A comparative study to evaluate the efficacy of EGF, FGF-2, and 0.3% (w/v) ofloxacin drops on eardrum regeneration

Abstract

Background: Traumatic tympanic membrane perforations (TMPs) tend to spontaneous healing, however, large TMPs usually fail to healing. Clinical and experimental studies had demonstrated that growth factors accelerated the healing of large TMPs. The aim of this study was to compare the effects of growth factors and 0.3% (w/v) ofloxacin drops n the healing of human large TMPs.

Methods: A total of 184 human large traumatic TMPs were randomly assigned to receive epidermal growth factor (EGF) treatment, fibroblast growth factor-2 (FGF-2) treatment, 0.3% (w/v) ofloxacin drops treatment, and conservative observation (only).

Results: A total of 180 patients were analyzed in this study at the 6-month follow-up. The closure rates of the perforations in the EGF, FGF-2, 0.3% (w/v) ofloxacin drops, and conservative observation groups were 91.11%, 93.18%, 95.65%, and 82.22%, respectively, the closure rates did not significantly differ among the groups (P = .165). Similarly, pairwise comparisons did not reveal any significant between-group differences (P > .0083). However, the difference of the mean closure time was significant among the 4 groups (P < .001), pairwise comparisons showed that closure time was significantly longer in the observational group than in the other 3 groups (P < .001). Nevertheless, no significant difference in mean closure time was evident between any 2 treated groups (P > .0083). The mean hearing gain after 6 months was 11.49 ± 5.88 dB for the EGF group, 10.89 ± 5.16 dB for the FGF-2 group, 10.54 ± 5.56 dB for the ofloxacin group, and 9.29 ± 5.36 dB for the observation group. Differences in hearing improvement rates among the 4 groups were not statistically significant (P = .283).

Conclusion: Epidermal growth factor, FGF-2, and 0.3% (w/v) ofloxacin drops accelerated the closure of large TMPs compared with conservative treatment. Surprisingly, neither the closure rate nor closure time differed significantly among the 3 treated groups. Further experimental studies to demonstrate whether 0.3% (w/v) ofloxacin per se accelerates the healing of TMPs will be interesting in the future.

Figure 1

Enrollment, randomization, and follow-up of study participants.

Figure 2

Time-to-closure rates of tympanic membrane perforations in the 4 groups.

Figure 3

Extent of healing at various times after starting topical application of epidermal growth factor (EGF) and ofloxacin drops: (A) 3 days after perforation; (B–F) 3, 7, 10, 13, and 19 days after starting EGF treatment; (G) 1 day after perforation; (H–J) 6, 11, and 15 days after starting treatment with ofloxacin drops.

Figure 4

Closure times of infected ears in all groups. The central horizontal lines are the medians and the vertical lines in the closed boxes are the first and third quartiles.

Figure 5

Mean closure times in each group (infected cases were eliminated). The central horizontal lines indicate the median values; the vertical lines in the closed box show the first and third of the 4 quartiles. ° and ^∗indicate discrete and extremely abnormal values, respectively. The vertical values were 30 days in the epidermal growth factor (EGF) group; 30 and 35 days in the fibroblast growth factor-2 (FGF-2) group; and 23, 28, and 41 days in the ofloxacin drops group. In the EGF group, the median value was 12 days, the 25th percentile was 9 days, and the 75th percentile was 16.50 days. In the FGF-2 group, these values were 10, 7, and 15 days. In the ofloxacin drops group, the values were 10, 7.25, and 13.75 days. In the observational group, they were 22, 14, and 34 days. The English in this document has been checked by at least 2 professional editors, both native speakers of English. For a certificate, please see: http://www.textcheck.com/certificate/p3ntjq.