爱普列特对良性前列腺增生的安全性观察

目的：观察爱普列特治疗良性前列腺增生（BPH）的安全性。方法：入选46例患者口服爱普列特片5mg,bid，疗程4个月。结果：受试者中7例停药，39例完成试验，7例（10例次）出现副作用（4例失眠，3例恶心，2例头昏，1例性欲减退）而停药。服药2，4个月后，部分血液生化指标较服药前差异有显著性，这些指标变化幅度较小且均在正常范围内，不具有临床意义。结论：爱普列特是一种较为安全的治疗良性前列腺增生药物。

Safety of Epristeride on Benign Prostatic Hyperplasia

Objective:To observe the safety of epristeride on benign prostatic hyperplasia. Methods:46 patients with benign prostatic hyperplasia (BPH) were recruited for the study. All of them were administered with oral intake of 5mg of epristeride, twice a day for 4 months. Results:Side effects were found in 7 patients, including anypanias (4/46, 8.70%), sicchasia (3/46, 6.52%), dizziness (2/46, 4.35%) and decrease of libido (1/46, 2.17%), but alleviated or disappeared in a short time. 7 patients dropped out of the study. The changes of some of the major blood biochemical parameters have statistical significance after 2 to 4 months of the treatment when compared with the baseline. However, all the parameters were still in the normal range and have not clinical significance. Conclusion: Epristeride is a safe drug for the treatment of human BPH.