Clinical study of sparfloxacin, a new quinolone derivative, on urinary tract infection

AUC 22例とCC-UTI 51例に投与した.1) AUC 1日1回100 mg, 3日間投与を主とした結果, UTI判定基準(19例)で100%の有効率(著効率78.9%)をえた.2) CC-UTI 1日1回200～300 mg, 5日間投与ではUTI判定基準(22例)で45.5%の有効率であった.7日間投与(21例)の主治医判定では61.9%の有効率を示した.総合的には55.1%の有効率であった.3) 2例に腎機能に軽い影響を与えた.自他覚的副作用では9例に副作用の発現をみた.このうち投与中止は2例でSparfloxacin (SPFX) was evaluated for its clinical efficacy in 22 patients with acute uncomplicated cystitis (AUC) and 51 with chronic complicated urinary tract infection (CC-UTI). SPFX was administered in a single oral daily dose of 100 mg for 3 days to the patients with AUC. According to the UTI criteria, the efficacy rate was 100% (excellent rate was 78.9%). SPFX was also administered in a single oral dose of 200 to 300 mg mostly for 5 days to patients with CC-UTI. The efficacy rate according to the UTI criteria in the evaluable 22 cases was 45.5%. The efficacy rate according to the physicians in charge, evaluated as either excellent or good for the 23 cases treated with SPFX for 7 and 14 days was 65.2%, the overall efficacy rate in 49 cases including the administration for 5 days being 55.1%. In safety profile, subjective side effects were observed in 9 cases (12.3%), in 2 of which the medication was discontinued (2.7%). These side effects, flowever, recovered without any treatment to normal at the completion or discontinuation of the medication. The clinical laboratory values showed a slight elevation of BUN in 2 cases. SPFX was the most potent antimicrobial brug with a long blood elimination half life among the existing current new quinolones (NQs), indicating a possibility of once-a-day treatment regimen. In safety, side effects of SPFX were similar in general to those of other current NQs. Thus, SPFX is regarded as a highly useful antimicrobial drug when the drug is administered with consideration for its unique characteristics