Clinical evaluation of a quinolone antimicrobial drug, grepafloxacin, for oral use in surgical infection

The clinical effects of a newly developed quinolone antimicrobial drug for oral use, grepailoxacin (GPFX), on infectious diseases in the surgical field were investigated by 13 collaborating organizations and 4 related institutions throughout the country. The results were as follows. GPFX was administered to 183 patients at a dose of 150∼400 mg once or twice a day for 3∼14 days. Eight patients were excluded or dropped out, leaving 177 patients to be evaluated for clinical effects. The efficacy rate was 85.9% in the patients with superficial purulent diseases, 66.7% in those with mastitis, 93.8% in those with periproctal abscess, 81.8% in those with secondary infections (19/23 for postoperative wound, 3/3 for wound, 1/1 for burn, and 4/6 for others), and 94.7% in those with cholecystitis and cholangitis. The total efficacy rate was 85.3%. The efficacy rate in 116 patients in whom bacteria were isolated before the start of administration was 85.3%. Eradication of bacteria could be assessed in 99 patients. The isolates were eradicated or superinfection was observed in 83 patients. The eradication rate was 83.8%. The eradication rate in the 170 strains whose eradication was confirmed was 91.7%(11/12 strains) for Staphylococcus aureus, 92.9%(13/14) for coagulase-negative staphylococci, 100%(13/13) for Staphylococcus epidermidis, 73.3%(11/15) for Escherichia coli and 100%(11/11) for Peptostreptococcus spp. The total rate was 86.5%(147/170). With regard to safety, slight and transient adverse reactions, mainly of bitter taste in the oral cavity, were observed in 7 of the 179 subjects. Abnormal change in s-GPT was observed in one patient on clinical laboratory tests. The above results suggest that GPFX is highly useful for infectious diseases in the surgical field.