Moore E, Bracken B, Bremner W, Geller J, Imperato-McGinley J, McConnell J, Roy J, Tenover L, Vaughan D, Pappas F
Merck Research Laboratories, Rahway, NJ 07065, USA.
Eur Urol. 1995;28(4):304-9. doi: 10.1159/000475071.
We assessed the long-term safety and efficacy of finasteride, an orally active 5 alpha-reductase inhibitor, in 2 previously reported groups of patients with symptomatic benign prostatic hyperplasia (BPH). Prostate volume was measured by magnetic resonance imaging, and the maximum urinary flow rate was assessed noninvasively. Symptoms were scored utilizing a patient self-administered symptom score questionnaire. Total symptom scores ranged from 0 (or asymptomatic) to 35 (severely symptomatic). After an initial double-blind period, the patients in study 1 were treated with 10 mg finasteride for 1 year and then switched to 5 mg finasteride for an additional 4 years, whereas patients in study 2 were treated with 5 mg finasteride for the entire 5 years. A total of 190 patients were randomized in the double-blind studies, 156 entered year 1 of the open extension and 70 patients completed 5 years of finasteride therapy. In both studies prostate volume was reduced from baseline by 30%, dihydrotestosterone was reduced by 72%, and the maximum urinary flow rate improved by approximately 1.5 ml/s. Prostate-specific antigen was decreased by approximately 50%. Finasteride was well tolerated; approximately 10% of patients reported sexual adverse experiences during the 5-year study period, which were considered drug related by the investigators. The incidence in reporting sexual adverse experiences did not increase with the increased duration of treatment: findings consistent with previous reports. In summary treatment of BPH with finasteride for 5 years inhibits the progression of the disease with an excellent safety profile and represents a low-risk medical option for the treatment of symptomatic BPH.
我们评估了非那雄胺（一种口服活性5α-还原酶抑制剂）在2组先前报道的有症状良性前列腺增生（BPH）患者中的长期安全性和疗效。通过磁共振成像测量前列腺体积，并采用非侵入性方法评估最大尿流率。利用患者自行填写的症状评分问卷对症状进行评分。总症状评分范围为0（无症状）至35（症状严重）。在初始双盲期后，研究1中的患者接受10mg非那雄胺治疗1年，然后改用5mg非那雄胺再治疗4年，而研究2中的患者在整个5年期间均接受5mg非那雄胺治疗。共有190例患者在双盲研究中随机分组，156例进入开放延长期的第1年，70例患者完成了5年的非那雄胺治疗。在两项研究中，前列腺体积较基线水平均减少了30%，二氢睾酮减少了72%，最大尿流率提高了约1.5ml/s。前列腺特异性抗原降低了约50%。非那雄胺耐受性良好；在5年研究期间，约10%的患者报告有性方面的不良经历，研究人员认为这些与药物有关。报告性不良经历的发生率并未随着治疗时间的延长而增加：这一结果与先前的报道一致。总之，用非那雄胺治疗BPH 5年可抑制疾病进展，安全性良好，是治疗有症状BPH的低风险医疗选择。
