論文

査読有り
2014年11月

A randomized controlled clinical trial of topical insulin-like growth factor-1 therapy for sudden deafness refractory to systemic corticosteroid treatment

BMC MEDICINE
  • 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

12
開始ページ
219
終了ページ
記述言語
英語
掲載種別
研究論文(学術雑誌)
DOI
10.1186/s12916-014-0219-x
出版者・発行元
BIOMED CENTRAL LTD

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.

Web of Science ® 被引用回数 : 41

リンク情報
DOI
https://doi.org/10.1186/s12916-014-0219-x
Web of Science
https://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=JSTA_CEL&SrcApp=J_Gate_JST&DestLinkType=FullRecord&KeyUT=WOS:000345303200001&DestApp=WOS_CPL
ID情報
  • DOI : 10.1186/s12916-014-0219-x
  • ISSN : 1741-7015
  • Web of Science ID : WOS:000345303200001

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