Fundamental and clinical studies of temafloxacin (TMFX), a newly developed oral quinolone, were carried out in the surgical field. The following results were obtained:<BR>1) Antibacterial activity<BR>The minimum inhibitory concentrations (MIC) of TMFX, ofloxacin (OFLX), norfloxacin (NFLX) and ciprofloxacin (CPFX) against Staphylococcus aureus, Escherichia coli, Klebsiella pneumoniae and Pseudomonas aeruginosa isolated from surgical specimens were measured. TMFX had the strongest activity against S. aureus (including methicillin-resistant S. aureus), with a peak MIC of 6.25μg/ml. Against E. coli and K. pneumoniae, these four quinolones had equal activities with peak MIC levels of 0.1μg/ml to E. coli and 0.2μg/ml to K. pneumoniae. Against P. aeruginosa, the activity of TMFX was the same as that of OFLX, but was slightly inferior to NFLX and CPFX.<BR>2) Distribution of TMFX to bile<BR>In three clinical cases with choledochal T-tube drainage, the distribution of TMFX to bile was measured after oral administration of 300mg TMFX (non-fasting). The peak bile levels of TMFX in these cases ranged from 9.65 to 15.2μg/ml, and the peak serum levels from 1.4 to 3.5μg/ml. A high level distribution of TMFX to bile was found; these data were the same as those of the other new quinolones.<BR>3) Clinical evaluation<BR>Fifty-six patients with surgical infections, mostly soft tissue infections such as infected atheroma, were treated with TMFX. The overall efficacy was excellent in 22 cases, good in 28, fair in 4 and poor in 2, with an efficacy rate of 89.3%. The only adverse reaction to TMFX was stomachache in one case (1.8%). Abnormal laboratory findings due to TMFX, including elevations of serum transaminase values, leucocytosis or glycosuria, were observed in two cases (4.7%); however, the adverse reactions and abnormal laboratory findings were mild and transient.