The impact of prulifloxacin on vaginal lactobacillus microflora: an in vivo study

The aim of this study was to evaluate the in vivo effect of a repeated-dose regimen with prulifloxacin in comparison to amoxicillin/clavulanate on vaginal lactobacillus microflora. Thirty healthy female volunteers were treated with prulifloxacin or amoxicillin/clavulanate in this open, randomized, parallel-group, repeated-dose study. Vaginal signs and symptoms were assessed at the first doctor's Visit 0 (3 weeks prior to the start of the study), and subsequent examinations (1, 3, 5, 6, 7 and 8) (followup). Some volunteers treated with amoxicillin-clavulanate showed increased pH values and 73.3% of them had lower lactobacillus flora at Visit 3. this reduction was still present in 66.7% 3 days after the last dose and in 26.7% of subjects at the follow-up, about 7 - 13 days after the last dose. The situation was completely normalized at the second follow-up about one month after treatment stop. On the contrary, the repeated administration of prulifloxacin 600 mg tablets affected neither the pH nor the lactobacillus component of the vaginal flora in healthy fertile women. The oral administration of prulifloxacin may have advantages over some other antimicrobial agents because it preserves the normal vaginal microbiota in healthy women.