頻尿・尿失禁患者における塩酸プロピベリン(バップフォー錠)の長期投与の有効性・安全性の検討

Abstract

1)安全性評価症例141例中, 12週以上投与された症例は101例, 半年(24週)以上の症例は81例, 1年(48週)投与された症例は57例であった.投与が中止された症例は84例であり, おもな理由は来院せず40例, 副作用14例, 症状改善11例などであった. 2)副作用は22例26件に認められ, おもな内訳は消化器系(口渇6件, 便秘4件, 嘔吐・嘔気2件, 下痢2件, 胃痛1件)が9.9%, 泌尿器系(排尿困難4件, 残尿1件)が3.5%であり, 副作用発現頻度は15.6%であった. 3)最終全般改善度は著明改善15例, 改善26例で, 改善率は82.0%(41/50例)であった. 4)1年以上投与例の自覚症状の推移は, 昼間排尿回数は投与前10.3±4.0回が投与1年後は7.1±2.9回に, 夜間排尿回数は投与前4.2±1.7回が投与1年後は2.1±1.1回に, 尿失禁回数については投与前2.9±2.1回が投与1年後は0.7±1.0回に有意に改善した.同様に症状改善度の推移も高い結果が得られた

The safety and efficacy of one-year administration of propiverine hydrochloride (BUP-4 tablets) were assessed in facilities affiliated with the Department of Urology of Yokohama City University School of Medicine. Changes in subjective symptoms showed significant improvement in mean frequency of urination in the daytime from 10.3 +/- 4.0 times before administration to 7.1 +/- 2.9 times 1 year after the start of administration, in mean frequency of voiding at night from 4.2 +/- 1.7 times to 2.1 +/- 1.1 times and in mean incidence of urinary incontinence from 2.9 +/- 2.1 times to 0.7 +/- 1.0 times. The final degree of overall improvement rate was 82.0% (41/50 cases). Adverse effects were observed 26 times in 22 patients, the incidence being 15.6% (22/141 cases). They consisted of digestive symptoms in 9.9% (6 events of dry mouth, 4 of constipation, 2 of abdominal discomfort, 2 of diarrhea and 1 of gastritis), urinary tract symptoms in 3.5% (4 of dysuria and 1 of residual urine), abnormal laboratory findings in 1.4% (increase in glutamic-oxaloacetic transaminase, glutamic-pyruvic transaminase or lactate dehydrogenase levels) and others (1.4%). These results provide further evidence of the safety and efficacy of propiverine hydrochloride (BUP-4 tablets) even when administered for a long-term in the treatment of patients with pollakiuria and urinary incontinence.