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帕罗西汀与文拉法辛治疗强迫症的双盲转换研究。

A double-blind switch study of paroxetine and venlafaxine in obsessive-compulsive disorder.

作者信息

Denys Damiaan, van Megen Harold J G M, van der Wee Nic, Westenberg Herman G M

机构信息

Rudolf Magnus Institute of Neuroscience, Department of Psychiatry, University Medical Center Utrecht, Utrecht, the Netherlands.

出版信息

J Clin Psychiatry. 2004 Jan;65(1):37-43. doi: 10.4088/jcp.v65n0106.

Abstract

BACKGROUND

The treatment guidelines for obsessive-compulsive disorder (OCD) propose to switch serotonin reuptake inhibitors (SRIs) in case of refractoriness. However, no controlled research has been published yet that prospectively examined the effects of changing SRIs. This article describes the first double-blind switch study of 2 SRIs in patients with OCD.

METHOD

150 patients with primary OCD, according to DSM-IV criteria, were randomly assigned in a 12-week, double-blind trial to receive dosages titrated upward to 300 mg/day of venlafaxine (N = 75) or 60 mg/day of paroxetine (N = 75). Primary efficacy was assessed by the change from baseline on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), and nonresponse was defined as less than 25% reduction on the Y-BOCS. After a 4-week tapering phase, 43 nonresponders were switched to 12 additional weeks of the alternate antidepressant, of which 16 patients received venlafaxine and 27 received paroxetine.

RESULTS

Eighteen of 43 patients benefited from a switch to the alternate SRI with a mean +/- SD decrease of at least 25% on the Y-BOCS. At the end of 12 weeks, responder rates were 56% for paroxetine (15/27) and 19% for venlafaxine (3/16). An intent-to-treat, last-observation-carried-forward analysis demonstrated a mean decrease on the Y-BOCS of 1.8 +/- 3.5 in the venlafaxine group and 6.5 +/- 7.1 in the paroxetine group. After 2 consecutive SRI trials, 109 of 150 patients (73%) achieved a Y-BOCS decrease of at least 25%.

CONCLUSION

The results of the current study show that 42% of the nonresponders benefited from a crossover to the other SRI, and that paroxetine was more efficacious than venlafaxine in the treatment of nonresponders to a previous SRI trial. Switching SRIs in case of refractoriness may be considered a useful strategy for patients with OCD.

摘要

背景

强迫症(OCD)治疗指南建议在难治性情况下更换5-羟色胺再摄取抑制剂(SRI)。然而,尚未发表前瞻性研究SRI更换效果的对照研究。本文描述了首个针对强迫症患者的两种SRI的双盲换药研究。

方法

150例符合DSM-IV标准的原发性强迫症患者,在一项为期12周的双盲试验中被随机分配,接受剂量递增至300mg/日的文拉法辛(N = 75)或60mg/日的帕罗西汀(N = 75)治疗。主要疗效通过耶鲁-布朗强迫症量表(Y-BOCS)相对于基线的变化来评估,无反应被定义为Y-BOCS降低少于25%。在为期4周的逐渐减量期后,43例无反应者转而接受另外12周的替代抗抑郁药治疗,其中16例患者接受文拉法辛,27例接受帕罗西汀。

结果

43例患者中有18例从更换为替代SRI中获益,Y-BOCS平均降低至少25%,标准差为±。在12周结束时,帕罗西汀的有效率为56%(15/27),文拉法辛为19%(3/16)。意向性分析、末次观察结转分析显示,文拉法辛组Y-BOCS平均降低1.8±3.5,帕罗西汀组为6.5±7.1。经过连续两次SRI试验后,150例患者中有109例(73%)Y-BOCS降低至少25%。

结论

当前研究结果表明,42%的无反应者从更换为另一种SRI中获益,并且在治疗对先前SRI试验无反应者方面,帕罗西汀比文拉法辛更有效。对于难治性强迫症患者,更换SRI可能是一种有用的策略。

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