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一项关于文拉法辛缓释剂、帕罗西汀和安慰剂治疗惊恐障碍疗效的双盲研究。

A double-blind study of the efficacy of venlafaxine extended-release, paroxetine, and placebo in the treatment of panic disorder.

作者信息

Pollack Mark H, Lepola Ulla, Koponen Hannu, Simon Naomi M, Worthington John J, Emilien Gerard, Tzanis Evan, Salinas Eliseo, Whitaker Timothy, Gao Bo

机构信息

Massachusetts General Hospital, Boston, Massachusetts 02114, USA.

出版信息

Depress Anxiety. 2007;24(1):1-14. doi: 10.1002/da.20218.

Abstract

To date, no large-scale, controlled trial comparing a serotonin-norepinephrine reuptake inhibitor and selective serotonin reuptake inhibitor with placebo for the treatment of panic disorder has been reported. This double-blind study compares the efficacy of venlafaxine extended-release (ER) and paroxetine with placebo. A total of 664 nondepressed adult outpatients who met DSM-IV criteria for panic disorder (with or without agoraphobia) were randomly assigned to 12 weeks of treatment with placebo or fixed-dose venlafaxine ER (75 mg/day or 150 mg/day), or paroxetine 40 mg/day. The primary measure was the percentage of patients free from full-symptom panic attacks, assessed with the Panic and Anticipatory Anxiety Scale (PAAS). Secondary measures included the Panic Disorder Severity Scale, Clinical Global Impressions--Severity (CGI-S) and--Improvement (CGI-I) scales; response (CGI-I rating of very much improved or much improved), remission (CGI-S rating of not at all ill or borderline ill and no PAAS full-symptom panic attacks); and measures of depression, anxiety, phobic fear and avoidance, anticipatory anxiety, functioning, and quality of life. Intent-to-treat, last observation carried forward analysis showed that mean improvement on most measures was greater with venlafaxine ER or paroxetine than with placebo. No significant differences were observed between active treatment groups. Panic-free rates at end point with active treatment ranged from 54% to 61%, compared with 35% for placebo. Approximately 75% of patients given active treatment were responders, and nearly 45% achieved remission. The placebo response rate was slightly above 55%, with remission near 25%. Adverse events were mild or moderate and similar between active treatment groups. Venlafaxine ER and paroxetine were effective and well tolerated in the treatment of panic disorder.

摘要

迄今为止,尚无关于将5-羟色胺去甲肾上腺素再摄取抑制剂和选择性5-羟色胺再摄取抑制剂与安慰剂比较用于治疗惊恐障碍的大规模对照试验报告。这项双盲研究比较了文拉法辛缓释剂(ER)和帕罗西汀与安慰剂的疗效。共有664名符合惊恐障碍(伴或不伴广场恐怖症)DSM-IV标准的非抑郁成年门诊患者被随机分配接受为期12周的安慰剂治疗、固定剂量的文拉法辛ER(75毫克/天或150毫克/天)治疗或帕罗西汀40毫克/天治疗。主要测量指标是使用惊恐和预期焦虑量表(PAAS)评估的无完全症状惊恐发作患者的百分比。次要测量指标包括惊恐障碍严重程度量表、临床总体印象——严重程度(CGI-S)和——改善程度(CGI-I)量表;反应(CGI-I评分为显著改善或明显改善)、缓解(CGI-S评分为无病或边缘性疾病且无PAAS完全症状惊恐发作);以及抑郁、焦虑、恐惧性恐惧和回避、预期焦虑、功能和生活质量的测量指标。意向性治疗、末次观察结转分析表明,在大多数测量指标上,文拉法辛ER或帕罗西汀的平均改善程度大于安慰剂。活性治疗组之间未观察到显著差异。活性治疗组终点时的无惊恐率在54%至61%之间,而安慰剂组为35%。接受活性治疗的患者中约75%有反应,近45%达到缓解。安慰剂反应率略高于55%,缓解率接近25%。不良事件为轻度或中度,活性治疗组之间相似。文拉法辛ER和帕罗西汀在治疗惊恐障碍方面有效且耐受性良好。

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