Effects of basic fibroblast growth factor dose on traumatic tympanic membrane perforation

Abstract

Objective: To compare the healing outcomes of higher and lower doses of basic fibroblast growth factor (bFGF) on human traumatic tympanic membrane perforation (TMP). Study design: Prospective clinical study. Methods: All patients with traumatic TMP were treated by direct application of bFGF, and were sequentially allocated into one of two groups: lower-dose group (2–3 drops of bFGF solution daily, approximately 0.1–0.15 mL) and higher-dose group (5–6 drops of bFGF solution daily, approximately 0.25–0.3 mL). The results of closure rate, closure time, and rate of otorrhea between the higher- and lower-dose groups were compared at 3 months. Results: In total, 126 patients were included in this study. The higher-dose group showed significantly improved purulent otorrhea rate compared with the lower-dose group (p < 0.01) for perforations of the same size, although the closure rate of the middle-sized perforations did not differ significantly between higher- and lower-dose groups (p > 0.05). However, the lower-dose group had a significantly shorter closure time of 5 d compared with the higher-dose group (p < 0.05). In addition, although the lower-dose group showed shorter healing times (about 3 d) compared to the higher-dose group for large-sized perforations, the dosage of bFGF did not significantly affect the large-sized perforation closure rate (p > 0.05) or closure time (p > 0.05). Nine large-sized perforations with secondary purulent otorrhea achieved complete closure, with closure times of 7–25 (14.2 ± 5.8) d. Conclusion: This study suggested that continued daily application of a lower dose of bFGF not only shortens the closure time of human traumatic TMP but also avoids secondary purulent otorrhea.