Nacey J N, Meffan P J, Delahunt B
Department of Surgery, Wellington School of Medicine, New Zealand.
Aust N Z J Surg. 1995 Jan;65(1):35-9. doi: 10.1111/j.1445-2197.1995.tb01744.x.
This study was designed to determine the efficacy of the 5 alpha-reductase inhibitor finasteride (Proscar, MK-906) in men with reduced urinary flow rates and symptoms of urinary outflow obstruction secondary to benign prostatic hyperplasia. Forty-five men were randomized to one of three groups receiving either placebo, 1 mg/day or 5 mg/day finasteride for the first 12 months of the study period. At the end of this period all men received 5 mg/day finasteride for a further 2 years. Efficacy was determined by measurement of prostate volume, maximum urinary flow rate, and symptom score using a modified Boyarsky assessment. Prostate volume reduced by 20 and 27%, respectively, for those on 1 and 5 mg after the first year. At 3 years the volume had reduced by 43%. This reduction in prostate volume was associated with an improvement in maximum urinary flow rate by 50% (1 mg), and 35% (5 mg) at 1 year, and 36% at 3 years. The total, obstructive and non-obstructive symptom scores decreased (improved) for patients on 1 and 5 mg finasteride, with the total score reducing by 33% from baseline at year 3. The results demonstrate that finasteride causes a modest but significant clinical improvement in men with urinary outflow obstruction secondary to benign prostatic hyperplasia.
本研究旨在确定5α-还原酶抑制剂非那雄胺（保列治，MK-906）对因良性前列腺增生导致尿流率降低和尿路梗阻症状的男性患者的疗效。45名男性被随机分为三组，在研究的前12个月分别接受安慰剂、1毫克/天或5毫克/天的非那雄胺治疗。在此期间结束时，所有男性再接受2年5毫克/天的非那雄胺治疗。通过使用改良的博亚尔斯基评估法测量前列腺体积、最大尿流率和症状评分来确定疗效。第一年，服用1毫克和5毫克非那雄胺的患者前列腺体积分别减少了20%和27%。3年后，体积减少了43%。前列腺体积的这种减少与最大尿流率在1年时提高50%（1毫克组）和35%（5毫克组）以及3年时提高36%相关。服用1毫克和5毫克非那雄胺的患者的总症状评分、梗阻性症状评分和非梗阻性症状评分均下降（改善），到第3年时总分较基线降低了33%。结果表明，非那雄胺对因良性前列腺增生导致尿路梗阻的男性患者有适度但显著的临床改善作用。
