Lou Zhengcai, Wang Yubizhuo
Department of Otorhinolaryngology, The Affiliated YiWu Hospital of Wenzhou Medical College , Yiwu , China.
Growth Factors. 2015 Apr;33(2):65-70. doi: 10.3109/08977194.2014.980905. Epub 2014 Nov 6.
The aim of this study was to determine the optimum time for direct application of basic fibroblast growth factor (bFGF) on large traumatic tympanic membrane perforations (TMPs).
Prospective clinical study.
Tertiary University Hospital.
Ninety-three patients, with traumatic TMPs greater in extent than 25% of the entire tympanic membrane, were randomized into observation and bFGF-treated groups (~0.2-0.25 mL of bFGF solution was applied directly onto the TM once daily and continued until the perforation closed). Initial visit times were subcategorized into perforation durations of ≤3 and >3 days, thereby rendering two subgroups, as follows: A and B in the observation group; and C and D in the bFGF-treated group. The closure rate and mean closure time were evaluated after 6 months.
Eighty-six patients were finally analyzed. After 6 months, the bFGF-treated group exhibited a significantly higher total closure rate (97.8 versus 82.5%, p < 0.05) and a shorter mean closure time (12.5 ± 3.4 versus 34.0 ± 5.9 days, p < 0.05) compared with the spontaneous healing group. In addition, in the observation group, visiting time was not associated with differences in closure rate (p > 0.05) and mean closure time (p > 0.05), between the A and B subgroups. Similarly, in the bFGF-treated group, visiting time was not associated with differences in closure rate (p > 0.05) between the C and D subgroups. However, the D subgroup was characterized by significantly shortened mean closure time compared with the C subgroup (p < 0.05).
This study shows the beneficial effect of bFGF on human traumatic large TMPs when applied after the 3rd day post-injury had passed (i.e. during the proliferative stage of wound healing). The procedure can not only significantly shorten closure time but can also reduce both the clinical administration duration and occurrence of side-effects associated with bFGF.
本研究旨在确定直接应用碱性成纤维细胞生长因子（bFGF）治疗大型外伤性鼓膜穿孔（TMP）的最佳时间。
前瞻性临床研究。
三级大学医院。
93例外伤性TMP范围超过整个鼓膜25%的患者被随机分为观察组和bFGF治疗组（每天一次将约0.2 - 0.25 mL的bFGF溶液直接滴于鼓膜上，持续至穿孔闭合）。初次就诊时间细分为穿孔持续时间≤3天和>3天，从而形成两个亚组，如下：观察组的A组和B组；bFGF治疗组的C组和D组。6个月后评估闭合率和平均闭合时间。
最终分析了86例患者。6个月后，与自然愈合组相比，bFGF治疗组的总闭合率显著更高（97.8%对82.5%，p < 0.05），平均闭合时间更短（12.5 ± 3.4天对34.0 ± 5.9天，p < 0.05）。此外，在观察组中，A组和B组之间的就诊时间与闭合率差异（p > 0.05）和平均闭合时间差异（p > 0.05）无关。同样，在bFGF治疗组中，C组和D组之间的就诊时间与闭合率差异（p > 0.05）无关。然而，D组的平均闭合时间与C组相比显著缩短（p < 0.05）。
本研究表明，在受伤后第3天过后（即伤口愈合的增殖期）应用bFGF对人类外伤性大型TMP有有益作用。该方法不仅可以显著缩短闭合时间，还可以减少与bFGF相关的临床给药持续时间和副作用的发生。
