Topical fibroblast growth factor-2 for treatment of chronic tympanic membrane perforations

Laryngoscope Investigative Otolaryngology

article

Felipe Santos¹  Edina Shu¹  Daniel J. Lee¹  David H. Jung¹  Alicia M. Quesnel¹  Konstantina M. Stankovic¹  Dunia E. Abdul-Aziz¹  Camden P. Bay³  Amy Quinkert¹  D. Bradley Welling¹ 

[1] Department of Otolaryngology Head and Neck Surgery, Harvard Medical School;Department of Infectious Disease, Massachusetts Eye and Ear and Massachusetts General Hospital;Department of Infectious Disease, Center for Clinical Investigation (CCI), Brigham and Women's Hospital

关键词: basic FGF;    bFGF;    chronic tympanic membrane perforation;    FGF2;    fibroblast growth factor;    growth factor;    tympanic membrane;    tympanic membrane perforation;   

DOI  :  10.1002/lio2.395

学科分类：环境科学（综合）

来源: Wiley

【 摘 要 】

Objective: To determine the efficacy of fibroblast growth factor-2 (FGF-2) in treating chronic nonhealing tympanic membrane (TM) perforations. Method: Double-blinded, randomized placebo controlled phase 2 clinical trial for patients with chronic TM perforations of more than 3 months duration with a crossover arm. Patients received either FGF-2 or placebo (sterile water) saturated gelatin sponge in the perforation after rimming the perforation under topical anesthesia. The perforation was then covered with Tisseel fibrin glue. The primary endpoint was complete closure of the TM perforation. Secondary end points included change in hearing and partial TM closure rates. The TM was examined every 3 weeks with otoendoscopy for closure. The treatment was repeated if there was incomplete closure every 3 weeks up to a total of three treatments per arm. Results: Seventy four patients were recruited for the study. Fifty seven met eligibility criteria and fifty four completed the study. Ten of 14 perforations closed completely in the placebo group (71.4%) and 23 of 40 perforations closed completely in the FGF-2 treatment group (57.5%), P value = .36. Pure tone averages and word recognition scores were not statistically significantly different between study groups post-treatment. After initial complete closure, re-perforation occurred in seven FGF-2 treated patients and two placebo patients making the effective final closure rate 40% for FGF and 57% for placebo, respectively. Conclusion: No statistically significant difference in tympanic membrane perforation closure rate was found between the FGF-2 and placebo groups. There were no differences in hearing outcomes between the groups.

【 授权许可】

CC BY|CC BY-NC-ND