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奥氮平治疗边缘型人格障碍:可变剂量12周随机双盲安慰剂对照研究。

Olanzapine for the treatment of borderline personality disorder: variable dose 12-week randomised double-blind placebo-controlled study.

作者信息

Schulz S Charles, Zanarini Mary C, Bateman Anthony, Bohus Martin, Detke Holland C, Trzaskoma Quynh, Tanaka Yoko, Lin Daniel, Deberdt Walter, Corya Sara

机构信息

Department of Psychiatry, University of Minnesota Medical School, Minneapolis, MN 55454, USA.

出版信息

Br J Psychiatry. 2008 Dec;193(6):485-92. doi: 10.1192/bjp.bp.107.037903.

Abstract

BACKGROUND

Despite the prevalence and clinical significance of borderline personality disorder, its treatment remains understudied.

AIMS

To evaluate treatment with variably dosed olanzapine in individuals with borderline personality disorder.

METHOD

In this 12-week randomised, double-blind trial, individuals received olanzapine (2.5-20 mg/day; n=155) or placebo (n=159) (trial registry: NCT00091650). The primary efficacy measure was baseline to end-point change on the Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) using last-observation-carried-forward methodology.

RESULTS

Both olanzapine and placebo groups showed significant improvements but did not differ in magnitude at end-point (-6.56 v. -6.25, P=0.661). Response rates (50% reduction in ZAN-BPD) were 64.7% with olanzapine and 53.5% with placebo (P=0.062); however, time to response was significantly shorter for olanzapine (P=0.022). Weight gain was significantly greater (2.86 v. -0.35 kg, P<0.001), with higher incidence of treatment-emergent abnormal high levels of prolactin for the olanzapine group.

CONCLUSIONS

Individuals treated with olanzapine and placebo showed significant but not statistically different improvements on overall symptoms of borderline personality disorder. The types of adverse events observed with olanzapine treatment appeared similar to those observed previously in adult populations.

摘要

背景

尽管边缘性人格障碍普遍存在且具有临床意义,但其治疗仍研究不足。

目的

评估不同剂量奥氮平治疗边缘性人格障碍患者的效果。

方法

在这项为期12周的随机双盲试验中,患者接受奥氮平(2.5 - 20毫克/天;n = 155)或安慰剂(n = 159)治疗(试验注册号:NCT00091650)。主要疗效指标是使用末次观察结转法,根据边缘性人格障碍赞纳里尼评定量表(ZAN - BPD)从基线到终点的变化。

结果

奥氮平和安慰剂组均显示出显著改善,但终点时改善幅度无差异(-6.56对-6.25,P = 0.661)。反应率(ZAN - BPD降低50%)奥氮平组为64.7%,安慰剂组为53.5%(P = 0.062);然而,奥氮平组的反应时间显著更短(P = 0.022)。奥氮平组体重增加显著更多(2.86对-0.35千克,P < 0.001),且治疗中出现高催乳素血症的发生率更高。

结论

接受奥氮平和安慰剂治疗的患者在边缘性人格障碍总体症状上均有显著改善,但无统计学差异。奥氮平治疗观察到的不良事件类型与先前在成人人群中观察到的相似。

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