Peters D H, Sorkin E M
Adis International Limited, Auckland, New Zealand.
Drugs. 1993 Jul;46(1):177-208. doi: 10.2165/00003495-199346010-00010.
Finasteride is a novel therapeutic agent that selectively inhibits the enzyme 5 alpha-reductase, thereby reducing prostatic dihydrotestosterone (DHT) levels and prostate size. In men with symptomatic benign prostatic hyperplasia (BPH), these effects have been associated with improvements in peak urinary flow rate and urological symptoms; withdrawal from therapy, however, results in regrowth of the adenoma and long term therapy is therefore necessary. Although the magnitude of clinical improvement seen with finasteride has been perceived to be modest [especially when compared with that associated with transurethral resection of the prostate (TURP)], it has been maintained in the medium term (up to 2 years) and thus may represent significant reversal of disease progression. Such beneficial effects, however, may not become apparent until completion of at least 6 months of therapy. Furthermore, since clinical studies have been unable to proactively identify a responsive subgroup, a trial period of 6 or possibly 12 months is necessary to assess patient responsiveness. Despite these potential shortcomings, the benefits of therapy appear to outweigh the risks. Indeed, finasteride is well tolerated; most adverse events have been related to sexual dysfunction (decreased libido, ejaculation disorders and impotence) and occurred in only a small proportion (about 2 to 3%) of patients. Moreover, although there has been concern that finasteride might mask the detection of prostate cancer through its decremental effects on serum prostate specific antigen (PSA) levels, careful monitoring in clinical trials appears to have avoided this problem. Thorough pretreatment assessment and periodic follow-up examinations for malignancy are therefore required in clinical practice. The role of finasteride in the treatment of patients with BPH is still emerging and will no doubt gain in clarity with further planned investigations. TURP (or other invasive procedures such as the insertion of prostatic stents in patients unsuitable for resection), continues to be the mainstay of therapy for those patients with severe symptomatic BPH. However, available data support a first line role for finasteride in the treatment of patients with uncomplicated symptomatic BPH. Within this setting, finasteride appears to offer a needed additional treatment option for those patients in whom surgery is not indicated, and may be of special benefit to the considerable proportion of patients who opt not to undergo prostatectomy.
非那雄胺是一种新型治疗药物，它能选择性抑制5α-还原酶，从而降低前列腺双氢睾酮（DHT）水平并缩小前列腺体积。在有症状的良性前列腺增生（BPH）男性患者中，这些作用与最大尿流率及泌尿系统症状的改善相关；然而，停药会导致腺瘤再生，因此需要长期治疗。尽管非那雄胺带来的临床改善程度被认为较为有限[尤其是与经尿道前列腺切除术（TURP）相关的改善程度相比]，但这种改善在中期（长达2年）得以维持，因此可能代表疾病进展的显著逆转。不过，这些有益效果可能要到至少6个月的治疗结束后才会显现。此外，由于临床研究无法预先确定有反应的亚组，因此需要6个月或可能12个月的试验期来评估患者的反应性。尽管存在这些潜在缺点，但治疗的益处似乎超过风险。事实上，非那雄胺耐受性良好；大多数不良事件与性功能障碍（性欲减退、射精障碍和阳痿）有关，且仅在一小部分（约2%至3%）患者中出现。此外，尽管有人担心非那雄胺可能因其对血清前列腺特异性抗原（PSA）水平的降低作用而掩盖前列腺癌的检测，但临床试验中的仔细监测似乎避免了这个问题。因此，临床实践中需要进行全面的治疗前评估和定期的恶性肿瘤随访检查。非那雄胺在BPH患者治疗中的作用仍在逐渐显现，随着进一步的计划研究，无疑会更加清晰。TURP（或其他侵入性手术，如在不适合切除的患者中插入前列腺支架）仍然是那些有严重症状的BPH患者的主要治疗方法。然而，现有数据支持非那雄胺在治疗无并发症的有症状BPH患者中作为一线治疗药物的作用。在这种情况下，非那雄胺似乎为那些不适合手术的患者提供了一种必要的额外治疗选择，对于相当一部分选择不接受前列腺切除术的患者可能特别有益。
