|Title:||A randomized controlled clinical trial of topical insulin-like growth factor-1 therapy for sudden deafness refractory to systemic corticosteroid treatment.|
Sakamoto, Tatsunori https://orcid.org/0000-0001-6669-7013 (unconfirmed)
Yamamoto, Norio https://orcid.org/0000-0001-8924-0710 (unconfirmed)
Yonezawa, Atsushi https://orcid.org/0000-0002-8057-6768 (unconfirmed)
|Author's alias:||中川, 隆之|
Drug delivery system
Sudden sensorineural hearing loss
|Publisher:||BioMed Central Ltd.|
|Journal title:||BMC medicine|
|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.|
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|Appears in Collections:||Journal Articles |
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