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他汀类药物、情绪、睡眠与身体机能:一项系统综述

Statins, mood, sleep, and physical function: a systematic review.

作者信息

Swiger Kristopher J, Manalac Raoul J, Blaha Michael J, Blumenthal Roger S, Martin Seth S

机构信息

Johns Hopkins Ciccarone Center for the Prevention of Heart Disease, 1800 Orleans Street, Zayed 7125, Baltimore, MD, 21287, USA.

出版信息

Eur J Clin Pharmacol. 2014 Dec;70(12):1413-22. doi: 10.1007/s00228-014-1758-y. Epub 2014 Oct 8.

Abstract

PURPOSE

We aimed to evaluate the effects of statins on mood, sleep, and physical function.

METHODS

We performed a systematic computer-aided search of MEDLINE/PubMed, EMBASE, and the Cochrane Central Register and augmented this search by scrutinizing reference lists and making inquiries among colleagues and experts in the field. All patient populations and study types were considered. We selected studies of statin therapy compared with no statin or placebo. Outcome measures included mood, sleep, and physical function.

RESULTS

Thirty-four studies were included in qualitative synthesis. Seven of eight (88 %) observational studies, 4/6 (66 %) randomized trials with mood as a primary endpoint (487 total participants; exposure 4 weeks to 1 year), and 3/3 (100 %) randomized trials with mood as a secondary endpoint (2,851 total participants; exposure 1-4 years) were not compatible with a negative mood effect of statins. Comparatively, fewer studies examined statin effects on sleep and physical function. Studies reporting negative effects contained potential sources of bias, including multiple testing or lack of adjustment for confounders in observational studies, and failure to prespecify outcomes or report blinding in trials.

CONCLUSIONS

A limited body of available evidence is most compatible with no adverse effect of statins on quality of life measures, namely, mood, sleep, and physical function. Studies suggesting such effects suffer from an increased risk of bias. High-quality, prospective, and adequately powered studies are needed, especially in the domains of sleep and physical function, with careful attention to patients who may be most vulnerable to adverse effects.

摘要

目的

我们旨在评估他汀类药物对情绪、睡眠和身体功能的影响。

方法

我们使用计算机系统检索了MEDLINE/PubMed、EMBASE和Cochrane中心对照试验注册库,并通过仔细查阅参考文献列表以及向该领域的同事和专家咨询来扩大检索范围。纳入了所有患者群体和研究类型。我们选择了将他汀类药物治疗与无他汀类药物或安慰剂治疗进行比较的研究。结局指标包括情绪、睡眠和身体功能。

结果

34项研究纳入了定性分析。八项观察性研究中的七项(88%)、以情绪为主要终点的六项随机试验中的四项(66%)(共487名参与者;暴露时间为4周至1年)以及以情绪为次要终点的三项随机试验中的三项(100%)(共2851名参与者;暴露时间为1至4年)均不支持他汀类药物具有负面情绪效应的观点。相比之下,研究他汀类药物对睡眠和身体功能影响的研究较少。报告有负面影响的研究存在潜在的偏倚来源,包括观察性研究中的多重检验或未对混杂因素进行调整,以及试验中未预先设定结局或未报告盲法情况。

结论

现有有限的证据最支持他汀类药物对生活质量指标(即情绪、睡眠和身体功能)无不良影响的观点。表明有此类影响的研究存在偏倚风险增加的问题。需要开展高质量、前瞻性且有足够效力的研究,尤其是在睡眠和身体功能领域,并应特别关注可能最易受到不良反应影响的患者。

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