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米氮平治疗强迫症:一项开放性试验及随后的双盲停药试验

Mirtazapine for obsessive-compulsive disorder: an open trial followed by double-blind discontinuation.

作者信息

Koran Lorrin M, Gamel Nona N, Choung Helen W, Smith Emily H, Aboujaoude Elias N

机构信息

Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA 94305, USA.

出版信息

J Clin Psychiatry. 2005 Apr;66(4):515-20.

PMID:15816795
Abstract

BACKGROUND

Many patients with obsessive-compulsive disorder (OCD) experience little response to standard treatment with serotonin reuptake inhibitors. Mirtazapine enhances serotonergic function by a mechanism distinct from reuptake inhibition. Because a pilot study suggested effectiveness of mirtazapine in OCD, we conducted a controlled trial.

METHOD

We recruited 30 subjects, 15 treatmentnaive and 15 treatment-experienced, with DSM-IV OCD of > or =1 year's duration and a Yale-Brown Obsessive Compulsive Scale (YBOCS) score of > or =20. In the 12-week, open-label phase, subjects received mirtazapine starting at 30 mg/day and titrated over 2 weeks as tolerated to 60 mg/day. At week 12, responders (YBOCS score decrease > 25%) were randomly assigned, double-blind, to continue mirtazapine or switch to placebo for 8 weeks, including a 1-week, double-blind taper week for placebo subjects.

RESULTS

In the open-label phase, the mean +/-SD YBOCS score fell from 28.3 +/-3.7 to 20.3 +/-8.5 (paired samples t = 4.81, p < .0001). Four subjects (13.3%) discontinued for side effects. Sixteen subjects (53.3%) (8 treatmentnaive, 8 treatment-experienced) were responders and 15 agreed to randomization. Response was independent of comorbid mood disorders. In the 8-week, double-blind, placebo-controlled discontinuation phase, the mirtazapine group's mean YBOCS score fell a mean +/-SD of 2.6 +/-8.7 points while the placebo group's mean score rose a mean +/-SD of 9.1 +/-7.5 points (Mann Whitney U = 6.5, p = .005, 1-tailed). All other outcome measures were consistent with mirtazapine's superiority versus placebo.

CONCLUSION

Mirtazapine may be an effective pharmacotherapy for OCD. If our results are replicated, larger double-blind studies would be indicated.

摘要

背景

许多强迫症(OCD)患者对5-羟色胺再摄取抑制剂的标准治疗反应甚微。米氮平通过一种不同于再摄取抑制的机制增强5-羟色胺能功能。由于一项初步研究表明米氮平对强迫症有效,我们进行了一项对照试验。

方法

我们招募了30名受试者,其中15名未接受过治疗,15名有过治疗经历,患有病程≥1年的DSM-IV强迫症,耶鲁-布朗强迫症量表(YBOCS)评分≥20。在为期12周的开放标签阶段,受试者从30毫克/天开始服用米氮平,并在2周内根据耐受情况逐渐增至60毫克/天。在第12周时,有反应者(YBOCS评分降低>25%)被随机双盲分配,继续服用米氮平或改用安慰剂,为期8周,其中安慰剂组受试者有1周的双盲减量期。

结果

在开放标签阶段,YBOCS评分均值±标准差从28.3±3.7降至20.3±8.5(配对样本t=4.81,p<.0001)。4名受试者(13.3%)因副作用停药。16名受试者(53.3%)(8名未接受过治疗,8名有过治疗经历)有反应,15名同意随机分组。反应与共病情绪障碍无关。在为期8周的双盲、安慰剂对照停药阶段,米氮平组的YBOCS评分均值±标准差下降了2.6±8.7分,而安慰剂组的评分均值±标准差上升了9.1±7.5分(曼-惠特尼U=6.5,p=.005,单尾)。所有其他结果指标均表明米氮平优于安慰剂。

结论

米氮平可能是一种有效的强迫症药物治疗方法。如果我们的结果得到重复验证,则需要进行更大规模的双盲研究。

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