[Fundamental and clinical studies of cefaclor in oral surgery]

Fundamental and clinical studies on cefaclor (CCL) have been performed and the following results were obtained. CCL was orally administered to NZW rabbits at the dose of 20 mg/kg, and its concentrations in blood and various tissues of oral organs were determined. Pattern of change in its blood concentration after the administration was similar to that of change in its concentration in the tissues of oral organs. Its concentration in blood was the highest followed by gingiva, parotid gland, submandibular gland, cervical lymph node and tongue in descending order. Comparative studies of CCL against cephalexin (CEX) were conducted in 5 healthy volunteers with cross over method. The 5 volunteers were orally given 500 mg of CCL or CEX at 1 dose after meal. Peak blood levels of CCL and CEX were 14.8 micrograms/ml at 2 hours and 11.5 micrograms/ml at 3 hours, respectively. The dose of 750 or 1,500 mg/day of CCL in 3 divided doses was orally administered to 71 patients with acute purulent infections in oral tissues for 3 to 13 days. Evaluation of effect was determined by the criteria for evaluation of antimicrobial agents in oral surgery. Out of the 70 patients, excellent clinical response was observed in 18 patients, good in 40, and poor in 12. Effective rate was 83%. In vitro antibacterial activities (MIC) of CCL and CEX were studied in 74 out of 81 strains (41 from aerobes and 40 from anaerobes) isolated from 47 patients. CCL showed stronger antibacterial activities than CEX. MICs of CCL against 30 strains of Gram-positive anaerobes were distributed from 0.10 to 3.13 micrograms/ml with a peak of 0.78 micrograms/ml. As adverse reaction due to CCL, eruption was observed in only 1 patient. Laboratory tests in 61 patients who received CCL showed elevation of GOT in 1 patient and elevation of GOT and GPT in 1 patient. From the above fundamental and clinical results, CCL was considered to be a useful antibiotic for the treatment of acute purulent infections caused by aerobes and anaerobes in oral surgery field.