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目的：临床研究新型非竞争性５ ａ－还原酶抑制剂——爱普列特（ｅｐｒｉｓｔｅｒｉｄｅ）治疗良性前列腺增生症（ＢＰＨ）的疗效及安全性。方法采用与保列治随机对照的方法在多中心临床应用爱普列特治疗良性前列腺增生症３０例，开放性治疗１３３例。结果：随机对照试验结果显示，爱普列特较保列治治疗良性前列腺增生起效更快，治疗２个月后，治疗组总有效率为８６．７％，对照组总有效率为４０．０％；治疗４个月后，治疗组总有效率为９３．３％，对照组总有效率为８６．７％，两者相比无显著性差异。治疗组不良反应发生率为６．７％（２／３０），对照组药物不良反应发生率为１３．３％（４／３０），两者比较有显著性差异（Ｐ＜０．０１）。爱普列特开放性治疗后２个月及４个月时的总有效率分别为５７．９４％和８３．３３％。结论：爱普列特可明显改善ＢＰＨ患者排尿症状、尿流率和残余尿量，缩小前列腺体积。用药后２个月即获得明显疗效，用药后４个月的疗效与保列治相比无显著性差别，无严重药物不良反应，对性功能的影响较小，可作为治疗ＢＰＨ的一种较为理想的新药。
Objective: To study the efficacy and safety of a novel non-competitive 5-a-reductase inhibitor epristeride in the treatment of benign prostatic hyperplasia (BPH). Methods A randomized controlled clinical trial of Epsilon was used in 30 patients with benign prostatic hyperplasia and 133 patients undergoing open-label treatment. Results: The results of randomized controlled trials showed that epristeride was more effective than Proliferation in the treatment of benign prostatic hyperplasia. After 2 months of treatment, the total effective rate was 86.7% in the treatment group and 40% in the control group. 0%. After 4 months of treatment, the total effective rate was 93.3% in the treatment group and 86.7% in the control group. There was no significant difference between the two groups. The incidence of adverse reactions in the treatment group was 6.7% (2/30), and the incidence of adverse drug reactions in the control group was 13.3% (4/30). There was significant difference between the two groups (P <0.01). The total effective rates at 2 and 4 months after the opening of Epsilon were 57.94% and 83.33% respectively. Conclusion: Epristeride can significantly improve urination symptoms, urinary flow rate and residual urine volume in BPH patients and reduce prostate volume. 2 months after treatment, significant effect was obtained. After 4 months of treatment, there was no significant difference between the two groups in the curative effect of Prism, no serious adverse drug reactions and less effect on sexual function, which could be used as a kind of treatment for BPH Ideal new drug.