[Cephalosporin treatment of maxillary sinusitis]

A new oral prodrug cephalosporin, cefcanel daloxate, was compared with cefaclor, another oral cephalosporin, in the treatment of acute purulent maxillary sinusitis. Three hundred fifty-four patients with purulent sinus secretion were recruited and randomized at thirteen European ENT clinics for the double blind study. The patients were treated with either cefcanel 300 mg tablets twice daily or cefaclor 250 mg capsules three times daily for ten days. Apart from the sinus puncture and secretion aspiration, the existence of sinus pain and purulent nasal secretion were inclusion criteria. Between days 12 and 15, reaspiration of the sinus was performed and signs and symptoms noted. The latter were checked again at the final visit between days 25 and 30. Samples of blood and urine were obtained for safety evaluation at inclusion, during and after treatment. The bacteriological culture of the purulent sinus secretion in 58.4% of patients revealed Haemophilus influenzae (37.9%) as the most prevalent pathogen followed by Streptococcus pneumonia (19.7%), while Streptococcus pyogenes, Branhamella catarrhalis, and Staphylococcus aureus amounted each to 6-7% only. The overall clinical outcome was defined as cure/improvement in 83.3% of the patients in the cefcanel group and 89.3% in the cefaclor group, respectively. No statistically significant differences with regard to efficacy were found between the two treatment groups. Adverse events, mostly related to gastrointestinal reactions, were reported by 36 patients (15.7%) in the cefcanel group and by 16 (13.4%) in the cefaclor group. Both cefcanel 300 mg twice daily and cefaclor 250 mg three times daily were highly effective with only minimal adverse events in the treatment of acute purulent maxillary sinusitis.