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辛伐他汀治疗动脉瘤性蛛网膜下腔出血的随机、双盲、安慰剂对照试验研究

A randomized, double-blind, placebo-controlled pilot study of simvastatin in aneurysmal subarachnoid hemorrhage.

作者信息

Chou Sherry H-Y, Smith Eric E, Badjatia Neeraj, Nogueira Raul G, Sims John R, Ogilvy Christopher S, Rordorf Guy A, Ayata Cenk

出版信息

Stroke. 2008 Oct;39(10):2891-3. doi: 10.1161/STROKEAHA.107.505875. Epub 2008 Jul 24.

Abstract

BACKGROUND AND PURPOSE

Studies suggest statins ameliorate aneurysmal subarachnoid hemorrhage (SAH)-induced cerebral vasospasm and ischemic complications. We tested safety and feasibility of simvastatin 80 mg/d for vasospasm prevention in SAH patients.

METHODS

Thirty-nine statin-naïve Fisher grade 3 SAH subjects were double-blind randomized to receive simvastatin 80 mg/d (n=19) or placebo (n=20), stratified by Hunt and Hess grade. Primary end points were death and drug morbidity.

RESULTS

Mortality was 3/20 in the placebo and 0/19 in the simvastatin group. Study drug was withdrawn in 1 subject in each treatment group for reversible liver enzyme or creatine phosphokinase elevation. Angiographically-confirmed vasospasm occurred in 8/20 placebo and 5/19 simvastatin-treated subjects. Vasospasm-related ischemic infarcts developed in 5/20 placebo and 2/19 simvastatin-treated subjects.

CONCLUSIONS

Simvastatin for the prevention of delayed cerebral ischemia is safe and feasible after SAH. A larger study is needed to test its efficacy.

摘要

背景与目的

研究表明他汀类药物可改善动脉瘤性蛛网膜下腔出血(SAH)所致的脑血管痉挛和缺血性并发症。我们测试了辛伐他汀80mg/d用于预防SAH患者血管痉挛的安全性和可行性。

方法

39例未使用过他汀类药物的Fisher 3级SAH患者,根据Hunt和Hess分级进行分层,双盲随机分为接受辛伐他汀80mg/d治疗组(n = 19)或安慰剂组(n = 20)。主要终点为死亡和药物相关不良事件。

结果

安慰剂组死亡率为3/20,辛伐他汀组为0/19。每个治疗组均有1例受试者因可逆性肝酶或肌酸磷酸激酶升高而停用研究药物。血管造影证实的血管痉挛在安慰剂组8/20例受试者中发生,辛伐他汀治疗组5/19例受试者中发生。血管痉挛相关的缺血性梗死在安慰剂组5/20例受试者中发生,辛伐他汀治疗组2/19例受试者中发生。

结论

SAH后使用辛伐他汀预防迟发性脑缺血是安全可行的。需要进行更大规模的研究来测试其疗效。

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