Sinusites maxillaires aiguës bactériennes de l'adulte : comparaison d'une durée de traitement de cinq jours versus dix jours par céfuroxime axetil

Abstract

Objective – The aim of this double blind, randomized, multicenter study carried out by 78 ENT specialists was to demonstrate that the two regimens (five days versus ten days) of cefuroxime axetil 250 mg twice daily present the same clinical efficacy in adults with acute maxillary sinusitis. Patients and methods – Diagnosis of sinusitis was defined as at least two of the following symptoms (purulent rhinorrhea, nasal congestion, headache, facial pain), and radiologically confirmed by an expert committee. Clinical efficacy, defined as success (cure or improvement) or failure, was assessed at the end of treatment (days 12–14) and on follow-up (days 21–28). A total of 401 patients (206 for the five-day group, 195 for the ten-day group) were randomized between January 1997 and January 1998. All patients were assessed for safety analysis, Intent-to-Treat and Per-Protocol analysis. Results – The most commonly isolated pre-treatment pathogens were S. pneumoniae (n = 60), H. influenzae (n = 56), and M. catarrhalis (n = 22). At the end of treatment, clinical success rates were equivalent, with 85% (176/206) in the five-day group and 87% (169/195) in the ten-day group. The difference in success rates was −1.2% with a 90%CI: [−6.9%; 4.5%]. On follow-up, 51 patients experienced a clinical relapse : 25 and 26 patients in the in the five-day group and ten-day group respectively. Radiological success rate on follow-up was 68% in the five-day group and 67% in the ten-day group. Bacteriological success rate was 89% and 91% in the five-day group and ten-day group respectively at end of treatment; it was 83% and 78% in the five-day group and ten-day group respectively on follow-up. No unexpected adverse event was observed and both regimens were well tolerated. Conclusion – A five-day course of cefuroxime 250mg twice daily is as effective as a ten-day course in the treatment of acute bacterial sinusitis.