COMPARATIVE-STUDY OF CIPROFLOXACIN AND AM OXICILLIN-CLAVULANIC ACID IN THE TREATMENT OF CHRONIC SINUSITIS

Over a ten months period, 251 patients with a mean age of 45 years, pr esenting with a chronic sinusitis, have been included in a multicenter , double-blind study. Its aim was to compare efficacy of 500 mg ciprof loxacin b.i.d. (122 patients) and 500 mg amoxicillin-clavulanic acid t .i.d. (129 patients), administered for 9 days. The diagnosis of chroni c sinusitis (persistence of clinical symptoms for at least 3 months) w as confirmed by C.T. scan and/or sinusoscopy. Patients, at inclusion, had purulent or muco-purulent rhinorrhoea. Bacteriological sample was made, prior treatment, at middle meatus; the most frequent pathogens w ere: Staphylococcus aureus (n = 45), Haemophilus influenzae (n = 35) a nd Streptococcus pneumoniae (n = 32). At the end of treatment, the cli nical cure rate and the bacteriological eradication rate are respectiv ely 58.6 % vs 51.2 % and 88.9 % vs 90.5 % in ciprofloxacin and amoxici llin-clavulanic acid groups (no statiscally significant difference). C linical safety appeared to be significantly better with ciprofloxacin (p = 0.012). This difference is mainly the result of a higher number o f digestive side effects in the amoxicillin-clavulanic acid group (n = 35). Ciprofloxacin was at least as effective as amoxicillin-clavulani c clavulanic acid. Due to a significantly better tolerance and to a si mplification of treatment owing to a b.i.d. regimen, it can be conside red that ciprofloxacin is an interesting alternative treatment of chro nic sinusitis.