前立腺肥大症に対するTZP-4238の臨床的検討 : 尿流動態におよぼす影響

Abstract

排尿障害を有する前立腺肥大症の患者24例を対象に, TZP-4238の尿流動態におよぼす影響ならびに有効性, 安全性, 有用性を検討した。1)自覚症状改善度の改善率は52.9%であった。2)尿流率のノモグラムはMFRおよびAFRともに, 投与後, 有意な改善を示した。膀胱内圧では投与後, 最大膀胱容量の有意な減少が認められたが, このとき有効膀胱容量は投与前後で変化が認められなかった。これらを総合した尿流動態の改善率は43.8%であった。3)超音波断層撮影による前立腺計測では投与後, 有意な縮小を認め, 縮小以上の改善度は57.1%であり, その縮小率は15.4%であった。4)有効性評価における改善率は, 58.8%であった

Twenty four cases of benign hypertrophy with bladder outlet obstruction were treated with 17 alpha-acetoxy-6-chloro-2-oxa-4, 6-pregnadiene-3, 20-dione (TZP-4238), and the effects on urodynamic parameters, clinical efficacy, safety, and usefulness were evaluated. Improvement rate of subjective rate of subjective symptoms was 52.9%. Obstructive symptoms improved more prominently than irritation symptoms. A significant improvement in flow rate of nomograms for maximum flow rate (MFR) and average flow rate (AFR) accompanied with the decrease in the prostatic weight were observed. However, no changes were observed on the urethral sphincter electromyography and the urethral pressure profile. A significant decrease of maximum cystometric capacity was observed, although the effective cystometric capacity was not changed. The overall improvement rate for urodynamic parameters was 43.7%. A significant decrease in weight and diameter of the prostate was observed. The prostatic weight decreased in 57.1%, and the average reduction rate was 15.4%. The overall improvement rate concerning clinical efficacy evaluating both subjective symptoms and objective parameters was 58.8%. Adverse reactions were observed in 5 cases. They were judged as not clinically problematic. Taking into account clinical safety and clinical efficacy, the clinical usefulness was 50.0%. TZP-4238 was considered to be an appropriate agent for treating patients with benign prostatic hypertrophy with bladder outlet obstruction.