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首页> 外文期刊>BJU international >Improvements in benign prostatic hyperplasia-specific quality of life with dutasteride, the novel dual 5alpha-reductase inhibitor.
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Improvements in benign prostatic hyperplasia-specific quality of life with dutasteride, the novel dual 5alpha-reductase inhibitor.

机译：新型双重5α-还原酶抑制剂dutasteride可改善前列腺增生所特有的生活质量。

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OBJECTIVES: To examine the effect of the dual-action 5alpha-reductase inhibitor dutasteride on benign prostatic hyperplasia (BPH)-specific health status, as measured by the BPH Impact Index (BII), and to identify baseline and treatment risk factors for those most bothered by their BPH symptoms at the end of the protocol. PATIENTS AND METHODS: Data were derived from three randomized, double-blind, placebo-controlled, 2-year studies conducted in 4325 men with lower urinary tract symptoms caused by benign prostatic enlargement. Each study comprised a 1-month single-blind placebo run-in period, followed by randomization to oral dutasteride 0.5 mg once daily or placebo for 2 years. Patients eligible for inclusion were consenting men aged >/= 50 years with moderate to severe symptoms (American Urological Symptom Index, AUA-SI, score >/= 12), a prostate volume of >/= 30 mL, a serum prostate-specific antigen (PSA) level of >/= 1.5 or < 10 ng/mL, and a maximum urinary flow rate (Qmax) of /= 5 (greatest symptomatic burden) treatment with dutasteride improved the scores by 2.41, while the scores in placebo-treated patients only improved by 1.64. Dutasteride-treated patients with a baseline BII score of < 5 (least symptom burden) had a clinically significant improvement in health status, while placebo-treated patients deteriorated. Regression analysis showed that men with a combination of a baseline BII item-3 score of 3 (bothered a lot) and a high symptom score (AUA-SI >/= 20) were more likely to be bothered by their symptoms at the end of the study. Men receiving placebo were also more likely to be bothered at the end of the study than were those receiving dutasteride. CONCLUSIONS: Dutasteride treatment is associated with clinically significant improvements in BII score, reflecting improvements in the quality of life of men with BPH. Taken together with previously reported improvements in prostate volume, lower urinary tract symptoms and urinary flow, and diminution of the risk of acute urinary retention and the need for BPH-related surgery, dutasteride offers demonstrable efficacy in the management of BPH.
机译：目的：研究双作用5α-还原酶抑制剂度他雄胺对良性前列腺增生（BPH）特定健康状况的影响（通过BPH影响指数（BII）进行衡量），并确定基线和治疗风险因素在方案结束时被其BPH症状困扰。患者与方法：数据来自于4325名因良性前列腺肥大引起的下尿路症状的男性进行的两项随机，双盲，安慰剂对照，为期2年的研究。每项研究包括一个1个月的单盲安慰剂试验期，然后随机分配给口服度他雄胺0.5 mg每天一次或安慰剂2年。符合纳入条件的患者为年龄≥/ = 50岁的中度至严重症状的同意男性（美国泌尿系统症状指数，AUA-SI，评分> / = 12），前列腺体积> / = 30 mL，血清前列腺特异性抗原（PSA）水平> / = 1.5或<10 ng / mL，最大尿流率（Qmax） / = 5（最大症状负担）的患者中，度他雄胺治疗可将评分提高2.41，而安慰剂治疗患者仅可改善1.64。基线BII评分<5（最小症状负荷）的度他雄胺治疗的患者的健康状况在临床上有明显改善，而安慰剂治疗的患者则恶化了。回归分析表明，基线BII项目3评分为3（承受很多）和较高的症状评分（AUA-SI> / = 20）相结合的男性更容易受到症状的困扰。研究。在研究结束时，接受安慰剂的男性比接受度他雄胺的男性更容易受到困扰。结论：度他雄胺治疗与BII评分的临床显着改善有关，反映了BPH男性生活质量的改善。结合以前报道的前列腺体积，下尿路症状和尿流改善，急性尿retention留风险降低以及与BPH相关的手术需求的改善，度他雄胺在BPH的治疗中具有明显的疗效。

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