This study aims to evaluate the effectiveness of hormone nasal drops in the olfactory cleft combined with olfactory training for treating postinfectious olfactory dysfunction (PIOD). The main questions this clinical trial seeks to answer are:
Can the combination of hormone nasal drops and olfactory training improve smell function better than olfactory training alone in PIOD patients? How does this combined treatment work?
Prospective enrollment of otolaryngology clinic patients aged 18-65 years with olfactory dysfunction. Diagnosis of post-infectious olfactory dysfunction (PIOD) will be based on the PPOD 2023 criteria. Participants must demonstrate olfactory impairment via Sniffin' Sticks testing, with TDI scores (sum of Threshold, Discrimination, and Identification) meeting: (1) Hyposmia: 16 < TDI < 30.75; (2) Anosmia: TDI ≤ 15.
Willingness to participate and signed informed consent.
Use of systemic corticosteroids within 4 weeks or intranasal steroids within 2 weeks prior to enrollment.
Severe nasal septum deviation, nasal tumors, acute upper respiratory infections, or uncontrolled allergic rhinitis.
History of functional endoscopic sinus surgery or other nasal procedures within 12 months.
Severe cardiovascular disease, hepatic/renal insufficiency, uncontrolled diabetes, or immune system disorders.
Parallel
Steroid nasal drops combined with olfactory training
Combination productThe intervention consists of two components: steroid nasal drops and modified olfactory training.
Placebo nasal drops combined with olfactory training
Combination productThe intervention consists of two components: normal saline nasal drops and modified olfactory training.
The Sniffin' Sticks test
A clinically significant olfactory improvement as measured by Sniffin' Sticks threshold, discrimination, and identification(TDI)
Questionnaire of Olfactory Disorders - Negative Statements (QOD-NS)
The QOD-NS includes 17 negative statements, each graded from 0 (disagree) to 3 (agree) for a maximum score of 51. Higher QOD-NS scores reflect worse QoL.
Olfactory-Visual Analogue Scale (VAS)
Subjects rate the impact of smell loss on their mood, ability to enjoy food, social interactions, safety, personal hygiene, sex life, ability to cook food, appetite and change in weight from 0 (no impact) to 10 (most impact) for a maximum score of 90. Higher olfactory-VAS scores reflect more severe impacts on daily life.
CT Evaluation of Olfactory Cleft Blockage
The olfactory cleft was divided into anterior and posterior, divided by the anterior end of the superior turbinate. The anterior and posterior olfactory cleft opacifications were graded separately on a scale of 0-4 by the ratio of the opacified area to the whole area of the olfactory cleft, with 0 (no opacification), 1 (25%), 2 (25%-50%), 3 (50%-75%), and 4 (\>75%). The olfactory cleft CT score, calculated as the sum of the anterior and posterior olfactory cleft scores, ranged from 1 to 8 (Kim DW, Kim JY, Jeon SY. The status of the olfactory cleft may predict postoperative olfactory function in chronic rhinosinusitis with nasal polyposis. Am J Rhinol Allergy. 2011;25(2):e90-4.).
Inflammatory Marker Levels in Olfactory Mucosa
Analysis of inflammatory cytokines （IL-4、IL-5、IL-13、IL-25、IL-33 and TSLP）via ELISA and single-cell sequencing from olfactory mucosal brush samples.
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