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Topical antifungal treatment of chronic rhinosinusitis with nasal polyps: A randomized, double-blind clinical trial

2004; Elsevier BV; Volume: 113; Issue: 6 Linguagem: Inglês

10.1016/j.jaci.2004.03.038

1097-6825

Michael Weschta, Dagmar Rimek, Marc Formanek, D. Polzehl, Andreas Podbielski, Herbert Riechelmann,

Infectious Diseases and Mycology

BackgroundRecently, fungal elements were suspected to be the causative agent of chronic rhinosinusitis, and benefits of topical amphotericin B therapy have been reported.ObjectiveThe effects of amphotericin B versus control nasal spray on chronic rhinosinusitis were compared in a double-blind, randomized clinical trial.MethodsPatients with chronic rhinosinusitis were administered 200 μL per nostril amphotericin B (3 mg/mL) or saline nasal spray 4 times daily over a period of 8 weeks. The response rate, defined as a 50% reduction of pretreatment computed tomography score, was the primary outcome variable. Additional outcome variables included a symptom score, a quality of life score, and an endoscopy score. Before and after treatment, nasal lavages were pretreated with dithiothreitol and examined for fungal elements by PCR and standard culture techniques.ResultsSeventy-eight patients were included, and 60 patients finished the study per protocol. In the control group, no positive response (0 of 32) was observed, and 2 of 28 patients responded in the amphotericin B group (P > .2). The symptom scores were distinctly worse after amphotericin B therapy (P < .005). The other parameters investigated did not differ remarkably between the treatment groups.ConclusionNasal amphotericin B spray in the described dosing and time schedule is ineffective and deteriorates patient symptoms. Recently, fungal elements were suspected to be the causative agent of chronic rhinosinusitis, and benefits of topical amphotericin B therapy have been reported. The effects of amphotericin B versus control nasal spray on chronic rhinosinusitis were compared in a double-blind, randomized clinical trial. Patients with chronic rhinosinusitis were administered 200 μL per nostril amphotericin B (3 mg/mL) or saline nasal spray 4 times daily over a period of 8 weeks. The response rate, defined as a 50% reduction of pretreatment computed tomography score, was the primary outcome variable. Additional outcome variables included a symptom score, a quality of life score, and an endoscopy score. Before and after treatment, nasal lavages were pretreated with dithiothreitol and examined for fungal elements by PCR and standard culture techniques. Seventy-eight patients were included, and 60 patients finished the study per protocol. In the control group, no positive response (0 of 32) was observed, and 2 of 28 patients responded in the amphotericin B group (P > .2). The symptom scores were distinctly worse after amphotericin B therapy (P < .005). The other parameters investigated did not differ remarkably between the treatment groups. Nasal amphotericin B spray in the described dosing and time schedule is ineffective and deteriorates patient symptoms.