Lou Zhengcai, Lou Zihan
Department of Otorhinolaryngology, The Affiliated Yiwu Hospital of Wenzhou Medical University, Yiwu, Zhejiang Department of Clinical Medicine, Xinxiang Medical University, Xinxiang, Henan, China.
Medicine (Baltimore). 2017 Jul;96(30):e7654. doi: 10.1097/MD.0000000000007654.
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.
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).
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).
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.
外伤性鼓膜穿孔（TMP）往往会自发愈合，然而，较大的TMP通常无法愈合。临床和实验研究表明，生长因子可加速较大TMP的愈合。本研究的目的是比较生长因子和0.3%（w/v）氧氟沙星滴眼液对人类较大TMP愈合的影响。
总共184例人类较大外伤性TMP患者被随机分配接受表皮生长因子（EGF）治疗、成纤维细胞生长因子-2（FGF-2）治疗、0.3%（w/v）氧氟沙星滴眼液治疗以及保守观察（仅观察）。
本研究在6个月随访时共分析了180例患者。EGF组、FGF-2组、0.3%（w/v）氧氟沙星滴眼液组和保守观察组的穿孔闭合率分别为91.11%、93.18%、95.65%和82.22%，各组闭合率差异无统计学意义（P = 0.165）。同样，两两比较未发现组间有任何显著差异（P > 0.0083）。然而，4组之间平均闭合时间的差异具有统计学意义（P < 0.001），两两比较显示观察组的闭合时间显著长于其他3组（P < 0.001）。尽管如此，任何2个治疗组之间的平均闭合时间均无明显差异（P > 0.0083）。EGF组6个月后的平均听力增益为11.49 ± 5.88 dB，FGF-2组为10.89 ± 5.16 dB，氧氟沙星组为10.54 ± 5.56 dB，观察组为9.29 ± 5.36 dB。4组之间听力改善率的差异无统计学意义（P = 0.283）。
与保守治疗相比，表皮生长因子、FGF-2和0.3%（w/v）氧氟沙星滴眼液可加速较大TMP的闭合。令人惊讶的是，3个治疗组之间的闭合率和闭合时间均无显著差异。未来进一步的实验研究以证明0.3%（w/v）氧氟沙星本身是否能加速TMP的愈合将很有意义。
