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丙戊酸缓释片治疗边缘型人格障碍的开放标签试验。

An open-label trial of divalproex extended-release in the treatment of borderline personality disorder.

作者信息

Simeon Daphne, Baker Bryann, Chaplin William, Braun Ashley, Hollander Eric

机构信息

Department of Psychiatry, the Mount Sinai School of Medicine, One Gustave L. Levy Place, New York, NY 10029, USA.

出版信息

CNS Spectr. 2007 Jun;12(6):439-43. doi: 10.1017/s1092852900015315.

Abstract

INTRODUCTION

Borderline personality disorder (BPD) is associated with several symptoms, including impulsivity, aggression, and intense unstable affect, which can be targeted with anticonvulsant agents. Divalproex extended-release (ER) is used widely in clinical practice, which leads to the question of its efficacy and tolerability in treating BPD.

METHODS

This study assessed the efficacy and tolerability of divalproex ER in 20 adult outpatients with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition BPD via a 12-week open-label trial. Primary outcome measures included the Clinical Global Impression-Improvement (CGI-I) scale and the Global Assessment Scale. Secondary outcome measures assessed aggression (Aggression Questionnaire, Overt Aggression Scale-Modified); affective disturbance (Affective Intensity Measure, Affective Lability Scale); dissociation (Dissociative Experiences Scale); and general psychopathology (Symptom-Checklist 90-Revised).

RESULTS

Thirteen subjects were male and seven were female with a mean age of 37.0+/-11.3 years. Treatment was associated with statistically significant improvement on the CGI-I, the Global Assessment Scale, the Overt Aggression Scale-Modified irritability subscale, and the Aggression Questionnaire. A trend toward significant improvement was observed on the Affective Intensity Measure. Seven out of 10 completers (70%) were treatment responders, with an endpoint CGI-I of 2 (much improved) or 1 (very much improved). There was no significant decline in affective lability or in dissociation. One participant discontinued treatment due to adverse events.

CONCLUSION

These findings support that divalproex ER is an efficacious and well-tolerated pharmacologic agent for BPD, with the additional advantage of single daily dosing at bedtime. Placebo-controlled trials are needed for replication.

摘要

引言

边缘性人格障碍(BPD)与多种症状相关,包括冲动、攻击性和强烈不稳定的情绪,抗惊厥药物可针对这些症状。丙戊酸缓释片(ER)在临床实践中广泛应用,这引发了其治疗BPD的疗效和耐受性问题。

方法

本研究通过一项为期12周的开放标签试验,评估了丙戊酸缓释片对20名符合《精神疾病诊断与统计手册》第四版BPD诊断标准的成年门诊患者的疗效和耐受性。主要结局指标包括临床总体印象改善量表(CGI-I)和总体评估量表。次要结局指标评估攻击性(攻击问卷、修订版公开攻击量表);情感障碍(情感强度量表、情感易变性量表);解离(解离体验量表);以及一般精神病理学(症状自评量表90修订版)。

结果

13名受试者为男性,7名受试者为女性,平均年龄为37.0±11.3岁。治疗在CGI-I、总体评估量表、修订版公开攻击量表的易激惹子量表和攻击问卷方面有统计学意义的显著改善。在情感强度量表上观察到显著改善的趋势。10名完成治疗者中有7名(70%)为治疗反应者,终点CGI-I评分为2(明显改善)或1(非常明显改善)。情感易变性或解离方面没有显著下降。一名参与者因不良事件停药。

结论

这些发现支持丙戊酸缓释片是一种治疗BPD有效且耐受性良好的药物,还有睡前每日单次给药的额外优势。需要进行安慰剂对照试验来重复验证。

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