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阿普唑仑对耳鸣的影响:一项交叉随机临床试验。

The effects of alprazolam on tinnitus: a cross-over randomized clinical trial.

机构信息

Otolaryngology Department, ENT-HandN Surgery Research Center, Amiralmomenin Hospital, Guilan University of Medical Sciences, Rasht, Iran.

出版信息

Med Sci Monit. 2009 Nov;15(11):PI55-60.

PMID:19865063
Abstract

BACKGROUND

Tinnitus remains a phenomenon with an unknown pathophysiology and for which few therapeutic measures are available. To date there has been insufficient evidence to support the use of alprazolam in the treatment of tinnitus. We sought to evaluate the efficacy of alprazolam for relief of tinnitus.

MATERIAL/METHODS: Thirty-six tinnitus sufferers participated in this cross-over, randomized, triple-blind, placebo-controlled trial. Inclusion criteria included patients between ages 21 and 65, with a complaint of non-pulsatile tinnitus of more than 1 year duration. Patients with depressive or anxiety disorders were excluded, as were those using hearing aids. Participants received alprazolam 1.5 mg daily versus placebo in each period. Primary outcome variables included the Tinnitus Handicap Inventory (THI), a Visual Analog Scale (VAS), and tinnitus loudness.

RESULTS

Thirty patients completed the study. The average age of patients was 47.58+/-7.65 years. Alprazolam in comparison with placebo did not result in statistically significantly greater relief in THI score and tinnitus loudness. There was a significant improvement in VAS score in the alprazolam group compared with the placebo group (p<0.001).

CONCLUSIONS

These results suggest that although alprazolam did not improve the THI score or sensation level of loudness significantly, it has a desirable effect on VAS. Further work is needed to determine the beneficial effects of alprazolam in distressed or depressed patients.

摘要

背景

耳鸣仍然是一种病理生理学不明的现象,目前可用的治疗方法很少。迄今为止,没有足够的证据支持使用阿普唑仑治疗耳鸣。我们试图评估阿普唑仑缓解耳鸣的疗效。

材料/方法:36 名耳鸣患者参与了这项交叉、随机、三盲、安慰剂对照试验。纳入标准包括年龄在 21 至 65 岁之间、有超过 1 年非搏动性耳鸣主诉的患者。排除有抑郁或焦虑障碍的患者,以及使用助听器的患者。参与者在每个时期分别接受阿普唑仑 1.5 毫克/天或安慰剂治疗。主要结局变量包括耳鸣残疾量表(THI)、视觉模拟量表(VAS)和耳鸣响度。

结果

30 名患者完成了研究。患者的平均年龄为 47.58±7.65 岁。与安慰剂相比,阿普唑仑并未在 THI 评分和耳鸣响度方面产生统计学上更大的缓解。与安慰剂组相比,阿普唑仑组的 VAS 评分有显著改善(p<0.001)。

结论

这些结果表明,尽管阿普唑仑并未显著改善 THI 评分或响度感知水平,但它对 VAS 有理想的影响。需要进一步研究确定阿普唑仑在焦虑或抑郁患者中的有益作用。

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