Abstract
DL-8280, a new synthetic oxazine derivative, was administered orally to 133 patients with urological infections at 18 departments of Urology of Kyushu University Hospital and its relevant hospitals.
The effectiveness of this drug was estimated in 38 cases of chronic complicated urinary tract infection and 6 cases of acute simple cystitis by the 2nd edition of judgement of UTI criteria. In the chronic complicated urinary tract infection group, the clinical effect proved excellent in 17 cases, moderate in 12 cases and poor in 9 cases (effective rate 76%) and in the acute simple cystitis group, excellent in 6 cases (effective rate 100%).
In the global judgement made by the attending physicians in the acute simple pyelonephritis group, the clinical efficacy proved excellent in 3 cases, moderate in one case (effective rate 100%), in the prostatitis group, the clinical efficacy proved excellent in 3 cases (effective rate 100%), in the prostatitis and epididymitis group, the clinical efficacy proved excellent in 2 cases (effective rate 100%), in the gonococcal urethritis group, the clinical efficacy proved excellent in 8 cases, moderate in one case (effective rate 100%) and in the non-gonococcal urethritis group, the clinical efficacy proved excellent in 2 cases (effective rate 100%).
Bacteriologically, 132 strains out of 156 strains isolated from all cases were disappeared after treatment with DL-8280. Eradicated were 16/16 of S. epidermidis, 5/6 of S. faecalis, 37/40 of E. coli, 9/11 of C. freundii, 15/15 of Klebsiella sp., 9/11 of Enterobacter sp., 7/10 of S. marcescens, 5/7 of Proteus sp., 11/18 of P. aeruginosa and 9/9 of N. gonorrhoeae.
Six of 133 patients exhibited side effect: one patient with thirst and epigastric discomfort, one with anemia and thrombocytopenia, one with anemia and elevated serum GOT and GPT, two with elevated serum GOT and GPT, one with elevated serum GPT. Anyway, those abnormal changes disappeared immediately after discontinuation of the administration.
