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奥氮平单药治疗创伤后应激障碍:一项随机、双盲、安慰剂对照研究的疗效

Olanzapine monotherapy in posttraumatic stress disorder: efficacy in a randomized, double-blind, placebo-controlled study.

作者信息

Carey Paul, Suliman Sharain, Ganesan Keith, Seedat Soraya, Stein Dan J

机构信息

MRC Research Unit on Anxiety Disorders, Department of Psychiatry, University of Stellenbosch, Cape Town, South Africa.

出版信息

Hum Psychopharmacol. 2012 Jul;27(4):386-91. doi: 10.1002/hup.2238. Epub 2012 Jun 22.

Abstract

OBJECTIVES

Although there have been important advances in the treatment of posttraumatic stress disorder (PTSD), many patients fail to respond to first-line pharmacotherapy. Limited evidence suggests that second generation antipsychotics may have a role to play as monotherapy in PTSD.

METHODS

We undertook a randomized, placebo-controlled study using flexible-dose olanzapine monotherapy for 8 weeks in 28 adult male and female participants (mean age: 40.75 ± 11.59 years) with non-combat related chronic PTSD. Data were analysed with repeated measures analysis of variance, using an intention to treat, last observation carried forward approach.

RESULTS

The olanzapine group (n = 14) demonstrated significantly greater improvement on the Clinician Administered PTSD Scale from baseline to endpoint than the placebo group (n = 14) (F = 5.71, p = 0.018). Olanzapine was generally well tolerated, with no serious adverse events recorded. Substantial weight gain (6-10 kg) was, however, reported in 6/14 participants in the olanzapine group.

CONCLUSIONS

To our knowledge, this is the first controlled evidence of the efficacy of olanzapine monotherapy in an exclusively non-combat related chronic PTSD group. Despite the small sample size, these data suggest that olanzapine may have a role in the treatment of PTSD. These findings warrant replication in a larger sample.

摘要

目的

尽管创伤后应激障碍(PTSD)的治疗已取得重要进展,但许多患者对一线药物治疗无反应。有限的证据表明,第二代抗精神病药物可能在PTSD的单药治疗中发挥作用。

方法

我们进行了一项随机、安慰剂对照研究,对28名患有与战斗无关的慢性PTSD的成年男性和女性参与者(平均年龄:40.75±11.59岁)使用灵活剂量的奥氮平进行为期8周的单药治疗。采用意向性分析、末次观察结转法,通过重复测量方差分析对数据进行分析。

结果

从基线到终点,奥氮平组(n = 14)在临床医生评定的PTSD量表上的改善明显大于安慰剂组(n = 14)(F = 5.71,p = 0.018)。奥氮平总体耐受性良好,未记录到严重不良事件。然而,奥氮平组14名参与者中有6名报告体重显著增加(6 - 10千克)。

结论

据我们所知,这是奥氮平单药治疗仅与战斗无关的慢性PTSD组疗效的首个对照证据。尽管样本量小,但这些数据表明奥氮平可能在PTSD治疗中发挥作用。这些发现值得在更大样本中重复验证。

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