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辛伐他汀作为中度至重度重度抑郁症患者氟西汀辅助治疗的双盲安慰剂对照试验。

Simvastatin as an adjuvant therapy to fluoxetine in patients with moderate to severe major depression: A double-blind placebo-controlled trial.

作者信息

Gougol Amirhossein, Zareh-Mohammadi Nahid, Raheb Samira, Farokhnia Mehdi, Salimi Samrand, Iranpour Negar, Yekehtaz Habibeh, Akhondzadeh Shahin

机构信息

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

Baharloo Hospital, Tehran University of Medical Sciences, Tehran, Iran.

出版信息

J Psychopharmacol. 2015 May;29(5):575-81. doi: 10.1177/0269881115578160. Epub 2015 Mar 31.

DOI:10.1177/0269881115578160
PMID:25827645
Abstract

Statins have been shown to decrease depressive symptoms in certain groups of patients, an effect that is mostly attributed to their anti-inflammatory and neurotransmitter modulatory potentials. We aimed to investigate the antidepressant effects of simvastatin as an adjuvant therapy in patients with moderate to severe depression. In this double-blind placebo-controlled clinical trial, 48 patients were randomly allocated to receive simvastatin or placebo as an adjunct to fluoxetine for six weeks. Patients were evaluated with the Hamilton Depression Rating Scale (HDRS) at baseline and weeks 2, 4 and 6. Probable clinical and laboratory adverse events were also monitored and compared between the two groups. Simvastatin-treated patients experienced significantly more reductions in HDRS scores compared to the placebo group by the end of the trial (p=0.02). Early improvement and response rates were significantly greater in the simvastatin group than the placebo group (p=0.02 and p=0.01, respectively) but remission rate was not significantly different between the two groups (p=0.36). No serious adverse event was reported during this trial. In conclusion, simvastatin seems to be a safe and effective adjuvant therapy for patients suffering from major depressive disorder. However, more confirmatory studies are warranted.

摘要

他汀类药物已被证明可减轻某些患者群体的抑郁症状,这种效果主要归因于其抗炎和神经递质调节潜能。我们旨在研究辛伐他汀作为中度至重度抑郁症患者辅助治疗的抗抑郁作用。在这项双盲安慰剂对照临床试验中,48名患者被随机分配接受辛伐他汀或安慰剂作为氟西汀的辅助治疗,为期六周。在基线以及第2、4和6周时,使用汉密尔顿抑郁量表(HDRS)对患者进行评估。还对两组之间可能的临床和实验室不良事件进行了监测和比较。到试验结束时,与安慰剂组相比,辛伐他汀治疗的患者HDRS评分显著降低更多(p = 0.02)。辛伐他汀组的早期改善率和缓解率显著高于安慰剂组(分别为p = 0.02和p = 0.01),但两组之间的缓解率无显著差异(p = 0.36)。在该试验期间未报告严重不良事件。总之,辛伐他汀似乎是重度抑郁症患者一种安全有效的辅助治疗方法。然而,需要更多的验证性研究。

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