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拉莫三嗪治疗无精神共病的人格解体障碍门诊患者的即刻治疗:随机、双盲、安慰剂对照研究。

Lamotrigine in the immediate treatment of outpatients with depersonalization disorder without psychiatric comorbidity: randomized, double-blind, placebo-controlled study.

机构信息

Central Mental Clinic for Outpatients of Baku City, FI Baku PO AZ0010, Azerbaijan Republic.

出版信息

J Clin Psychopharmacol. 2011 Feb;31(1):61-5. doi: 10.1097/JCP.0b013e31820428e1.

DOI:10.1097/JCP.0b013e31820428e1
PMID:21192145
Abstract

OBJECTIVE

Depersonalization disorders (DPDs) are highly prevalent in population. However, the effect of lamotrigine on outpatients with DPD without psychiatric comorbidity has not been studied in a double-blind placebo-controlled design.

METHOD

Eighty patients (all men) were washed out from all medications. Each patient was randomized either to receive lamotrigine (40 patients) for 12 weeks or matched on placebo (40 patients) in a double-blind manner. Eligible participants, in addition to meeting the criteria for DPD from Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision, were required to be between 18 and 65 years. Response was defined as a 50% reduction in the Cambridge Depersonalization Scale. Response effects with lamotrigine and placebo were compared by using analysis of variance and χ² tests. Six patients did not return for at least 1 subsequent assessment, and 74 patients dropped out (36 taking lamotrigine and 38 taking placebo) in the valuables study group.

RESULTS

Of the 36 lamotrigine-treated participants, 26 responded by 12 weeks versus 6 of the 38 placebo-treated participants (P < 0.001). The most common and problematic adverse effect in the lamotrigine group was rash.

CONCLUSIONS

The authors believe this to be the first double-blind placebo-controlled randomization study to test the efficacy of lamotrigine in the management of outpatients with DPDs. These need to be replicated in a larger study group.

摘要

目的

人格解体障碍(DPD)在人群中发病率很高。然而,在双盲安慰剂对照设计中,尚未研究拉莫三嗪对无精神共病的 DPD 门诊患者的疗效。

方法

80 名患者(均为男性)均停用所有药物。每位患者均以双盲方式随机分为拉莫三嗪组(40 例)或安慰剂组(40 例)治疗 12 周。合格的参与者除了符合《精神障碍诊断与统计手册》第 4 版修订本的 DPD 标准外,还需要年龄在 18 至 65 岁之间。反应定义为剑桥人格解体量表评分降低 50%。使用方差分析和 χ²检验比较拉莫三嗪和安慰剂的反应效果。6 名患者至少有 1 次后续评估未返回,74 名患者(拉莫三嗪组 36 名,安慰剂组 38 名)退出了有价值的研究组。

结果

36 名接受拉莫三嗪治疗的患者中,有 26 名在 12 周时出现反应,而接受安慰剂治疗的 38 名患者中只有 6 名出现反应(P < 0.001)。拉莫三嗪组最常见和最成问题的不良反应是皮疹。

结论

作者认为这是第一项测试拉莫三嗪在管理 DPD 门诊患者中的疗效的双盲安慰剂对照随机研究。这些需要在更大的研究组中进行复制。

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