Lowe Franklin C, McConnell John D, Hudson Perry B, Romas Nicholas A, Boake Rex, Lieber Michael, Elhilali Mostafa, Geller Jack, Imperto-McGinely Juliane, Andriole Gerald L, Bruskewitz Reginald C, Walsh Patrick C, Bartsch Georg, Nacey John N, Shah Sukrut, Pappas Frances, Ko Amy, Cook Thomas, Stoner Elizabeth, Waldstreicher Joanne
Department of Urology, Saint Luke's-Roosevelt Hospital Center, New York, NY 10019, USA.
Urology. 2003 Apr;61(4):791-6. doi: 10.1016/s0090-4295(02)02548-7.
To summarize the 6-year clinical trial data with finasteride. Benign prostatic hyperplasia is a chronic and progressive disease and therefore assessment of long-term safety and efficacy is important.
The North American and International Phase III Finasteride trials enrolled symptomatic men with enlarged prostate glands. The initial 1-year placebo-controlled study was followed by a 5-year open-label extension. In total, 6-year finasteride data were available in 487 patients originally randomized to finasteride, and 5-year data were available on 238 patients originally randomized to placebo.
After 6 years of treatment with finasteride 5 mg, the mean quasi-American Urological Association Symptom Score improved by 4.0 points, the median prostate volume decreased by 24%, and the mean maximal urinary flow rate increased by 2.9 mL/s (P <0.001 for all parameters). Long-term finasteride treatment was well tolerated, with a low incidence of drug-related sexual adverse events occurring during the first year and even fewer occurrences during the 5-year open extension.
Treatment with finasteride leads to durable improvement in urinary tract symptoms, flow rate, and prostate volume, with no increase in the prevalence of drug-related adverse events over time.
总结非那雄胺6年的临床试验数据。良性前列腺增生是一种慢性进行性疾病，因此评估其长期安全性和有效性很重要。
北美和国际非那雄胺III期试验纳入了有前列腺增大症状的男性。最初为期1年的安慰剂对照研究之后是为期5年的开放标签扩展研究。共有487例最初随机分配接受非那雄胺治疗的患者有6年的非那雄胺数据，238例最初随机分配接受安慰剂治疗的患者有5年的数据。
接受5mg非那雄胺治疗6年后，美国泌尿外科学会症状评分平均改善4.0分，前列腺体积中位数下降24%，最大尿流率平均增加2.9mL/s（所有参数P<0.001）。长期非那雄胺治疗耐受性良好，第一年药物相关性不良事件发生率较低，在5年的开放扩展期发生率更低。
非那雄胺治疗可持久改善尿路症状、尿流率和前列腺体积，且随着时间推移药物相关性不良事件的发生率没有增加。
