神経因性膀胱に対するEa-0643の臨床評価 --2重盲検比較試験による検討--

Abstract

前立腺肥大症患者37例を3群に分け, CZXをおのおの0.5 g, 1 g, 2 g静脈内投与し, 血清および前立腺組織内濃度について検討した.1) CZXの前立腺組織内濃度は, 前立腺感染症の治療に充分な有効濃度を示した.2) CZX投与後の血清および前立腺組織内濃度はその投与量により, 良好なdose responseを示した.3)摘出前立腺重量および腎機能と前立腺組織内濃度には, 有意の相関関係はなかった

The clinical effectiveness, safety and usefullness of the alpha-adrenergic blocker, Ea-0643 tablet, for the treatment of the neurogenic bladder were evaluated by the double blind test method. A total of 61 patients was treated. Five of them were excluded or dropped out. Eighteen patients (group-A) received a 1.0 mg tablet of Ea-0643, 20 patients (group-B) received a 0.5 mg tablet of Ea-0643 and 17 patients (group-C) received a placebo tablet. Each tablet was administered orally three times a day for two weeks. There was no significant difference in the background factors between the three groups. The rate of effectiveness for subjective symptoms was 22.2% in group-A, 30.0% in group-B and 35.3% in group-C. There was no significant difference between the three groups. The rate of effectiveness for residual urine, judged by decrease in value of residual urine rate after treatment of less than 25%, was 55.6% in group-A, 35.0% in group-B and 17.6% in group-C. The rate of effectiveness in group-A was significantly higher than that in group-C. The mean value of net decreased residual urine rate after treatment in group-A was significantly higher than that in group-C. Decrease of maximal urethral pressure by more than 5 cm H2O was seen in 44.4% of group-A, 35.0% of group-B and 41.2% of group-C. There was no significant difference between the three groups. The rate of improvement for flow rate was 66.7% in group-A, 46.2% in group-B and 36.4% in group-C.(ABSTRACT TRUNCATED AT 250 WORDS)