慢性細菌性前立腺炎に対するTosufloxacinの臨床的検討

Abstract

慢性細菌性前立腺炎19症例についてTFLXの薬効評価を行うとともに, 分離菌のMICの比較, 再発症例, 安全性について検討を加えた。1)感受性:EPSからの分離菌18菌種27株のMICはTFLXがCPFX, NFLX, OFLX, CCLに比較して最も低く, 特にGPCと嫌気性菌に対する抗菌活性が優れている傾向を認めた。2)細菌学的効果:薬効評価基準に合致した19症例からの分離菌は14菌種19株で, 除菌率は17/19であった。3)薬効評価:白血球の正常化率は11/19, 細菌の陰性化率は16/19であり, 総合臨床効果は18/19であった。4)主治医判定:有効率13/19をえた。5)再発症例の検討:TFLX投与終了1ヵ月後の再発を3例で検討したが, 全例とも再発はなかった。6)安全性:自覚的副作用は消化器症状を3例に認めたが重篤なものはなく, 臨床検査値の異常変動もなかった

In a multicenter trial at 17 institutions, the usefulness of an oral dose of 300 mg of tosufloxacin (TFLX) twice a day for 14 days were assessed in the management of chronic bacterial prostatitis (CBP) diagnosed by Meares and Stamey method. Nineteen patients who were evaluated by the UTI criteria were chosen out of the 27 patients diagnosed with CBP. The isolated bacteria from EPS were 18 species and 27 strains. In terms of MICs of isolates, TFLX gave lower MICs than any of the control drugs (CPFX, NFLX, OFLX, CCL). In particular, this tendency was clear for gram-positive coccus and anaerobes. The bacteriological elimination rate obtained for 14 strains and 19 species was 89.5% (17/19) [GPC; 75.0% (6/8), GNR; 100% (7/7), Anaerobes; 100% (4/4)]. The overall clinical efficacy by the UTI criteria was documented in 94.7% (18/19). According to the doctor's evaluation, the overall clinical efficacy rate was 68.4%. Safety evaluation revealed the development of gastrointestinal symptoms in 3 cases, which were not serious, with an incidence rate of 4.0% (3/75), while no laboratory abnormalities were observed. Transference of TFLX into the prostate is slightly lower than in other new quinolones. However, from this study we considered that the higher antibacterial activity of TFLX is one of the reasons for its usefulness for CBP.