Nicolini H, Bakish D, Duenas H, Spann M, Erickson J, Hallberg C, Ball S, Sagman D, Russell J M
Grupo Medico Carracci, Mexico City, Mexico.
Psychol Med. 2009 Feb;39(2):267-76. doi: 10.1017/S0033291708003401. Epub 2008 May 19.
This study examined the efficacy and tolerability of duloxetine and venlafaxine extended-release (XR) treatment for generalized anxiety disorder (GAD), with a secondary focus on psychic and somatic symptoms within GAD.
The design was a 10-week, multi-center, double-blind placebo-controlled study of duloxetine (20 mg or 60-120 mg once daily) and venlafaxine XR (75-225 mg once daily) treatment. Efficacy was measured using the Hamilton Anxiety Rating Scale (HAMA), which includes psychic and somatic factor scores. Tolerability was measured by occurrence of treatment-emergent adverse events (TEAEs) and discontinuation rates.
Adult out-patients (mean age 42.8 years; 57.1% women) with DSM-IV-defined GAD were randomly assigned to placebo (n=170), duloxetine 20 mg (n=84), duloxetine 60-120 mg (n=158) or venlafaxine XR 75-225 mg (n=169) treatment. Each of the three active treatment groups had significantly greater improvements on HAMA total score from baseline to endpoint compared with placebo (p=0.01-0.001). For the HAMA psychic factor score, both duloxetine treatment arms and venlafaxine XR demonstrated significantly greater improvement compared with placebo (p=0.01-0.001). For the HAMA somatic factor score, the mean improvement in the duloxetine 60-120 mg and venlafaxine XR groups was significantly greater than placebo (p0.05 and p0.01 respectively), whose mean improvement did not differ from the duloxetine 20 mg group (p=0.07). Groups did not differ in study discontinuation rate due to adverse events.
Duloxetine and venlafaxine treatment were each efficacious for improvement of core psychic anxiety symptoms and associated somatic symptoms for adults with GAD.
本研究考察了度洛西汀和文拉法辛缓释剂（XR）治疗广泛性焦虑症（GAD）的疗效和耐受性，次要关注点为GAD的精神症状和躯体症状。
该设计为一项为期10周的多中心、双盲、安慰剂对照研究，比较度洛西汀（每日一次，20毫克或60 - 120毫克）和文拉法辛XR（每日一次，75 - 225毫克）的治疗效果。疗效通过汉密尔顿焦虑量表（HAMA）进行评估，该量表包括精神和躯体因子得分。耐受性通过治疗中出现的不良事件（TEAE）发生率和停药率来衡量。
符合DSM - IV标准的GAD成年门诊患者（平均年龄42.8岁；57.1%为女性）被随机分配至安慰剂组（n = 170）、度洛西汀20毫克组（n = 84）、度洛西汀60 - 120毫克组（n = 158）或文拉法辛XR 75 - 225毫克组（n = 169）进行治疗。与安慰剂组相比，三个活性治疗组从基线到终点的HAMA总分均有显著改善（p = 0.01 - 0.001）。对于HAMA精神因子得分，度洛西汀治疗组和文拉法辛XR组与安慰剂组相比均有显著更大的改善（p = 0.01 - 0.001）。对于HAMA躯体因子得分，度洛西汀60 - 120毫克组和文拉法辛XR组的平均改善显著大于安慰剂组（分别为p < 0.05和p < 0.01），安慰剂组的平均改善与度洛西汀20毫克组无差异（p = 0.07）。各治疗组因不良事件导致的研究停药率无差异。
度洛西汀和文拉法辛治疗对GAD成年患者改善核心精神焦虑症状及相关躯体症状均有效。
