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托吡酯辅助治疗双相情感障碍的维持治疗:一项开放标签研究。

Adjunctive topiramate in the maintenance treatment of bipolar disorders: an open-label study.

作者信息

Lykouras Lefteris, Hatzimanolis John

机构信息

Department of Psychiatry, Athens University Medical School, 'Eginition' Hospital, Athens, Greece.

出版信息

Curr Med Res Opin. 2004 Jun;20(6):843-7. doi: 10.1185/030079904125003665.

DOI:10.1185/030079904125003665
PMID:15200741
Abstract

OBJECTIVE

A considerable number of patients with bipolar disorder fail to respond completely to mood stabilizers. The anti-epileptic topiramate shares some pharmacological actions with carbamazepine and valproate. We therefore explored the efficacy and tolerability of topiramate in the prophylaxis of bipolar disorder.

METHODS

Fifty-six patients receiving outpatient treatment for bipolar affective disorder who had been on mood stabilizers, and had relapsed at least once in the past 12 months, were treated with topiramate in an add-on design and were evaluated for 1 year. Patients were assessed biweekly for the first 3 months and every month thereafter.

RESULTS

Fifty out of 56 patients completed the 1-year study, which indicated that adjunctive topiramate was associated with a significant reduction of new manic and depressive episodes compared to the past 12 months. The most common adverse effects were reduced appetite, fatigue and somnolence.

CONCLUSIONS

This was an open-label, uncontrolled study involving retrospective evaluation of episodes prior to the initiation of treatment, and the use of more than one mood stabilizer in a few patients. However, these preliminary observations of adjunctive topiramate as a maintenance treatment encourage further investigations, especially with controlled trials, for its long-term effect.

摘要

目的

相当一部分双相情感障碍患者对心境稳定剂未能完全起效。抗癫痫药物托吡酯与卡马西平和丙戊酸盐具有一些共同的药理作用。因此,我们探讨了托吡酯预防双相情感障碍的疗效和耐受性。

方法

56例接受门诊治疗的双相情感障碍患者,他们一直在服用心境稳定剂,且在过去12个月内至少复发过一次,采用加用托吡酯的方案进行治疗,并进行为期1年的评估。患者在最初3个月每两周评估一次,之后每月评估一次。

结果

56例患者中有50例完成了1年的研究,这表明与过去12个月相比,加用托吡酯与显著减少新的躁狂和抑郁发作相关。最常见的不良反应是食欲减退、疲劳和嗜睡。

结论

这是一项开放标签、无对照的研究,涉及对治疗开始前发作情况的回顾性评估,且部分患者使用了不止一种心境稳定剂。然而,这些关于加用托吡酯作为维持治疗的初步观察结果鼓励进一步开展研究,尤其是进行对照试验,以探究其长期效果。

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