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

To compare the healing outcomes of higher and lower doses of basic fibroblast growth factor (bFGF) on human traumatic tympanic membrane perforation (TMP).

Prospective clinical study.

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.

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.

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.