[Clinical study of a new injectable cephem, FK037, for acute bacterial prostatitis]

FK037, a new injectable cephem antibiotic, was administered in the treatment of 13 acute bacterial prostatitis (mean age 53.5, range 30-79), and its effectiveness and safety were evaluated. The human prostatic fluid (PF) concentration of FK037 on 7 specimens 1 hour after 1 g i.v.d., was in the range of 0.87-7.47 micrograms/ml (mean +/- SD, 3.43 +/- 2.23 micrograms/ml), whereas, the serum concentration averaged 45.3 +/- 2.88 micrograms/ml, the ratio of PF/serum consequently being 0.08 +/- 0.05. In the clinical study, 1g of FK037 was administered to 13 patients by i.v.d. twice a day for 7-9 days. Bacteriological eradication on expressed prostatic secretion (EPS) was obtained for all clinical isolates which included 11 strains of Escherichia coli (MIC < or = 0.05 microgram/ml), 2 of Enterococcus faecalis, and each one of Staphylococcus aureus and Morganella morganii. Symptomatical cure was 100% in all cases. As for safety profile, no side effects were noted. In laboratory values, slight elevation of transaminase were detected in 3 cases, but they were transient and returned to normal 1-2 weeks after completion of the therapy. We conclude that FK037 is highly effective in the treatment of acute bacterial prostatitis, and is well tolerated in comparison with other relative antimicrobials.