イハラ　トシコ   Toshiko Ito-Ihara   猪原　登志子    所属   川崎医科大学  医学部 応用医学　先端医療開発学    職種   教授
論文種別	原著
言語種別	英語
査読の有無	査読あり
表題	A randomized controlled clinical trial of topical insulin-like growth factor-1 therapy for sudden deafness refractory to systemic corticosteroid treatment.
掲載誌名	正式名：BMC medicine 略　 称：BMC Med ISSNコード：17417015/17417015
掲載区分	国外
巻・号・頁	12,pp.219
著者・共著者	Takayuki Nakagawa, Kozo Kumakawa, Shin-ichi Usami, Naohito Hato, Keiji Tabuchi, Mariko Takahashi, Keizo Fujiwara, Akira Sasaki, Shizuo Komune, Tatsunori Sakamoto, Harukazu Hiraumi, Norio Yamamoto, Shiro Tanaka, Harue Tada, Michio Yamamoto, Atsushi Yonezawa, Toshiko Ito-Ihara, Takafumi Ikeda, Akira Shimizu, Yasuhiko Tabata, Juichi Ito
発行年月	2014/11
概要	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.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.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).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.TRIAL REGISTRATION:UMIN Clinical Trials Registry Number UMIN000004366, October 30th, 2010.
DOI	10.1186/s12916-014-0219-x
PMID	25406953