Analysis of the characteristics of rare complications after tympanic
injection in south China: a randomized controlled trial
Objectives: To study the complications of intratymapanic dexamethasone
for Méniere’s disease. Study Design:a randomized controlled trial.
Methods:124 patients with Méniere’s disease were randomly divided into
two groups: Intratympanic dexamethasone(ITD) group (n=62) and
Intratympanic lidocaine(ITL) group (n=62). According to the dose of
dexamethasone used during treatment, the patients in ITD group were
further divided intoITD1(2mg/ml) group (n=31) and ITD2(5mg/ml) group
(n=31).The complications in each group were observed and evaluated after
10 times of intratympanic treatment with ear endoscopy. Results:3
patients suffered from the external auditory canal mycosis after ITD
therapy. All the 3 patients were in the ITD2 group and the the
infectious rate between patients who used 5mg/ml of dexamethasone and
those who used 2mg/ml exhibited significant statistical difference.
There were 5 cases of tympanic membrane atrophy thinning in ITD group ,
while no tympanic membrane atrophy thinning was observed in ITL group,
the incidence rate between these two groups showed significant
statistical difference. In addition, two patients in the ITD group had
perforation accompanied by external auditory meatus mycosis, while no
tympanic membrane perforation was observed in the ITL group. There was
no statistical difference in the incidence of vertigo, pain, tongue
numbness, tinnitus and other complications between the two groups.
Conclusions: Our study suggests that the occurrence of external auditory
canal mycosis and tympanic membrane atrophy thinning were significantly
correlated with the use of dexamethasone and the occurrence of external
auditory canal mycosis was closely related to the drug concentration,
while the occurrence of tympanic membrane atrophy thinning showed not
significantly correlated with the drug concentration. Further
understanding of the clinical characteristics of complications after ITD
will help clinicians select the appropriate concentration of
dexamethasone in the therapy and better manage these complications.