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氟西汀与其他选择性5-羟色胺再摄取抑制剂、三环类及新型抗抑郁药相比的副作用情况:临床试验数据的荟萃分析

Side-effect profile of fluoxetine in comparison with other SSRIs, tricyclic and newer antidepressants: a meta-analysis of clinical trial data.

作者信息

Brambilla P, Cipriani A, Hotopf M, Barbui C

机构信息

Department of Pathology and Experimental Medicine, Section of Psychiatry, University of Udine, Udine, Italy.

出版信息

Pharmacopsychiatry. 2005 Mar;38(2):69-77. doi: 10.1055/s-2005-837806.

DOI:10.1055/s-2005-837806
PMID:15744630
Abstract

BACKGROUND

In the last ten years, SSRIs have increasingly replaced TCAs as comparators of newer antidepressants (ADs), because of their better tolerability profile. In particular, fluoxetine has become a reference drug for the treatment of depression, but the occurrence of individual side effects in depressed subjects treated with fluoxetine and each comparator AD have not been systematically investigated.

METHODS

This meta-analysis investigated the frequency of side effects induced by fluoxetine or alternative ADs and compared the occurrence of individual side effects in depressed subjects. All randomised clinical trials (RCTs) comparing fluoxetine with any other AD drug in patients with major depression were located by searching the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register and the Cochrane Controlled Trials Register. Two reviewers independently extracted information.

RESULTS

Significantly less percentage of patients treated with fluoxetine experienced any side effects in comparison with TCAs (50.9 % vs 60.3 %, 29 RCTs; RR = 0.84, p = 0.003), but not in comparison with other SSRIs (59.4 % vs 59.3 %, 15 RCTs; RR = 1.00, p = 0.902). In addition, fluoxetine was better tolerated in comparison with TCAs and related ADs (RR 0.61, 95 % CI 0.52, 0.71), but not in comparison with other SSRIs. Regard to individual side effects, activating (insomnia, agitation, tremor and anxiety) and gastrointestinal adverse events (nausea, vomiting, diarrhoea, weight loss and anorexia) were significantly more frequent in fluoxetine-treated patients, whereas cholinergic side effects were significantly less frequent.

CONCLUSIONS

Fluoxetine compared to other ADs had more activating and gastrointestinal adverse effects, which often require additional pharmacotherapy or other managements strategies, leading to discontinuation and non-compliance and increasing the costs. This information is relevant to base on evidence the prescription of ADs in everyday clinical practice.

摘要

背景

在过去十年中,由于耐受性更好,选择性5-羟色胺再摄取抑制剂(SSRIs)越来越多地取代三环类抗抑郁药(TCAs)作为新型抗抑郁药(ADs)的对照药物。特别是,氟西汀已成为治疗抑郁症的参考药物,但氟西汀及每种对照抗抑郁药治疗的抑郁症患者个体副作用的发生情况尚未得到系统研究。

方法

本荟萃分析调查了氟西汀或替代抗抑郁药引起的副作用频率,并比较了抑郁症患者个体副作用的发生情况。通过检索Cochrane协作抑郁、焦虑和神经症对照试验注册库以及Cochrane对照试验注册库,找出了所有比较氟西汀与任何其他抗抑郁药物治疗重度抑郁症患者的随机临床试验(RCTs)。两名评审员独立提取信息。

结果

与三环类抗抑郁药相比,接受氟西汀治疗的患者出现任何副作用的比例显著较低(50.9%对60.3%,29项RCTs;RR = 0.84,p = 0.003),但与其他SSRIs相比则不然(59.4%对59.3%,15项RCTs;RR = 1.00,p = 0.902)。此外,与三环类抗抑郁药及相关抗抑郁药相比,氟西汀的耐受性更好(RR 0.61,95%CI 0.52,0.71),但与其他SSRIs相比则不然。关于个体副作用,接受氟西汀治疗的患者中,激活(失眠、激动、震颤和焦虑)和胃肠道不良事件(恶心、呕吐、腹泻、体重减轻和厌食)明显更频繁,而胆碱能副作用明显更不频繁。

结论

与其他抗抑郁药相比,氟西汀有更多的激活和胃肠道不良反应,这通常需要额外的药物治疗或其他管理策略,导致停药和不依从,并增加成本。这些信息对于在日常临床实践中基于证据开具抗抑郁药处方具有重要意义。

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