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成纤维细胞生长因子2与氧氟沙星滴耳液修复外伤性大穿孔的对比研究:一项随机对照研究。

Comparative study of fibroblast growth factor 2 and ofloxacin ear drops for repairing large traumatic perforations: A randomized controlled study.

作者信息

Ding Yongqing, Wei Ruili, Li Dong, Li Yanping, Tian Zedong, Xie Qi, Liu Yachao

机构信息

Dept Otolaryngol Head & Neck Surg. Hebei North Univ, Affiliated Hosp 1, 12 Changqing Rd, Zhangjiakou City 075000, Hebei, China.

Dept Otolaryngol Head & Neck Surg. Hebei North Univ, Affiliated Hosp 1, 12 Changqing Rd, Zhangjiakou City 075000, Hebei, China.

出版信息

Am J Otolaryngol. 2023 Sep-Oct;44(5):103954. doi: 10.1016/j.amjoto.2023.103954. Epub 2023 Jun 17.

DOI:10.1016/j.amjoto.2023.103954
PMID:37348245
Abstract

OBJECTIVE

The objective of this study was to compare the healing outcome of fibroblast growth factor 2 (FGF2), ofloxacin ear drops (OFLX) and spontaneous healing for repairing large traumatic tympanic membrane (TM) perforations.

MATERIAL AND METHODS

A total of 75 traumatic large perforations with >1/4 of TM were randomly divided into FGF2 (n = 25), OFLX (n = 25), and spontaneous healing (n = 25) groups. The closure rates, closure times, and hearing gains were compared at 3 months.

RESULTS

At 2 weeks after treatment, the closure rate was 95.8 % in the FGF2 group, 96.0 % in the ofloxacin ear drops group, and 14.3 % in the spontaneous healing group (P < 0.01), respectively. At 3 months after treatment, the closure rate was 100 % in the FGF2 group, 100 % in the OFLX group, and 85.7 % in the spontaneous healing group, no among-group differences were significant (P > 0.05). The mean closure time was 9.69 ± 2.46 days in the FGF2 group, 9.45 ± 2.32 days in the OFLX group, and 30.94 ± 8.95 days in the spontaneous healing group (P < 0.01). The mean ABG was 10.37 ± 2.51 dB for the FGF2 group, 11.01 ± 1.31 dB for the OFLX group, and 10.86 ± 1.94 dB for the spontaneous healing group, no significant difference was found among three groups (P > 0.05).

CONCLUSIONS

This study suggested that both FGF2 and OFLX significantly shortened the mean closure time and improved the closure rate compared with spontaneous healing for repairing large traumatic perforations, while the healing outcome wasn't significantly different among FGF2 and OFLX groups.

摘要

目的

本研究旨在比较成纤维细胞生长因子2(FGF2)、氧氟沙星滴耳液(OFLX)以及自然愈合对大的外伤性鼓膜(TM)穿孔的修复效果。

材料与方法

总共75例鼓膜穿孔面积大于1/4的外伤性大穿孔患者被随机分为FGF2组(n = 25)、OFLX组(n = 25)和自然愈合组(n = 25)。比较3个月时的愈合率、愈合时间和听力增益。

结果

治疗2周后,FGF2组的愈合率为95.8%,氧氟沙星滴耳液组为96.0%,自然愈合组为14.3%(P < 0.01)。治疗3个月后,FGF2组的愈合率为100%,OFLX组为100%,自然愈合组为85.7%,组间差异无统计学意义(P > 0.05)。FGF2组的平均愈合时间为9.69 ± 2.46天,OFLX组为9.45 ± 2.32天,自然愈合组为30.94 ± 8.95天(P < 0.01)。FGF2组的平均气骨导差(ABG)为10.37 ± 2.51 dB,OFLX组为11.01 ± 1.31 dB,自然愈合组为10.86 ± 1.94 dB,三组间差异无统计学意义(P > 0.05)。

结论

本研究表明,与自然愈合相比,FGF2和OFLX在修复大的外伤性穿孔时均显著缩短了平均愈合时间并提高了愈合率,而FGF2组和OFLX组的愈合效果无显著差异。

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