一项双盲随机研究，旨在提供关于在无洗脱期的情况下将氟西汀治疗的患者换用帕罗西汀的安全性信息。

A double-blind, randomized study to provide safety information on switching fluoxetine-treated patients to paroxetine without an intervening washout period.

作者信息

Kreider M S, Bushnell W D, Oakes R, Wheadon D E

机构信息

SmithKline Beecham Pharmaceuticals, Four Falls Corporate Center, Conshohocken, PA 19428, USA.

出版信息

J Clin Psychiatry. 1995 Apr;56(4):142-5.

PMID:7713852

Abstract

BACKGROUND

The long elimination half-lives of fluoxetine and norfluoxetine, the active metabolite of fluoxetine, are of potential consequence when alternative antidepressant agents are introduced after the termination of fluoxetine therapy. It is not known whether paroxetine, an antidepressant agent in the same pharmacologic class as fluoxetine, can be substituted for fluoxetine without the need for an intervening washout period. The objective of this trial was to assess the tolerability of an immediate switch from fluoxetine to paroxetine therapy.

METHOD

Patients who were treated for moderate to moderately severe major depressive disorder (DSM-III-R 296.2 or 296.3) with a stable dose of fluoxetine for a minimum of 6 weeks' duration were randomized in a double-blind fashion to one of two treatment groups. One group (N = 123) was started on 20 mg of paroxetine daily the morning after their last dose of fluoxetine, and the other group (N = 119) was started on 20 mg of paroxetine daily following a 2-week placebo-washout period. Patient visits were scheduled at weekly intervals for a total of 4 weeks. Adverse experience monitoring was conducted at each visit.

RESULTS

There was no difference in the proportion of patients who discontinued prematurely from the trial due to an adverse experience. Eight patients in the immediate-switch group and 6 patients in the placebo-washout group withdrew from the trial in response to an adverse experience (p = .63, chi-square). The overall profile of adverse experiences was similar in the two treatment groups over the 4-week period. The incidence of adverse experiences in the first 2 weeks following the initiation of paroxetine was generally lower in the group with the intervening 2-week placebo-washout period.

CONCLUSION

The immediate switch from fluoxetine to paroxetine was as well tolerated as the switch to paroxetine after a 2-week placebo-washout period.

摘要

背景

氟西汀及其活性代谢产物去甲氟西汀的消除半衰期较长，在氟西汀治疗结束后换用其他抗抑郁药时可能会产生潜在影响。与氟西汀属于同一药理类别的抗抑郁药帕罗西汀，在无需中间洗脱期的情况下能否替代氟西汀尚不清楚。本试验的目的是评估从氟西汀立即转换为帕罗西汀治疗的耐受性。

方法

使用稳定剂量的氟西汀治疗中度至中度严重重度抑郁症（DSM-III-R 296.2或296.3）至少6周的患者，以双盲方式随机分为两个治疗组之一。一组（N = 123）在最后一剂氟西汀后的次日早晨开始每日服用20 mg帕罗西汀，另一组（N = 119）在经过2周的安慰剂洗脱期后开始每日服用20 mg帕罗西汀。患者每周就诊一次，共4周。每次就诊时进行不良事件监测。