MEDICAL THERAPY IN BENIGN PROSTATIC HYPERPLASIA

两种不同类型的药物治疗的症状良性 前列腺增生症（BPH）现在已经被美国食品和药物管理局批准， 药品监督管理总局. 第一个是芬替林，一种5-α还原酶 抑制剂;另一种是特拉唑嗪，一种选择性α-1-肾上腺素能 受体抑制剂 这两种药物以及其他α受体阻滞剂， 如多沙唑嗪和哌唑嗪，现在正在美国广泛使用， 美国和世界各地，泌尿科医生和初级保健 医生，治疗前列腺增生症的症状。 但殊不知 用这些药物治疗是否会减少或预防临床 前列腺增生的进展，当这些药物是长期服用。 临床上重要的BPH终点包括急性尿潴留， 肾功能衰竭加重，严重膀胱失代偿伴慢性 尿潴留和尿失禁，复发性尿路感染， 需要手术干预的进行性排尿症状。 泌尿 NIH NIDDK的临床试验项目已经适当地开发了 一项前瞻性随机临床研究，调查长期- 前列腺增生症的长期药物治疗，使用芬氟拉明，多沙唑嗪，联合用药 多沙唑嗪和安慰剂组。 有了这个应用程序，来自马约诊所的临床研究人员 泌尿科（罗切斯特，明尼苏达州）正在申请成为其中一个 新RFA中描述的“临床中心”。 我们的研究小组寻求 进一步利用前六年产生的人才和经验， 年由马约人员前瞻性研究男性BPH。 我们已经 在开展多中心前瞻性研究方面具有丰富的经验 研究BPH自然史的临床试验， 治疗，以及许多多中心前瞻性随机 行业赞助的临床试验，研究芬迪，α- 前列腺增生症的阻断剂和新设备。 我们的临床研究团队也有 目前在400多名中年男性患者中招募的经验 过去八个月的新NCI-SWOG前列腺化学预防试验 癌症（PCPT），其中有芬鲁胺和安慰剂组， 在总体方面与拟议的NIDDK BPH研究相似 多中心试验的组织和持续时间。 我们相信马约诊所的能力和经验， 泌尿外科临床研究小组在进行前瞻性试验， 前列腺疾病应该使我们成为一个强有力的候选人之一， 当前NIDDK RFA中所述的临床中心。

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.