MEDICAL THERAPY IN BENIGN PROSTATIC HYPERPLASIA

两种不同类型药物治疗良性疾病的临床研究 前列腺增生症(BPH)现在已经被美国食品和药物管理局批准 药品管理局。第一种是非那雄胺，一种5-α还原酶 另一种是特拉唑嗪，一种选择性的α-1-肾上腺素能 受体抑制剂。这两种药物以及其他阿尔法阻滞剂， 如多沙唑嗪和哌唑嗪，目前正在美国广泛使用 美国和世界各地，由泌尿科医生和初级保健人员提供 医生，用来治疗前列腺癌的症状。然而，目前尚不清楚 这些药物的治疗是否会减少或防止临床 当长期服用这些药物时，前列腺增生症的进展。 临床上重要的良性前列腺增生症终点包括急性尿潴留， 慢性肾功能衰竭加重，严重的膀胱失代偿 尿潴留和大小便失禁，反复尿路感染和 进行性排尿症状需要手术干预。泌尿外科 NIH NIDDK的临床试验计划也得到了适当的发展 一项前瞻性随机临床研究 非那雄胺、多沙唑嗪联合用药治疗良性前列腺增生症 非那雄胺和多沙唑嗪，以及安慰剂手臂。 通过这一应用，梅奥诊所的临床研究人员 明尼苏达州罗切斯特的泌尿外科正在申请成为 新的RFA中所描述的“临床中心”。我们的研究小组正在寻找 进一步利用前六年积累的人才和经验 多年来，梅奥的工作人员对患有BPH的男性进行了前瞻性研究。我们已经 在进行多中心前瞻性研究方面有丰富的经验 研究良性前列腺增生症自然病史的临床试验 治疗方面，也在众多多中心前瞻性随机分组 行业赞助的临床试验研究非那雄胺，阿尔法- 良性前列腺增生症的阻滞剂和新设备。我们的临床研究团队也有 招收400多名中年男性住院患者的现状和体会 NCI-SWOG新的前列腺癌化学预防试验的过去8个月 癌症(PCPT)，有非那雄胺和安慰剂手臂，有许多 与拟议的NIDDK良性前列腺增生症研究在总体上相似 多中心试验的组织和持续时间。 我们相信梅奥门诊部的能力和经验 泌尿外科临床调查组开展前瞻性试验 前列腺癌应该使我们成为成为 目前的NIDDK RFA中描述的临床中心。

Two different types of medical therapy for the symptoms of benign prostatic hyperplasia (BPH) now have been approved by the U.S. Food and Drug Administration. The first was finasteride, a 5-alpha reductase inhibitor; the other was terazosin, a selective alpha-1-adrenergic receptor inhibitor. Both of these drugs as well as other alpha blockers, such as doxazosin and prazosin, now are being used widely in the United States and around the world, both by urologists and primary care physicians, to treat the symptoms of prostatism. However, it is not known whether treatment with these agents will reduce or prevent the clinical progression of BPH when these medications are taken chronically. Clinically important BPH endpoints include acute urinary retention, increasing renal failure, severe bladder decompensation with chronic retention and incontinence, recurrent urinary tract infections and progressive voiding symptoms requiring surgical intervention. The Urology and Clinical Trials Program of the NIH NIDDK appropriately has developed a prospective randomized clinical research study investigating the long- term medical therapy of BPH using finasteride, doxazosin, the combination of finasteride and doxazosin, and a placebo arm. With this application, clinical research personnel from the Mayo Clinic Department of Urology (Rochester, Minnesota) are applying to be one of the "Clinical Centers" as described in the new RFA. Our research group seeks to further utilize talent and experience generated over the preceding six years by Mayo personnel prospectively studying men with BPH. We already have had extensive experience in conducting multi-center prospective clinical trials investigating the natural history of BPH without treatment, and also in numerous multi-center prospective randomized industry sponsored clinical trials investigating finasteride, alpha- blockers and new devices for BPH. Our clinical research team also has had current experience in enrolling over 400 middle-aged male patients in the past eight months for the new NCI-SWOG chemoprevention trial of prostate cancer (PCPT) which has finasteride and placebo arms and which has many similarities to the proposed NIDDK BPH study in terms of overall organization of the multi-center trial and duration. We believe the ability and experience of the Mayo Clinic Department of Urology clinical investigation team in carrying out prospective trials of prostate disease should make us a strong candidate to become one of the clinical centers as described in the current NIDDK RFA.