The objectives of this study were to determine if the size of nasal polyps could be assessed in a reproducible way and to study the effect of budesonide in patients suffering from eosinophilic nasal polyposis with small and medium sized polyps. Ninety-one patients entered the study. Budesonide 200 micrograms b.i.d. (aerosol or aqua) and placebo (aerosol or aqua) were compared in a 3-month double-blind, multi-centre, randomized study. Efficacy was measured by an assessment of polyp size, nasal peak-flow index and the patient's assessment of nasal symptoms. The conclusions were that the size of polyps could be assessed in a reproducible way, and that budesonide delivered either as a water-based suspension or as an aerosol is effective in the treatment of patients with small and medium sized polyps.
From 274 adenoidectomized children 1-16 years of age two groups were selected: children with a history of recurrent otitis media and/or otosalpingitis (middle ear effusion) and those in which nasal obstruction was the main symptom. In all, 154 children were subjected to an allergy investigation including history, skin tests, eye tests, determination of IgE and RAST, blood eosinophils and immunoglobulins G, A and M. No increased incidence of immunoglobulin deficiency was found in either group in comparison with unselected children. A family history of atopic disease and/or otitis media was highly overrepresented, especially in the children with recurrent otitis media as the reason for the adenoidectomy. Atopic diseases had occurred in 24.4% of the children. Furthermore, in both groups there was a high incidence of positive skin and eye tests. An increased incidence of eosinophila, positive RAST tests and elevated IgE levels were also found. In all, 39.6% of the children had two or more laboratory findings characteristic of the atopic state but no significant difference was found between the two groups. Possible connections between atopic allergy and recurrent otitis media are discussed.
In sinus empyema, H. influenzae is the most prevalent pathogen in some subpopulations and in case of therapeutic failure. Cefixime, the first oral cephalosporin of the 3rd generation, is highly potent in vitro against H. influenzae. To study the efficacy and safety of cefixime in adults with acute sinusitis, a coordinated, double-blind multicenter trial was designed for purulent cases, as confirmed by antral aspiration. A total of 364 patients were enrolled in the study with 125 cases randomized to the reference group, assigned to treatment with cefaclor. Evaluation was based on clinical outcome and on antral reaspiration (86% of the cases). No significant differences between the treatment groups were found, as regards short-term or long-term clinical outcome. However, the clinical examination overestimated the therapeutic results. Only 4% of the patients were considered as failures, but the re-aspiration demonstrated remaining suppuration in 14% of all cases (p less than 0.001). Based on re-aspiration, the failure rate among patients with initial growth of pathogens was lower for cefixime (8%) than for cefaclor (20%) (p less than 0.05). Such a difference was not found among patients with growth of H. influenzae. No serious adverse reactions were recorded, but loose stools and diarrhoea were significantly more frequent in the cefixime treatment group. Five patients (2%) in the cefixime treatment group discontinued their treatment due to adverse events.
SUMMARY To evaluate possible differences in efficacy and safety between budesonide and beclomethasone dipropionate when used intranasally in the treatment of perennial non‐allergic rhinitis, a 12‐month open study was undertaken in 24 patients suffering from perennial non‐allergic rhinitis. Both drugs were applied intranasally from pressurised aerosols at a daily dosage of 400 μg. On entry and at visits after 1, 2, 4, 6, 9 and 12 months, rhinoscopy was performed and the severity of nasal symptoms graded according to a four‐point rating scale. All nasal symptoms were reduced from baseline during the treatment period in both groups. Tachyphylaxis was not observed. No clinically significant changes in haematology or blood chemistry parameters were observed in either group, and analysis of plasma cortisol levels revealed no influence of either drug on the hypothalamic‐pituitary‐adrenal axis. Local adverse reactions were uncommon and mild. Budesonide and beclomethasone dipropionate used intranasally at 400 μg per day were found to be safe, and budesonide was found to have a significantly higher (p<0.05) efficacy than beclomethasone dipropionate in alleviating symptoms of perennial non‐allergic rhinitis.
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