Liebowitz Michael R, Gelenberg Alan J, Munjack Dennis
New York State Psychiatric Institute, New York 10032, USA.
Arch Gen Psychiatry. 2005 Feb;62(2):190-8. doi: 10.1001/archpsyc.62.2.190.
Evidence indicates that venlafaxine hydrochloride extended release (ER) effectively ameliorates anxiety symptoms.
To evaluate the efficacy, safety, and tolerability of flexible-dose venlafaxine ER compared with placebo in the short-term treatment of generalized social anxiety disorder and, secondarily, to compare paroxetine with venlafaxine ER and paroxetine with placebo.
Adult outpatients with DSM-IV generalized social anxiety disorder for 6 months or longer were randomly assigned to receive venlafaxine hydrochloride ER (75-225 mg/d), paroxetine (20-50 mg/d), or placebo for 12 weeks or less at 26 centers in the United States. The primary outcome measure was the total Liebowitz Social Anxiety Scale score. Secondary measures included response (Clinical Global Impression-Improvement score, 1 or 2) rates and Clinical Global Impression-Severity of Illness and Social Phobia Inventory scores.
Of 440 patients treated, 413 (93.9%) were included in the last-observation-carried-forward efficacy analysis; of the 429 patients in the safety population, 318 (74.1%) completed the study. Mean daily doses were 201.7 mg (SD, 38.1 mg) of venlafaxine hydrochloride ER and 46.0 mg (SD, 7.9 mg) of paroxetine. Venlafaxine ER treatment was significantly superior to placebo at weeks 1 through 12 on the Liebowitz Social Anxiety Scale and Social Phobia Inventory and at week 2 and weeks 6 through 12 for Clinical Global Impression-Severity of Illness and responder status, and was significantly superior to paroxetine treatment at weeks 1 and 2 for the Social Phobia Inventory (P < .05 for all). Paroxetine treatment was significantly superior to placebo at weeks 3 through 12 on the Liebowitz Social Anxiety Scale, the Clinical Global Impression-Severity of Illness scale, and the Social Phobia Inventory, and at weeks 4 through 12 for response (P < .05 for all). Week 12 response rates were significantly greater for the venlafaxine ER and paroxetine groups (58.6% and 62.5%, respectively) vs the placebo group (36.1%) (P < .001 for both).
Venlafaxine ER is effective in the short-term treatment of generalized social anxiety disorder, with efficacy and tolerability comparable to paroxetine.
有证据表明，盐酸文拉法辛缓释剂（ER）能有效改善焦虑症状。
评估灵活剂量的文拉法辛ER与安慰剂相比，在短期治疗广泛性社交焦虑障碍中的疗效、安全性和耐受性；其次，比较帕罗西汀与文拉法辛ER以及帕罗西汀与安慰剂的疗效。
在美国26个中心，将患有DSM-IV广泛性社交焦虑障碍6个月或更长时间的成年门诊患者随机分配，接受盐酸文拉法辛ER（75 - 225毫克/天）、帕罗西汀（20 - 50毫克/天）或安慰剂治疗12周或更短时间。主要结局指标是利博维茨社交焦虑量表总分。次要指标包括缓解率（临床总体印象改善评分，1或2）以及临床总体印象疾病严重程度和社交恐惧症量表评分。
在接受治疗的440例患者中，413例（93.9%）纳入末次观察结转疗效分析；在429例安全人群中，318例（74.1%）完成研究。文拉法辛ER的平均日剂量为201.7毫克（标准差，38.1毫克），帕罗西汀为46.0毫克（标准差，7.9毫克）。在第1至12周，文拉法辛ER治疗在利博维茨社交焦虑量表和社交恐惧症量表上显著优于安慰剂，在第2周以及第6至12周，在临床总体印象疾病严重程度和缓解状态方面也显著优于安慰剂；在第1和2周，在社交恐惧症量表上显著优于帕罗西汀治疗（所有P值均<0.05）。在第3至12周，帕罗西汀治疗在利博维茨社交焦虑量表、临床总体印象疾病严重程度量表和社交恐惧症量表上显著优于安慰剂，在第4至12周在缓解率方面也显著优于安慰剂（所有P值均<0.05）。文拉法辛ER组和帕罗西汀组的第12周缓解率（分别为58.6%和62.5%）显著高于安慰剂组（36.1%）（两者P值均<0.001）。
文拉法辛ER在短期治疗广泛性社交焦虑障碍中有效，其疗效和耐受性与帕罗西汀相当。
