非那雄胺对良性前列腺增生男性急性尿潴留风险及手术治疗需求的影响。非那雄胺长期疗效和安全性研究组。

The effect of finasteride on the risk of acute urinary retention and the need for surgical treatment among men with benign prostatic hyperplasia. Finasteride Long-Term Efficacy and Safety Study Group.

作者信息

McConnell J D, Bruskewitz R, Walsh P, Andriole G, Lieber M, Holtgrewe H L, Albertsen P, Roehrborn C G, Nickel J C, Wang D Z, Taylor A M, Waldstreicher J

机构信息

University of Texas Southwestern Medical Center, Dallas 75235-9110, USA.

出版信息

N Engl J Med. 1998 Feb 26;338(9):557-63. doi: 10.1056/NEJM199802263380901.

DOI:10.1056/NEJM199802263380901

PMID:9475762

Abstract

BACKGROUND

Finasteride is known to improve urinary symptoms in men with benign prostatic hyperplasia, but the extent to which the benefit is sustained and whether finasteride reduces the incidence of related events, including the need for surgery and the development of acute urinary retention, is not known.

METHODS

In this double-blind, randomized, placebo-controlled trial, we studied 3040 men with moderate-to-severe urinary symptoms and enlarged prostate glands who were treated daily with 5 mg of finasteride or placebo for four years. Symptom scores (on a scale of 1 to 34), urinary flow rates, and the occurrence of outcome events were assessed every four months in 3016 men. Prostate volume was measured in a subgroup of the men. Complete data on outcomes were available for 2760 men.

RESULTS

During the four-year study period, 152 of the 1503 men in the placebo group (10 percent) and 69 of the 1513 men in the finasteride group (5 percent) underwent surgery for benign prostatic hyperplasia (reduction in risk with finasteride, 55 percent; 95 percent confidence interval, 41 to 65 percent). Acute urinary retention developed in 99 men (7 percent) in the placebo group and 42 men (3 percent) in the finasteride group (reduction in risk with finasteride, 57 percent; 95 percent confidence interval, 40 to 69 percent). Among the men who completed the study, the mean decreases in the symptom score were 3.3 in the finasteride group and 1.3 in the placebo group (P<0.001). Treatment with finasteride also significantly improved urinary flow rates and reduced prostate volume (P<0.001).

CONCLUSIONS

Among men with symptoms of urinary obstruction and prostatic enlargement, treatment with finasteride for four years reduces symptoms and prostate volume, increases the urinary flow rate, and reduces the risk of surgery and acute urinary retention.

摘要

背景

非那雄胺已知可改善良性前列腺增生男性的排尿症状，但获益能持续的程度以及非那雄胺是否能降低包括手术需求和急性尿潴留发生在内的相关事件的发生率尚不清楚。

方法

在这项双盲、随机、安慰剂对照试验中，我们研究了3040名有中度至重度排尿症状且前列腺增大的男性，他们每天接受5毫克非那雄胺或安慰剂治疗四年。每四个月对3016名男性评估症状评分（1至34分）、尿流率和结局事件的发生情况。对部分男性亚组测量前列腺体积。有2760名男性可获得完整的结局数据。

结果

在四年研究期间，安慰剂组1503名男性中有152名（10%）因良性前列腺增生接受手术，非那雄胺组1513名男性中有69名（5%）接受手术（非那雄胺降低风险55%；95%置信区间，41%至65%）。安慰剂组99名男性（7%）发生急性尿潴留，非那雄胺组42名男性（3%）发生急性尿潴留（非那雄胺降低风险57%；95%置信区间，40%至69%）。在完成研究的男性中，非那雄胺组症状评分平均降低3.3分，安慰剂组降低1.3分（P<0.001）。非那雄胺治疗还显著改善了尿流率并减小了前列腺体积（P<0.001）。