Clinical study of a new injectable cephem, FK 037, 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 μg/ml (mean±SD, 3.43±2.23 μg/ml), whereas, the serum concentration averaged 45.3±2.88 μg/ml, the ratio of PF/serum consequently being 0.08±0.05. In the clinical study, Ig 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≤0.05 μg/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 efects 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.