神経因性膀胱にともなう排尿障害に対する塩酸ブナゾシンの臨床効果 - 二重盲検比較試験による検討 -

Abstract

標記障碍に対する塩酸プナゾシン(E)の臨床効果を塩化ベタネコール(B), プラセボ(P)を対照薬とする多施設二重盲検比較試験により検討した.総症例数は323例であり, 全般改善度で改善以上を示したものは, E群32.5%, B群28.2%, P群21.2%であり, 有用度においてE群はP群に優れる傾向にあり, 使用にたえないとされた症例においてB群より有意に少なかった.自覚症状改善度において3群に差を認めなかった.他覚所見改善度においてE群がP群に比べ有意に優れていた.他覚所見の変化をみると, E群では最大膀胱容量, 最大膀胱静止圧, 最大尿道内圧への影響が少ないが, 残尿量, 残尿率, 平均尿流量率を有意に改善した.他覚所見改善度の層別解析では, E群は最大膀胱容量, 最大膀胱静止圧のいかんにかかわらず効果を示し, また尿道内圧の高い症例についても明らかな改善を示した.副作用の発現頻度, 臨床検査値異常変動例は3群間で差はなかった.内容についても既に報告されているもの以外特別なものはなかった.塩酸ブナゾシンは神経性膀胱患者の排尿障碍に有用であると認められた

The therapeutic utility of bunazosin hydrochloride was evaluated by a multi-center (67 hospitals) double-blind controlled study in patients who complained of voiding disturbances due to neurogenic bladder. For means of comparison, bethanechol chloride and placebo were used as reference drugs. Bunazosin hydrochloride was orally administered 1.5 mg per day for the first week and 3.0 mg per day for two weeks thereafter (Group E). Bethanechol chloride 15 mg (Group B) and placebo (Group P) were orally administered three times daily for three weeks. Three hundred and twenty-three cases were subjected to this study. The global improvement rating was analyzed for 244 cases (83 in Group E, 78 in Group B and 83 in Group P). The global utility rating (GUR) was analyzed for 252 cases (84 in Group E, 81 in Group B and 87 in Group P). Three hundred and twenty cases (107 in Group E, 104 in Group B and 109 in Group P) were analyzed with respect to overall safety rating (OSR). The global improvement ratings (excellent and good) were 32.5% in Group E, 28.2% in Group B and 21.2% in Group P. In the evaluation of GUR, Group E was superior to Group P. In addition, the incidence judged to be useless in Group E was significantly lower than that in Group B. There were no differences in OSR among these three groups. In the total evaluation of the subjective symptoms, the rates of improvement were not different among these three groups. In the total evaluation of the objective findings, the improvement rate in Group E was significantly higher than that in Group P. In addition, the deterioration rate in Group E was significantly lower than that in Group B. In objective findings before and after administration of bunazosin hydrochloride (Group E), the volume of residual urine, the rate of residual urine and the average flow rate improved significantly However, the bladder capacity, the maximum resting bladder pressure and the maximum urethral pressure did not change significantly. Bunazosin hydrochloride improved the objective findings regardless of the bladder capacity and the maximum resting bladder pressure. These significant improvements were marked in the neurogenic bladder patients who were able to urinate and in the patients whose urethral pressure was high. There were no differences in the incidence of side effects or in the appearance of abnormal values of laboratory findings in these three groups. Neither specific signs nor serious clinical side effects except those reported previously were observed.(ABSTRACT TRUNCATED AT 400 WORDS)