[Postoperative application of amphotericin B nasal spray in chronic rhinosinusitis with nasal polyposis. Can recidive polyposis be prevented?]. / Amphotericin B-tartalmú orrspray posztoperatív alkalmazása orrpolyposissal járó krónikus rhinosinusitis eseteiben. Megelozheto-e a recidíva?

UNLABELLED: Chronic rhinosinusitis affects 1-4% of the adult population. The aetiology of this multifactorial, chronic disease, which leads to a significant impairment of the quality of life, often accompanied by nasal polyposis, is not fully understood. In the past decade it was presumed that the disease, which causes characteristic eosinophilic infiltration of the nasal mucosa, is triggered by an enhanced (but not classical allergic IgE type) immune response. AIM: If this supposition is correct, then it appears obvious that the administration of amphotericin B nasal spray in adequate concentration following endoscopic polypectomy should be advantageous for these patients, and might even reduce the number of recurrent cases. METHODS: To check on this assumption, the authors conducted a prospective randomized placebo-controlled trial involving 33 patients, 30 of whom remained in the study throughout. Patients with nasal polyposis were operated on with an endoscopic technique between 1 November 2005 and 1 October 2006; one group of them (group A, 14 randomly selected patients) was treated with a nasal spray containing 5 mg/ml amphotericin B, while the placebo group (group B, 16 randomly selected patients) received a nasal spray lacking amphotericin B. The results were evaluated with the aid of a modified Lund-Mackay CT score, the SNAQ-11 test (which evaluates changes in the symptoms), the life-quality test and endoscopy. The SPSS 14.0 for Windows program was utilized to process the data of examinations performed preoperatively and one year postoperatively. RESULTS: The CT scores of the group A patients exhibited wide scattering without signs of recovery one year after the operation. The CT scores of the group B patients indicated a slight improvement, though this did not prove significant in relation to group A. Both the SNAQ-11 test and the life-quality test revealed a significant improvement in each group, but the degrees of change in these tests did not significantly differ between the two groups of patients. The endoscopic findings indicated a slight improvement to the advantage of the amphotericin B-treated group 12 months after the operation. CONCLUSION: These results lead to the conclusion that the administration of amphotericin B nasal spray to patients operated on for nasal polyposis does not give rise to a significant alteration in CT scores, clinical symptoms, or quality of life. The more favourable clinical aspects observed in the amphotericin B-treated group during the endoscopic follow-up did not correspond to an improvement in the symptoms. In connection with the conclusions drawn from this study the authors discuss the available data on the fungal theory. They critically analyse the contradictory observations of 7 recent clinical studies.

[Stability testing of amphotericin B nasal spray solutions with chemical and biological analysis]. / Amfotericin B tartalmú orrspray oldat stabilitásvizsgálata biológiai es kémiai detektálással.

Recent studies have shown that the presence of fungal cells in the nasal mucosa may play an important role in the development of chronic rhinosinusitis with nasal polyps. In 2006 a pilot clinical trial was organized by the Department of Otorhinolaryngology, Head and Neck Surgery and the Pharmaceutical Institute of the Medical University of Pécs for the treatment of patients with chronic rhinosinusitis with nasal polyps. In our study we investigated the stability of the 5 mg/ml amphotericin B solutions (Fungizone) with chemical (spectrophotometry) and biological (bioassay) detection. The effect of storage temperature and the addition of 5% glucose was evaluated on the stability of the solutions for three months. The two detection methods showed different results. According to the chemical analysis the samples are considered relatively stable under all observed conditions (loss of concentration is: 14.2% at 20 degrees C and 4.5% at 4 degrees C). The bioassay shows complete loss of antifungal activity after 35 days of storage at room temperature and notable decrease can be observed at 4 degrees C (glucose containing solution 17.6%; glucose free solution 37.2%). Storage temperature had significant effect (p < 0.05), while 5% glucose had no significant effect (p > 0.05) on the stability of the examined solutions. Bioassay is considered to be the official quantitative analytical method for the analysis of amphotericin B recommended by the European Pharmacopoeia 4. Thus we estimated the shelf life of the glucose-free solutions, being stored at 4 degrees C, to be 30 days in accordance with our bioassay results.