Basic and clinical studies of FK037 in orthopaedic surgery

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We investigated the distribution of FK037, a newly developed parenteral cephalosporin antibiotic, into human bone and joint fluid, and its clinical efficacy and safety for infectious disease in orthopaedics. The concentrations of FK037 in the bone tissue and joint fluid after a 60 min intravenous drip infusion of the drug (FK037=1.0g) were measured in 8 cases. The concentrations of FK037 were 37.8-45.3μg/ml in the bone marrow blood, 4.5-11.2μg/g in the cancellous bone, 1.6-11.7μg/g in the cortical bone, 120 min after administration, and 22.6-49.0μg/ml in the joint fluid, 110-135 min after administration. In a clinical trial, FK037 was administered to 4 patients with infection (1 patient with suppurative arthritis and 3 patients with osteomyelitis) in doses of 0.5-2.0g twice a day for 7-24 days. The clinical efficacy was excellent in 1, good in 2, and poor in 1. Bacteriologically, 2 strains of Staphylococcus aureus were isolated from 2 patients and eradicated. No side effects were observed, and abnormal laboratory findings of a slight elevation of GPT, LAP and γ-GTP were noted in 1.
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