外科領域感染症におけるｐａｚｕｆｌｏｘａｃｉｎ注射薬の臨床効果および体内動態

DOI 被引用文献3件 参考文献27件

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  • Clinical investigation and tissue concentrations of injectable pazufloxacin mesilate in patients with surgical infections.

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Pazufloxacin (PZFX) mesilate, a newly developed injectable fluoroquinolone antibacterial agent, was clinically evaluated for the treatment of surgical infections and its tissue concentrations were measured. The following results were obtained. PZFX was intravenously administered at dose of 300mg or 500mg, 2 or 3 times daily for 3-14 days to patients with surgical infections. The clinical efficacy rates were 77.8%(21/27) for intra-abdominal infections, 88.2%(15/17) for biliary tract infections, 3/3 for liver abscesses, and 71.4%(15/21) for wound infbctions, and the overall efficacy rate was 79.4%(54/68), and therate 84.6%(11/13) for Pseudononas aeruginosa mixed infections was especially noteworthy. The clinical efficacy rates were 80.0%(40/50) for moderate infections and 77.8%(14/18) for severe infections. When severe infections or severe underlying diseases/complications were categorized in the severe disease group, the clinical efficacy rate was 76.0%(19/25) in the severe disease group, and it was 5/8 even for severe infections plus severe underlying diseases/complications. The clinical efficacy rate for infections with SIRS (systemic inflammatory response syndrome) at the start of this trial was 79.3%(23/29). The clinical efficacy rate in poor responders to other antimicrobial agents was 72.0%(18/25), and the rate of 75.0%(12/16) in poor responders to β-lactams (including carbapenems) was especially noteworthy. The bacteriological eradication rates were 64.0%(16/25) for Gram-positive bacteria, 78.9%(30/38) for Gram-negative bacteria and 79.3%(23/29) for anaerobic bacteria. The bacteriological eradication rate in P. aeruginosa infections was 72.7%(8/11). Adverse effects were observed in 3 cases: rash/itching, melena, and eruption. Abnormal laboratory data were observed in 14 cases (17.7%) and major findings were elevated serum transaminase levels, and a decreased leukocyte count was observed in 1 case. PZFX was intravenously administered at dose of 500mg to patients scheduled to undergo cholecystectomy. PZFX showed useful transfer, with tissue concentrations of 9.85-35.5 μg/g in the gallbladder tissue and 4.27-46.5μg/mL in gallbladder bile, compared to the corresponding serum concentrations of 3.69-19.0μg/mL. PZFX was intravenously administered at dose of 500mg to patients scheduled to undergo lung resection. PZFX yielded tissue concentrations of 3.49-12.7μg/g in the pulmonary tissues, 1.1-1.5 times higher than the corresponding serum concentrations of 3.20-9.40μg/mL. In postoperative patients, PZFX showed pus concentrations of 4.61, 4.84μg/mL, which was half the corresponding serum concentrations of 10.5, 8.12μg/mL. These results suggested that injectable PZFX is a useful antimicrobial agent for the treatment of surgical infections.

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