Topical Application of bFGF Alone for the Regeneration of Chronic Tympanic Membrane Perforations: A Preliminary Case Series

Abstract

Background/objective. Most researchers consider that basic fibroblast growth factor (bFGF) facilitates the repair of chronic tympanic membrane (TM) perforations in chronic otitis media (COM). However, the addition of biological materials affects bFGF levels. This study was performed to compare the effects of bFGF alone and myringoplasty for the repair of chronic perforations. Study design. A prospective cohort control study. Materials and methods. Patients with chronic central perforations who met the inclusion criteria were divided into two groups, i.e., bFGF alone group and underlay myringoplasty group. In the bFGF alone group, the epithelium was removed circumferentially around the perforation edge to create fresh edges. Approximately, 0.1–0.15 mL of bFGF solution was applied twice daily for 3 months to the TM, to keep the edges moist without a scaffold. In the myringoplasty group, the perichondrium graft was placed underneath the TM remnant by endoscopy. TM closure and hearing outcomes were evaluated at 12 weeks after surgery or at the end of bFGF treatment. Results. A total of 29 patients consisting 13 in the bFGF alone group and 16 in the myringoplasty group were finally included in the analysis. Of the 13 patients in the bFGF alone group, the perforations were small in 6 and medium in 7; the etiology was secondary to COM in 11 and to trauma in 2. One patient with an unhealed perforation continued bFGF treatment until 6 months, while the others stopped at 3 months. Of the seven medium-sized perforations, none of the five COM perforations closed, while the two traumatic perforations achieved complete closure within 2 and 4 weeks, respectively. The successful closure rate was 28.6% (2/7). Successful closure was achieved in 66.7% (4/6) of the six small perforations with COM, with a mean closure time of 4.75 weeks. Of the 16 patients in the myringoplasty group, all perforations were medium-sized and were secondary to COM in 15 cases and traumatic in 1 case; all achieved complete closure. Conclusions. bFGF alone facilitated the repair of chronic traumatic perforations and small perforations with COM, but not medium-sized perforations with COM. These observations indicated that the regenerative conditions of traumatic perforations are better than those of COM perforations when using bFGF alone, and that graft materials could play a critical role in the regeneration of larger-sized chronic perforations with COM.