新注射用セフェム系抗生物質FK037の急性細菌性前立腺炎に対する臨床的検討

Abstract

PFへの移行濃度:FK037 1.0gを前立腺炎患者に点滴静注(i.v.d.)で投与した。1時間後のPFの濃度は3.43±2.23μg/ml (n=7)で血中濃度との比は0.08±0.05であった。臨床成績:急性細菌性前立腺炎(ABP)に対して, 本剤を1回1.0g, 1日2回, 2～9日間投与した。臨床効果は, UTI薬効評価基準で13例全例有効であった。シードスワブ法による前立腺液中の細菌学的効果はE. coli 11株, E. faecalis 2株, S. aureus 1株, M. morganii 1株すべてが治療後に除菌された。本剤による自他覚的副作用は認められず, 臨床検査値異常変動としては肝機能検査値の軽度上昇を3例に認めた

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.