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鼓室内地塞米松注射治疗难治性耳鸣:前瞻性安慰剂对照研究。

Intratympanic dexamethasone injection for refractory tinnitus: prospective placebo-controlled study.

机构信息

Department of Otorhinolaryngology, College of Medicine, Konyang University, Daejon.

出版信息

Laryngoscope. 2013 Nov;123(11):2817-22. doi: 10.1002/lary.24126. Epub 2013 Apr 25.

DOI:10.1002/lary.24126
PMID:23620150
Abstract

OBJECTIVES/HYPOTHESIS: The purpose of this study is to investigate the effectiveness of intratympanic dexamethasone injections (ITDI) for refractory tinnitus.

STUDY DESIGN

A prospective, placebo-controlled, randomized, double-blind study.

METHODS

Thirty patients with refractory tinnitus who were diagnosed in the Department of Otolaryngology, Ajou University Hospital, Suwon, Republic of Korea, between 2006 and 2007 were enrolled and then were assigned into two groups of ITDI (15 patients) or saline (15 patients) by permuted block randomization. Intratympanic injections were double-blind performed four times within 2 weeks. After 4 weeks, we analyzed the improvement and aggravation rates of tinnitus using the following parameters: questionnaires, tinnitus handicap index (THI), loudness matching test, frequency, and duration of tinnitus.

RESULTS

The effectiveness rates of ITDI for refractory tinnitus reported in the tinnitus questionnaires, in the THI, and in the loudness matching test were all 33.3% in the steroid group, and 26.7%, 40.0%, and 26.7% in the saline group, respectively. However, there were no statistically significant differences in both groups. To analyze the therapeutic effect of ITDI on tinnitus under 6 months of its development, the improvement rates reported in the tinnitus questionnaires, in the THI, and in the loudness matching test were all 28.5% in the steroid group, and 40.0%, 40.0%, and 30.0% in the saline group, respectively. There were also no statistically significant differences in both groups.

CONCLUSIONS

ITDI may not be effective for refractory tinnitus. The indication of ITDI for tinnitus needs to be limited to specific cases.

摘要

目的/假设:本研究旨在探讨鼓室内注射地塞米松(ITDI)治疗难治性耳鸣的效果。

研究设计

前瞻性、安慰剂对照、随机、双盲研究。

方法

2006 年至 2007 年期间,韩国水原市 Ajou 大学医院耳鼻喉科诊断为难治性耳鸣的 30 名患者被纳入研究,并通过区组随机化分为 ITDI 组(15 例)或生理盐水组(15 例)。在 2 周内进行 4 次鼓室内注射,采用双盲法。4 周后,采用耳鸣问卷、耳鸣残疾指数(THI)、响度匹配测试、耳鸣频率和持续时间等参数分析耳鸣的改善和加重率。

结果

在类固醇组中,ITDI 治疗难治性耳鸣的有效率在耳鸣问卷、THI 和响度匹配测试中分别为 33.3%,而在生理盐水组中分别为 26.7%、40.0%和 26.7%,但两组之间无统计学差异。为了分析 ITDI 对发病 6 个月内耳鸣的治疗效果,在类固醇组中,耳鸣问卷、THI 和响度匹配测试的改善率分别为 28.5%,而在生理盐水组中分别为 40.0%、40.0%和 30.0%,两组之间也无统计学差异。

结论

ITDI 可能对难治性耳鸣无效。ITDI 治疗耳鸣的适应证需要限制在特定病例。

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