爱普列特治疗良性前列腺增生Ⅱ期临床研究

A Multicentre Clinical Trial on Epristeride for Treatment of Benign Prostate Hyperplasia

目的：采用多中心随机对照试验和开放试验观察爱普列特治疗前列腺增生的疗效和安全性。方法：对照药为保列治， ４６７例病人试验组 １１４例，对照组 １１９例，开放组２３４例，试验组服用爱普列特５ｍｇ，每日三次，对照组服用保列治５ｍｇ，每日一次，疗程４个月。结果：试验组总有效率为９１．６％，对照组为８０．４％，开放组为８０．７％，药物不良反应均为轻中度，分别为３．７％，７．１％和７．８％。结论：爱普列特是治疗前列腺增生的一种安全有效的药物，其疗效和耐受性与对照药保列治类似。

OBJECWIE: To study the efficacy and safety of epristeride in the treatment of Benign Prostate hyperplasia(BPH). METHODS: A multicentral randomized controlled clinic trial on epristeride compared with finasteride was conducted. RESULTS: 233 Patients were randomized to receive either epristeride 5mg p.o. bid or finasteride 5mg p.o.qd for 4 months. After 4 months of therapy, the clinic efficacy rate of epristeride and finasteride were 91.6% and 80.7% respectively. The adverse reaction was mild and moderate with the rates of 3.7% and 7. 1 % respectively. An open trial on epristeride for 234-patients wigh BPH was Performed. The clinic efficacy rate and adverse reaction were 80.7% and 7.8% respectively. CONCLUSION: The result suggests that epristeride if efficacy and safe in treatment of BPH. The efficacy and tolerance are similar to that of finasteride.