複雑性尿路感染症に対するAmikacin静脈内点滴投与に関する基礎的, 臨床的検討

Abstract

In order to examine effectiveness, safety and usefulness of intravenous injection of amikacin (AMK), it was compared with intramuscular injection of AMK for treatment of complicated urinary tract infection. Antimicrobial activity of AMK was also evaluated on clinically isolated gramnegative bacilli and pharmacokinetics of AMK was determined in patients with impaired renal function after one hour continuous intravenous administration. The following results were obtained. 1) Antibacterial activities of AMK, DKB and GM were compared on the strains isolated from patients with urinary tract infections. The MIG of AMK was equal to that of GM and DKB against E. coli and P. aeruginosa, while it was superior to that of GM and DKB against Serratia. 2) Pharmacokinetics of AMK was determined in patients with impaired renal function, ranging Gcr from 30 to 80 rnl/min, after one-hour intravenous administration of a 200 mg dose. Serum concentration of AMK revealed the peak of 12.7 to 23.8 pg/ml within 15 minutes after intravenous administration. Urinary concentration of AMK showed over 200 pg/ml and the excretion rates were 50.4 to 75.2% 5 hours after intravenous administration. In patients with 5 days administration of a dosage of 400 mg in 2 divided doses no accumulative tendency was observed. 3) AMK was administered for 5 days in a dosage of 400 mg in 2 divided doses. Drugs were administered intramuscularly in 31 patients and intravenously in 19 patients. The overall clinical effectiveness rate was 52% for intramuscular injection and 79% for intravenous injection. In overall clinical effectiveness, effect on improvement of pyuria and bacteriuria and bacteriological response, no significant difference was noted statistically between the two treated groups. Side effects were evaluated in 47 patients with intramuscular AMK and in 30 patients with intravenous AMK. There was no subjective clinical evidence of toxicity. No significant difference was noted statistically between the two groups. There was no significant difference in the clinical efficacy and safety between intravenous and intramuscular AMK if it was administered at adequate speed and dose.