Hartford James, Kornstein Susan, Liebowitz Michael, Pigott Teresa, Russell James, Detke Michael, Walker Daniel, Ball Susan, Dunayevich Eduardo, Dinkel Jeff, Erickson Janelle
Community Research, Cincinnati, Ohio 45227, USA.
Int Clin Psychopharmacol. 2007 May;22(3):167-74. doi: 10.1097/YIC.0b013e32807fb1b2.
This study examined the efficacy and tolerability of duloxetine 60-120 mg/day for the treatment of patients with generalized anxiety disorder. This was a multicenter, randomized, double-blind, flexible-dose, placebo and active-controlled (venlafaxine extended-release 75-225 mg/day) trial designed to assess duloxetine 60-120 mg/day during 10 weeks of treatment in adults with Diagnostic and statistical manual of mental disorders-IV-defined generalized anxiety disorder. The primary efficacy outcome measure was mean change from baseline to endpoint in the Hamilton Anxiety Rating Scale total score assessed using analysis of covariance. A total of 487 patients were randomly assigned to duloxetine (n=162), venlafaxine XR (n=164), or placebo (n=161). Significantly greater improvement on the Hamilton Anxiety Rating Scale total score occurred in the duloxetine (P=0.007) and venlafaxine XR (P<0.001) groups compared with the placebo group. Overall discontinuation rates did not differ among the three groups, but adverse event-related discontinuation was significantly higher in the duloxetine (14.2%, P<0.001) and venlafaxine XR (11.0%, P=0.001) groups than in the placebo group (1.9%). During the 2-week drug-tapering phase, discontinuation-emergent adverse events were significantly greater in the venlafaxine XR group (26.9%, P=0.04), but not in the duloxetine group (19.4%, P=0.448) compared with placebo (15.8%). Duloxetine 60-120 mg/day and venlafaxine XR 75-225 mg/day were each efficacious treatments for patients with generalized anxiety disorder.
本研究考察了度洛西汀60 - 120毫克/天治疗广泛性焦虑症患者的疗效和耐受性。这是一项多中心、随机、双盲、灵活剂量、安慰剂对照和活性药物对照（文拉法辛缓释片75 - 225毫克/天）试验，旨在评估度洛西汀60 - 120毫克/天对符合《精神障碍诊断与统计手册》第四版定义的广泛性焦虑症成年患者进行10周治疗的效果。主要疗效指标是采用协方差分析评估的汉密尔顿焦虑量表总分从基线到终点的平均变化。共有487例患者被随机分配至度洛西汀组（n = 162）、文拉法辛缓释片组（n = 164）或安慰剂组（n = 161）。与安慰剂组相比，度洛西汀组（P = 0.007）和文拉法辛缓释片组（P < 0.001）的汉密尔顿焦虑量表总分改善更为显著。三组的总体停药率无差异，但度洛西汀组（14.2%，P < 0.001）和文拉法辛缓释片组（11.0%，P = 0.001）因不良事件导致的停药率显著高于安慰剂组（1.9%）。在为期2周的药物减量阶段，与安慰剂组（15.8%）相比，文拉法辛缓释片组停药后出现的不良事件显著更多（26.9%，P = 0.04），但度洛西汀组（19.4%，P = 0.448）并非如此。度洛西汀60 - 120毫克/天和文拉法辛缓释片75 - 225毫克/天对广泛性焦虑症患者均为有效的治疗方法。
