Davidson Jonathan R T, Foa Edna B, Huppert Jonathan D, Keefe Francis J, Franklin Martin E, Compton Jill S, Zhao Ning, Connor Kathryn M, Lynch Thomas R, Gadde Kishore M
Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC 27710, USA.
Arch Gen Psychiatry. 2004 Oct;61(10):1005-13. doi: 10.1001/archpsyc.61.10.1005.
Generalized social phobia is common, persistent, and disabling and is often treated with selective serotonin reuptake inhibitor drugs or cognitive behavioral therapy.
We compared fluoxetine (FLU), comprehensive cognitive behavioral group therapy (CCBT), placebo (PBO), and the combinations of CCBT/FLU and CCBT/PBO.
Randomized, double-blind, placebo-controlled trial.
Two academic outpatient psychiatric centers.
Subjects meeting a primary diagnosis of generalized social phobia were recruited via advertisement. Seven hundred twenty-two were screened, and 295 were randomized and available for inclusion in an intention-to-treat efficacy analysis; 156 (52.9%) were male, 226 (76.3%) were white, and mean age was 37.1 years.
Treatment lasted for 14 weeks. Fluoxetine and PBO were administered at doses from 10 mg/d to 60 mg/d (or equivalent). Group comprehensive cognitive behavioral therapy was administered weekly for 14 sessions.
An independent blinded evaluator assessed response with the Brief Social Phobia Scale and Clinical Global Impressions scales as primary outcomes. A videotaped behavioral assessment served as a secondary outcome, using the Subjective Units of Distress Scale. Adverse effects were measured by self-rating. Each treatment was compared by means of chi2 tests and piecewise linear mixed-effects models.
Clinical Global Impressions scales response rates in the intention-to-treat sample were 29 (50.9%) (FLU), 31 (51.7%) (CCBT), 32 (54.2%) (CCBT/FLU), 30 (50.8%) (CCBT/PBO), and 19 (31.7%) (PBO), with all treatments being significantly better than PBO. On the Brief Social Phobia Scale, all active treatments were superior to PBO. In the linear mixed-effects models analysis, FLU was more effective than CCBT/FLU, CCBT/PBO, and PBO at week 4; CCBT was also more effective than CCBT/FLU and CCBT/PBO. By the final visit, all active treatments were superior to PBO but did not differ from each other. Site effects were found for the Subjective Units of Distress Scale assessment, with FLU and CCBT/FLU superior to PBO at Duke University Medical Center, Durham, NC. Treatments were well tolerated.
All active treatments were superior to PBO on primary outcomes. Combined treatment did not yield any further advantage. Notwithstanding the benefits of treatment, many patients remained symptomatic after 14 weeks.
广泛性社交恐惧症常见、持续且会导致功能障碍，常采用选择性5-羟色胺再摄取抑制剂药物或认知行为疗法进行治疗。
我们比较了氟西汀（FLU）、综合性认知行为团体疗法（CCBT）、安慰剂（PBO）以及CCBT/FLU和CCBT/PBO的联合疗法。
随机、双盲、安慰剂对照试验。
两个学术性门诊精神科中心。
通过广告招募符合广泛性社交恐惧症初步诊断标准的受试者。共筛查了722人，295人被随机分组并纳入意向性治疗疗效分析；其中156人（52.9%）为男性，226人（76.3%）为白人，平均年龄为37.1岁。
治疗持续14周。氟西汀和安慰剂的给药剂量为10毫克/天至60毫克/天（或等效剂量）。团体综合性认知行为疗法每周进行1次，共14节。
由一名独立的盲法评估者使用社交恐惧症简明量表和临床总体印象量表评估反应作为主要结局。录像行为评估作为次要结局，采用痛苦主观单位量表。通过自评测量不良反应。采用卡方检验和分段线性混合效应模型对每种治疗进行比较。
在意向性治疗样本中，临床总体印象量表的反应率分别为29例（50.9%）（FLU）、31例（51.7%）（CCBT）、32例（54.2%）（CCBT/FLU）、30例（50.8%）（CCBT/PBO）和19例（31.7%）（PBO），所有治疗组均显著优于安慰剂组。在社交恐惧症简明量表上，所有积极治疗组均优于安慰剂组。在线性混合效应模型分析中，第4周时氟西汀比CCBT/FLU、CCBT/PBO和安慰剂更有效；CCBT也比CCBT/FLU和CCBT/PBO更有效。到最后一次访视时，所有积极治疗组均优于安慰剂组，但彼此之间无差异。在痛苦主观单位量表评估中发现了地点效应，在北卡罗来纳州达勒姆的杜克大学医学中心，氟西汀和CCBT/FLU优于安慰剂。各治疗的耐受性良好。
在主要结局方面，所有积极治疗组均优于安慰剂组。联合治疗未产生进一步优势。尽管治疗有效果，但许多患者在14周后仍有症状。
