Prospective open-label study of add-on and monotherapy topiramate in civilians with chronic nonhallucinatory posttraumatic stress disorder.
Prospective open-label study of add-on and monotherapy topiramate in civilians with chronic nonhallucinatory posttraumatic stress disorder.
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DOI：
10.1186/1471-244x-4-24
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发表时间：
2004-08-18
期刊：
影响因子：
4.4
通讯作者：
Berlant JL
中科院分区：
文献类型：
--
作者：
Berlant JL
为了证实托吡酯对先前研究中观察到的创伤后应激障碍（PTSD）的治疗作用，进行了一项新的前瞻性、开放标签研究，以检查慢性、非幻觉性PTSD的急性反应。33例连续招募的DSM-IV诊断为慢性PTSD的平民成人门诊患者（平均年龄46岁，85%为女性），排除了并发幻听或幻视的患者，接受托吡酯单药治疗（n = 5）或强化治疗（n = 28）。主要指标是PTSD检查表-平民版（PCL-C）评分从基线到4周的变化，反应定义为PTSD症状减少≥ 30%。对于那些在基线和第4周都服用PCL-C的患者（n = 30），总症状在第4周下降了49%（配对t检验，P < 0.001），重复体验、回避/麻木和过度觉醒症状的子量表下降幅度相似。第4周的应答率为77%。年龄、性别、双相共病、PTSD发作时的年龄、症状持续时间、基线PCL-C评分的严重程度以及单药治疗与添加药物治疗相比，不能预测PTSD症状的减轻。至完全缓解的中位时间为9天，中位剂量为50 mg/天。新样本中有希望的开放标签结果与先前研究的结果一致。使用托吡酯治疗慢性PTSD，至少在平民中，需要进行对照临床试验。
In order to confirm therapeutic effects of topiramate on posttraumatic stress disorder (PTSD) observed in a prior study, a new prospective, open-label study was conducted to examine acute responses in chronic, nonhallucinatory PTSD. Thirty-three consecutive newly recruited civilian adult outpatients (mean age 46 years, 85% female) with DSM-IV-diagnosed chronic PTSD, excluding those with concurrent auditory or visual hallucinations, received topiramate either as monotherapy (n = 5) or augmentation (n = 28). The primary measure was a change in the PTSD Checklist-Civilian Version (PCL-C) score from baseline to 4 weeks, with response defined as a ≥ 30% reduction of PTSD symptoms. For those taking the PCL-C at both baseline and week 4 (n = 30), total symptoms declined by 49% at week 4 (paired t-test, P < 0.001) with similar subscale reductions for reexperiencing, avoidance/numbing, and hyperarousal symptoms. The response rate at week 4 was 77%. Age, sex, bipolar comorbidity, age at onset of PTSD, duration of symptoms, severity of baseline PCL-C score, and monotherapy versus add-on medication administration did not predict reduction in PTSD symptoms. Median time to full response was 9 days and median dosage was 50 mg/day. Promising open-label findings in a new sample converge with findings of a previous study. The use of topiramate for treatment of chronic PTSD, at least in civilians, warrants controlled clinical trials.