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特发性主观性耳鸣的缓解:加巴喷丁是否有效?

Relief of idiopathic subjective tinnitus: is gabapentin effective?

作者信息

Piccirillo Jay F, Finnell Joshua, Vlahiotis Anna, Chole Richard A, Spitznagel Edward

机构信息

Division of Clinical Outcomes Research, Department of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, St Louis, MO 63110, USA.

出版信息

Arch Otolaryngol Head Neck Surg. 2007 Apr;133(4):390-7. doi: 10.1001/archotol.133.4.390.

DOI:10.1001/archotol.133.4.390
PMID:17438255
Abstract

OBJECTIVE

To assess the therapeutic benefit of gabapentin (Neurontin) for subjective idiopathic troublesome tinnitus.

DESIGN

An 8-week, double-blind, randomized clinical trial.

SETTING

Academic otolaryngology clinic in St Louis, Mo.

SUBJECTS

One hundred thirty-five subjects with severe idiopathic subjective tinnitus of 6 months' duration or longer.

INTERVENTION

Gabapentin, at a maintenance dosage of 900 to 3600 mg/d for 8 weeks, or lactose placebo.

MAIN OUTCOME MEASURE

Change in the Tinnitus Handicap Inventory score from baseline to the study end point.

RESULTS

The overall change in the Tinnitus Handicap Inventory score for the entire cohort from baseline to week 8 was 11.2; the change among the 59 subjects randomized to the gabapentin arm was 11.3 and the change among the 56 subjects in the placebo arm was 11.0. The difference was 0.03 (95% confidence interval, -5.5 to 6.2; P = .91).

CONCLUSION

Gabapentin is no more effective than placebo for the relief of idiopathic subjective tinnitus.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00317850.

摘要

目的

评估加巴喷丁(Neurontin)对主观性特发性耳鸣的治疗效果。

设计

一项为期8周的双盲随机临床试验。

地点

密苏里州圣路易斯的学术性耳鼻喉科诊所。

受试者

135名患有严重特发性主观性耳鸣且病程持续6个月或更长时间的受试者。

干预措施

加巴喷丁,维持剂量为900至3600毫克/天,持续8周,或乳糖安慰剂。

主要观察指标

从基线到研究终点耳鸣障碍量表得分的变化。

结果

整个队列从基线到第8周耳鸣障碍量表得分的总体变化为11.2;随机分配到加巴喷丁组的59名受试者的变化为11.3,安慰剂组的56名受试者的变化为11.0。差异为0.03(95%置信区间,-5.5至6.2;P = 0.91)。

结论

加巴喷丁在缓解特发性主观性耳鸣方面并不比安慰剂更有效。

试验注册

clinicaltrials.gov标识符:NCT00317850。

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