Abstract:
OBJECTIVE : To investigate the effectiveness of basic fibroblast
growth factor (bFGF) versus placebo or no intervention
in the treatment of tympanic membrane (TM) perforations
from randomized controlled trials (RCTs), prospective and
retrospective studies.
DATA SOURCES : PubMed, EMBASE, and Cochrane databases
were screened from their inceptions to June 2019.
STUDY SELECTION : Inclusion criteria: 1) English language; 2)
observational (retrospective or prospective) or treatment
(RCT) studies; 3) reported the outcomes on the application
of bFGF in adult or pediatric population. Exclusion criteria:
1) studies without a control group; 2) animal studies, in vitro
studies, review studies, and case reports.
DATA EXTRACTION : Number of patients, cause of TM perforation,
perforation size, treatment, mean age, follow-up time, sex,
closure rate, healing time, mean air-bone gap improvement.
DATA SYNTHESIS : A total of 14 studies were included,
including seven RCTs and seven non-RCTs with a total of
1,072 participants. The odds ratio for closure rate of bFGF
treatment was 7.33 (95% confidence interval [CI], 4.65 to
11.53; p<0.01; I2¼44%) and the standardized mean difference
(SMD) for healing time was –5.89 (95% CI: –7.85 to
–3.93, p<0.01, I2¼98%), suggesting bFGF application has
a significant effect on closure of TM perforations. However,
no significant change in hearing (SMD: 0.08, 95% CI: –0.11
to 0.27, p¼0.39, I2¼0%) was seen as a result of bFGF
treatment.
CONCLUSIONS : Our meta-analysis has revealed that the application
of bFGF can significantly enhance the closure rate as
well as shorten the healing time for TM perforations. In
terms of hearing, there is as yet no evidence that bFGF has a
significant effect. Given its ease, availability, and safety,
bFGF can be used effectively for TM repair.