ENT Department, General Hospital of Volos Achillopoulio, Volos, Greece.
Otol Neurotol. 2013 Jun;34(4):771-6. doi: 10.1097/MAO.0b013e31828bb567.
To investigate the therapeutic efficacy of intratympanic dexamethasone combined with systemic prednisolone in patients with idiopathic sudden sensorineural hearing loss (ISSNHL).
Prospective, quasirandomized, multicenter clinical trial.
One university hospital and 2 affiliated hospitals.
A total of 92 eligible patients with ISSNHL were allocated into 2 groups. Patients in the control group were treated with systemic prednisolone alone. Patients of the combined treatment group received additionally 3 intratympanic dexamethasone injections within 5 days.
The main outcome measures used were the differences between pretreatment and posttreatment pure-tone audiometry averages (PTAs) and speech discrimination scores (SDSs). Successful treatment was defined as a greater than 10 dB improvement in PTA and 15% in SDS. The final assessment of hearing was performed 3 months after completion of treatment.
Significant hearing recovery was observed in 31 (67.39%) of 46 cases, and in 24 (52.17%) of 46 control patients. Patients receiving combination therapy had a median improvement in PTA of 23.12 dB and a median increase in SDS of 32%. In the control group, the median hearing gain was 16.87 dB and 18%, respectively. The differences between the 2 groups were not statistically significant (p = 0.10 and p = 0.13). However, after performing a post hoc analysis by excluding individuals with profound hearing loss (PTA, >90 dB), the combined treatment group showed significant improvement compared with the control group (p = 0.04). No serious complications or adverse reactions were reported.
The addition of intratympanic steroids to the conventional systemic steroid therapy may provide a safe and potentially effective therapeutic option in patients with mild-to-severe ISSNHL.
研究鼓室内地塞米松联合全身泼尼松治疗特发性突发性聋(ISSNHL)的疗效。
前瞻性、半随机、多中心临床试验。
一所大学医院和 2 所附属医院。
共 92 例符合条件的 ISSNHL 患者分为 2 组。对照组患者单独接受全身泼尼松治疗。联合治疗组患者在 5 天内额外接受 3 次鼓室内地塞米松注射。
使用治疗前后纯音听阈平均值(PTAs)和言语辨别评分(SDSs)的差异作为主要观察指标。听力改善定义为 PTA 提高 10dB 以上,SDS 提高 15%以上。治疗结束后 3 个月进行最终听力评估。
46 例中有 31 例(67.39%)和 24 例(52.17%)的听力显著恢复。联合治疗组 PTA 中位数改善 23.12dB,SDS 中位数增加 32%。对照组的中位数听力增益分别为 16.87dB 和 18%。两组间差异无统计学意义(p=0.10 和 p=0.13)。然而,在排除极重度听力损失(PTA>90dB)个体后进行事后分析,联合治疗组与对照组相比,听力改善有显著差异(p=0.04)。未报告严重并发症或不良反应。
在常规全身激素治疗的基础上联合鼓室内激素治疗,可能为轻至重度 ISSNHL 患者提供一种安全有效的治疗选择。