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Steroids for idiopathic sudden sensorineural hearing loss: some questions answered, others remain.

机译:类固醇用于特发性突然的感音神经性听力丧失:回答了一些问题,还有其他问题。

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The primary finding of the study was a 2.0-dB difference in PTA between the 2 treatment groups at 2 months with a maximum difference (upper limit of the confidence interval) of 6.6 dB. This value of 6.6 dB was below the required value of 10 dB to demonstrate clinical significance and reject the null hypothesis of noninferiority (ie, intratym-panic treatment is worse than oral prednisone). Among the patients who presented with hearing loss of 90 dB or greater and dizziness, came for treatment in fewer than 7 days from onset, or had no prior steroid use, the possibility of a clinically meaningful difference in hearing recovery between the 2 groups could not be ruled out. Overall, the 2 treatments were well tolerated, and the number and severity of serious adverse events and adverse events were similar between groups, as had been anticipated from prior studies. However, of the patients randomized to receive intratympanic steroids, 3.1% had persistent tympanic membrane perforation and 4.7% had persistent otitis media vs 0% and 0.8% in the oral group, respectively.
机译:这项研究的主要发现是两个治疗组在两个月时的PTA差异为2.0-dB,最大差异(置信区间的上限)为6.6dB。该6.6 dB的值低于10 dB的要求值,以证明其临床意义并拒绝非劣效性的无效假设(即鼓膜内恐慌治疗比口服泼尼松差)。在听力损失超过90 dB且头昏眼花,发病后不到7天就接受治疗或以前没有使用类固醇的患者中,两组之间听力恢复的临床意义差异不可能被排除在外。总体而言,这2种治疗方法耐受性良好,严重不良事件的数量和严重程度以及各组之间的不良事件相似,正如先前研究所预期的那样。然而,在随机接受鼓膜内类固醇治疗的患者中,有3.1%的患者存在持续性鼓膜穿孔和4.7%的患者存在持续性中耳炎,而口服组分别为0%和0.8%。

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