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大剂量他汀类药物在缺血性脑卒中及短暂性脑缺血发作急性期的疗效与安全性:一项系统评价

The efficacy and safety of high-dose statins in acute phase of ischemic stroke and transient ischemic attack: a systematic review.

作者信息

Fang Jing-Xue, Wang Er-Qiang, Wang Wei, Liu Yang, Cheng Gang

机构信息

School of Life Sciences and Biopharmaceutis, Shenyang Pharmaceutical University, Shenyang, Liaoning, China.

Department of Neurology, General Hospital of Shenyang Military Command, Shenyang, Liaoning, China.

出版信息

Intern Emerg Med. 2017 Aug;12(5):679-687. doi: 10.1007/s11739-017-1650-8. Epub 2017 Mar 16.

DOI:10.1007/s11739-017-1650-8
PMID:28303440
Abstract

Inconsistent findings in the studies have been observed concerning the higher dose of statins use in the acute phase of ischemic stroke and transient ischemic attack (TIA). Therefore, we performed a systematic review to assess this issue. A computerized literature search in PubMed, Cochrane Library databases, and EMBASE for randomized controlled trials (RCTs) was conducted. The efficacy outcome indicators were National Institutes of Health Stroke Scale (NIHSS) score, infarct volume, and recurrence of stroke; the safety outcome indicators were intracranial hemorrhage events, cardiovascular and cerebrovascular events, and all-cause death. Pre-specified subgroup analyses were carried out. A total of seven RCTs with 1089 patients were included. Six studies reported the results of the NHISS score. A great reduction was found in NIHSS score in the statins group, and the difference is statistically significant [mean difference (MD) -1.15, 95% confidence interval (CI) -1.64 to -0.66, P < 0.00001]. However, no significant differences in the effect on recurrence of stroke [odds ratio (OR) 1.05, 95% CI 0.65-1.69, P = 0.85] (available in 3 studies), infarct volume [std. mean difference (SMD) 0.04, 95% CI -0.55 to 0.63, P = 0.89] (available in 2 studies), intracerebral hemorrhage events (OR 3.25, 95% CI 0.34-31.52, P = 0.31) (available in 2 studies), cardiovascular and cerebrovascular events (OR 0.70, 95% CI 0.35-1.43, P = 0.33) (available in 2 studies), and all-cause death (OR 1.18, 95% CI 0.60-2.35, P = 0.63) (available in 2 studies) were found. High-dose statin therapy in the acute phase of ischemic stroke and TIA significantly reduce the NIHSS score and improve short-term functional outcome without increasing related adverse events.

摘要

关于在缺血性中风和短暂性脑缺血发作(TIA)急性期使用高剂量他汀类药物的研究结果并不一致。因此,我们进行了一项系统评价以评估此问题。我们在PubMed、Cochrane图书馆数据库和EMBASE中进行了计算机化文献检索,以查找随机对照试验(RCT)。疗效结局指标为美国国立卫生研究院卒中量表(NIHSS)评分、梗死体积和中风复发;安全性结局指标为颅内出血事件、心脑血管事件和全因死亡。进行了预先指定的亚组分析。共纳入7项RCT,涉及1089例患者。6项研究报告了NHISS评分结果。他汀类药物组的NIHSS评分有显著降低,差异具有统计学意义[平均差(MD)-1.15,95%置信区间(CI)-1.64至-0.66,P < 0.00001]。然而,在对中风复发的影响方面[优势比(OR)1.05,95% CI 0.65 - 1.69,P = 0.85](3项研究中有数据)、梗死体积方面[标准化平均差(SMD)0.04,95% CI -0.55至0.63,P = 0.89](2项研究中有数据)、脑出血事件方面(OR 3.25,95% CI 0.34 - 31.52,P = 0.31)(2项研究中有数据)、心脑血管事件方面(OR 0.70,95% CI 0.35 - 1.43,P = 0.33)(2项研究中有数据)以及全因死亡方面(OR 1.18,95% CI 0.60 - 2.35,P = 0.63)(2项研究中有数据)均未发现显著差异。在缺血性中风和TIA急性期使用高剂量他汀类药物治疗可显著降低NIHSS评分并改善短期功能结局,且不会增加相关不良事件。

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