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Title: Topical insulin-like growth factor 1 treatment using gelatin hydrogels for glucocorticoid-resistant sudden sensorineural hearing loss: a prospective clinical trial.
Authors: Nakagawa, Takayuki  kyouindb  KAKEN_id
Sakamoto, Tatsunori  kyouindb  KAKEN_id  orcid (unconfirmed)
Hiraumi, Harukazu
Kikkawa, Yayoi S
Yamamoto, Norio  kyouindb  KAKEN_id  orcid (unconfirmed)
Hamaguchi, Kiyomi
Ono, Kazuya
Yamamoto, Masaya  kyouindb  KAKEN_id
Tabata, Yasuhiko  kyouindb  KAKEN_id
Teramukai, Satoshi
Tanaka, Shiro  kyouindb  KAKEN_id  orcid (unconfirmed)
Tada, Harue  kyouindb  KAKEN_id
Onodera, Rie
Yonezawa, Atsushi  kyouindb  KAKEN_id  orcid (unconfirmed)
Inui, Ken-Ichi
Ito, Juichi  KAKEN_id
Author's alias: 中川, 隆之
Issue Date: 25-Nov-2010
Publisher: BioMed Central
Journal title: BMC medicine
Volume: 8
Issue: 1
Thesis number: 76
Abstract: BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
Description: 突発性難聴に対するIGF1治療について. 京都大学プレスリリース. 2010-11-30.
Rights: © 2010 Nakagawa et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
DOI(Published Version): 10.1186/1741-7015-8-76
PubMed ID: 21108784
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