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Laboratory and clinical studies on fosmicin s in the field of urology



Laboratory and clinical studies on fosmicin s in the field of urology



Acta Urologica Japonica 27(10): 1251-1263



The clinical effectiveness of Fosmicin-S, a new antibiotic, was studied in 30 patients with genito-urinary tract infections (9 acute simple cases and 21 chronic complicated cases). The drug was given in doses of 2 g, once or twice a day by i.v. injection (11 cases), or by i.v. drip infusion (19 cases) for 3 to 7 days. For the judgment of clinical efficacy, Case 4 in the acute case group and Cases 10 and 29 in the chronic case group were excluded from the analysis. The reasons were that the urine sample collected from Case 4 before treatment gave a negative culture, while the latter 2 patients received the drug for only 1 day. The overall efficacy rates for the analyzed cases were 75% (6 out of 8 cases) for acute simple genito-urinary tract infections and 47.4% (9 out of 19 cases) for chronic complicated genito-urinary tract infections. Adverse reactions were observed in 3 cases. Bacteriologically, Pseudomonas aeruginosa was isolated from 7 cases and complete elimination of the organism was observed in only 1 case. This suggested that the doses employed in this trial were too small to produce satisfactory results. There have been no reports on this possibility. The authors thus felt it necessary to determine the urinary excretion rate and the serum concentration, following administration of relatively higher doses. For this purpose, 3 different higher doses of Fosmicin-S were given to 3 healthy adult volunteers using the crossover method: 1-h i.v. infusion of 4 g dissolved in 100 ml of water for injection, 2-h infusion of 4 g dissolved in 300 ml of 5% glucose solution and 2-h infusion of 6 g dissolved in 500 ml of 5% glucose solution. The peak blood concentrations occurred at the end of each infusion, showing levels of 239.2 .mu.g/ml 214.2 .mu.g/ml and 318.0 .mu.g/ml, respectively. Thereafter, these concentrations decreased to 6.7 .mu.g/ml, 15.9 .mu.g/ml and 19.5 .mu.g/ml at 8 h. The urinary recovery rates within the first 12 h were 98.5, 96 and 97.2%.

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