Topical insulin-like growth factor 1 treatment using gelatin hydrogels for glucocorticoid-resistant sudden sensorineural hearing loss: a prospective clinical trial.
Topical insulin-like growth factor 1 treatment using gelatin hydrogels for glucocorticoid-resistant sudden sensorineural hearing loss: a prospective clinical trial.
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DOI：
10.1186/1741-7015-8-76
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发表时间：
2010-11-25
期刊：
影响因子：
9.3
通讯作者：
Ito J
中科院分区：
文献类型：
--
作者：
Nakagawa T;Sakamoto T;Hiraumi H;Kikkawa YS;Yamamoto N;Hamaguchi K;Ono K;Yamamoto M;Tabata Y;Teramukai S;Tanaka S;Tada H;Onodera R;Yonezawa A;Inui K;Ito J
突发性感音神经性听力损失（SSHL）是一种常见的疾病，患者在3天内失去一只耳朵的听力。全身性糖皮质激素治疗已被用作SSHL的标准治疗;然而，约20%的患者无反应。我们测试了使用明胶水凝胶局部应用胰岛素样生长因子1（IGF 1）治疗SSHL的安全性和有效性。招募了全身糖皮质激素给药后未恢复的SSHL患者。我们应用明胶水凝胶，浸渍重组人IGF 1，到中耳。主要结果指标是试验治疗后12周听力改善的患者比例。次要结局指标是24周时表现出改善的患者比例和不良事件的发生率。零假设是33%的患者在高压氧治疗后表现出听力改善，与历史对照报告相同。在2007年至2009年期间，共有25例患者在SSHL发作后中位23天（范围15-32）接受了试验治疗。试验治疗后12周，48%（95% CI 28%至69%; P = 0.086）的患者显示听力改善，24周时该比例增加至56%（95% CI 35%至76%; P = 0.015）。未观察到严重不良事件。使用明胶水凝胶局部应用IGF 1耐受性良好，可能对全身性糖皮质激素耐药的SSHL患者的听力恢复有效。
Sudden sensorineural hearing loss (SSHL) is a common condition in which patients lose the hearing in one ear within 3 days. Systemic glucocorticoid treatments have been used as standard therapy for SSHL; however, about 20% of patients do not respond. We tested the safety and efficacy of topical insulin-like growth factor 1 (IGF1) application using gelatin hydrogels as a treatment for SSHL. Patients with SSHL that showed no recovery to systemic glucocorticoid administration were recruited. We applied gelatin hydrogels, impregnated with recombinant human IGF1, into the middle ear. The primary outcome measure was the proportion of patients showing hearing improvement 12 weeks after the test treatment. The secondary outcome measures were the proportion of patients showing improvement at 24 weeks and the incidence of adverse events. The null hypothesis was that 33% of patients would show hearing improvement, as was reported for a historical control after hyperbaric oxygen therapy. In total, 25 patients received the test treatment at a median of 23 days (range 15-32) after the onset of SSHL, between 2007 and 2009. At 12 weeks after the test treatment, 48% (95% CI 28% to 69%; P = 0.086) of patients showed hearing improvement, and the proportion increased to 56% (95% CI 35% to 76%; P = 0.015) at 24 weeks. No serious adverse events were observed. Topical IGF1 application using gelatin hydrogels is well tolerated and may be efficacious for hearing recovery in patients with SSHL that is resistant to systemic glucocorticoids.
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