MEDICAL THERAPY BENIGN PROSTATIC HYPERPLASIA

描述（改编自主要研究者的摘要） 在过去的十年中，BPH 的治疗被重新定义。 医疗 目前治疗 BPH 已被广泛接受。 医疗 自诞生以来，该疗法对临床 BPH 的治疗具有独特的吸引力 药物治疗的副作用很小并且是可逆的，治疗是 如果不良经历严重或治疗无效，则简单终止 无效。 大约有1000万美国50岁以上男性 年患有继发于 BPH 的中度/重度泌尿系统症状。 的 所有受影响的美国男性每年的估计医疗费用 临床BPH为36亿美元。 由于医疗保健资源 药物治疗的价值是有限的 定义的。 确定任何 BPH 治疗的价值需要 了解疾病的自然史、最初和 治疗的长期有效性和发病率，以及影响 对疾病进展的治疗。 美国国立卫生研究院 (NIH) 投入了大量资源来开展全面的研究 主要目的是确定药物治疗是否有效的临床试验 延缓或阻止 BPH 的进展。 研究设计还将 允许直接比较近期和长期的安全性 α阻断剂（多沙唑嗪）和激素疗法（非那雄胺）的功效 对于前列腺增生症。 14 个临床中心将招募约 2,800 名患者 两年时间内遍布美国各地。 纳入和 排除标准旨在识别具有显着临床症状的男性 没有绝对手术干预指征的 BPH。 的 纽约大学 (NYU) 医学中心泌尿外科拥有 人员、设施、患者转诊基础、机构支持和 致力于成为 NIH 资助的有效临床中心 BPH 的全面临床试验。 研究人员表示，目前的拨款申请将 证明主要研究人员和副主要研究人员都已 参与了许多随机临床试验，评估了 BPH 的药物和设备治疗的安全性和有效性。 纽约大学 医学中心泌尿外科作为全国六大临床科室之一 初步 BPH 试点研究中心。 这个的表现 中心在试点研究期间表明了能力和承诺 支持人员的数量以及临床中心的招募能力 足够的患者参加随机安慰剂对照临床试验。 参加试点研究的患者的种族分布 纽约大学临床中心证明该中心将遵守规定 1993 年 NIH 振兴法案。研究人员希望 拟建临床中心将有机会参与 这项具有里程碑意义的 BPH 临床试验。

DESCRIPTION (adapted from the principal investigator's abstract) The treatment of BPH has been redefined over the past decade. Medical therapy is currently widely accepted for the treatment of BPH. Medical therapy has a unique appeal for the treatment of clinical BPH since the side effects of medical therapy are minor and reversible, and therapy is simply terminated if the adverse experiences are severe or the treatment ineffective. Approximately 10 million American males over the age of 50 years have moderate/severe urinary symptoms secondary to BPH. The estimated annual cost of medical therapy for all American males affected with clinical BPH is 3.6 billion dollars. Since health care resources are limited, it is imperative that the value of medical therapy be defined. Ascertaining the value of any BPH treatment requires an understanding of the natural history of the disease, the initial and long-term effectiveness and morbidity of therapy, and the impact of therapy on disease progression. The NIH has committed significant resources to conduct a full scale clinical trial with the primary objective to determine if medical therapy delays or prevents the progression of BPH. The study design will also allow for a direct comparison of the immediate and long-term safety and efficacy of alpha blockade (Doxazosin) and hormonal therapy (Finasteride) for BPH. Approximately 2,800 will be enrolled at 14 Clinical Centers throughout the United States over a two-year period. The inclusion and exclusion criteria are intended to identify men with significant clinical BPH without absolute indications for surgical intervention. The Department of Urology at New York University (NYU) Medical Center has the personnel, facilities, patient referral base, institutional support, and commitment to serve as an effective Clinical Center for the NIH sponsored full scale clinical trial on BPH. The investigators indicate that the present grant application will demonstrate that both the principal and co-principal investigators have participated in numerous randomized clinical trials, evaluating the safety and efficacy of both medical and device therapy for BPH. The NYU Medical Center, Department of Urology served as one of the six clinical centers for the initial BPH-pilot study. The performance of this center, during the pilot study, indicates the competence and commitment of the support staff and the ability of the clinical center to enroll sufficient patients into a randomized placebo-controlled clinical trial. The ethnic distribution of patients enrolled into the pilot study at the NYU Clinical Center demonstrates that the center will be in compliance with the NIH Revitalization Act of 1993. The investigators hope that the proposed clinical center will have the opportunity to participate in this landmark BPH clinical trial.