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在缓解期双相情感障碍合并焦虑症患者中,联用奥氮平或拉莫三嗪与锂盐:一项随机、单盲的试点研究。

Olanzapine or lamotrigine addition to lithium in remitted bipolar disorder patients with anxiety disorder comorbidity: a randomized, single-blind, pilot study.

作者信息

Maina Giuseppe, Albert Umberto, Rosso Gianluca, Bogetto Filippo

机构信息

Department of Neurosciences, Mood and Anxiety Disorders Unit, University of Turin, Turin, Italy.

出版信息

J Clin Psychiatry. 2008 Apr;69(4):609-16. doi: 10.4088/jcp.v69n0413.

Abstract

OBJECTIVE

The aim of the present randomized, single-blind, pilot study was to assess the efficacy of the addition of a second mood stabilizer, either olanzapine or lamotrigine, to lithium in patients with remitted bipolar disorder and comorbid anxiety disorder.

METHOD

Adult DSM-IV bipolar disorder patients with a current anxiety disorder and a Hamilton Rating Scale for Anxiety (HAM-A) score of 12 or higher, in remission from an affective episode for at least 2 months while on lithium maintenance treatment, were randomly assigned to receive 12 weeks of single-blind olanzapine 5 to 10 mg/day (N = 24) or lamotrigine 50 to 200 mg/day (N = 23) addition to lithium. The primary outcome measure was the HAM-A; secondary outcome measures were the Clinical Global Impressions-Severity of Illness scale and the Global Assessment of Functioning (GAF) scale. Data were collected from July 2005 to February 2007.

RESULTS

Twenty-two patients in the olanzapine and 18 in the lamotrigine group completed the trial. Mean +/- SD final doses of olanzapine and lamotrigine were, respectively, 7.7 +/- 4.2 mg/day and 96.7 +/- 46.7 mg/day in the intent-to-treat sample (N = 47). Both olanzapine and lamotrigine were effective in reducing HAM-A scores from baseline to endpoint (paired t test for completers: t = 11.361, df = 21, p < .001 for olanzapine and t = 6.301, df = 17, p < .001 for lamotrigine). Both drugs were also effective on the secondary outcome measures. Olanzapine was more effective than lamotrigine at weeks 6 and 12 with a last-observation-carried-forward analysis on all 3 outcome measures, while such differences disappeared on the HAM-A and GAF at week 12 with the visit-wise analysis.

CONCLUSIONS

The addition of a second mood stabilizer (olanzapine or lamotrigine) to lithium is effective in reducing anxiety symptoms in bipolar disorder patients with a co-occurring anxiety disorder.

摘要

目的

本随机、单盲先导研究旨在评估在缓解期双相情感障碍合并焦虑症患者中,加用第二种心境稳定剂(奥氮平或拉莫三嗪)至锂盐治疗方案中的疗效。

方法

成年DSM-IV双相情感障碍患者,目前患有焦虑症且汉密尔顿焦虑量表(HAM-A)评分≥12分,在接受锂盐维持治疗期间情感发作缓解至少2个月,随机分配接受12周单盲治疗,在锂盐基础上加用奥氮平5至10毫克/天(N = 24)或拉莫三嗪50至200毫克/天(N = 23)。主要结局指标为HAM-A;次要结局指标为临床总体印象-疾病严重程度量表和功能总体评定量表(GAF)。数据收集时间为2005年7月至2007年2月。

结果

奥氮平组22例患者和拉莫三嗪组18例患者完成试验。在意向性治疗样本(N = 47)中,奥氮平和拉莫三嗪的平均±标准差最终剂量分别为7.7±4.2毫克/天和96.7±46.7毫克/天。奥氮平和拉莫三嗪均能有效降低从基线到终点的HAM-A评分(完成者配对t检验:奥氮平t = 11.361,自由度 = 21,p <.001;拉莫三嗪t = 6.301,自由度 = 17,p <.001)。两种药物对次要结局指标也有效。在第6周和第-12周,采用末次观察结转分析对所有3项结局指标进行评估时,奥氮平比拉莫三嗪更有效,而在第12周采用逐次访视分析时,HAM-A和GAF上的这种差异消失。

结论

在锂盐治疗基础上加用第二种心境稳定剂(奥氮平或拉莫三嗪)可有效减轻双相情感障碍合并焦虑症患者的焦虑症状。

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