Background and importance Otomycosis is a suppurative fungal infection that affects the external auditory canal. Patients have a high rate of recurrence and are prone to invasive fungal infections after receiving limited therapeutic options with low response.
Aim and objectives The aim of the study was to describe the use of a sterile formulation of topical voriconazole ear drops (VE) for the treatment of otomycosis and analyse its effectiveness and safety.
Material and methods Antifungal ear drops are not commercially available. The otolaryngology service requested a broad spectrum topical antifungal for recurrent otomycosis. After a literature review, a sterile aqueous formulation of voriconazole 10 mg/mL was considered, ensuring the absence of ototoxic effects, with an optimal pH of 6.3 that allowed contact with the external channel. We assigned a beyond use date of 14 days refrigerated, 45 days frozen and protected from light.
Baseline data were collected from the clinical history. Patients reported their outcomes in interviews with the pharmacists,: humidity, otorrhoea, earache, itching, loss of hearing before/after treatment and possible adverse events (AE) were recorded. Patients were informed and consent was requested for participation. Statistical analysis was made with SPSS and STATA. The results were analysed using the McNemar test of paired data.
Results Following the macroscopic finding of hyphae, microbiological culture was requested in 55.5% of cases, and Candida (33%) and Aspergillus (22%) isolates were found. All patients were treated previously with topical drugs (94.4% antibiotics, 55.5% antifungals) and 83.3% also with oral agents (83.3% antibiotics, 22.2% antifungals), without improvement. Eighteen patients (58.8% women, median age 67 years (range 44.5–75)), were treated with VE for an average of 4 weeks (SD 1.8), administering 1–2 drops 2–3 times a day.
Interviews were conducted in 14 patients: 93.3% reported a general improvement in symptoms and 86.7% associated it with VE. Patients experienced a significant improvement in humidity (pre 88.2%, post 13.3%, p<0.05), otorrhoea (pre 100%, post 6.7%, p<0.05), earache (pre 41.2%, post 0%, p<0.05) and itching (pre 41.2%, post 6.7%, p<0.05), and 36.4% perceived an improvement in hearing loss (p>0.05). Only one AE (mild tingling) was recorded.
Conclusion and relevance Our observations showed that voriconazole ear drops were an effective and safe option that significantly reduced symptoms in patients with recurrent otomycosis which failed to respond to other therapeutic alternatives. Further prospective studies are needed to confirm these findings.
References and/or acknowledgements No conflict of interest.
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