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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。
OBJECTIVE: To observe the efficacy and safety of epristeride in the treatment of benign prostatic hyperplasia by multicenter randomized controlled trials and open trials. Methods: The control drug was Pristine, 467 patients in the experimental group of 114 cases, 119 cases of control group, 234 cases of open group, the experimental group took Epsilol 5mg, three times daily, the control group took Prolong 5mg daily Once, treatment for 4 months. Results: The total effective rate was 91.6% in the trial group, 80.4% in the control group and 80.7% in the open group. The adverse drug reactions were mild to moderate with 3.7% and 7.1%, respectively 7.8%. Conclusion: Epristeride is a safe and effective drug for the treatment of benign prostatic hyperplasia. Its efficacy and tolerability are similar to those of the control drug Prostate.