Efficacy and safety of second-generation antidepressants in the treatment of major depressive disorder
Efficacy and safety of second-generation antidepressants in the treatment of major depressive disorder
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DOI：
10.7326/0003-4819-143-6-200509200-00006
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发表时间：
2005-09-20
影响因子：
39.2
通讯作者：
Carey, TS
中科院分区：
文献类型：
--
作者：
Hansen, RA;Gartlehner, G;Carey, TS
背景：文献综述比较了较新的第二代抗抑郁药与安慰剂或旧疗法的疗效和耐受性，但尚未评估使用第二代抗抑郁药治疗重度抑郁症的比较证据。目的：系统评价常用第二代抗抑郁药（选择性5 -羟色胺再摄取抑制剂、安非他酮、度洛西汀、米氮平、文拉法辛）治疗重度抑郁症的疗效、有效性和耐受性的比较数据。数据来源：MEDLINE， EMBASE和PsychLit；科克伦图书馆；检索1980年1月至2005年2月的《国际药物文摘》进行综述；随机对照试验；荟萃分析;还有观察性研究。研究选择：作者回顾了46项随机对照试验，比较了一种第二代抗抑郁药与另一种抗抑郁药。还纳入了24项观察性研究和安慰剂对照试验，以评估安全性和耐受性。数据提取：两位研究者独立审阅了题目和摘要。训练有素的审稿人从每个研究中提取数据并分配初始质量评级。另一位审稿人验证了数据提取和质量评级。数据综合：根据充分的证据，对比第二代抗抑郁药的疗效差异很小，88%的比较疗效研究报告在研究结束时，任何结果测量都没有统计学上的显著差异。一项有效性试验被评为良好，两项有效性试验被评为一般，在比较药物的主要结局指标上没有统计学上的显著差异。荟萃分析显示舍曲林和文拉法辛与氟西汀相比有适度但统计学上显著的额外治疗效果。大约96%的比较试验是由制药公司赞助的，或者至少有一位作者与制药公司有关联；其余的试验没有报告资金来源。不同药物的不良事件概况不同；然而，不良事件评估的程度和质量各不相同，只有13%的试验使用标准化量表来评估不良事件。局限性：由于证据的数量和质量不足，许多药物比较无法进行定量分析。大多数发表的证据来自制药公司赞助的试验，可能会出现发表偏倚。结论：总体而言，第二代抗抑郁药在治疗重度抑郁障碍方面可能没有实质性差异。选择最适合特定患者的药物是困难的。
Background: Reviews have compared the efficacy and tolerability of newer second-generation antidepressants with those of placebo or older treatments, but comparative evidence for use of second-generation antidepressants to treat major depressive disorder has not been evaluated.Purpose: To systematically evaluate comparative data on the efficacy, effectiveness, and tolerability of commonly prescribed second-generation antidepressants (selective serotonin reuptake inhibitors, bupropion, duloxetine, mirtazapine, and venlafaxine) in the treatment of major depressive disorder.Data Sources: MEDLINE, EMBASE, and PsychLit; the Cochrane Library; and the International Pharmaceutical Abstracts were searched from January 1980 through February 2005 for reviews; randomized, controlled trials; meta-analyses; and observational studies.Study Selection: The authors reviewed 46 head-to-head randomized, controlled trials comparing one second-generation antidepressant with another. Twenty-four observational studies and placebo-controlled trials were also included for assessment of safety and tolerability.Data Extraction: Two researchers independently reviewed titles and abstracts. Trained reviewers abstracted data from each study and assigned an initial quality rating. A second reviewer verified the data extraction and quality rating.Data Synthesis: According to fair to good evidence, the second-generation antidepressants that were compared had only minimal differences in efficacy, and 88% of comparative efficacy studies reported no statistically significant difference in any outcome measure at the end of the study. One effectiveness trial rated good and 2 effectiveness trials rated fair reported no statistically significant differences in primary outcome measures for compared drugs. Meta-analyses showed a modest but statistically significant additional treatment effect for sertraline and venlafaxine compared with fluoxetine. About 96% of comparative trials were sponsored by or had at least 1 author affiliated with a pharmaceutical company; the remaining trials did not report funding sources. Adverse event profiles differed among drugs; however, the degree and quality of adverse event assessment varied and only 13% of trials used a standardized scale to assess adverse events.Limitations: Quantitative analyses could not be done for many drug comparisons because the quantity and quality of the evidence were inadequate. Most published evidence was from trials sponsored by pharmaceutical companies, and publication bias may have occurred.Conclusions: Overall, second-generation antidepressants probably do not differ substantially for treatment of major depressive disorder. Choosing the agent that is most appropriate for a given patient is difficult.