Department for Evidence-Based Medicine and Clinical Epidemiology, Danube University Krems, Krems, Austria.
Drug Saf. 2009;32(12):1159-73. doi: 10.2165/11318930-000000000-00000.
Second-generation antidepressants dominate the management of patients with major depressive disorder (MDD). Evidence on the general and comparative benefits and harms is still accruing.
To systematically review the general and comparative efficacy and safety of duloxetine for the treatment of acute-phase MDD in adults.
We conducted a search of MEDLINE, Embase, PsychLit, The Cochrane Library, and the International Pharmaceutical Abstracts from 1980 to July 2009, as well as manually searching reference lists of pertinent review articles and exploring the Center for Drug Evaluation and Research database to identify unpublished research.
For efficacy, randomized controlled trials (RCTs) comparing duloxetine with placebo or second-generation antidepressants were included. For safety, both experimental and observational studies were eligible.
Abstracts and full-text articles were independently reviewed by two people, one investigator extracted relevant data, and a senior reviewer checked data for completeness and accuracy.
We included 36 experimental and observational studies and, where sufficient data were available, meta-analyses of RCTs were conducted. Findings indicated that duloxetine is an effective treatment option for acute-phase MDD, with a tolerability profile similar to other second-generation antidepressants. No substantial differences in efficacy and safety appear to exist when duloxetine is compared with other second-generation antidepressants. Overall, about 40% of patients treated with duloxetine achieved remission. Compared with other treatments, duloxetine had frequently higher rates of nausea, vomiting and dry mouth; however, these differences did not lead to higher discontinuation rates compared with selective serotonin reuptake inhibitors as a class. There is insufficient evidence to draw conclusions about rare but severe adverse events.
Current evidence does not warrant the choice of duloxetine over other second-generation antidepressants based on greater efficacy or safety for patients with acute-phase MDD with or without accompanying symptoms such as pain.
第二代抗抑郁药在治疗重度抑郁症（MDD）患者中占主导地位。关于其一般疗效和比较疗效及安全性的证据仍在不断增加。
系统评价度洛西汀治疗成人急性 MDD 的一般疗效和安全性。
我们检索了 1980 年至 2009 年 7 月的 MEDLINE、Embase、PsychLit、The Cochrane Library 和国际药学文摘，并手动检索了相关综述文章的参考文献列表，同时探索了美国食品与药品管理局数据库，以确定未发表的研究。
疗效方面，纳入了比较度洛西汀与安慰剂或第二代抗抑郁药的随机对照试验（RCT）。安全性方面，纳入了实验性和观察性研究。
两名研究人员分别对摘要和全文进行了独立评估，一位研究人员提取了相关数据，一位资深审稿人对数据的完整性和准确性进行了检查。
我们纳入了 36 项实验性和观察性研究，并且在有足够数据的情况下，对 RCT 进行了荟萃分析。结果表明，度洛西汀是急性 MDD 的有效治疗选择，其耐受性与其他第二代抗抑郁药相似。与其他第二代抗抑郁药相比，度洛西汀在疗效和安全性方面似乎没有明显差异。总体而言，约 40%接受度洛西汀治疗的患者达到了缓解。与其他治疗方法相比，度洛西汀更常引起恶心、呕吐和口干，但与选择性 5-羟色胺再摄取抑制剂相比，这些差异并未导致更高的停药率。关于罕见但严重的不良反应，目前尚无足够的证据得出结论。
目前的证据不支持在治疗伴有或不伴有疼痛等伴随症状的急性 MDD 患者时，选择度洛西汀而不是其他第二代抗抑郁药，因为其疗效或安全性更好。
