Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery · 2012
Impact of basic fibroblast growth factor on healing of tympanic membrane perforations due to direct penetrating trauma: a prospective non-blinded/controlled study.
Контролируемое клиническое исследованиеСтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Zhang Q, Lou Z
Аннотация
OBJECTIVE: To investigate the effect of direct application of basic fibroblast growth factor (bFGF) on healing of tympanic membrane perforations due to direct traumatic penetration through the external auditory canal.
DESIGN: A prospective non-blinded controlled study.
SETTING: University-affiliated teaching hospital.
PARTICIPANTS: In total, 104 patients with small [<25%] penetrating perforations were recruited. They were alternatively allocated to two groups: Control (spontaneous healing, n = 51) and FGF treatment (direct application of bFGF drops in the clinic and repeated daily by the patient, n = 53).
OUTCOMES: Perforation closure rate and time and hearing gain were recorded and compared between the two groups. Information on earache, dizziness and facial paralysis was also collected.
RESULTS: In total, 93 (89%) patients were finally analysed. The closure rate at 3 m of the perforations in the control spontaneous healing and bFGF treatment groups were 77% and 100%, respectively; the difference was statistically significant (P = 0.01). The average closure time was 43.1 ± 2.5 days (range, 17-57 days) for control patients, which was significantly longer (P < 0.01) than that for the bFGF-treated patients (12.6 ± 1.2 days; range, 3-21 days). The mean hearing improvement at 3 m was not significantly different between the FGF treatment and control groups (1.7 ± 2.4 dB vs 11.5 ± 1.9 dB, P > 0.05). No significant difference was observed in earache, dizziness and facial paralysis between two groups.
CONCLUSIONS: Direct application of bFGF may offer an effective topical management of penetrating traumatic tympanic membrane perforations, particularly for small-sized perforations.
DESIGN: A prospective non-blinded controlled study.
SETTING: University-affiliated teaching hospital.
PARTICIPANTS: In total, 104 patients with small [<25%] penetrating perforations were recruited. They were alternatively allocated to two groups: Control (spontaneous healing, n = 51) and FGF treatment (direct application of bFGF drops in the clinic and repeated daily by the patient, n = 53).
OUTCOMES: Perforation closure rate and time and hearing gain were recorded and compared between the two groups. Information on earache, dizziness and facial paralysis was also collected.
RESULTS: In total, 93 (89%) patients were finally analysed. The closure rate at 3 m of the perforations in the control spontaneous healing and bFGF treatment groups were 77% and 100%, respectively; the difference was statistically significant (P = 0.01). The average closure time was 43.1 ± 2.5 days (range, 17-57 days) for control patients, which was significantly longer (P < 0.01) than that for the bFGF-treated patients (12.6 ± 1.2 days; range, 3-21 days). The mean hearing improvement at 3 m was not significantly different between the FGF treatment and control groups (1.7 ± 2.4 dB vs 11.5 ± 1.9 dB, P > 0.05). No significant difference was observed in earache, dizziness and facial paralysis between two groups.
CONCLUSIONS: Direct application of bFGF may offer an effective topical management of penetrating traumatic tympanic membrane perforations, particularly for small-sized perforations.