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他汀类药物治疗与缺血性卒中结局:观察性研究和随机试验的系统评价和荟萃分析。

Statin therapy and outcome after ischemic stroke: systematic review and meta-analysis of observational studies and randomized trials.

机构信息

Neurovascular Unit for Applied Translational Research and Therapeutics, Mater University Hospital/Dublin Academic Medical Centre, University College Dublin, Ireland.

出版信息

Stroke. 2013 Feb;44(2):448-56. doi: 10.1161/STROKEAHA.112.668277. Epub 2013 Jan 3.

Abstract

BACKGROUND AND PURPOSE

Although experimental data suggest that statin therapy may improve neurological outcome after acute cerebral ischemia, the results from clinical studies are conflicting. We performed a systematic review and meta-analysis investigating the relationship between statin therapy and outcome after ischemic stroke.

METHODS

The primary analysis investigated statin therapy at stroke onset (prestroke statin use) and good functional outcome (modified Rankin score 0 to 2) and death. Secondary analyses included the following: (1) acute poststroke statin therapy (≤ 72 hours after stroke), and (2) thrombolysis-treated patients.

RESULTS

The primary analysis included 113 148 subjects (27 studies). Among observational studies, statin treatment at stroke onset was associated with good functional outcome at 90 days (pooled odds ratio [OR], 1.41; 95% confidence interval [CI], 1.29-1.56; P<0.001), but not 1 year (OR, 1.12; 95% CI, 0.9-1.4; P=0.31), and with reduced fatality at 90 days (pooled OR, 0.71; 95% CI, 0.62-0.82; P<0.001) and 1 year (OR, 0.80; 95% CI, 0.67-0.95; P=0.01). In the single randomized controlled trial reporting 90-day functional outcome, statin treatment was associated with good outcome (OR, 1.5; 95% CI, 1.0-2.24; P=0.05). No reduction in fatality was observed on meta-analysis of data from 3 randomized controlled trials (P=0.9). In studies restricted to of thrombolysis-treated patients, an association between statins and increased fatality at 90 days was observed (pooled OR, 1.25; 95% CI, 1.02-1.52; P=0.03, 3 studies, 4339 patients). However, this association was no longer present after adjusting for age and stroke severity in the largest study (adjusted OR, 1.14; 95% CI, 0.90-1.44; 4012 patients).

CONCLUSIONS

In the largest meta-analysis to date, statin therapy at stroke onset was associated with improved outcome, a finding not observed in studies restricted to thrombolysis-treated patients. Randomized trials of statin therapy in acute ischemic stroke are needed.

摘要

背景与目的

虽然实验数据表明他汀类药物治疗可能改善急性脑缺血后的神经功能结局,但临床研究结果存在矛盾。我们进行了一项系统评价和荟萃分析,以研究他汀类药物治疗与缺血性卒中后结局之间的关系。

方法

主要分析研究了卒中发病时(卒中前他汀类药物使用)和良好功能结局(改良 Rankin 评分 0 至 2 分)以及死亡的关系。次要分析包括以下内容:(1)急性卒中后他汀类药物治疗(卒中后 72 小时内),和(2)溶栓治疗患者。

结果

主要分析纳入了 113148 例患者(27 项研究)。在观察性研究中,卒中发病时的他汀类药物治疗与 90 天的良好功能结局相关(合并优势比[OR],1.41;95%置信区间[CI],1.29-1.56;P<0.001),但与 1 年结局无关(OR,1.12;95%CI,0.9-1.4;P=0.31),且与 90 天(合并 OR,0.71;95%CI,0.62-0.82;P<0.001)和 1 年(合并 OR,0.80;95%CI,0.67-0.95;P=0.01)死亡率降低相关。在唯一报告 90 天功能结局的随机对照试验中,他汀类药物治疗与良好结局相关(OR,1.5;95%CI,1.0-2.24;P=0.05)。对 3 项随机对照试验的数据进行荟萃分析,未观察到死亡率降低(P=0.9)。在仅纳入溶栓治疗患者的研究中,他汀类药物与 90 天死亡率升高相关(合并 OR,1.25;95%CI,1.02-1.52;P=0.03,3 项研究,4339 例患者)。然而,在最大的研究中,在校正年龄和卒中严重程度后,这种关联不再存在(校正 OR,1.14;95%CI,0.90-1.44;4012 例患者)。

结论

在迄今为止最大的荟萃分析中,卒中发病时的他汀类药物治疗与改善结局相关,而在仅纳入溶栓治疗患者的研究中未观察到这一结果。需要进行急性缺血性卒中他汀类药物治疗的随机试验。

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