Invasive sinus aspergillosis infection has been reported with increasing frequency in the last decade, especially, in immunocompromised patients with chronic invasive sinus aspergillosis (CISA). The gold standard for treatment has been wide surgical debridement, intravenous administration of antifungal agents, such as amphotericin B, but the prognosis remains poor. Newer antifungal agents are being tried but no standard treatment option with new antifungal agents has yet been established for chronic invasive fungal sinusitis. Therefore, we undertook this study to evaluate the efficacy of voriconazole in patients of chronic invasive sinus aspergillosis.
Materials and methods
This study is a prospective randomized unblinded study with primary aim of evaluating the feasibility and effectivity of voriconazole in patients of chronic invasive sinus aspergillosis with intraorbital or intracranial extension, and secondarily to compare voriconazole with amphotericin B therapy in patients with chronic invasive sinus aspergillosis.
Observations and results
Thirty-three patients who fulfilled the eligibility criteria were included in this study. There were 18 patients enrolled in group I who received amphotericin therapy and 15 patients in group II who received voriconazole therapy. Out of 33 patients, 9 patients had complete response, 10 had partial response, in eight patients disease became stable and there were seven failures. Overall 50% patients had a successful outcome in group I, whereas 60% had a successful outcome in group II receiving oral voriconazole. On comparing only in extradural group, 5/10 had a successful outcome in group I receiving amphotericin B, whereas 8/12 (66.7%) had a successful outcome in group 2 receiving voriconazole. There was significant difference between adverse reactions of the two drugs, with amphotericin B having a significant renal and cardiotoxicity as compared to voriconazole; though patients on voriconazole developed skin rashes which were transient and disappeared on completion of the therapy.
The present series demonstrates that oral voriconazole can be the primary line of therapy in chronic invasive sinus aspergillosis in carefully monitored immunocompetent cases. Multicentric, randomized studies are required to define disease definition, duration and successful outcome.