To observe the clinical efficacy and safety of recombinant epidermal growth factor (rhEGF) gel combined with gelatin sponge application under ear endoscopy in the treatment of traumatic tympanic membrane perforations.

Patients with traumatic tympanic membrane perforations were divided into control group and treatment group using cohort method. The control group received intravenous infusion of clindamycin phosphate injection (0.9 g, once daily). The treatment group received rhEGF gel (1 drop per dose, twice daily) combined with gelatin sponge application under ear endoscopy. Both groups received treatment for 1 week. The clinical efficacy, inflammatory markers [white blood cell count (WBC), C-reactive protein (CRP)], hearing status, and safety were compared between the two groups.

A total of 37 patients in the control group and 43 patients in the treatment group were enrolled. The overall treatment efficacy in the treatment and control groups were 95.35% (41 cases /43 cases) and 78.38% (29 cases/37 cases), respectively, with statistically significant difference (P<0.05). After treatment, the WBC levels in the treatment and control groups were (7.74±1.47) and (10.68±1.64) × 10·L^-1, respectively; the CRP levels were (3.37±0.97) and (6.35±1.01) pg·mL^-1, respectively; the air conduction hearing thresholds were (25.64±2.13) and (29.68±2.24) dB HL, respectively; and the air-bone conduction gap were (6.54±1.24) and (12.36±2.47) dB, respectively. The treatment group showed statistically significant differences in all these indicators compared to the control group (all P<0.05). The adverse drug reactions in the treatment group, the main adverse drug reaction was infection, while in the control group mainly included infection and re-perforation. The incidence of adverse drug reactions in the treatment and control groups were 4.65% (2 cases /43 cases) and 10.81% (4 cases /37 cases), respectively, with no significant difference (P>0.05).

The clinical efficacy of treating patients with traumatic tympanic membrane perforation by combining rhEGF gel with absorbable gelatin sponge patch is better than that of conservative treatment. It has a low incidence of adverse drug reactions and high safety.