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舍曲林与帕罗西汀治疗惊恐障碍的疗效比较:一项急性、双盲非劣效性对照研究

Sertraline versus paroxetine in the treatment of panic disorder: an acute, double-blind noninferiority comparison.

作者信息

Bandelow Borwin, Behnke Kirsten, Lenoir Sergio, Hendriks G J, Alkin Tunc, Goebel Claus, Clary Cathryn M

机构信息

Department of Psychiatry and Psychotherapy, University of Göttingen, von-Siebold-Strasse 5, D-37505 Göttingen, Germany.

出版信息

J Clin Psychiatry. 2004 Mar;65(3):405-13. doi: 10.4088/jcp.v65n0317.

Abstract

OBJECTIVE

Several classes of medications have demonstrated efficacy in panic disorder, but direct comparison of 2 proven treatments is still uncommon. The purpose of this study was to compare sertraline and paroxetine in the acute treatment of panic disorder.

METHOD

Adult outpatients with panic disorder with or without agoraphobia (DSM-IV and ICD-10 criteria) were randomly assigned in double-blind fashion to 12 weeks of treatment with flexible doses of sertraline (titrated up to 50-150 mg/day; N = 112) or paroxetine (titrated up to 40-60 mg/day; N = 113). Patients were then tapered off medication over 3 weeks. The primary analysis was a noninferiority analysis of Panic and Agoraphobia Scale (PAS) scores. Secondary measures included panic attack frequency and the Clinical Global Impressions-Improvement scale (CGI-I) (with responders defined as those with a CGI-I score < or = 2). Data were collected from January 2000 to June 2001.

RESULTS

Sertraline and paroxetine were associated with equivalent levels of improvement on the PAS total score, as well as on all secondary outcome measures. Eighty-two percent of patients taking sertraline versus 78% of those taking paroxetine were CGI-I responders at endpoint. Numerically more patients on paroxetine treatment compared with sertraline treatment discontinued due to adverse events (18% vs. 12%; NS), and a significantly higher proportion of paroxetine patients showed > or = 7% weight gain (7% vs. < 1%; p <.05). During the taper period, the proportion of panic-free patients increased by 4% with sertraline but decreased by 11% with paroxetine (p <.05).

CONCLUSION

Sertraline and paroxetine had equivalent efficacy in panic disorder, but sertraline was significantly better tolerated and was associated with significantly less clinical worsening during taper than paroxetine.

摘要

目的

几类药物已在惊恐障碍治疗中显示出疗效,但对两种已证实的治疗方法进行直接比较仍不常见。本研究的目的是比较舍曲林和帕罗西汀在惊恐障碍急性治疗中的效果。

方法

符合惊恐障碍伴或不伴广场恐惧症(依据《精神疾病诊断与统计手册》第四版和《国际疾病分类》第十版标准)的成年门诊患者,以双盲方式随机分配,接受为期12周的灵活剂量舍曲林(滴定至50 - 150毫克/天;N = 112)或帕罗西汀(滴定至40 - 60毫克/天;N = 113)治疗。然后患者在3周内逐渐减药。主要分析是对惊恐与广场恐惧症量表(PAS)评分的非劣效性分析。次要测量指标包括惊恐发作频率和临床总体印象改善量表(CGI - I)(将反应者定义为CGI - I评分≤2的患者)。数据收集时间为2000年1月至2001年6月。

结果

舍曲林和帕罗西汀在PAS总分以及所有次要结局指标上的改善水平相当。在终点时,服用舍曲林的患者中有82%是CGI - I反应者,而服用帕罗西汀的患者中这一比例为78%。与舍曲林治疗相比,接受帕罗西汀治疗因不良事件停药的患者在数量上更多(18%对12%;无统计学差异),且帕罗西汀患者体重增加≥7%的比例显著更高(7%对<1%;p <.05)。在减药期间,服用舍曲林的无惊恐患者比例增加了4%,而服用帕罗西汀的患者这一比例下降了11%(p <.新的行<.0新的行5)。

结论

舍曲林和帕罗西汀在惊恐障碍治疗中疗效相当,但舍曲林耐受性明显更好,且在减药期间临床恶化明显少于帕罗西汀。

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