Russell James, Raskin Joel, Wiltse Curtis, Walker Daniel, Brawman-Mintzer Olga
Psychiatry (Edgmont). 2007 Jun;4(6):33-45.
To compare the efficacy and tolerability of duloxetine 60mg/day versus placebo in treating elderly patients with major depressive disorder (MDD) and concurrent anxiety symptoms.
Patients (>/=65) were randomized to eight weeks of treatment with duloxetine 60mg/day (n=207) or placebo (n=104). Anxiety measures were analyzed for all patients, by age (<75 and >/=75), and in patients having concurrent high anxiety (HAMD(17), item 10; Psychic Anxiety baseline score of 2, 3, or 4). Psychic Anxiety, Somatic Anxiety item 11, and the Anxiety/Somatization subscale were analyzed for all patients and subgroups by mean change from baseline to endpoint and repeated measures. Tolerability was assessed via treatment-emergent adverse events (TEAEs), and adverse events were reported as the reason for discontinuation. The analyses presented are primarily post hoc in nature.
Duloxetine produced significantly greater reductions than placebo in Psychic Anxiety (least-squares mean change: -0.62 vs. -0.18, p<0.001) and the Anxiety/Somatization subscale (-1.88 vs. -0.99, p=0.002). Repeated measures analyses showed separation between the treatment groups beginning at Week 1 for Psychic Anxiety and Week 4 for the Anxiety/Somatization subscale. Significant improvement occurred in the <75 and >/=75 age groups for Psychic Anxiety, but only the <75 group for the Anxiety/Somatization subscale. Duloxetine-treated patients with high anxiety showed significant improvement compared with placebo-treated patients on Psychic Anxiety, Anxiety/Somatization subscale, the 17-item Hamilton Depression Rating Scale (HAMD(17)) total score, and several other measures. Duloxetine and placebo had similar TEAE rates and discontinuation rates due to adverse events.
Duloxetine (60mg/day) was efficacious and tolerable in elderly patients with MDD and concurrent anxiety symptoms.
比较度洛西汀60mg/天与安慰剂治疗老年重度抑郁症（MDD）合并焦虑症状患者的疗效和耐受性。
年龄≥65岁的患者被随机分为两组，分别接受为期8周的度洛西汀60mg/天治疗（n = 207）或安慰剂治疗（n = 104）。对所有患者、按年龄（<75岁和≥75岁）以及合并高焦虑症状的患者（汉密尔顿抑郁量表（HAMD(17)）第10项；精神焦虑基线评分为2、3或4）进行焦虑测量分析。对所有患者及其亚组，通过从基线到终点的平均变化和重复测量，分析精神焦虑、躯体焦虑第11项以及焦虑/躯体化分量表。通过治疗中出现的不良事件（TEAE）评估耐受性，并将不良事件报告为停药原因。所呈现的分析本质上主要是事后分析性质。
度洛西汀在精神焦虑（最小二乘均值变化：-0.62对-0.18，p<0.001）和焦虑/躯体化分量表（-1.88对-0.99，p = 0.002）方面比安慰剂产生了显著更大的降低。重复测量分析显示，治疗组在第1周时精神焦虑开始出现分离，在第4周时焦虑/躯体化分量表开始出现分离。<75岁和≥75岁年龄组在精神焦虑方面有显著改善，但在焦虑/躯体化分量表方面只有<75岁组有改善。与安慰剂治疗的高焦虑患者相比，度洛西汀治疗的高焦虑患者在精神焦虑、焦虑/躯体化分量表、17项汉密尔顿抑郁量表（HAMD(17)）总分以及其他几项测量指标上有显著改善。度洛西汀和安慰剂的TEAE发生率和因不良事件导致的停药率相似。
度洛西汀（60mg/天）对患有MDD合并焦虑症状的老年患者有效且耐受性良好。
