前立腺肥大症に対するCerniltonの臨床評価 -多施設共同によるParaprostとの二重盲検比較試験 -

Abstract

前立腺肥大症に対するCernilton(R)の有用性を検討するため, Paraprost(R)を対照薬とする多施設二重盲検群間比較試験を行った.1)総投与症例数192例中, 総合効果は159例, 総合安全度は178例, 有用度は159例について集計解析した.解析対象例と除外・脱落例の症例の構成および患者の背景因子において両群間に偏りはみられなかった.2)委員会と主治医判定による総合結果, 患者の印象のいずれにおいてもCN群の成績はPP群より高かったが, 両群間に有意差はなかった.3)自覚症状全般改善度の推移において, 4週後の委員会判定による中等度改善以上の改善率でCN群はPP群より有意に優れていた.また排尿困難の有力な指標である苒延性排尿に対する改善率でCN群はPP群より有意に優れていた.4)他覚所見の計測値の検討では, CN群は残尿量, 平均排尿量率, 最大排尿量率, 前立腺重量(Thumann計測)において投与前後の比較で有意の改善が認められた.また残尿量の段階推移においてもCN群で有意の改善が認められた.5)副作用, 臨床検査値で新たな異常値の発現のいずれもCN群にはみられなかった.6)委員会判定による有用度は, CN群はかなり有用以上で49.1%, PP群は41.2%でCN群の成績はPP群より高かったが両群間に有意差はなかった

A multiple center double blind study was performed to study the effectiveness of Cernilton (CN) on benign prostatic hypertrophy in comparison to Paraprost (PP). Among a total of 192 patients, overall effect was studied on 159 patients, overall safety rate on 178 patients and rate of effectiveness on 159 patients. There were no differences between the two groups in the selected patients, criteria for exclusion and drop out cases or background data of the patients. Impression of patients and overall effect by committee and physician judgment were slightly higher in the CN group compared to the PP group, but there was no significant difference between the two groups. For the improvement in subjective symptoms, the rate of moderate improvement or more after 4 weeks by committee judgement was higher in the CN group compared to the PP group. The rate of improvement in protracted miction, which is an effective marker of urinary disturbance, was also higher in the CN group compared to the PP group. An analysis of objective symptoms showed a significant improvement in residual urinary volume, average flow rate, maximum flow rate and prostatic weight in the CN group. A significant improvement in the phased change of residual urinary volume was also seen in the CN group. No side effects or abnormalities in clinical test levels were noted in the CN group. By committee judgement, the rate of more than moderate effectiveness was 49.1% in the CN group compared to 41.2% in the PP group, but there was no significant difference between the two groups. By physician's judgment, the rate of more than moderate effectiveness was 49.4% in the CN group compared to 46.3% in the PP group, but there was also no significant difference between the two groups. These results suggested that Cernilton was an effective drug for benign prostatic hypertrophy.