前立腺症による排尿困難に対するα-遮断剤(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

前立腺肥大症174例, 膀胱頸部硬化症31例, 計205例の前立腺症患者に対して, α-交感神経遮断剤である塩酸ブナゾシンを投与してその有効性と至適投与量を検討した.対象症例を4群に分け, 塩酸ブナゾシンの投与量は, 高用量群では初めの1週間を3 mg/日, その後の3週間を4.5 mg/日とした.以下同様に中用量群は1.5 mg/日から3 mg/日, 低用量群は0.15 mg/日から1.5 mg/日, 対照群は0.15 mg/日のままとした.その結果, 本剤による自覚症状を中心とした臨床的有効性が認められた.立ちくらみなどの副作用に注意しつつ, 少量から投与を開始して3 mg/日まで漸増投与することが望ましいと考えられた

A double-blind placebo-controlled study of bunazosin for the treatment of symptomatic prostatism is reported, incorporating urologic departments of 25 hospitals. Four different doses of bunazosin hydrochloride was administrated orally to 174 patients having benign prostatic hyperplasia and 31 with bladder neck contracture for a period of four weeks; high dose group (45 patients, 3 mg/day for the first week followed by 4.5 mg/day for the next three weeks), middle dose group (45 patients, from 1.5 mg/day for the first week to 3.0 mg/day for the next three), low dose group (39 patient, 0.15 mg/day for the first to 1.5 mg/day for the next three) and a control group (40 patients, 0.125 mg/day for the entire four weeks). Subjective symptoms (urinary frequency, retarded urination, prolonged urination, condition of urinary stream and abdominal pressure at voiding) and objective signs (residual ratio, maximum and mean flow rate, voiding time) were observed and analyzed statistically. No bias in the background features was confirmed between any of the four groups. The subjective improvement rates evaluated by the attending doctors demonstrated a significant dose-dependent efficacy of bunazosin by H-test (p less than 0.01), although the objective improvement rates revealed no significant difference between any of the four groups. The global improvement rate evaluated by the same means demonstrated that the middle dose group was significantly superior to the control group (p less than 0.05 by U-test). According to each subjective symptom evaluated by the criteria of the drug efficacy, a dose-dependent significant (p less than 0.01) was noticed between the four groups in the improvement of the voiding condition. Although there was no significant difference by use of the H-test, the middle dose group had a significant superiority to the control group in the improvement rate of retarded voiding by use of the U-test (p less than 0.05). Only in the symptomatic cases of prolonged voiding, were dose-dependent significant differences observed between all four groups by use of the H-test (p less than 0.05). On the other hand, there was no significant difference between the four groups in the subjective or global improvement rates. Judging from the real data and the graded classification of objective signs, the high and middle dose groups were significantly superior to the control in terms of voiding time, and the high and low dose groups were the same as the control for residual urine ratio.(ABSTRACT TRUNCATED AT 400 WORDS)