Stein M B, Chartier M J, Hazen A L, Kroft C D, Chale R A, Coté D, Walker J R
Department of Psychiatry, St. Boniface General Hospital, University of Manitoba, Winnipeg, Canada.
J Clin Psychopharmacol. 1996 Jun;16(3):218-22. doi: 10.1097/00004714-199606000-00005.
We conducted an 11-week forced-escalation open-label study of paroxetine in the treatment of 36 patients with generalized social phobia. At the mean dosage of 47.9 +/- 6.2 mg/day, 23 of 30 completers (77%) were deemed responders on the basis of a clinician rating of either "very much improved" or "much improved" on the Clinical Global Impressions scale. Duke Social Phobia Scale ratings declined from 35.5 +/- 13.1 at baseline to 19.7 +/- 17.4 at week 11 (p < 0.0005), and Liebowitz Social Anxiety Scale ratings declined from 75.1 +/- 25.4 at baseline to 37.2 +/- 32.5 at week 11 (p < 0.0005). Sixteen responders were randomized to an additional 12 weeks of either paroxetine (with no dosage change) or placebo (after a taper period) on a double-blind basis. To the best of our knowledge, this is the first controlled medication-discontinuation study in social phobia. One of eight patients randomized to continue paroxetine relapsed versus five of eight patients randomized to placebo. These findings call for a double-blind, placebo-controlled treatment study of paroxetine in generalized social phobia. They also suggest that relapse rates are high if medication is discontinued early and that further study is needed to determine (1) the optimal duration of maintenance pharmacotherapy for social phobia and (2) if specific psychotherapeutic interventions before medication discontinuation may prevent relapse.
我们进行了一项为期11周的开放性帕罗西汀强制递增研究，以治疗36例广泛性社交恐惧症患者。平均剂量为47.9±6.2毫克/天，在30例完成治疗的患者中，有23例（77%）根据临床总体印象量表上“显著改善”或“明显改善”的临床医生评分被视为有反应者。杜克社交恐惧症量表评分从基线时的35.5±13.1降至第11周时的19.7±17.4（p<0.0005），利博维茨社交焦虑量表评分从基线时的75.1±25.4降至第11周时的37.2±32.5（p<0.0005）。16例有反应者被随机分为两组，在双盲基础上，一组继续服用帕罗西汀（剂量不变）12周，另一组服用安慰剂（经过逐渐减量期）。据我们所知，这是第一项社交恐惧症的对照药物停药研究。随机分组继续服用帕罗西汀的8例患者中有1例复发，而随机分组服用安慰剂的8例患者中有5例复发。这些发现需要开展一项帕罗西汀治疗广泛性社交恐惧症的双盲、安慰剂对照治疗研究。它们还表明，如果过早停药，复发率很高，并且需要进一步研究以确定：（1）社交恐惧症维持药物治疗的最佳持续时间；（2）在停药前进行特定的心理治疗干预是否可以预防复发。
