多奈哌齐对慢性耳鸣患者的疗效。

文献信息

中文摘要

引言： 耳鸣是指在无外部听觉刺激的情况下出现的任何声音感知。多奈哌齐常用于治疗痴呆，但尚未在耳鸣患者中进行评估。通过增加乙酰胆碱的突触可用性——乙酰胆碱是一种广泛分布于中枢神经系统的神经递质，并可能对谷氨酸诱导的兴奋性毒性具有神经保护作用——多奈哌齐可能为这种疾病的管理提供一种药理学方法。
方法： 我们进行了一项双盲、前瞻性、随机对照试验，样本包括慢性主观性、非躯体感觉性耳鸣组和年龄、性别匹配的对照组各35例。参与者接受多奈哌齐或安慰剂治疗3个月。使用量表和问卷监测治疗效果：THI、VAS、CDR、MMSE；以及耳鸣的心理声学测量。
结果： 根据评估工具，多奈哌齐组与安慰剂组之间在症状改善方面未观察到统计学显著差异。值得注意的是，对THI评分改善至少达到≥7分和≥11分的患者进行置信区间分析，提示可能存在有利于多奈哌齐的具有临床意义的趋势。此外，在一名患者中观察到耳鸣完全缓解，且仅发生在多奈哌齐组。
结论： 在本双盲、随机、安慰剂对照临床试验中，两组在主要结局方面未发现统计学显著差异。然而，多奈哌齐治疗组的表现优于安慰剂组，并且在治疗组中使用放大装置的患者中观察到可能具有更大临床获益的迹象，提示潜在的治疗相关性，但仍需要更大规模、更深入的研究来证实我们的发现。

英文摘要

INTRODUCTION: Tinnitus is any perception of sound that occurs in the absence of an external auditory stimulus. Donepezil, commonly prescribed for dementia, has not yet been evaluated in individuals with tinnitus. By increasing synaptic availability of acetylcholine, a neurotransmitter widely distributed in the central nervous system and potentially neuroprotective against glutamate induced excitotoxicity, donepezil may offer a pharmacological approach for the management of this condition.
METHODOLOGY: We conducted a double-blind, prospective, randomized controlled trial with a sample of 35 each in a chronic subjective, non-somatosensory tinnitus group and an age- and gender-matched control group. Participants received either donepezil or a placebo for 3-months. Treatment effects were monitored using scales and questionnaires: THI, VAS, CDR, MMSE; and psychoacoustic measurements of tinnitus.
RESULTS: No statistically significant difference in symptom improvement was observed between the donepezil and placebo groups as assessed by the evaluation instruments. Notably, analysis of confidence intervals for patients achieving a minimum improvement of ≥ 7 and ≥ 11-points in THI scores suggested a potential clinically meaningful trend favoring donepezil. Additionally, complete remission of tinnitus was observed in a single patient, occurring only in the donepezil group.
CONCLUSION: In the present double-blind, randomized, placebo-controlled clinical trial, no statistically significant difference was identified between the groups regarding the primary outcome. However, the donepezil-treated group demonstrated better performance than the placebo group, and a possible indication of greater clinical benefit was observed in the treatment group in those using amplification, suggesting a potential therapeutic relevance, but larger, more in-depth studies are needed to confirm our findings.