Lepor H, Williford W O, Barry M J, Haakenson C, Jones K
Veterans Affairs Medical Center and New York University Medical Center, New York, USA.
J Urol. 1998 Oct;160(4):1358-67.
We determine the effect of placebo, finasteride, terazosin and a combination of drugs on bother due to symptoms, quality of life and patient perception of improvement, and identify baseline clinical factors that predict clinical response to medical therapy.
A total of 1,229 subjects with clinical benign prostatic hyperplasia (BPH) were randomized to 1 year of placebo, finasteride, terazosin or drug combination. The primary outcome measures were American Urological Association (AUA) symptom score and peak flow rate. Relevant secondary outcome measures were symptom problem score, BPH impact score and global rating of improvement.
Group mean differences in symptom problem and BPH impact scores between the finasteride versus placebo, and terazosin versus combination groups were not statistically or clinically significant. Group mean differences in all outcome measures were highly statistically significant between the terazosin and finasteride, and combination and finasteride groups. The percentage of subjects who rated improvement as marked or moderate with placebo, finasteride, terazosin and combination was 39, 44, 61 and 65%, respectively. In the subsets of men in the placebo, finasteride, terazosin and combination groups with prostates greater than 50 cm.3 group mean decrease from baseline in AUA symptom score was -2.5, -3.6, -6 and -7, group mean increase in peak flow rate was 0.6, 2.7, 3.6 and 3.7 ml. per second, group mean decrease in symptom problem score was -2.2, - 1.9, -3.1 and -4.5, and group mean decrease in BPH impact score was -0.6, -0.3, -1.1 and -1.5, respectively. A correlational analysis failed to show a significant relationship between baseline prostate volume and treatment response to finasteride. There was a significant but weak relationship between change in AUA symptom score and peak flow rate in the finasteride and combination groups. The symptom responses with terazosin were independent of baseline peak flow rate.
In men with clinical BPH finasteride and placebo are equally effective, while terazosin and combination are significantly more effective. In men with clinical BPH and large prostates the advantage of finasteride over placebo in terms of symptom reduction, impact on bother due to symptoms and quality of life is small at best, while the advantage of terazosin and combination over finasteride and placebo is highly significant. Baseline prostate volume was not a predictor of response to finasteride in the overall study population. On the basis of our results alpha1 blockers, such as terazosin, should be first line medical treatment for BPH.
我们确定安慰剂、非那雄胺、特拉唑嗪及联合用药对症状所致困扰、生活质量和患者改善感知的影响，并识别预测药物治疗临床反应的基线临床因素。
总共1229例临床良性前列腺增生（BPH）患者被随机分为接受1年安慰剂、非那雄胺、特拉唑嗪或联合用药治疗。主要结局指标为美国泌尿外科学会（AUA）症状评分和尿流率峰值。相关次要结局指标为症状问题评分、BPH影响评分和总体改善评级。
非那雄胺与安慰剂组、特拉唑嗪与联合用药组之间症状问题和BPH影响评分的组均值差异在统计学或临床上均无显著意义。特拉唑嗪与非那雄胺组、联合用药与非那雄胺组之间所有结局指标的组均值差异在统计学上具有高度显著性。使用安慰剂、非那雄胺、特拉唑嗪和联合用药治疗后，将改善程度评为显著或中度的受试者百分比分别为39%、44%、61%和65%。在安慰剂、非那雄胺、特拉唑嗪和联合用药组中前列腺体积大于50 cm³ 的男性亚组中，AUA症状评分较基线的组均值下降分别为 -2.5、-3.6、-6和 -7，尿流率峰值的组均值增加分别为0.6、2.7、3.6和3.7 ml/秒，症状问题评分的组均值下降分别为 -2.2、-1.9、-3.1和 -4.5，BPH影响评分的组均值下降分别为 -0.6、-0.3、-1.1和 -1.5。相关性分析未显示基线前列腺体积与非那雄胺治疗反应之间存在显著关系。在非那雄胺组和联合用药组中，AUA症状评分变化与尿流率峰值之间存在显著但较弱的关系。特拉唑嗪的症状反应与基线尿流率峰值无关。
在临床BPH男性患者中，非那雄胺和安慰剂疗效相当，而特拉唑嗪和联合用药显著更有效。在临床BPH且前列腺体积较大的男性患者中，非那雄胺在减轻症状、对症状所致困扰和生活质量的影响方面相对于安慰剂的优势充其量很小，而特拉唑嗪和联合用药相对于非那雄胺和安慰剂的优势则非常显著。在整个研究人群中，基线前列腺体积并非非那雄胺治疗反应的预测指标。基于我们的研究结果，α1受体阻滞剂，如特拉唑嗪，应作为BPH的一线药物治疗。
