[Norfloxacine efficacy in acute cystitis in the region with 10% resistance of E. coli to fluoroquinolones: a comparative randomized study]

Abstract

We have conducted a clinicomicrobiological study the first stage of which consisted in collection of information on uropathogens resistance to fluoroquinolones in 89 females with uncomplicated urinary infections (UI). Sensitivity to antibacterial drugs was determined by the agar dilution test (CLSI, 2007). At stage two of the study we made a prospective multicenter randomized trial including 108 females aged 18-55 years with acute uncomplicated cystitis. The patients were randomized into two groups: group 1 (n = 55) received norfloxacin (400 mg twice a day for 3 days); group 2 (n = 53) received phosphomycin (a single 3.0 g dose). Clinical and microbiological assessment of efficacy and safety was performed before the treatment, on treatment day 5, 10 and 28. Isolation of E. coli strains in the region highly and moderately resistant to cyprofloxacine was rather high--10 and 1.1%, respectively. Before the treatment E. coli was isolated from the urine in 82.4% cases, E. faecalis--5.9%, S. saprophyticus--3.9%, Staphylococcus spp--2.0%, others--< 1%. No significant differences by bacteriological and clinical efficacy were found between the groups. Eradication of the agent and persistent bacteriological response were seen in 100 and 95.2%, 95.8 and 100% patients of groups 1 and 2, respectively. Complete and partial responses were registered in 68.5 and 76%, 76 and 98% patients of groups 1 and 2, respectively. Thus, treatment with norfloxacin in a dose 400 mg twice a day for 3 days and with phosphomycin in a 3.0 g single dose have high clinical and microbiological efficacy in uncomplicated cystitis. Norfloxacin retains clinical and microbiological efficacy in acute uncomplicated cystitis even in conditions of 10% prevalence of fluoroquinolone-resistant strains. We think that there are reasons for revision of criteria of interpretation of uropathogens sensitivity to fluoroquinolones in the treatment of uncomplicated UI.