新型5α-还原酶抑制剂爱普列特治疗良性前列腺增生的Ⅳ期临床研究

Phase Ⅳ study with epristeride,a new type of 5α-reductase inhibitor,on treatment of benign prostatic hyperplasia

目的 探讨新型非竞争性 5α 还原酶抑制剂爱普列特 (epristeride)治疗良性前列腺增生(BPH)的有效性及安全性。 方法 采用多中心开放临床试验方法 ,对 2 0 0 6例BPH患者进行为期4个月的观察。口服爱普列特每日 2次 ,每次 5mg。 结果 给药后 4个月 ,国际前列腺症状 (IPSS)评分较治疗前平均降低 6 .12分 (2 8.8% ) ,P <0 .0 0 0 1;最大尿流率较治疗前平均增加 3.48ml/s(33.4% ) ,P <0 .0 0 0 1,前列腺体积平均缩小 4.91ml(11.6 % ) ,P <0 .0 0 0 1;剩余尿量平均减少 19.1ml(38.4% ) ,P <0 .0 0 0 1,差别均有极显著性意义。治疗总有效率 83.4%。临床不良反应发生率6 .6 3% ,多为轻中度。实验室检查异常发生率 2 .49%。 结论 爱普列特可明显改善BPH患者的排尿症状、缩小前列腺体积、增加尿流率、减少剩余尿量 ,不良反应发生率低 ,是一种安全有效的治疗BPH的新药。

Objective Study the efficacy and safety of epristeride, a new uncompetitive 5α-reductase inhibitor, in the treatment of benign prostatic hyperplasia(BPH). Methods A multicentral opened clinical trial was conducted. 2 006 BPH patients were enrolled in the trial, in which 5mg epristeride was orally administered twice a day. Results After 4 months therapy, IPSS score was averagely decreased 6.12(28.8%) ( P <0.0001); maximum urinary flow rate was averagely increased 3.48 ml/s(33.4%) ( P <0.0001); prostatic volume was averagely decreased 4.91 ml(11.6%) ( P < 0.0001 ); residual urinary volume was averagely decreased 19.1 ml(38.4%) ( P < 0.0001 ). The total effective rate was 83.4%. The clinical adverse rate was 6.63%, and most of adverse reaction were mild and moderate. The laboratory abnormity rate was 2.49%. Conclusions Epristeride, as a new 5α-reductase inhibitor, for the treatment of BPH, is effective and safe to improve the subjective symptom and objective data of the patients.