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

Accession number;00A0593242
Title;Clinical investigation and tissue concentrations of injectable pazufloxacin mesilate in patients with surgical infections.
Author; TANIMURA HIROSHI (Wakayama Med. Coll.) ENDO SHIGEATSU (Iwate Med. Univ., Crir. and Emerg. Center Sch. of Med.) KUNII YASUO (Sendai Natl. Hosp.) SHIMIZU TAKEAKI (Shinrakuen Byoin) ONO SHIGEO (Tokyo Dent. Coll.) SUMIYAMA YOSHINOBU (Toho Univ., Sch. of Med.) IWAI SHIGETOMI (Nihon Univ., Sch. of Med.) SATO TAKESHI (Nihon Univ., Surugadai Hosp.) YASUNAMI YOICHI (Fukuoka Univ.)
Journal Title;Japanese Journal of Chemotherapy
Journal Code:F0608A
ISSN:1340-7007
VOL.48;NO.5;PAGE.353-374(2000)
Figure&Table&Reference;FIG.1, TBL.25, REF.27
Pub. Country;Japan
Language;Japanese
Abstract;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 infections, and the overall efficacy rate was 79.4% (54/68), and the rate 84.6% (11/13) for Pseudomonas 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 .BETA.-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.... (author abst.)