| DEPARTMENT OF CONVERGENCE MEDICINE, YONSEI UNIVERSITY WONJU COLLEGE OF MEDICINE 1, RESEARCH INSTITUTE OF HEARING ENHANCEMENT, YONSEI UNIVERSITY WONJU COLLEGE OF MEDICINE 2, DEPARTMENT OF OTORHINOLARYNGOLOGY - HEAD AND NECK SURGERY, YONSEI UNIVERSITY WONJU COLLEGE OF MEDICINE, WONJU, REPUBLIC OF KOREA 3 |
¸ñÀû: Glucocorticoids are the first-line therapy for idiopathic sudden
sensorineural hearing loss (I-SSNHL), with intratympanic (IT) steroid
injection used as immediate or salvage after initial treatment fails
or after 2 weeks of symptom onset. However, effective drug delivery to
the inner ear remains a significant challenge, leading to recent
efforts to explore new drug delivery technologies.
Dexamethasone palmitate (DP), a dexamethasone prodrug, is
encapsulated in solid lipid nanoparticles composed of palmitic acid.
Due to its hydrophobic properties, which differ from the hydrophilic
nature of conventionally used dexamethasone sodium phosphate (DSP),
DP¡¯s lipid nanoparticles are expected to enhance drug delivery
efficacy when administered intratympanically.
To evaluate whether the chemical properties of these drugs are
reflected in clinical practice, DSP and DP were injected into patients
with I-SSNHL to compare the degree of hearing recovery. ¹æ¹ý: Patients aged 19 years or older who consented to participate in the
study were included. Patients diagnosed with I-SSNHL and admitted to
the hospital, who received oral methylprednisolone, also underwent
simultaneous IT steroid injection. Patients were divided into two
groups: those who received IT DSP and those who received IT DP. Pure-
tone audiometry was evaluated serially, and the results were
classified using the modified Siegel¡¯s criteria. The hearing recovery
group was defined as patients who achieved the complete recovery or
partial recovery, while the non-recovery group included patients who
had slight improvement or no improvement. Patients classified as non-
serviceable ear according to the modified Siegel¡¯s criteria were
excluded from the analysis. °á°ú: 30 patients received IT DSP, and 15 patients received IT DP. There
were no differences in age, gender, past medical history, BMI or
impaired site between the two groups. In the laboratory findings, the
percentage of neutrophils was higher in the IT DP group, and the
percentage of lymphocytes was higher in the IT DSP group.
The initial grade of the hearing impairment according to the
modified Siegel¡¯s criteria was more severe in the IT DP group,
although the difference was not statistically significant.
During the follow-up period, hearing recovery was higher in the IT
DP group compared to the IT DSP group, with a p-value of 0.004 at 2
months of follow-up. °á·Ð: In I-SSNHL, IT steroid injection is a relatively commonly used
treatment method, and various reports have been published regarding
its efficacy. According to this study, patients treated with DP, a
dexamethasone binding with lipid nanoparticles, showed better hearing
recovery outcomes, which may be attributed to differences in
pharmacokinetic properties.
Further large-scale clinical studies, as well as cellular and organ-
level research, are needed to investigate the drug¡¯s mode of action,
evaluate its delivery process, and optimize the drug delivery into the
inner ear. |