MEDICAL THERAPY OF BPH

良性前列腺增生（BPH）的临床范围从 只有轻微的泌尿系统症状到危及生命的事件。 经尿道前列腺切除术（TURP）目前代表了 唯一被广泛接受的治疗BPH的方法。约30%的50岁 男性将在80岁之前接受TURP。 由于临床BPH的范围是 如此多样，很难想象这种疾病的过程可以 最好通过一次手术治疗。 的专属角色 用于治疗BPH的TURP目前正受到严格审查，因为 越来越多的证据表明药物治疗也是有效的 治疗方案。 制定一个合理的方法， BPH的药物治疗目前是不可行的， 安慰剂对照研究，比较 不同的药物治疗尚未报告，参数预测 尚未确定对药物治疗的治疗反应， 排除前列腺癌的指南尚未建立。 的7 补助金提案的具体目标是确定安全性， α受体阻滞剂、雄激素抑制剂和联合用药的有效性 BPH治疗（α阻断+雄激素抑制）;确定 预测治疗效果的临床、尿动力学和组织学因素 药物治疗反应;确定血清PSA水平是否 与前列腺上皮细胞总量直接相关; 确定是否可以可靠地排除前列腺癌的基础上， 直肠指检和血清PSA水平。 特拉唑嗪及 选择非那普利作为药理学药物，因为这两种药物 在前列腺增生的男性中进行了广泛的研究。 共100例受试者 将入组4组随机安慰剂对照试验 study. 主要结局指标将包括AUA症状评分和 生活质量评分。 入选和排除标准将定义 一组患有临床显著BPH的受试者， 干预的指示。 将对前列腺组织进行分析， 提供与检测前列腺癌和预测 对药物治疗的反应

The clinical spectrum of benign prostatic hyperplasia (BPH) ranges from only slightly bothersome urinary symptoms to life threatening events. Transurethral resection of the prostate (TURP) currently represents the only widely accepted treatment for BPH. Approximately 30% of 50 year old men will undergo a TURP by age 80. Since the spectrum of clinical BPH is so diverse, it is difficult to imagine that this disease process can be optimally treated by a single surgical procedure. The exclusive role of TURP for the treatment of BPH is presently under intense scrutiny since there is increasing evidence that medical therapies are also effective treatment options. The development of a rational approach for the medical management of BPH is presently not feasible since randomized placebo controlled studies comparing the safety and effectiveness of different medical therapies have not been reported, parameters predicting therapeutic response to medical therapies have not been identified, and guidelines to exclude prostate cancer have not been established. The 7 specific aims of the grant proposal are designed to ascertain the safety and effectiveness of alpha blockade, androgen suppression and combination therapy (alpha blockade + androgen suppression) for BPH; identify clinical, urodynamic, and histologic factors that predict therapeutic response to medical therapy; determine whether serum PSA levels are directly correlated with the total amount of prostatic epithelium; and determine whether prostate cancer can be reliably excluded on the basis of digital rectal examination and serum PSA levels. Terazosin and finasteride were selected as the pharmacologic agents since both drugs have been extensively studied in males with BPH. A total of 100 subjects will be enrolled into the 4 arm randomized placebo controlled pilot study. The primary outcome measures will include AUA symptom scores and quality of life score. The inclusion and exclusion criteria will define a cohort of subjects with clinically significant BPH lacking absolute indications for intervention. Prostatic tissue will be analyzed in order to provide insights related to detecting prostate cancer and predicting therapeutic response to medical therapy.