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他汀类药物与卒中患者颅内出血风险:系统评价和荟萃分析。

Statins and the risk of intracerebral haemorrhage in patients with stroke: systematic review and meta-analysis.

机构信息

Stroke Research Centre, Department of Brain Repair and Rehabilitation, UCL, London, UK.

The National Hospital for Neurology and Neurosurgery, Queen Square, London, UK.

出版信息

J Neurol Neurosurg Psychiatry. 2019 Jan;90(1):75-83. doi: 10.1136/jnnp-2018-318483. Epub 2018 Aug 27.

DOI:10.1136/jnnp-2018-318483
PMID:30150320
Abstract

OBJECTIVE

Whether statins increase the risk of intracerebral haemorrhage (ICH) in patients with a previous stroke remains uncertain. This study addresses the evidence of statin therapy on ICH and other clinical outcomes in patients with previous ischaemic stroke (IS) or ICH.

METHODS

A systematic literature review and meta-analysis was performed in conformity with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to assess observational and randomised studies comparing statin therapy with control (placebo or no treatment) in patients with a previous ICH or IS. The risk ratios (RR) for the primary outcome (ICH) and secondary outcomes (IS, any stroke, mortality and function) were pooled using random effects meta-analysis according to stroke subtype.

RESULTS

Forty-three studies with a combined total of 317 291 patient-years of follow-up were included. In patients with previous ICH, statins had no significant impact on the pooled RR for recurrent ICH (1.04, 95% CI 0.86 to 1.25; n=23 695); however, statins were associated with significant reductions in mortality (RR 0.49, 95% CI 0.36 to 0.67; n=89 976) and poor functional outcome (RR 0.71, 95% CI 0.67 to 0.75; n=9113). In patients with previous IS, statins were associated with a non-significant increase in ICH (RR 1.36, 95% CI 0.96 to 1.91; n=103 525), but significantly lower risks of recurrent IS (RR 0.74, 95% CI 0.66 to 0.83; n=53 162), any stroke (RR 0.82, 95% CI 0.67 to 0.99; n=55 260), mortality (RR 0.68, 95% CI 0.50 to 0.92; n=74 648) and poor functional outcome (RR 0.83, 95% CI 0.76 to 0.91; n=34 700).

CONCLUSIONS

Irrespective of stroke subtype, there were non-significant trends towards future ICH with statins. However, this risk was overshadowed by substantial and significant improvements in mortality and functional outcome among statin users.

TRIAL REGISTRATION NUMBER

CRD42017079863.

摘要

目的

他汀类药物是否会增加既往卒中患者发生脑出血(ICH)的风险仍不确定。本研究旨在评估他汀类药物治疗对既往缺血性卒中(IS)或 ICH 患者的 ICH 和其他临床结局的影响。

方法

根据系统评价和荟萃分析的首选报告项目,对比较他汀类药物治疗与对照组(安慰剂或不治疗)的观察性和随机研究进行了系统文献回顾和荟萃分析,纳入了既往有 ICH 或 IS 的患者。采用随机效应荟萃分析,根据卒中亚型汇总主要结局(ICH)和次要结局(IS、任何卒中、死亡率和功能)的风险比(RR)。

结果

共纳入 43 项研究,总随访时间为 317 291 患者年。在既往有 ICH 的患者中,他汀类药物对复发性 ICH 的汇总 RR 无显著影响(1.04,95%CI 0.86 至 1.25;n=23695);然而,他汀类药物与死亡率降低(RR 0.49,95%CI 0.36 至 0.67;n=89976)和功能不良结局(RR 0.71,95%CI 0.67 至 0.75;n=9113)显著相关。在既往有 IS 的患者中,他汀类药物与 ICH 发生率增加无显著相关性(RR 1.36,95%CI 0.96 至 1.91;n=103525),但与复发性 IS(RR 0.74,95%CI 0.66 至 0.83;n=53162)、任何卒中(RR 0.82,95%CI 0.67 至 0.99;n=55260)、死亡率(RR 0.68,95%CI 0.50 至 0.92;n=74648)和功能不良结局(RR 0.83,95%CI 0.76 至 0.91;n=34700)的风险降低显著相关。

结论

无论卒中亚型如何,他汀类药物治疗均存在未来发生 ICH 的非显著趋势。然而,与他汀类药物使用者死亡率和功能结局的显著改善相比,这种风险相形见绌。

试验注册号

CRD42017079863。

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