MEDICAL THERAPY BENIGN PROSTATIC HYPERPLASIA

描述(改编自首席调查员的摘要) 在过去的十年里，对良性前列腺增生症的治疗进行了重新定义。医疗 目前，治疗良性前列腺增生症被广泛接受。医疗 治疗对临床前列腺增生症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，治疗是 如果不良经历严重或治疗严重，则直接终止 效果不佳。大约有1000万50岁以上的美国男性 继发于BPH的中度/严重的尿路症状。这个 所有受影响的美国男性每年的估计医疗费用 与临床上的良性前列腺增生症是36亿美元。由于卫生保健资源 是有限的，当务之急是医学治疗的价值 已定义。确定任何良性前列腺增生症治疗的价值需要 了解该病的自然病史，最初和 治疗的长期有效性和发病率，以及 疾病进展的治疗。 美国国立卫生研究院承诺投入大量资源进行全面的 临床试验的主要目的是确定药物治疗 延缓或防止良性前列腺增生症的进展。研究设计还将 允许直接比较当前和长期的安全性和 α-受体阻滞剂(多沙唑嗪)和激素治疗(非那雄胺)的疗效 治疗良性前列腺增生症。大约2800人将在14个临床中心注册 在两年的时间里在全美范围内。包括和 排除标准旨在确定有显著临床症状的男性 无绝对手术指征的前列腺增生症。这个 纽约大学(NYU)医学中心的泌尿科 人员、设施、患者转介基地、机构支持和 承诺成为美国国立卫生研究院赞助的有效临床中心 前列腺增生症的全面临床试验。 调查人员表示，目前的赠款申请将 证明主要调查人员和共同主要调查人员都有 参与了许多随机临床试验，评估了 药物和器械治疗良性前列腺增生症的安全性和有效性。纽约大学 医学中心，泌尿外科是六个临床之一 中心进行了最初的BPH先导研究。这一点的表现 中心，在初步研究期间，表明能力和承诺 支持人员和临床中心的招生能力 足够的患者进入一项随机的安慰剂对照临床试验。 参加这项试点研究的患者的种族分布 纽约大学临床中心证明，该中心将符合 1993年美国国立卫生研究院振兴法案。调查人员希望 拟建的临床中心将有机会参与 这项里程碑式的良性前列腺增生症临床试验。

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.