アリルエストレノールによる前立腺肥大症の治療成績 ―排尿障害臨床試験ガイドラインに基づいて―

Abstract

尿障害を訴える前立腺肥大症患者129例を対象とし, アリルエストレノール50mg/dayによる内服治療を16週間行い, アリルエストレノールの治療効果と薬剤の安全性を多施設共同研究として検討した.全般治療効果は, 有効27.1%, やや有効43.8%であり, 70.9%にやや有効以上の治療効果が認められた.副作用としては, 性欲の低下5例(3.9%), 紅斑等の皮膚症状2例(1.6%)であった.薬剤投与を中止は4例であり性欲低下, 皮膚症状各々2例であった.皮膚症状は投与中止後, 早期に回復した.性欲の低下については薬剤の投与中止後速やかに回復した症例1例, 中止後変化のなかった症例が1例であった.投与中に生じた臨床検査値異常は21例(16.3%)に38件認められた.LDH上昇, BUN上昇, GPT上昇等がおもなものであった.いずれも軽度であり臨床上特に問題はなく, これらを理由に薬剤の投与を中断或いは中止に至った症例はなかった

One hundred and twenty-nine patients with benign prostatic hypertrophy (BPH) were registered and treated with allylestrenol. Allylestrenol was administered at a dose of 50 mg/day given twice a day for 16 weeks. Out of 129 patients with a mean age of 67.8 years old, 92 cases completed the study and 48 cases with moderate symptoms were objectively evaluated with "Criteria for Treatment Efficacy in BPH" proposed by The Japanese Urological Association in 1997. Prostate volume was significantly decreased from 32.7 +/- 11.9 to 27.4 +/- 11.2 ml (mean +/- SD), and maximum flow rate was significantly increased from 8.4 +/- 3.4 to 10.8 +/- 5.0 ml/sec. Residual urine volume was significantly decreased from 62.4 +/- 57.4 to 37.0 +/- 38.7 ml. IPSS was significantly decreased from 15.3 +/- 4.9 to 9.9 +/- 4.0, and QOL index was significantly decreased from 4.4 +/- 0.8 to 2.7 +/- 1.2. The efficacy of allylestrenol was shown by its effects on prostate volume (anatomy), maximum urinary flow rate (function), and symptom scores (symptom) at the end of 16 weeks of treatment. The rates of improvement for symptoms, QOL, function, and anatomy are 68.7% (N = 48), 79.2% (N = 48), 50.0% (N = 48), and 61.0% (N = 41), respectively. Overall efficacy (Good and Fair) was 70.9% (N = 48). During this study, 5 patients (3.9%) complained of loss of libido and 2 patients dropped out. In conclusion, allylestrenol was demonstrated to be a quite effective and safe medical treatment for patients with symptomatic BPH based on the criteria for treatment efficacy in BPH.