Division of Otorhinolaryngology, Department of Clinical and Experimental Medicine, Medical Faculty, Linköping University, Linköping, Sweden.
Otol Neurotol. 2012 Jun;33(4):523-31. doi: 10.1097/MAO.0b013e31824b78da.
To compare the effect of Prednisolone and placebo on the recovery of unilateral idiopathic sudden sensorineural hearing loss.
Prospective, randomized, triple-blind, placebo-controlled multicenter trial.
Four tertiary and 10 secondary referral centers.
Of 103 patients randomly assigned, 93 were included in the modified intention-to-treat analysis. The patients, aged 18 to 80 years, were seeking care within 1 week after onset of acute unilateral sensorineural hearing loss with a mean decrease of 30 dB or greater in the 3 most affected contiguous frequencies.
Patients were randomly assigned in permuted blocks of 10 to receive Prednisolone or placebo in tapering doses from 60 mg for 3 days and, thereafter, 10 mg less each day until Day 8. If complete recovery, no more medication given, otherwise medication continued at 10 mg per day until Day 30. Final follow-up was after 3 months with audiogram; 47 patients received Prednisolone and 46 placebo.
The primary endpoint was efficacy of treatment on recovery at Day 90. Secondary endpoints were prognostic factors for hearing recovery. Analyses were by modified intention-to-treat and per protocol.
Hearing improvement for 47 Prednisolone-treated patients was 25.5 ± 27.1 dB compared to 26.4 ± 26.2 dB for 46 placebo-treated patients at Day 8 and 39 ± 20.1 dB versus 35.1 ± 38.3 dB after 3 months. Vertigo had significant negative effect on hearing improvement and inflammatory signs in the laboratory workup-a positive prognostic effect, irrespective of treatment.
Prednisolone in customary dosage does not seem to influence recovery of idiopathic sudden sensorineural hearing loss.
比较泼尼松龙和安慰剂对单侧特发性突发性聋恢复的影响。
前瞻性、随机、三盲、安慰剂对照的多中心试验。
四个三级和十个二级转诊中心。
103 例随机分配的患者中，93 例纳入意向治疗修改分析。患者年龄 18 至 80 岁，在急性单侧感音神经性听力损失发作后 1 周内就诊，3 个最受影响的连续频率下降 30dB 或以上。
患者按 10 例的置换块随机分组，接受泼尼松龙或安慰剂逐渐减量治疗，前 3 天每天 60mg，然后每天减少 10mg，直至第 8 天。如果完全恢复，则不再给予药物治疗，否则继续以每天 10mg 的剂量治疗至第 30 天。最终随访在 3 个月后进行听力检查；47 例患者接受泼尼松龙治疗，46 例患者接受安慰剂治疗。
主要终点为第 90 天治疗效果。次要终点为听力恢复的预测因素。分析采用意向治疗修改和方案。
47 例泼尼松龙治疗患者在第 8 天的听力改善为 25.5 ± 27.1dB，46 例安慰剂治疗患者为 26.4 ± 26.2dB，3 个月后分别为 39 ± 20.1dB 和 35.1 ± 38.3dB。眩晕对听力改善和实验室检查中的炎症标志物有显著的负面影响，但无论治疗与否，这种炎症标志物对听力恢复有积极的预测作用。
常规剂量的泼尼松龙似乎不会影响特发性突发性聋的恢复。
