Omori Ichiro M, Watanabe Norio, Nakagawa Atsuo, Cipriani Andrea, Barbui Corrado, McGuire Hugh, Churchill Rachel, Furukawa Toshi A
Department of Psychiatry & Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya, Japan, 467-8601.
Cochrane Database Syst Rev. 2010 Mar 17;2010(3):CD006114. doi: 10.1002/14651858.CD006114.pub2.
Fluvoxamine, one of the oldest selective serotonin reuptake inhibitors (SSRIs), is prescribed to patients with major depression in many countries. Several studies have previously reviewed the efficacy and tolerability of fluvoxamine for the treatment of major depression. However, these reviews are now outdated.
Our objective is to evaluate the effectiveness, tolerability and side effect profile of fluvoxamine for major depression in comparison with other anti-depressive agents, including tricyclics (TCAs), heterocyclics, other SSRIs, SNRIs, other newer agents and other conventional psychotropic drugs.
We searched the Cochrane Collaboration Depression, Anxiety and Neurosis Controlled Trials Register. Trial databases and ongoing trial registers in North America, Europe, Japan and Australia, were handsearched for randomised controlled trials. We checked reference lists of the articles included in the review, previous systematic reviews and major textbooks of affective disorder for published reports and citations of unpublished research. The date of last search was 31 August 2008.
We included all randomised controlled trials, published in any language, that compared fluvoxamine with any other active antidepressants in the acute phase treatment of major depression.
Two independent review authors inspected citations and abstracts, obtained papers, extracted data and assessed the risk of bias of included studies. We analysed dichotomous data using odds ratios (ORs) and continuous data using the standardised mean difference (SMD). A random effects model was used to combine studies.
A total of 54 randomised controlled trials (n = 5122) were included. No strong evidence was found to indicate that fluvoxamine was either superior or inferior to other antidepressants regarding response, remission and tolerability. However, differing side effect profiles were evident, especially with regard to gastrointestinal side effects of fluvoxamine when compared to other antidepressants. For example, fluvoxamine was generally associated with a higher incidence of vomiting/nausea (versus imipramine, OR 2.23, CI 1.59 to 3.14; versus clomipramine, OR 2.13, CI 1.06 to 4.27; versus amitriptyline, OR 2.86, CI 1.31 to 2.63).
AUTHORS' CONCLUSIONS: We found no strong evidence that fluvoxamine was either superior or inferior to any other antidepressants in terms of efficacy and tolerability in the acute phase treatment of depression. However, differing side effect profiles were evident. Based on these findings, we conclude that clinicians should focus on practical or clinically relevant considerations, including these differences in side effect profiles.
氟伏沙明是最早的选择性5-羟色胺再摄取抑制剂(SSRI)之一,在许多国家被用于治疗重度抑郁症患者。此前已有多项研究对氟伏沙明治疗重度抑郁症的疗效和耐受性进行了综述。然而,这些综述现已过时。
我们的目的是评估氟伏沙明治疗重度抑郁症的有效性、耐受性和副作用情况,并与其他抗抑郁药进行比较,这些抗抑郁药包括三环类抗抑郁药(TCA)、杂环类抗抑郁药、其他SSRI、5-羟色胺去甲肾上腺素再摄取抑制剂(SNRI)、其他新型药物和其他传统精神药物。
我们检索了Cochrane协作网抑郁症、焦虑症和神经症对照试验注册库。对北美、欧洲、日本和澳大利亚的试验数据库及正在进行的试验注册库进行手工检索,以查找随机对照试验。我们查阅了综述中纳入文章的参考文献列表、先前的系统综述以及情感障碍的主要教科书,以获取已发表报告及未发表研究的引用文献。最后一次检索日期为2008年8月31日。
我们纳入了所有以任何语言发表的随机对照试验,这些试验在重度抑郁症的急性期治疗中将氟伏沙明与任何其他活性抗抑郁药进行了比较。
两位独立的综述作者检查了文献引用和摘要,获取论文,提取数据并评估纳入研究的偏倚风险。我们使用比值比(OR)分析二分数据,使用标准化均数差(SMD)分析连续数据。采用随机效应模型合并研究。
共纳入54项随机对照试验(n = 5122)。未发现有力证据表明氟伏沙明在反应、缓解和耐受性方面优于或劣于其他抗抑郁药。然而,不同的副作用情况很明显,尤其是与其他抗抑郁药相比,氟伏沙明的胃肠道副作用。例如,氟伏沙明通常与呕吐/恶心的发生率较高相关(与丙咪嗪相比,OR 2.23,CI 1.59至3.14;与氯米帕明相比,OR 2.13,CI 1.06至4.27;与阿米替林相比,OR 2.86,CI 1.31至2.63)。
我们没有发现有力证据表明氟伏沙明在抑郁症急性期治疗的疗效和耐受性方面优于或劣于任何其他抗抑郁药。然而,不同的副作用情况很明显。基于这些发现,我们得出结论,临床医生应关注实际或临床相关的考虑因素,包括这些副作用情况的差异。