Basic and clinical studies of balofloxacin effects on surgical infectious diseases

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Pharmacokinetics and clinical effects of a new oral quinolone, balofloxacin (BLFX), in the field of surgery were investigated.<BR>The pharmacodynamic study was performed on five patients with cholelithiasis, two with choledocholithiasis, one with acute gangrenous appendicitis, and two with peritonitis derived from acute appendicitis. BLFX was orally administered at a single dose of 200 mg preoperatively, and body fluids and tissue specimens were collected during surgery. The gallbladder bile concentration to plasma concentration ratio was 0.15 to 33.4, and the bile concentration in the common bile duct to plasma concentration ratio was 11.71 to 31.11, and the gallbladder wall concentration to plasma concentration ratio was 0.93 to 2.10. These results indicate good transfer to bile. The concentration in intraperitoneal exudate was 0.86 to 2.73μg/ml, and the appendicular tissue concentration to plasma concentration ratio was 1.32 to 1.96.<BR>The drug was administered to 10 patients, including seven with infectius atheroma, one with subcutaneous abscess, one with mastitis, and one with infection secondary to operative wound. The clinical efficacy was rated as excellent in six and good in four, for an efficacy rate of 100%. No side effects were observed in any of the patients. Slightly elevated GPT was observed in one patient, but no abnormal changes in other clinical laboratory tests occurred.
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