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丙戊酸半钠治疗边缘型人格障碍和双相II型障碍女性:一项双盲安慰剂对照试验性研究。

Divalproex sodium treatment of women with borderline personality disorder and bipolar II disorder: a double-blind placebo-controlled pilot study.

作者信息

Frankenburg Frances R, Zanarini Mary C

机构信息

Laboratory for the Study of Adult Development, McLean Hospital, Belmont, MA 02478, USA.

出版信息

J Clin Psychiatry. 2002 May;63(5):442-6. doi: 10.4088/jcp.v63n0511.

Abstract

BACKGROUND

The intent of this study was to compare the efficacy and safety of divalproex sodium and placebo in the treatment of women with borderline personality disorder and comorbid bipolar II disorder.

METHOD

We conducted a placebo-controlled double-blind study of divalproex sodium in 30 female subjects aged 18 to 40 years who met Revised Diagnostic Interview for Borderlines and DSM-IV criteria for borderline personality disorder and DSM-IV criteria for bipolar II disorder. Subjects were randomly assigned to divalproex sodium or placebo in a 2:1 manner. Treatment duration was 6 months. Primary outcome measures were changes on the interpersonal sensitivity, anger/hostility, and depression scales of the Symptom Checklist 90 (SCL-90) as well as the total score of the modified Overt Aggression Scale (MOAS).

RESULTS

Twenty subjects were randomly assigned to divalproex sodium; 10 subjects to placebo. Using a last-observation-carried-forward paradigm and controlling for baseline severity, divalproex sodium proved to be superior to placebo in diminishing interpersonal sensitivity and anger/hostility as measured by the SCL-90 as well as overall aggression as measured by the MOAS. Adverse effects were infrequent.

CONCLUSION

The results of this study suggest that divalproex sodium may be a safe and effective agent in the treatment of women with criteria-defined borderline personality disorder and comorbid bipolar II disorder, significantly decreasing their irritability and anger, the tempestuousness of their relationships, and their impulsive aggressiveness.

摘要

背景

本研究旨在比较丙戊酸钠与安慰剂治疗边缘型人格障碍合并双相II型障碍女性患者的疗效与安全性。

方法

我们对30名年龄在18至40岁之间、符合《边缘型人格障碍修订诊断访谈》及《精神疾病诊断与统计手册》第四版(DSM-IV)边缘型人格障碍标准和双相II型障碍标准的女性受试者进行了一项丙戊酸钠安慰剂对照双盲研究。受试者以2:1的方式随机分配至丙戊酸钠组或安慰剂组。治疗持续时间为6个月。主要结局指标为症状自评量表90(SCL-90)的人际敏感、愤怒/敌意和抑郁量表的变化以及改良外显攻击量表(MOAS)的总分。

结果

20名受试者被随机分配至丙戊酸钠组;10名受试者被分配至安慰剂组。采用末次观察结转法并控制基线严重程度,结果显示,丙戊酸钠在降低SCL-90所测量的人际敏感和愤怒/敌意以及MOAS所测量的总体攻击性方面优于安慰剂。不良反应较少。

结论

本研究结果表明,丙戊酸钠可能是治疗符合标准的边缘型人格障碍合并双相II型障碍女性患者的一种安全有效的药物,可显著降低她们的易怒性和愤怒情绪、人际关系的动荡性以及冲动攻击性。

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