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タイトル: | A randomized controlled clinical trial of topical insulin-like growth factor-1 therapy for sudden deafness refractory to systemic corticosteroid treatment. |
著者: | Nakagawa, Takayuki Kumakawa, Kozo Usami, Shin-ichi Hato, Naohito Tabuchi, Keiji Takahashi, Mariko Fujiwara, Keizo Sasaki, Akira Komune, Shizuo Sakamoto, Tatsunori https://orcid.org/0000-0001-6669-7013 (unconfirmed) Hiraumi, Harukazu Yamamoto, Norio https://orcid.org/0000-0001-8924-0710 (unconfirmed) Tanaka, Shiro https://orcid.org/0000-0001-6817-5235 (unconfirmed) Tada, Harue Yamamoto, Michio Yonezawa, Atsushi https://orcid.org/0000-0002-8057-6768 (unconfirmed) Ito-Ihara, Toshiko Ikeda, Takafumi Shimizu, Akira Tabata, Yasuhiko Ito, Juichi |
著者名の別形: | 中川, 隆之 |
キーワード: | Dexamethasone Drug delivery system IGF-1 Local application Sudden sensorineural hearing loss |
発行日: | 19-Nov-2014 |
出版者: | BioMed Central Ltd. |
誌名: | BMC medicine |
巻: | 12 |
論文番号: | 219 |
抄録: | [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. |
記述: | 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. |
著作権等: | © 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(出版社版): | 10.1186/s12916-014-0219-x |
PubMed ID: | 25406953 |
関連リンク: | https://www.kyoto-u.ac.jp/ja/research-news/2014-12-10 |
出現コレクション: | 学術雑誌掲載論文等 |
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