ホスミシンSの基礎的臨床的検討

Abstract

The clinical effectiveness of Fosmicin-S, a new antibiotic, was studied in 30 patients with genitourinary 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 intravenous injection (11 cases), or by intravenous 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 two patients received the drug for only one day. The overall efficacy rates for the analyzed cases were 75% (6 out of8 cases) for acute simple genitourinary tract infections and 47.4% (9 out of 19 cases) for chronic complicated genito-urinary tract infections. Adverse reactions were observed in 3 cases, taking the form of diarrhea, rise in GOT and GPT, and transient blurred vision in one case each. Bacteriologically, Pseudomonas aeruginosa was isolated from 7 cases, and complete elimination of the organism was observed in only one 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, as well as 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) one hour i.v. infusion of 4g dissolved in 100 ml of water for injection, (2) two-hour infusion of 4g dissolved in 300 ml of 5% glucose solution, and (3) two-hour infusion of 6 g dissolved in 500 ml of 5% glucose solution.