Abstract
Chronic invasive fungal rhino sinusitis (CIFS) is a well described clinical entity characterized by mucosal and sub mucosal infiltration of mycotic organisms and angio-centric extension into orbital and intracranial structures. Itraconazole, Voriconazole and Amphotericin B are commonly used for CIFS. In the present study we have evaluated short term clinical response of these drugs. Thirty diagnosed patients of CIFS who presented to us from January 2011 to December 2015 were divided into three groups randomly. Group A, B and C received Itraconazole, Voriconazole and Amphotericin respectively. Visual Analogue scale (VAS), Lund Mackay (LM) radiological scores and Kupferberg’s nasal endoscopic grades were seen and compared in all patients before treatment, after primary surgical debridement and biopsy and after post biopsy antifungal drug treatment. We assessed the serum drug levels using HPLC assay at 4 and 8 weeks of therapy and correlated them for efficacy and safety. All the groups had significant improvement after treatment compared to beginning of study. Inter group comparison showed that mean LM, NE and VAS scores were significantly better in Voriconazole group compared to Itraconazole and amphotericin B therapy. The reduction of these objective parameters with treatment was also significantly high in Voriconazole group compared to the other two groups. Voriconazole has shown to be the most effective treatment modality for chronic invasive fungal sinusitis compared to other commonly used drugs such as Itraconazole and Amphotericin B.
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SD: Part of the MS thesis of the author. Took part in the management of the patients, collected data and analysed. RG: Conceptualised and mentored the study and finalised the manuscript. SKP: Did Statistical analysis and interpretation of the data, prepared the manuscript and finalized the current manuscript. AKG: Mentoring of the study along with active guidance to Dr SD in this study and the thesis to which this study is a part to. PP: Conceptualisation of the study and supervising the serum drug level analysis in the study. NS: Analysis of the serum samples, analysis and interpretation of the experimental results. She has guided the first author to carry out the pharmacological analyses as a part of the study.
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The research involved human participants and was done as a part of the thesis of the first author. Hence approval was taken from institutional ethical review board for conducting the study.
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Detailed informed consent regarding the study, possible therapeutic options, outcomes and the possible adverse effects that might arise out of the drug treatment was taken from each participant. A separate consent was also taken from patients receiving amphotericin B therapy mentioning long term in hospital stay, continuous iv therapy and need of central venous catheterization and its complications.
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Debbarma, S., Gupta, R., Patro, S.K. et al. Randomised Comparison of Safety Profile and Short Term Response of Itraconazole, Voriconazole and Amphotericin B in the Management of Chronic Invasive Fungal Rhinosinusitis. Indian J Otolaryngol Head Neck Surg 71 (Suppl 3), 2165–2175 (2019). https://doi.org/10.1007/s12070-019-01602-4
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DOI: https://doi.org/10.1007/s12070-019-01602-4