经皮迷走神经刺激术治疗慢性耳鸣的初步研究

Preliminary results of transcutaneous vagus nerve stimulation for chronic subjective tinnitus: A controlled clinical study

目的探讨经皮外耳道迷走神经刺激术对慢性主观性耳鸣的治疗效果、安全性及可行性。方法选取THI评分≥38分,病史6≥个月的慢性主观性耳鸣患者,在常规治疗基础上以G6805-I型电针治疗仪实施经皮外耳道迷走神经刺激术(transcutaneous vagus nerve stimulation,T-VNS),对照组仅接受常规治疗。以耳鸣残障量表(tinnitus handicap inventory,THI),匹茨堡睡眠质量指数(Pittsburgh Sleep QualityIndex,PSQI),抑郁-焦虑-压力量表(Depression,Anxiety and Stress Scale-21,DASS-21)评价患者治疗前后的变化。结果第10天,T-VNS组主观症状改善率高于常规治疗组,差异显著;PSQI评分显示,T-VNS治疗期间睡眠质量获得明显改善,但3个月随访时,PSQI评分有轻度反弹;DASS-21评分显示,T-VNS治疗期间,T-VNS组焦虑评分较治疗前以及对照组均有下降;THI评分,治疗期间以及3个月随访时,组间对比无显著差异;T-VNS组治疗前后比较,治疗期间较治疗前THI评分降低,但差异不显著;3个月随访时,THI评分降低,差异显著。结论 T-VNS用于慢性主观性耳鸣的治疗对患者焦虑程度及睡眠质量有明显改善,仅少数患者治疗期间有短暂咳嗽或耳部刺痛感,安全性好。疗程及刺激参数的设置需要扩大样本进行进一步的探讨。

Objective To report the efficacy and safety of transcutaneous vagus nerve stimulation（T-VNS） for treatment of chronic subjective tinnitus. Methods Chronic subjective tinnitus patients whose THI score was ≥38 points, and with a tinnitus history of ≥6 months, were randomly divided into a T-VNS and a control groups. For patients in the T-VNS group, in addition to routine treatments, T-VNS was added using a G6805-type I cupping therapy apparatus,while only routine treatment were provided to patients in the control group. Treatment efficacy was evaluated with the Tinnitus Handicap Inventory（THI）, Pittsburgh Sleep Quality Index（PSQI） and Depression and Anxiety-Stress Scale-21（DASS-21） administered before and after treatment. Results Tinnitus symptoms improved more in the T-VNS group than in the control group during the 10 days of T-VNS treatment（p〈0.05）, with significantly improved PSQI scores, although there was a mild rebound of the scores at 3 months follow-up. DASS-21 scores showed decreased anxiety in the T-VNS group during VNS therapy, but no change in the control group. THI scores showed no significant difference between the T-VNS and control groups either during treatment or at 3 months follow-up, although within the T-VNS group, THI scores reduced after T-VNS therapy（with no statistically significant difference） and at 3 months follow-up（statistically significant）. Conclusion T-VNS may improve anxiety and sleep quality in patients who suffer from chronic subjective tinnitus. The primary study showed that this therapy was safe, with only transient cough or ear tingling during treatment in a minority of patients, while partially improving tinnitus distress over the 10-days treatment. Stimulation parameters and treatment course remain to be further investigated.