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丙戊酸二钠治疗与童年期虐待相关的创伤后应激障碍的开放标签试验性研究。

An open-label pilot study of divalproex sodium for posttraumatic stress disorder related to childhood abuse.

作者信息

Goldberg Joseph F, Cloitre Marylene, Whiteside Joyce E, Han Hyemee

机构信息

Weill Medical College of Cornell University and the Payne Whitney Clinic, New York Presbyterian Hospital, USA.

Institute for Trauma and Stress, Child Study Center, New York University, New York, New York, USA.

出版信息

Curr Ther Res Clin Exp. 2003 Jan;64(1):45-54. doi: 10.1016/S0011-393X(03)00003-1.

Abstract

BACKGROUND

Few effective pharmacotherapeutic strategies have been established for the treatment of symptoms associated with posttraumatic stress disorder (PTSD). Preliminary evidence supports the efficacy of serotonergic agents and anticonvulsants, such as divalproex sodium, for the treatment of PTSD symptoms, particularly in military populations.

OBJECTIVE

The aim of this study was to obtain pilot data on the use of divalproex sodium for the treatment of PTSD among adult civilian outpatients with a history of childhood physical and/or sexual abuse.

METHODS

Outpatients with a primary psychiatric diagnosis of PTSD received open-label, flexibly dosed divalproex sodium as adjuvant therapy or monotherapy for 8 weeks. Overall and subcluster PTSD features, as well as affective symptoms and clinical global improvement, were monitored using standardized assessment scales.

RESULTS

A total of 7 patients (5 women, 2 men; mean age, 44.1 years [range, 29-57 years]) were enrolled. At a mean (SD) peak dosage of 1500 (661) mg/d, significant improvement occurred in overall PTSD symptom severity (P<0.02) and in the diagnostic subclusters of hyperarousal and avoidance (P<0.02 for both). Depressive symptoms also were significantly improved from baseline (P<0.02). Divalproex sodium was well tolerated, except in 1 patient who prematurely discontinued treatment due to cognitive adverse events.

CONCLUSIONS

These provisional findings support the possible utility of divalproex sodium therapy for adult outpatients with PTSD related to physical and/or sexual abuse during childhood. Controlled trials with larger sample sizes powered to show safety and efficacy are needed to substantiate these initial findings.

摘要

背景

针对创伤后应激障碍(PTSD)相关症状的治疗,目前尚未建立起有效的药物治疗策略。初步证据支持血清素能药物和抗惊厥药(如丙戊酸钠)治疗PTSD症状的疗效,尤其是在军人中。

目的

本研究旨在获取关于丙戊酸钠用于治疗有童年身体和/或性虐待史的成年门诊平民PTSD的试验性数据。

方法

主要精神诊断为PTSD的门诊患者接受开放标签、灵活剂量的丙戊酸钠作为辅助治疗或单一疗法,为期8周。使用标准化评估量表监测PTSD的总体和亚组特征,以及情感症状和临床整体改善情况。

结果

共纳入7例患者(5例女性,2例男性;平均年龄44.1岁[范围29 - 57岁])。平均(标准差)峰值剂量为1500(661)mg/d时,PTSD总体症状严重程度显著改善(P<0.02),高唤醒和回避的诊断亚组也显著改善(两者均P<0.02)。抑郁症状也较基线显著改善(P<0.02)。丙戊酸钠耐受性良好,除1例因认知不良事件提前停药的患者外。

结论

这些初步研究结果支持丙戊酸钠治疗童年期遭受身体和/或性虐待相关PTSD的成年门诊患者可能有效的观点。需要进行更大样本量的对照试验以证明安全性和有效性,从而证实这些初步研究结果。

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