Oral vs Intratympanic Corticosteroid Therapy for Idiopathic Sudden Sensorineural Hearing Loss A Randomized Trial
Oral vs Intratympanic Corticosteroid Therapy for Idiopathic Sudden Sensorineural Hearing Loss A Randomized Trial
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DOI：
10.1001/jama.2011.679
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发表时间：
2011-05-25
影响因子：
120.7
通讯作者：
Reda, Domenic J.
中科院分区：
文献类型：
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作者：
Rauch, Steven D.;Halpin, Christopher F.;Reda, Domenic J.
研究背景30多年来，特发性突发感音神经性听力损失一直采用口服皮质类固醇治疗。最近，许多患者的症状已经通过鼓室内类固醇治疗得到控制。没有令人满意的比较有效性的研究，以支持这种practicees.Objective比较口服与鼓室内类固醇治疗突发感音神经性听力损失的有效性设计，设置，和患者前瞻性，随机，非劣效性试验，涉及250例单侧感音神经性听力损失的患者在14天内出现50分贝或更高的纯音平均（PTA）听力阈值。该研究于2004年12月至2009年10月在16个基于学术社区的耳科实践中进行。参与者随访6 months.Intervention一百二十一例患者接受口服泼尼松60毫克/天，为期14天，5天的锥度和129例患者接受4个剂量超过14天的40毫克/毫升的甲基强的松龙注射到middleear.Main结果测量主要终点是在治疗后2个月的听力变化。非劣效性被定义为小于10 dB的差异，在听力treatment.Results组之间的口服泼尼松，PTA改善了30.7 dB相比，28.7 dB的改善，鼓室内治疗组。口服类固醇治疗组2个月时的平均纯音平均值为56.0 dB，鼓室内治疗组为57.6 dB。通过意向治疗分析，口服治疗2个月后的听力恢复比鼓室内治疗高2.0 dB（95.21%置信区间上限，6.6 dB）。符合方案分析证实了意向治疗结果。结论在特发性突发性耳聋患者中，鼓室内甲基强的松龙治疗2个月后的听力水平并不劣于口服强的松治疗。
Context Idiopathic sudden sensorineural hearing loss has been treated with oral corticosteroids for more than 30 years. Recently, many patients' symptoms have been managed with intratympanic steroid therapy. No satisfactory comparative effectiveness study to support this practice exists.Objective To compare the effectiveness of oral vs intratympanic steroid to treat sudden sensorineural hearing loss.Design, Setting, and Patients Prospective, randomized, noninferiority trial involving 250 patients with unilateral sensorineural hearing loss presenting within 14 days of onset of 50 dB or higher of pure tone average (PTA) hearing threshold. The study was conducted from December 2004 through October 2009 at 16 academic community-based otology practices. Participants were followed up for 6 months.Intervention One hundred twenty-one patients received either 60 mg/d of oral prednisone for 14 days with a 5-day taper and 129 patients received 4 doses over 14 days of 40 mg/mL of methylprednisolone injected into the middle ear.Main Outcome Measures Primary end point was change in hearing at 2 months after treatment. Noninferiority was defined as less than a 10-dB difference in hearing outcome between treatments.Results In the oral prednisone group, PTA improved by 30.7 dB compared with a 28.7-dB improvement in the intratympanic treatment group. Mean pure tone average at 2 months was 56.0 for the oral steroid treatment group and 57.6 dB for the intratympanic treatment group. Recovery of hearing on oral treatment at 2 months by intention-to-treat analysis was 2.0 dB greater than intratympanic treatment (95.21% upper confidence interval, 6.6 dB). Per-protocol analysis confirmed the intention-to-treat result. Thus, the hypothesis of inferiority of intratympanic methylprednisolone to oral prednisone for primary treatment of sudden sensorineural hearing loss was rejected.Conclusion Among patients with idiopathic sudden sensorineural hearing loss, hearing level 2 months after treatment showed that intratympanic treatment was not inferior to oral prednisone treatment.