頻尿を主とした排尿異常に対するKL 007(塩酸オキシブチニン)の臨床的効果 --第2相試験

Abstract

神経性頻尿, 刺激膀胱, 神経因性膀胱などの, 頻尿症状を主とした排尿異常52例に6～12 mg/日を1乃至2週間投与したところ, 一日投与量とは無関係に, 頻尿, 尿意促迫感, 排尿時不快感, 尿失禁などに有効で, 残尿感, 排尿痛にもある程度の効果があった.初発尿意量, 最大膀胱容量は増大する傾向にあったが, 残尿量, 残尿率についてはほとんど変化を与えなかった.総合効果においてやや有効以上は神経性頻尿で75.0%, 刺激膀胱で59.4%, 神経因性膀胱で66.7%であった.副作用は, 41.1%の症例にみられたが, 口渇が主であり, 重篤なものはなかった

The clinical effectiveness of KL 007 (oxybutynin hydrochloride) was studied on patients with urinary disturbance, mostly complaints of urinary frequency, who were suffering from nervous pollakisuria, irritable bladder or neurogenic bladder. Fifty two patients were administered KL 007 three times daily at the dose of 6 mg, 9 mg, or 12 mg per day for one or two weeks. An overall clinical effectiveness of KL 007 was seen in the cases of hypertonic bladder. As to the clinical effectiveness of subjective symptoms, KL 007 improved the symptoms of urinary frequency, urinary incontinence, discomfort upon micturition, urinary urgency and sense of residual urine. Transient side effects were observed in 23 cases (41.4%), and dry mouth was most observed. No severe side effects were noticed.