A randomized controlled clinical trial of topical insulin-like growth factor-1 therapy for sudden deafness refractory to systemic corticosteroid treatment

作者：Nakagawa Takayuki^*; Kumakawa Kozo; Usami Shin ichi; Hato Naohito; Tabuchi Keiji; Takahashi Mariko; Fujiwara Keizo; Sasaki Akira; Komune Shizuo; Sakamoto Tatsunori; Hiraumi Harukazu; Yamamoto Norio; Tanaka Shiro; Tada Harue; Yamamoto Michio; Yonezawa Atsushi; Ito Ihara Toshiko; Ikeda Takafumi; Shimizu Akira; Tabata Yasuhiko; Ito Juichi

来源：BMC Medicine, 2014, 12(1): 219.

DOI：10.1186/s12916-014-0219-x

• Dexamethasone
• Drug delivery system
• IGF-1
• Local application
• Sudden sensorineural hearing loss

Background: 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. %26lt;br%26gt;Methods: 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. %26lt;br%26gt;Results: 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). %26lt;br%26gt;Conclusions: 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.

• 出版日期2014-11-19
• 单位河北医科大学