MEDICAL THERAPY BENIGN PROSTATIC HYPERPLASIA

良性前列腺增生的药物治疗

• 批准号: 2145624
• 负责人: HERBERT LEPOR
• 金额: $ 38.07万
• 依托单位: NEW YORK UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-04-01 至 2002-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2145624
• 关键词: androgen inhibitor; antihypertensive agents; benign prostate hyperplasia; clinical trials; cooperative study; human subject; human therapy evaluation; prostate; reproductive system disorder chemotherapy; urination

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.

描述（改编自主要研究者摘要） BPH的治疗在过去十年中被重新定义。 医疗 该疗法目前被广泛接受用于治疗BPH。 医疗 治疗对于临床BPH的治疗具有独特的吸引力， 药物治疗的副作用很小，而且是可逆的， 如果不良反应严重或治疗无效， 无效。 大约有一千万50岁以上的美国男性 年有中度/重度泌尿系统症状继发于BPH。 的 所有受影响的美国男性的估计年度医疗费用 临床上的BPH是36亿美元。 由于医疗保健资源 是有限的，这是当务之急，医学治疗的价值是 定义了 确定任何BPH治疗的价值需要一个 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 治疗疾病进展。 美国国立卫生研究院已经投入了大量的资源来进行全面的 临床试验，主要目的是确定药物治疗是否 延缓或阻止BPH的进展。 研究设计还将 允许直接比较即刻和长期安全性， α受体阻滞剂（多沙唑嗪）和激素治疗（芬达）的疗效 前列腺增生 将在14个临床中心招募约2，800名患者 在美国的两年时间里。 入选和 排除标准旨在识别具有显著临床症状的男性。 BPH无手术干预的绝对指征。 的 纽约大学（NYU）医学中心的泌尿科 人员、设施、患者转诊基础、机构支持，以及 致力于成为NIH赞助的有效临床中心 前列腺增生症的全面临床试验 研究人员表示，目前的赠款申请将 证明主要研究者和联合主要研究者都已 参加了许多随机临床试验，评估 BPH医疗和器械治疗的安全性和有效性。 纽约大学 医学中心泌尿外科担任六个临床之一 最初的BPH试点研究中心。 履行本 中心，在试点研究期间，表明能力和承诺 支持人员的数量和临床中心的入组能力 足够的患者进入随机安慰剂对照临床试验。 在2011年12月15日， 纽约大学临床中心证明该中心将符合 1993年的NIH振兴法案 调查人员希望， 拟议的临床中心将有机会参加 这个里程碑式的BPH临床试验