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Title: A randomized controlled clinical trial of topical insulin-like growth factor-1 therapy for sudden deafness refractory to systemic corticosteroid treatment.
Authors: Nakagawa, Takayuki
Kumakawa, Kozo
Usami, Shin-ichi
Hato, Naohito
Tabuchi, Keiji
Takahashi, Mariko
Fujiwara, Keizo
Sasaki, Akira
Komune, Shizuo
Sakamoto, Tatsunori  kyouindb  KAKEN_id  orcid https://orcid.org/0000-0001-6669-7013 (unconfirmed)
Hiraumi, Harukazu
Yamamoto, Norio  kyouindb  KAKEN_id  orcid https://orcid.org/0000-0001-8924-0710 (unconfirmed)
Tanaka, Shiro  kyouindb  KAKEN_id
Tada, Harue  kyouindb  KAKEN_id
Yamamoto, Michio  kyouindb  KAKEN_id
Yonezawa, Atsushi  kyouindb  KAKEN_id  orcid https://orcid.org/0000-0002-8057-6768 (unconfirmed)
Ito-Ihara, Toshiko
Ikeda, Takafumi  kyouindb  KAKEN_id
Shimizu, Akira  kyouindb  KAKEN_id
Tabata, Yasuhiko  kyouindb  KAKEN_id
Ito, Juichi
Author's alias: 中川, 隆之
Keywords: Dexamethasone
Drug delivery system
IGF-1
Local application
Sudden sensorineural hearing loss
Issue Date: 19-Nov-2014
Publisher: BioMed Central Ltd.
Journal title: BMC medicine
Volume: 12
Thesis number: 219
Abstract: [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.
Description: 突発性難聴に対する新規治療法の有効性を報告. 京都大学プレスリリース. 2014-12-10.
Rights: © 2014 Nakagawa et al.; licensee BioMed Central Ltd.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
URI: http://hdl.handle.net/2433/192275
DOI(Published Version): 10.1186/s12916-014-0219-x
PubMed ID: 25406953
Related Link: http://www.kyoto-u.ac.jp/ja/research/research_results/2014/141209_2.html
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