下部尿路通過障害患者に対するYM617の長期投与における有効性および安全性

Abstract

前立腺肥大症111例, 膀胱頸部硬化症6例, 前立腺肥大症+膀胱頸部硬化症3例, 女性の排尿困難1例の計121例に対して, α1受容体遮断薬であるYM 617を0.1～0.4 mg/日投与した.1)患者の印象および主治医による自覚症状改善度の改善率は投与期間が増すにしたがって高くなり, 16～20週以降はほぼ一定の値に維持された.他覚所見改善度の改善率は4週以降ほぼ一定の値に維持された.2)患者の印象および自覚症状改善度において増量効果が認められた.3)副作用は3例にみられたが, 重篤なものはなかった.血圧・脈拍, 臨床検査値に影響をおよぼさなかった.以上, YM 617は長期間投与しても効果は維持され, 安全性も高いことから, 前立腺肥大症に代表される下部尿路通過障害患者に対し有用性の高い薬剤である

The efficacy and safety of YM617, a new alpha 1-blocker, were evaluated in 121 patients with urinary obstruction of the lower urinary tract in the long-term administration study for 1 year. A total of 121 patients, i.e., 111 with benign prostatic hypertrophy (BPH), 6 with bladder neck sclerosis (BNS), 3 with BPH with BNS and 1 with female urinary obstruction, were orally administered 0.1 to 0.4 mg of YM617 once daily. Patients showing improvement of patient's impression and of subjective symptoms judged by the physician were increased until the 16th to 20th week, and it had been maintained there after. Objective findings were improved to a constant level after the 4th week. Patient's impression and subjective symptoms were improved in a certain dose-response relationship Side effects were observed in 3 patients but none were serious. YM617 proved to be useful in the treatment of patients with urinary obstruction of the lower urinary tract like BPH because it maintained the efficacy and safety in the long-term administration.