依那西普对银屑病患者疲劳和抑郁症状的临床疗效:一项双盲、随机、安慰剂对照、III期试验

作     者：Tyring S. Gottlieb A. Papp K. R. Krishnan 王琼(译) 

作者机构：不详 Department of Psychiatry and Behavioral Sciences Box 3950 Duke University Medical Center South Durham NC 27710 United States 

出 版 物：《世界核心医学期刊文摘（皮肤病学分册）》 (Digest of the World Core Medical JOurnals:Dermatology)

年 卷 期：2006年第2卷第3期

页      面：5-6页

学科分类：1002[医学-临床医学] 100204[医学-神经病学] 100206[医学-皮肤病与性病学] 10[医学] 

主　　题：银屑病患者 双盲治疗 安慰剂对照 临床疗效 抑郁症状 依那西普 疲劳 Ⅲ期试验 Hamilton抑郁量表 严重度指数 

摘      要：Background: Psoriasis has substantial psychological and emotional effects. We assessed the effect of etanercept, an effective treatment for the clinical symptoms of psoriasis, on fatigue and symptoms of depression associated with the condition. Methods: 618 patients with moderate to severe psoriasis received double-blind treatment with placebo or 50 mg twice-weekly etanercept. The primary efficacy endpoint was a 75% or greater improvement from baseline in psoriasis area and severity index score (PASI 75) at week 12. Secondary and other endpoints included the functional assessment of chronic illness therapy fatigue (FACIT-F) scale, the Hamilton rating scale for depression (Ham-D), the Beck depression inventory (BDI), and adverse events. Efficacy analyses were based on the allocated treatment. Analyses and summaries of safety data were based on the actual treatment received. This study is registered with *** with the identifier NCT00111449. Findings: 47% (147 of 311) of patients achieved PASI 75 at week 12, compared with 5% (15 of 306) of those receiving placebo (p 0.0001; difference 42% , 95% CI 36- 48). Greater proportions of patients receiving etanercept had at least a 50% improvement in Ham-D or BDI at week 12 compared with the placebo group; patients treated with etanercept also had significant and clinically meaningful improvements in fatigue (mean FACIT-F improvement 5.0 vs 1.9; p 0.0001, difference 3.0, 95% CI 1.6- 4.5). Improvements in fatigue were correlated with decreasing joint pain, whereas improvements in symptoms of depression were less correlated with objective measures of skin clearance or joint pain. Interpretation: Etanercept treatment might relieve fatigue and symptoms of depression associated with this chronic disease.