Slattery William H, Fisher Laurel M, Iqbal Zarina, Friedman Rick A, Liu Nancy
House Ear Institute, House Ear Clinic, Los Angeles, California 90057, USA.
Otolaryngol Head Neck Surg. 2005 Aug;133(2):251-9. doi: 10.1016/j.otohns.2005.05.015.
To conduct a clinical trial of intratympanic steroid injection for idiopathic sudden sensorineural hearing loss in subjects who failed oral steroid therapy.
Open-label methylprednisolone injection clinical trial in a tertiary neurotologic referral center. Twenty subjects (14 males; 6 females) received 4 injections within a 2-week period (4 days apart). Hearing, dizziness, and tinnitus were evaluated before and after treatment.
There were no serious unexpected adverse events and 2 types of expected adverse events (tympanic membrane perforation, nausea after injection). No increases in dizziness or tinnitus lasting longer than 24 hours were observed after injections. One of 20 (5%) improved to near-normal hearing. In addition, there was statistically significant improvement in 4-frequency pure-tone average and speech discrimination score at 1 month after treatment.
Four intratympanic injections of methylprednisolone improved pure-tone average or speech discrimination scores for a subset of sudden hearing loss subjects that failed to benefit from oral steroids.
A clinical trial of intratympanic injections for idiopathic sudden hearing loss was successfully completed and promising results were found.
针对口服类固醇治疗无效的特发性突发性感音神经性听力损失患者,开展鼓室内注射类固醇的临床试验。
在一家三级神经耳科转诊中心进行的开放标签甲泼尼龙注射临床试验。20名受试者(14名男性;6名女性)在2周内接受4次注射(间隔4天)。在治疗前后对听力、头晕和耳鸣进行评估。
未出现严重的意外不良事件,出现了2种预期的不良事件(鼓膜穿孔、注射后恶心)。注射后未观察到头晕或耳鸣加重持续超过24小时的情况。20名受试者中有1名(5%)听力改善至接近正常。此外,治疗后1个月时,4频率纯音平均听阈和言语识别得分有统计学意义的改善。
对于一部分未能从口服类固醇中获益的突发性听力损失患者,4次鼓室内注射甲泼尼龙可改善纯音平均听阈或言语识别得分。
成功完成了一项针对特发性突发性听力损失的鼓室内注射临床试验,并发现了有前景的结果。