頻尿・残尿感に対する塩酸テロジリンの臨床薬効評価 - 塩酸フラボキサートを対照とした二重盲検比較試験 -

Abstract

神経性頻尿, 慢性前立腺炎, 慢性膀胱炎などに基づく頻尿, 残尿感を主訴とする患者225例を対象に, 塩酸テロジリン24 mg/日投与, あるいは塩酸フラボキサート600 mg/日投与の2群による二重盲検比較試験を行い, 有用性の検討を行った.1)最終全般改善度は, 塩酸テロジリン投与で70%, 塩酸フラボキサート投与で48%であり, 両群間に有意差を認めた.2)概括安全度では, 両群間に有意差はなかった.3)全般有用度は, 塩酸テロジリン投与では68%, 塩酸フラボキサート投与では45%であり, 両群間に有意差があった.4)昼間頻尿, 夜間頻尿, 尿失禁の改善率並びに昼間頻尿の消失率では塩酸テロジリン投与が塩酸フラボキサート投与に比して有意に優れていた.残尿感は塩酸テロジリン投与と塩酸フラボキサート投与で同程度の成績であった.5) 1日の排尿回数については塩酸テロジリン投与が塩酸フラボキサート投与に比して有意な減少を示した.6)副作用は塩酸テロジリン投与では13例(12%), 塩酸フラボキサート投与では17例(16%)で, 両群間に有意差はなく, また臨床検査成績についても特記すべき変動はなかった

A double blind clinical trial was performed as a multicenter study to determine the usefulness of terodiline hydrochloride (HCl), an anticholinergic and calcium antagonistic agent, for urinary frequency or sense of residual urine in patients with psychogenic diseases, chronic prostatitis or chronic cystitis. Either 24 mg of terodiline HCl a day or 600 mg of flavoxate HCl a day was given for 4 weeks. One hundred and ninety-nine patients completed the test. The final global improvement rating was 70% in patients given terodiline HCl and 48% in patients given flavoxate HCl. The difference was statistically significant (p less than 0.01). Diurnal and nocturnal urinary frequency and urinary incontinence were less in patients given terodiline HCl than in patients given flavoxate HCl (p less than 0.01). No difference was noted between the two agents in relieving sense of residual urine. Compared with the control period, the average urinary frequency decreased 2.0 times a day in patients given terodiline HCl and 0.7 times in patients given flavoxate HCl. The difference was statistically significant (p less than 0.01). Adverse effects were observed in 12% of the patients given terodiline HCl and in 16% of the patients given flavoxate HCl. They included thirst, difficult urination, constipation, slight increase of serum GOT, GPT or alkaline phosphatase, and so forth. They disappeared with discontinued use of the agent. The global utility rating was 68% in patients given terodiline HCl and 45% in patients given flavoxate HCl, the difference being significant (p less than 0.01). These results indicate that terodiline HCl is useful for the treatment of urinary symptoms in patients with psychogenic diseases, chronic prostatitis or chronic cystitis.