Wilde M I, Goa K L
Adis International Limited, Mairangi Bay, Auckland, New Zealand.
Drugs. 1999 Apr;57(4):557-81. doi: 10.2165/00003495-199957040-00008.
Finasteride inhibits type 25alpha-reductase activity, significantly reducing dihydrotestosterone levels. Consequent reductions in prostate volume, increases in urinary flow rates and improvements in symptoms compared with placebo have been observed in trials of up to 4 years' duration and in noncomparative extensions (for up to 6 years). Results from the 4-year placebo-controlled PLESS trial show finasteride to significantly reduce the risk of benign prostatic hypertrophy (BPH)-related acute urinary retention and the requirement for surgical intervention. Finasteride has significantly greater efficacy in patients with a large prostate (> or = 40 ml) than in patients with a small prostate. However, the predictive value of prostate size has been questioned. Results of an earlier comparative 1-year trial show terazosin monotherapy and terazosin plus finasteride therapy to be significantly more effective than both finasteride monotherapy and placebo in reducing symptom scores and improving maximum urinary flow rates. Prostatic volume was significantly reduced by finasteride monotherapy and combination therapy only. The overall efficacy of finasteride in patients with mild to moderate symptomatic BPH tended to be greater than that of serenoa repens (Permixon) in a 6-month trial. A US cost analysis model indicates that finasteride and terazosin are less expensive than transurethral resection of the prostate (TURP) during the first 2 years of initiation. Canadian cost-effectiveness and cost-utility analyses using decision analysis modelling have shown primary intervention with finasteride to provide more quality-adjusted life years (QALYs) at lesser cost than watchful waiting or TURP in patients with moderate symptoms who receive the drug for < or = 3 years and < or = 14 years, respectively, but fewer QALYs at a higher cost in patients with severe symptoms needing therapy for > or = 4 years. Confirmatory prospective economic studies are required. Finasteride appears to improve overall quality of life to a similar extent to serenoa repens; patient satisfaction appears similar with finasteride and TURP. Finasteride is generally well tolerated. Most commonly reported adverse effects are sexually related (1 to 2.1 %). Gynaecomastia has been reported in 0.4% of patients.
Despite modest improvements in maximum urinary flow rates and symptom scores, finasteride is a first-line treatment option in those with moderate uncomplicated BPH, especially in patients with a large prostate (> or = 40 ml). It is also an option in patients with more severe symptoms who are unable or unwilling to undergo surgery and in those awaiting surgery. Importantly, finasteride appears to reduce disease progression, significantly decreasing the incidence of acute urinary retention and the requirement for surgical intervention; to date, no other pharmacological agent has been shown to reduce these outcomes.
非那雄胺可抑制25α -还原酶活性，显著降低双氢睾酮水平。在长达4年的试验以及非对照性延长试验（长达6年）中，与安慰剂相比，已观察到前列腺体积缩小、尿流率增加以及症状改善。为期4年的安慰剂对照PLESS试验结果表明，非那雄胺可显著降低良性前列腺增生（BPH）相关急性尿潴留的风险以及手术干预的需求。非那雄胺对前列腺体积较大（≥40 ml）的患者疗效显著优于前列腺体积较小的患者。然而，前列腺大小的预测价值受到质疑。一项早期为期1年的比较试验结果显示，在降低症状评分和提高最大尿流率方面，特拉唑嗪单药治疗以及特拉唑嗪联合非那雄胺治疗比非那雄胺单药治疗和安慰剂均显著更有效。仅非那雄胺单药治疗和联合治疗可显著降低前列腺体积。在一项为期6个月的试验中，非那雄胺对轻度至中度有症状BPH患者的总体疗效往往大于锯叶棕果实提取物软胶囊（保列治）。美国的一项成本分析模型表明，在开始治疗的前2年，非那雄胺和特拉唑嗪比经尿道前列腺切除术（TURP）成本更低。加拿大使用决策分析模型进行的成本效益和成本效用分析表明，对于中度症状患者，分别在接受药物治疗≤3年和≤14年时，非那雄胺作为初始干预措施比观察等待或TURP能以更低成本提供更多质量调整生命年（QALY），但对于需要治疗≥4年的重度症状患者，成本更高且QALY更少。需要进行确证性前瞻性经济学研究。非那雄胺似乎在改善总体生活质量方面与锯叶棕果实提取物软胶囊程度相似；患者对非那雄胺和TURP的满意度似乎相近。非那雄胺一般耐受性良好。最常报告的不良反应与性功能有关（1%至2.1%）。0.4%的患者报告有乳腺增生。
尽管最大尿流率和症状评分有适度改善，但非那雄胺是中度单纯性BPH患者的一线治疗选择，尤其是前列腺体积较大（≥40 ml）的患者。对于有更严重症状但无法或不愿接受手术的患者以及等待手术的患者，它也是一种选择。重要的是，非那雄胺似乎可减少疾病进展，显著降低急性尿潴留的发生率和手术干预的需求；迄今为止，尚无其他药物被证明可降低这些结局。
