泌尿器科領域におけるTA-058の基礎的臨床的経験

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  • HUMAN PHARMACOKINETIC AND CLINICAL STUDY OF TA-058
  • タンジンシャ ノ イシュク ボウコウ ニ タイスル ボウコウ カクチョウジュツ

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Human pharmacokinetic and clinical evaluation of TA-058, a new synthetic penicillin preparation, were made and the following conclusions were obtained:<BR>(1) As to the pharmacokinetics, after one hour drip infusion administration of 4g of TA-058 and carbenicillin in 4 healthy male volunteers (crossover test), the peak serum levels were yielded 224.4 μg/ml and 242.6 μg/ml at the end of infusion, respectively.<BR>The half-life in serum was estimated to be 84.0 min. and 60.0 mm. The mean urinary recovery rates in 8 hours were 59.0 and 81.8%.<BR>(2) Concentrations of TA-058 were examined in genital organs such as testis, epididymis and prepuce of phimosis. After intravenous injection of 1 g of TA-058, the levels in those tissues, were highest in epididymis and followed by the testis and prepuce of phimosis, and those concentrations ranged from 1/5 to 1/2 of the serum levels.<BR>(3) TA-058 was administesrd to chronic complicated cystitis in 5 cases and chronic complicated pyelonephritis in 5 cases. Eight cases satisfied the requirements of “Criteria for Evaluation of Drug Efficacy in U. T. I.”. The results were excellent in 1 case, moderate in 1 case, and the effective rate was found to be 25%. Bacteriological test demonstrated that 3 strains out of 11 (27.3%) were eradicated by TA-058.<BR>As TA-058 is hydrolyzed by β-lactamase, we concluded that it is necessary to administer this drug with β-lactamase inhibitor in chronic urinary tract infections.

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