Lam Jenny Y, Freeman Maisha Kelly, Cates Marshall E
University of Alabama Health System-Birmingham, Birmingham, AL, USA.
Ann Pharmacother. 2007 Jun;41(6):1005-12. doi: 10.1345/aph.1H526. Epub 2007 May 22.
To evaluate the literature discussing the use of modafinil in the treatment of residual symptoms of fatigue in patients with depression.
PubMed (1966-March 2007) and International Pharmaceutical Abstracts (1970-March 2007) were searched using the key words modafinil and depression. A manual search of the reference section of the articles retrieved was conducted to identify articles not indexed in either of these sources.
All articles published in English were evaluated. Studies were included if modafinil was used to treat patients with residual fatigue from depression and the effects were measured with validated fatigue subscales.
One retrospective study, 5 open-label trials, and 2 randomized controlled clinical trials met the inclusion criteria for assessment of residual symptoms of fatigue as assessed by commonly used fatigue subscales after modafinil administration. Although improvement with fatigue has occurred with modafinil therapy, literature regarding the topic is limited by the lack of well-controlled clinical trials. Modafinil does appear to improve residual fatigue with depression as evidenced by open-label trials; however, the efficacy of this agent has not been duplicated in randomized controlled trials. The open-label trials that have been conducted often had no comparator and a small number of patients. In addition, outcome measures used in the studies were not consistent between trials. Modafinil appears to be well tolerated, with the main adverse effects being headache and nausea.
Open-label trials indicate that modafinil may be effective in ameliorating fatigue associated with depression; however, this effect has not been reproduced in randomized, double-blind, placebo-controlled clinical trials. Therefore, the use of modafinil for the treatment of residual fatigue is not recommended due to the lack of reproducible data of its efficacy. Long-term, adequately powered clinical trials should be conducted to determine its place in therapy.
评估关于使用莫达非尼治疗抑郁症患者残余疲劳症状的文献。
使用关键词“莫达非尼”和“抑郁症”检索了PubMed（1966年 - 2007年3月）和国际药学文摘（1970年 - 2007年3月）。对检索到的文章的参考文献部分进行了人工检索，以识别未在这两个来源中索引的文章。
评估所有以英文发表的文章。如果使用莫达非尼治疗抑郁症残余疲劳患者，并使用经过验证的疲劳分量表测量效果，则纳入研究。
一项回顾性研究、5项开放标签试验和2项随机对照临床试验符合纳入标准，可通过常用疲劳分量表评估莫达非尼给药后疲劳残余症状。虽然莫达非尼治疗使疲劳有所改善，但关于该主题的文献因缺乏严格对照的临床试验而受到限制。开放标签试验表明，莫达非尼似乎确实能改善抑郁症的残余疲劳；然而，该药物的疗效在随机对照试验中尚未得到重复验证。已进行的开放标签试验通常没有对照且患者数量较少。此外，各试验中使用的结局指标不一致。莫达非尼似乎耐受性良好，主要不良反应为头痛和恶心。
开放标签试验表明，莫达非尼可能有效改善与抑郁症相关的疲劳；然而，这种效果在随机、双盲、安慰剂对照的临床试验中尚未得到重现。因此，由于缺乏其疗效的可重复数据，不建议使用莫达非尼治疗残余疲劳。应进行长期、有足够样本量的临床试验以确定其在治疗中的地位。
