为 280（128，1559）mm²，P=0.79），无显著差异。除以下情况外，各组间无其他显著差异：
高敏 C 反应蛋白浓度，厄贝沙坦治疗组第 30 天浓度较低（平均差异 12.6mg/L；95%CI：-25.1，-0.1；P=0.048）；
中风后 30 天患侧大脑半球的平均脑血流量，与安慰剂相比，厄贝沙坦治疗组显著降低（患侧大脑半球为-7.5mL/100mL/min（95%CI：-1.7，-13.4，P=0.01），非患侧大脑半球为-7.3mL/100mL/min（95%CI：-1.3，-13.4；P=0.02））。
阿托伐他汀治疗耐受良好，但厄贝沙坦治疗组停药率较高（n=10（29%），安慰剂组 n=3（9%），P=0.04）。
结论
阿托伐他汀和厄贝沙坦在急性缺血性中风发作后第 3 天开始治疗，似乎并未明显改变梗死灶的生长。
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