Goldstein Larry B, Amarenco Pierre, Zivin Justin, Messig Michael, Altafullah Irfan, Callahan Alfred, Hennerici Michael, MacLeod Mary J, Sillesen Henrik, Zweifler Richard, Michael K, Welch A
Department of Medicine, Division of Neurology, Duke University Medical Center, Durham, NC 27710, USA.
Stroke. 2009 Nov;40(11):3526-31. doi: 10.1161/STROKEAHA.109.557330. Epub 2009 Sep 10.
Laboratory experiments suggest statins reduce stroke severity and improve outcomes. The Stroke Prevention by Aggressive Reduction in Cholesterol Levels (SPARCL) trial was a placebo-controlled, randomized trial designed to determine whether treatment with atorvastatin reduces strokes in subjects with recent stroke or transient ischemic attack (n=4731). We analyzed SPARCL trial data to determine whether treatment favorably shifts the distribution of severities of ischemic cerebrovascular outcomes.
Severity was assessed with the National Institutes of Health Stroke Scale, Barthel Index, and modified Rankin Scale score at enrollment (1 to 6 months after the index event) and 90 days poststroke in subjects having a stroke during the trial.
Over 4.9 years, strokes occurred in 576 subjects. There were reductions in fatal, severe (modified Rankin Scale score 5 or 4), moderate (modified Rankin Scale score 3 or 2), and mild (modified Rankin Scale score 1 or 0) outcome ischemic strokes and transient ischemic attacks and an increase in the proportion of event-free subjects randomized to atorvastatin (P<0.001 unadjusted and adjusted). Results were similar for all outcome events (ischemic and hemorrhagic, P<0.001 unadjusted and adjusted) with no effect on outcome hemorrhagic stroke severity (P=0.174 unadjusted, P=0.218 adjusted). If the analysis is restricted to those having an outcome ischemic stroke (ie, excluding those having a transient ischemic attack or no event), there was only a trend toward lesser severity with treatment based on the modified Rankin Scale score (P=0.0647) with no difference based on the National Institutes of Health Stroke Scale or Barthel Index.
The present exploratory analysis suggests that the outcome of recurrent ischemic cerebrovascular events might be improved among statin users as compared with nonusers.
实验室实验表明他汀类药物可降低中风严重程度并改善预后。强化降低胆固醇水平预防卒中（SPARCL）试验是一项安慰剂对照的随机试验，旨在确定阿托伐他汀治疗是否能降低近期发生中风或短暂性脑缺血发作的受试者（n = 4731）的中风发生率。我们分析了SPARCL试验数据，以确定治疗是否能有利地改变缺血性脑血管病预后严重程度的分布。
在试验期间发生中风的受试者中，在入组时（索引事件后1至6个月）以及中风后90天，使用美国国立卫生研究院卒中量表、巴氏指数和改良Rankin量表评分评估严重程度。
在4.9年的时间里，576名受试者发生了中风。阿托伐他汀组中，致死性、重度（改良Rankin量表评分5或4）、中度（改良Rankin量表评分3或2）和轻度（改良Rankin量表评分1或0）结局的缺血性中风和短暂性脑缺血发作有所减少，且无事件受试者的比例增加（未调整和调整后P<0.001）。所有结局事件（缺血性和出血性，未调整和调整后P<0.001）的结果相似，对出血性中风严重程度无影响（未调整P = 0.174，调整后P = 0.218）。如果分析仅限于发生缺血性中风的受试者（即排除那些发生短暂性脑缺血发作或无事件的受试者），基于改良Rankin量表评分，治疗仅显示出严重程度降低的趋势（P = 0.0647），基于美国国立卫生研究院卒中量表或巴氏指数则无差异。
目前的探索性分析表明，与未使用他汀类药物的患者相比，使用他汀类药物的患者复发性缺血性脑血管事件的预后可能会得到改善。
