神経因性膀胱に対する塩酸ブナゾシンの長期投与に関する検討

Abstract

塩酸ブナゾシン(Ea-0643)を神経因性膀胱に伴う排尿障害患者14名に長期投与した.1)自覚症状のgradeを1～4に分類して観察したところ, 12週後にgradeが1ランク以上改善した改善率は遷延性排尿50.0%, 苒延性排尿16.7%, 尿線の状態25.0%, 腹圧排尿25.0%, 残尿感28.6%であった.2)他覚所見に対する効果では, 投与12週後において自排尿の排尿量, 尿流測定の最大尿流率, 平均尿流率がそれぞれ統計学的に有意の改善を示した.なお最大尿流率, 平均尿流率には投与2週後の早期から有意な改善が認められた.3)自覚症状改善度, 他覚所見改善度, および全般改善度において, 投与2週後よりも12週後に, より良好な効果が認められた.4)本剤の作用機序からいって投与直後から効果が発現し, 尿流動態の改善を契期に, 長期投与においても改善効果が持続するものと思われたが, 本剤の病態薬理学的機序については今後も検討する必要がある.12週後の有用度では有用以上41.7%, やや有用以上91.7%であり, 本剤の臨床的投与には十分期待できるものがある.5)副作用の出現は1例に口内炎がみられた.一旦休薬し口内炎消失後投薬を再開したが, 試験終了まで口内炎の再発はみられなかった

Bunazosin hydrochloride (Ea-0643), a selective alpha 1-blocker, was administered to 14 patients with neurogenic bladder over prolonged periods of time in order to determine its efficacy and safety. Subjective symptoms were classified into 4 grades, and their response assessed after 12 weeks of treatment. The proportion of patients showing improvement by at least one grade was 50.0% for retarded urination, 16.7% for prolonged urination, 25.0% for urinary stream condition, 25.0% for abdominal pressure at voiding, and 28.6% for residual urine. Objective symptoms were also assessed after 12 weeks of treatment, and a statistically significant improvement was recognized in the volume of spontaneously voided urine, the maximum and mean flow rates on uroflowmetry. It should be noted that both of those flow rates had improved significantly only 2 weeks into the treatment. The degree of improvement in subjective and objective symptoms and the degree of general improvement were all higher at week 12 than at week 2 of treatment. Current knowledge of the mechanism of action of this drug, coupled with the observations made in this study, suggests that, once it has improved the urodynamics, it exhibits a sustained effect for prolonged periods of treatment. However, further studies are warranted concerning the mechanisms of the pharmacological action of the drug from a pathological viewpoint. The proportion of patients in whom Ea-0643 was judged to be useful at 12 weeks of treatment was 41.7%, but when the assessment of 'slightly useful' was taken into consideration, the usefulness rate rose as high as 91.7%. Stomatitis was observed in only one case as a side effect of this drug.(ABSTRACT TRUNCATED AT 250 WORDS)