Tsounis Michael, Psillas George, Tsalighopoulos Miltiadis, Vital Victor, Maroudias Nicolas, Markou Konstantinos
Department of Otorhinolaryngology, Health Directorate of Hellenic Police Headquarters, 153 Piraeus Street, 11854, Athens, Greece.
1st Academic ENT Department, AHEPA Hospital, Aristotle University of Thessaloniki, 1 St. Kyriakidi Street, 54636, Thessaloniki, Greece.
Eur Arch Otorhinolaryngol. 2018 Jan;275(1):103-110. doi: 10.1007/s00405-017-4803-5. Epub 2017 Nov 22.
The purpose of this prospective, randomized, multicenter clinical trial was to compare the therapeutic efficacy of systemic versus intratympanic versus combined administration of steroids in the treatment of idiopathic sudden sensorineural hearing loss.
102 patients with an up to 14 days history of idiopathic sudden sensorineural hearing loss were randomized to 1 of 3 arms and followed prospectively. Group A (35 patients) received prednisolone intravenously followed by methylprednisolone orally, whereas Group B (34 patients) were administered intratympanic methylprednisolone. Patients in Group C (33 patients) were administered the combination of the above-mentioned treatment modalities. The patients were followed-up with pure tone audiograms on days 1 (initiation of treatment), 3, 5, 10, 30 and 90.
The final mean hearing gain was 29.0 dB HL for Group A, 27.0 dB HL for Group B and 29.8 dB HL for Group C. The differences between the three groups were not statistically significant. When hearing improvement was assessed according to Siegel's criteria, no statistically significant difference was recorded either. Furthermore, patients younger than 60 years old achieved significantly better hearing outcomes.
The results demonstrated that systemic, intratympanic and combined steroid administration have similar results in the primary treatment of idiopathic sudden hearing loss. Younger patients are more likely to achieve better hearing outcomes.
这项前瞻性、随机、多中心临床试验的目的是比较全身应用、鼓室内应用以及联合应用类固醇激素治疗特发性突发性感音神经性听力损失的疗效。
102例有长达14天特发性突发性感音神经性听力损失病史的患者被随机分为3组中的1组,并进行前瞻性随访。A组(35例患者)静脉注射泼尼松龙,随后口服甲泼尼龙,而B组(34例患者)接受鼓室内注射甲泼尼龙。C组(33例患者)接受上述治疗方式的联合应用。在治疗第1天(开始治疗时)、第3天、第5天、第10天、第30天和第90天对患者进行纯音听力图随访。
A组最终平均听力增益为29.0dB HL,B组为27.0dB HL,C组为29.8dB HL。三组之间的差异无统计学意义。根据西格尔标准评估听力改善情况时,也未记录到统计学上的显著差异。此外,60岁以下的患者听力改善效果明显更好。
结果表明,全身、鼓室内和联合应用类固醇激素在特发性突发性感音神经性听力损失的初始治疗中效果相似。年轻患者更有可能获得更好的听力改善效果。