Liebowitz Michael R, DeMartinis Nicholas A, Weihs Karen, Londborg Peter D, Smith Ward T, Chung Henry, Fayyad Rana, Clary Cathryn M
New York State Psychiatric Institute, New York, NY, USA.
J Clin Psychiatry. 2003 Jul;64(7):785-92. doi: 10.4088/jcp.v64n0708.
Generalized social anxiety disorder is an early onset, highly chronic, frequently disabling disorder with a lifetime prevalence of approximately 13%. The goal of the current study was to evaluate the efficacy and tolerability of sertraline for the treatment of severe generalized social anxiety disorder in adults.
After a 1-week single-blind placebo lead-in period, patients with DSM-IV generalized social phobia were randomly assigned to 12 weeks of double-blind treatment with flexible doses of sertraline (50-200 mg/day) or placebo. Primary efficacy outcomes were the mean change in the Liebowitz Social Anxiety Scale (LSAS) total score and the responder rate for the Clinical Global Impressions-Improvement scale (CGI-I), defined as a CGI-I score </= 2. Data were collected in 2000 and 2001.
211 patients were randomly assigned to sertraline (intent-to-treat [ITT] sample, 205), and 204 patients, to placebo (ITT sample, 196). At week 12, sertraline produced a significantly greater reduction in LSAS total score compared with placebo (mean last-observation-carried-forward [LOCF] change from baseline: -31.0 vs. -21.7; p =.001) and a greater proportion of responders (CGI-I score </= 2: 55.6% vs. 29% among week 12 completers and 46.8% vs. 25.5% in the ITT-LOCF sample; p <.001 for both comparisons). Sertraline was well tolerated, with 7.6% of patients discontinuing due to adverse events versus 2.9% of placebo-treated patients.
The results of the current study confirm the efficacy of sertraline in the treatment of severe social anxiety disorder.
广泛性社交焦虑障碍是一种起病早、高度慢性、常导致功能障碍的疾病，终生患病率约为13%。本研究的目的是评估舍曲林治疗成人重度广泛性社交焦虑障碍的疗效和耐受性。
经过1周的单盲安慰剂导入期后，患有DSM-IV广泛性社交恐惧症的患者被随机分配接受为期12周的双盲治疗，舍曲林剂量灵活（50 - 200毫克/天）或安慰剂。主要疗效指标是利博维茨社交焦虑量表（LSAS）总分的平均变化以及临床总体印象改善量表（CGI-I）的有效率，有效率定义为CGI-I评分≤2。数据于2000年和2001年收集。
211例患者被随机分配至舍曲林组（意向性治疗[ITT]样本，205例），204例患者被分配至安慰剂组（ITT样本，196例）。在第12周时，与安慰剂相比，舍曲林使LSAS总分显著降低（末次观察结转[LOCF]均值从基线的变化：-31.0 vs. -21.7；p = 0.001），且有效率更高（CGI-I评分≤2：第12周完成治疗者中为55.6% vs. 29%，ITT-LOCF样本中为46.8% vs. 25.5%；两组比较p均<0.001）。舍曲林耐受性良好，7.6%的患者因不良事件停药，而安慰剂治疗患者为2.9%。
本研究结果证实了舍曲林治疗重度社交焦虑障碍的疗效。
