De Nayer Andre, Geerts Stefaan, Ruelens Leo, Schittecatte Michel, De Bleeker Eugeen, Van Eeckhoutte Ignace, Evrard Jean-Luc, Linkowski Paul, Fossion Pierre, Leyman Sophie, Mignon Annick
Hôpital Ste Thérèse, Montignies sur Sambre, Belgium.
Int J Neuropsychopharmacol. 2002 Jun;5(2):115-20. doi: 10.1017/S1461145702002857.
The aim of this double-blind study was to compare the efficacy and safety of venlafaxine vs. fluoxetine in the treatment of patients with depression and anxiety. A total of 146 moderately depressed patients with associated anxiety were randomized to receive 75 mg/d venlafaxine or 20 mg/d fluoxetine for 12 wk. Dose increases were permitted after 2 wk of treatment, to 150 mg/d venlafaxine and 40 mg/d fluoxetine, to optimize response. At the final visit, a statistically significantly greater efficacy of venlafaxine over fluoxetine was observed on depressive symptoms and concomitant anxiety, and 75.0 and 50.7% of patients administered venlafaxine and fluoxetine, respectively, showed an overall response. A sustained response (for at least 2 wk), present at the end of the study was achieved in 57.8 and 43.3% of patients in the venlafaxine and fluoxetine groups, respectively, and at the final visit, 59.4 and 40.3% of patients, respectively, were in remission (virtually asymptomatic). Dose increases were required by a greater percentage of patients in the fluoxetine group (52.9%), than in the venlafaxine group (37.1%), and in those patients whose dose was increased, a higher efficacy was again observed with venlafaxine. Venlafaxine and fluoxetine were well tolerated, with the most frequently experienced adverse events being nausea and headache. Fewer patients in the venlafaxine group than in the fluoxetine group reported at least one adverse event (55.7 and 67.1% patients, respectively). Venlafaxine therefore proved to be significantly more effective than fluoxetine in improving depressive symptoms and concomitant anxiety.
这项双盲研究的目的是比较文拉法辛与氟西汀治疗抑郁和焦虑患者的疗效和安全性。共有146例伴有焦虑的中度抑郁患者被随机分为两组,分别接受每日75毫克文拉法辛或每日20毫克氟西汀治疗,为期12周。治疗2周后允许增加剂量,文拉法辛增至每日150毫克,氟西汀增至每日40毫克,以优化疗效。在最后一次访视时,观察到文拉法辛在治疗抑郁症状和伴发焦虑方面的疗效在统计学上显著优于氟西汀,分别有75.0%和50.7%接受文拉法辛和氟西汀治疗的患者显示出总体疗效。在研究结束时,文拉法辛组和氟西汀组分别有57.8%和43.3%的患者实现了持续缓解(至少持续2周),在最后一次访视时,分别有59.4%和40.3%的患者达到缓解(几乎无症状)。氟西汀组需要增加剂量的患者比例(52.9%)高于文拉法辛组(37.1%),在那些增加剂量的患者中,再次观察到文拉法辛具有更高的疗效。文拉法辛和氟西汀耐受性良好,最常见的不良事件是恶心和头痛。文拉法辛组报告至少一种不良事件的患者少于氟西汀组(分别为55.7%和67.1%的患者)。因此,在改善抑郁症状和伴发焦虑方面,文拉法辛被证明比氟西汀显著更有效。