細菌性前立腺炎に対する薬効評価法の再検討 : Temafloxacinの臨床試験成績を用いた解析

Abstract

1)小委員会判定が可能であった症例における有効率は急性細菌性前立腺炎(ABP)で100%(15/15), 慢性細菌性前立腺炎(CBP)で66.7%(18/27)と満足すべき成績がえられた。細菌学的効果はABPで100%(15/15), CBPで81.5%(22/27)の菌陰性化率であった。2)自他覚的副作用は100例中8例に, 臨床検査値異常変動は71例中9例にみられたが, いずれも臨床上特に問題となるものではなかった。3) ABPでは7日間, CBPでは14日間の投与期間で薬剤の有効性は評価可能である。4) ABPではE. coliをはじめとするGNRがおもな起炎菌であり, CBPでは, GNRあるいはE. faecalisは半数弱の症例でしか分離されず, 他の症例ではCNSが検出された

The clinical efficacy of temafloxacin (TMFX) was evaluated in the patients with acute prostatitis (AP: 31 cases) and chronic prostatitis (CP: 75 cases), and the criteria for clinical evaluation on bacterial prostatitis by the Japanese UTI Committee were re-examined. The clinical efficacy of TMFX on prostatitis was examined. The number of the evaluable cases by doctors in charge were 30 and 68 for AP and CP, respectively. The efficacy rates were as high as 96.7% for AP and 80.9% for CP. In the patients whose efficacy could be evaluated by the Committee, the efficacy rates were as high as 100% (15/15) for acute bacterial prostatitis (ABP) and 66.7% (18/27) for chronic bacterial prostatitis (CBP). The bacteriological eradication rates were 100% (15/15) for ABP and 81.5% (22/27) for CBP. Adverse drug reactions were observed in 8 of 100 cases (total evaluable cases) but they clinically did not consist any problems. Abnormal laboratory test findings were observed in 9 of 71 cases (total evaluable cases), whose changes were all slight and did not clinically cause any problem. Therefore, TMFX was concluded to be highly useful in the treatment of ABP and CBP. The criteria for clinical evaluation on bacterial prostatitis were re-examined. Concerning the treatment period, comparison of the evaluation at Day 7 with that at Day 14 in ABP revealed that the efficacy was evaluable at Day 7. In the same way, comparison of the evaluation at Day 14 with that at Day 28 in CBP revealed that the efficacy was evaluable at Day 14. Concerning the pathogens, in ABP, the major pathogens were considered to be GNR as well as E. coli. On the other hand, in CBP, GNR and E. faecalis, that were generally authorized to be pathogens, were detected in less than half of the patients, and CNS were detected in the other patients. Among the CNS cases, there were some cases that showed no relationship between improvement of clinical symptoms and bacterial response. Therefore, it is necessary to perform further studies on this matter. In conclusion, regarding the criteria for clinical evaluation on bacterial prostatitis proposed by the Japanese UTI committee, the treatment period for evaluation of efficacy was appropriate, and it is necessary to perform further studies in order to determine the pathogens in bacterial prostatitis.