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辛伐他汀与阿托伐他汀改善冠状动脉旁路移植术后患者轻中度抑郁的比较:一项双盲、安慰剂对照、随机临床试验。

Simvastatin versus atorvastatin for improving mild to moderate depression in post-coronary artery bypass graft patients: A double-blind, placebo-controlled, randomized trial.

机构信息

Tehran Heart Center, Tehran University of Medical Sciences, Tehran, Iran; Family Health Research Center, Iranian Petroleum Industry Health Research Institute, Tehran, Iran.

Psychiatric Research Center, Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

J Affect Disord. 2015 Sep 1;183:149-55. doi: 10.1016/j.jad.2015.04.049. Epub 2015 May 7.

Abstract

BACKGROUND

A decreased risk of developing depression has been reported among statin users. Aside from their lipid-lowering effects, statins are considered immunomodulatory agents and have protective effects against oxidative stress and inflammation which are well known for their association with depression. The aim of the present study was to compare the probable antidepressant effects of simvastatin and atorvastatin among post-coronary artery bypass graft (CABG) surgery patients with high and low potentials for blood-brain-barrier penetration, respectively.

METHOD

Forty-six outpatients who had undergone CABG in the last 6 months and suffered from mild to moderate depression participated in a parallel, double-blind, placebo-controlled trial, and were randomized to undergo 6 weeks of treatment with either simvastatin (20mg/day) or atorvastatin (20mg/day). Participants were evaluated using Hamilton depression rating scale (HDRS) at baseline and weeks 3 and 6. The primary outcome was to evaluate the efficacy of simvastatin in improving the depressive symptoms.

RESULT

General linear model repeated measures demonstrated significant effect for time×treatment interaction on the HDRS scores [F (1.62, 71.06)=3.41, P=0.048]. There was no significant difference between the treatment groups regarding the adverse events. No one experienced serious adverse event.

LIMITATION

The limitations of the present study were its small sample size and the short-term follow-up period.

CONCLUSION

Treatment with simvastatin seems to be well tolerated with superior antidepressant effects compared to atorvastatin in post-CABG patients. Long-term outcomes of this practice and its probable influence on other psychological aspects are yet to be investigated in future studies.

TRIAL REGISTRATION

Iranian registry of clinical trials (http://www.irct.ir): IRCT201410271556N68.

摘要

背景

有报道称,使用他汀类药物的患者患抑郁症的风险降低。除了降低血脂的作用外,他汀类药物还被认为具有免疫调节作用,并具有抗氧化应激和炎症的保护作用,这些作用与抑郁症密切相关。本研究的目的是比较辛伐他汀和阿托伐他汀在具有高和低血脑屏障穿透潜力的冠状动脉旁路移植术(CABG)术后患者中的潜在抗抑郁作用。

方法

46 名在过去 6 个月内接受 CABG 手术且患有轻度至中度抑郁症的门诊患者参与了一项平行、双盲、安慰剂对照试验,并随机分为辛伐他汀(20mg/天)或阿托伐他汀(20mg/天)治疗 6 周。患者在基线和第 3 周和第 6 周时使用汉密尔顿抑郁量表(HDRS)进行评估。主要结局是评估辛伐他汀改善抑郁症状的疗效。

结果

重复测量的一般线性模型显示,HDRS 评分的时间×治疗交互作用有显著影响[F(1.62,71.06)=3.41,P=0.048]。两组在不良反应方面无显著差异。没有人出现严重不良反应。

局限性

本研究的局限性在于样本量小和随访时间短。

结论

与阿托伐他汀相比,CABG 术后患者使用辛伐他汀治疗耐受性良好,抗抑郁效果更好。在未来的研究中,还需要研究这种治疗的长期结果及其对其他心理方面的可能影响。

试验注册

伊朗临床试验注册中心(http://www.irct.ir):IRCT201410271556N68。

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