A randomized controlled clinical trial of topical insulin-like growth factor-1 therapy for sudden deafness refractory to systemic corticosteroid treatment.
A randomized controlled clinical trial of topical insulin-like growth factor-1 therapy for sudden deafness refractory to systemic corticosteroid treatment.
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DOI：
10.1186/s12916-014-0219-x
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发表时间：
2014-11-19
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;Kumakawa K;Usami S;Hato N;Tabuchi K;Takahashi M;Fujiwara K;Sasaki A;Komune S;Sakamoto T;Hiraumi H;Yamamoto N;Tanaka S;Tada H;Yamamoto M;Yonezawa A;Ito-Ihara T;Ikeda T;Shimizu A;Tabata Y;Ito J
到目前为止，还没有针对突发性耳聋的系统性皮质类固醇治疗方案。本研究旨在检验外用胰岛素样生长因子-1 （IGF-1）治疗与鼓室内皮质类固醇治疗的疗效和安全性。我们随机分配对全身性皮质类固醇难治性突发性耳聋患者，在中耳接受浸透IGF-1的明胶水凝胶治疗（62例），或4次鼓室内注射地塞米松治疗（58例）。主要结果是治疗后8周听力改善（纯音平均听力阈值10分贝或更高）的患者比例。次要结果包括纯音平均听力阈值随时间的变化和不良事件的发生率。在IGF-1组中，66.7%（95%可信区间[CI]， 52.9 ~ 78.6%）的患者听力改善，而Dex组为53.6% (95% CI, 39.7 ~ 67.0%) （P = 0.109）。两组纯音平均听力阈值随时间的变化差异有统计学意义（P = 0.003）。两组均未见严重不良事件发生。在IGF-1组中，鼓膜穿孔未在任何患者中持续存在，但在Dex组中，有15.5% （95% CI, 7.3-27.4%）的患者持续存在（P = 0.001）。IGF-1局部应用对听力水平的积极影响及其良好的安全性表明IGF-1局部治疗在突发性耳聋患者中的实用性。UMIN临床试验注册号为UMIN000004366, 2010年10月30日。
To date, no therapeutic option has been established for sudden deafness refractory to systemic corticosteroids. This study aimed to examine the efficacy and safety of topical insulin-like growth factor-1 (IGF-1) therapy in comparison to intratympanic corticosteroid therapy. We randomly assigned patients with sudden deafness refractory to systemic corticosteroids to receive either gelatin hydrogels impregnated with IGF-1 in the middle ear (62 patients) or four intratympanic injections with dexamethasone (Dex; 58 patients). The primary outcome was the proportion of patients showing hearing improvement (10 decibels or greater in pure-tone average hearing thresholds) 8 weeks after treatment. The secondary outcomes included the change in pure-tone average hearing thresholds over time and the incidence of adverse events. In the IGF-1 group, 66.7% (95% confidence interval [CI], 52.9–78.6%) of the patients showed hearing improvement compared to 53.6% (95% CI, 39.7–67.0%) of the patients in the Dex group (P = 0.109). The difference in changes in pure-tone average hearing thresholds over time between the two treatments was statistically significant (P = 0.003). No serious adverse events were observed in either treatment group. Tympanic membrane perforation did not persist in any patient in the IGF-1 group, but did persist in 15.5% (95% CI, 7.3–27.4%) of the patients in the Dex group (P = 0.001). The positive effect of topical IGF-1 application on hearing levels and its favorable safety profile suggest utility for topical IGF-1 therapy in patients with sudden deafness. UMIN Clinical Trials Registry Number UMIN000004366, October 30th, 2010.
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