Nickel Marius K, Nickel Cerstin, Mitterlehner Ferdinand O, Tritt Karin, Lahmann Claas, Leiberich Peter K, Rother Wolfhardt K, Loew Thomas H
Clinic for Psychosomatic Medicine, Inntalklinik, Simbach/Inn, Germany.
J Clin Psychiatry. 2004 Nov;65(11):1515-9. doi: 10.4088/jcp.v65n1112.
The goal of this study was to compare the efficacy and safety of topiramate versus placebo in the treatment of aggression in women who meet the criteria for borderline personality disorder.
We conducted a double-blind, placebo-controlled study of topiramate in 29 female subjects (response rate 93.5%) meeting SCID (Structured Clinical Interview for DSM-IV) criteria for borderline personality disorder. The subjects were randomly assigned in a 2:1 ratio to topiramate (N = 21, analysis based on N = 19) or placebo (N = 10). Treatment lasted 8 weeks (November 2003-January 2004). Primary outcome measures were self-reported changes on the anger subscales of the State-Trait Anger Expression Inventory (STAXI).
Significant improvements on 4 subscales of the STAXI (state-anger, trait-anger, anger-out, anger-control) were observed in the topiramate-treated subjects after 8 weeks, in comparison with the placebo group. The difference in improvement in score between the 2 groups for state-anger, trait-anger, and anger-out ranged from 21% to 24%, and the difference for anger-control was -13%. As an exception, a difference of only 8.5% (p < .2) was found on the anger-in subscale. Significantly greater weight loss was observed in the topiramate-treated group than in those treated with placebo (difference in weight loss between the 2 groups: 2.3 kg [5.1 lb] [3.2%]; 95% CI = 1.3% to 4.4%, p < .01). All patients tolerated topiramate well.
Topiramate appears to be a safe and effective agent in the treatment of anger in women with borderline personality disorder as defined by SCID criteria. Additionally, significant weight loss can be expected.
本研究的目的是比较托吡酯与安慰剂在治疗符合边缘型人格障碍标准的女性攻击行为方面的疗效和安全性。
我们对29名符合DSM-IV(《精神疾病诊断与统计手册》第四版)边缘型人格障碍标准的女性受试者(应答率93.5%)进行了一项托吡酯的双盲、安慰剂对照研究。受试者按2:1的比例随机分配至托吡酯组(N = 21,基于N = 19进行分析)或安慰剂组(N = 10)。治疗持续8周(2003年11月至2004年1月)。主要结局指标是自我报告的状态-特质愤怒表达量表(STAXI)愤怒分量表上的变化。
与安慰剂组相比,托吡酯治疗的受试者在8周后STAXI的4个分量表(状态愤怒、特质愤怒、愤怒外显、愤怒控制)上有显著改善。两组在状态愤怒、特质愤怒和愤怒外显得分改善方面的差异在21%至24%之间,愤怒控制方面的差异为-13%。作为例外,在愤怒内化分量表上仅发现8.5%的差异(p < 0.2)。托吡酯治疗组的体重减轻明显大于安慰剂治疗组(两组体重减轻差异:2.3千克[5.1磅][3.2%];95%可信区间 = 1.3%至4.4%,p < 0.01)。所有患者对托吡酯耐受性良好。
托吡酯似乎是一种安全有效的药物,可用于治疗符合SCID标准的边缘型人格障碍女性的愤怒情绪。此外,预计会有显著的体重减轻。