采用开-关-开设计的开放试验中，托吡酯对11例患者的抗躁狂疗效。

Antimanic efficacy of topiramate in 11 patients in an open trial with an on-off-on design.

作者信息

Grunze H C, Normann C, Langosch J, Schaefer M, Amann B, Sterr A, Schloesser S, Kleindienst N, Walden J

机构信息

Department of Psychiatry, LMU Munich, Germany.

出版信息

J Clin Psychiatry. 2001 Jun;62(6):464-8. doi: 10.4088/jcp.v62n0610.

DOI:10.4088/jcp.v62n0610

PMID:11465524

Abstract

BACKGROUND

A series of open studies suggests that topiramate has efficacy in bipolar disorder. To further investigate the potential value of topiramate as an antimanic agent, we conducted an open trial in 11 manic patients.

METHOD

Eleven patients with bipolar I disorder with an acute manic episode (DSM-IV) were treated with a mood stabilizer and/or antipsychotics in sufficient and fixed doses. All had a Young Mania Rating Scale (YMRS) score of at least 24 (mean +/- SD = 33.5+/-8.1). Topiramate was added after stable plasma levels of concomitant mood stabilizers had been reached and was titrated within 1 week to a final dose in the range of 25 to 200 mg/day, depending on clinical efficacy and tolerability. Topiramate was discontinued after 10 days, while concomitant medication remained unchanged. After 5 days, topiramate was reintroduced at similar or increased dosages for another 7 days. Patients were assessed with the YMRS; the Clinical Global Impressions scale version for bipolar patients; and the 21-item Hamilton Rating Scale for Depression.

RESULTS

Seven of the 11 patients initially showed a good antimanic response with > 50% reduction in YMRS score. One patient showed psychotic features following rapid increase in topiramate dosage and dropped out on day 10. After discontinuation of topiramate, 7 of the remaining 10 patients worsened (increase of > or = 25% in YMRS score), 2 remained stable, and 1 discontinued follow-up after good recovery. After reintroducing topiramate, all patients improved again within a week, with 8 of 9 meeting the responder criterion of > or = 50% YMRS score reduction when comparing baseline values with those of day 22. With the exception of the patient who developed psychosis, topiramate was well tolerated. Concomitant medication did not interfere with plasma levels of drug, except for carbamazepine level in 1 patient.

CONCLUSION

The antimanic response among patients in this study appears reproducibly linked to the addition of topiramate.

摘要

背景

一系列开放性研究表明，托吡酯在双相情感障碍中具有疗效。为了进一步研究托吡酯作为抗躁狂药物的潜在价值，我们对11名躁狂患者进行了一项开放性试验。

方法

11例患有急性躁狂发作的双相I型障碍（DSM-IV）患者接受了足量且固定剂量的心境稳定剂和/或抗精神病药物治疗。所有患者的杨氏躁狂评定量表（YMRS）评分至少为24分（平均±标准差=33.5±8.1）。在达到稳定的血浆水平后，添加托吡酯，并在1周内根据临床疗效和耐受性将剂量滴定至25至200毫克/天的最终剂量。10天后停用托吡酯，同时维持原伴随用药不变。5天后，以相似或增加的剂量重新引入托吡酯，持续7天。使用YMRS、双相情感障碍患者临床总体印象量表以及汉密尔顿抑郁评定量表21项版对患者进行评估。

结果

11例患者中有7例最初表现出良好的抗躁狂反应，YMRS评分降低超过50%。1例患者在托吡酯剂量快速增加后出现精神病性症状，并在第10天退出研究。停用托吡酯后，其余10例患者中有7例病情恶化（YMRS评分增加≥25%），2例病情稳定，1例在康复良好后停止随访。重新引入托吡酯后，所有患者在一周内再次改善，与基线值相比，9例患者中有8例在第22天达到了YMRS评分降低≥50%的有效标准。除出现精神病性症状的患者外，托吡酯耐受性良好。除1例患者的卡马西平水平外，伴随用药未干扰药物的血浆水平。