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托吡酯辅助治疗难治性强迫症:一项随机、双盲、安慰剂对照试验。

Topiramate augmentation in refractory obsessive-compulsive disorder: A randomized, double-blind, placebo-controlled trial.

作者信息

Afshar Hamid, Akuchekian Shahla, Mahaky Behzad, Zarean Elham

机构信息

Psychosomatic Research Center, Department of Psychiatry, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.

Behavioral Sciences Research Center, Nour Hospital, Department of Psychiatry, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.

出版信息

J Res Med Sci. 2014 Oct;19(10):976-81.

PMID:25538783
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4274576/
Abstract

BACKGROUND

This study aimed to assess the efficacy of topiramate, a glutamate-modulating agent, in patients with treatment-resistant obsessive-compulsive disorder (OCD) as an adjunct to serotonin reuptake inhibitors (SRIs).

MATERIALS AND METHODS

Thirty-eight patients with refractory OCD, were randomly assigned to receive topiramate or placebo. This study was designed as a 12 weeks, double-blind, placebo-controlled trial. Primary outcome measures were the change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score and the rate of treatment response in each group at the study end point. Treatment response was considered as 25% or more reduction in Y-BOCS score.

RESULTS

A total of 13 patients in the topiramate group and 14 ones in the placebo group completed the trial. Topiramate-assigned patients showed significantly improved mean Y-BOCS score over time (P < 0.001). Although differences between two groups were significant in the Y-BOCS score at the first 2 months (P = 0.01), this was not significant at the end of the study (P = 0.10). Changes of Clinical Global Impression (CGI)-Severity of Illness Scale score and CGI-Improvement Scale score were not significantly different between two groups (P > 0.05). Treatment response was almost significantly different in the topiramate group comparing placebo group (P = 0.054). Mean topiramate dosage was 137.5 mg/day (range, 100-200).

CONCLUSION

This study didn't show efficacy of topiramate as an agent to augment SRIs in treatment-resistant OCD patients.

摘要

背景

本研究旨在评估谷氨酸调节剂托吡酯作为5-羟色胺再摄取抑制剂(SRIs)辅助药物治疗难治性强迫症(OCD)患者的疗效。

材料与方法

38例难治性强迫症患者被随机分配接受托吡酯或安慰剂治疗。本研究设计为一项为期12周的双盲、安慰剂对照试验。主要结局指标为耶鲁布朗强迫症量表(Y-BOCS)评分的变化以及研究终点时每组的治疗反应率。治疗反应被定义为Y-BOCS评分降低25%或更多。

结果

托吡酯组共有13例患者、安慰剂组共有14例患者完成试验。分配接受托吡酯治疗的患者随着时间推移Y-BOCS平均评分显著改善(P < 0.001)。虽然两组在前2个月的Y-BOCS评分差异显著(P = 0.01),但在研究结束时差异不显著(P = 0.10)。两组间临床总体印象(CGI)-疾病严重程度量表评分和CGI-改善量表评分的变化无显著差异(P > 0.05)。托吡酯组与安慰剂组的治疗反应几乎有显著差异(P = 0.054)。托吡酯平均剂量为137.5毫克/天(范围100 - 200)。

结论

本研究未显示托吡酯作为增强剂辅助SRIs治疗难治性OCD患者的疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3c98/4274576/94a13d828123/JRMS-19-976-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3c98/4274576/e769d852da42/JRMS-19-976-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3c98/4274576/94a13d828123/JRMS-19-976-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3c98/4274576/e769d852da42/JRMS-19-976-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3c98/4274576/94a13d828123/JRMS-19-976-g004.jpg

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