MEDICAL THERAPY OF BENIGN PROSTATIC HYPERPLASIA

良性前列腺增生症(BPH)的临床范围从 对危及生命的事件来说，只有轻微的尿路症状。 经尿道前列腺电切术(TURP)目前代表着 只有被广泛接受的治疗BPH的方法。约30%的50岁老人 男性将在80岁前接受TURP。由于临床良性前列腺增生症的谱系 如此多样化，很难想象这种疾病过程可以 通过单一的外科手术进行最佳治疗。独家扮演的角色 TURP治疗良性前列腺增生症目前正在接受严格的审查，因为 越来越多的证据表明，药物治疗也是有效的。 治疗方案。开发一种合理的方法来解决 由于随机化，目前对BPH的医疗管理是不可行的 比较安慰剂对照研究的安全性和有效性 参数预测，目前还没有报道不同的药物治疗方法 对药物治疗的治疗反应尚未确定，以及 排除前列腺癌的指南尚未建立。《7》 赠款提案的具体目的是为了确保安全 α受体阻滞剂、雄激素抑制和联合应用的有效性 治疗(α-受体阻滞剂+雄激素抑制)治疗BPH；识别 预测疗效的临床、尿动力学和组织学因素 对药物治疗的反应；确定血清PSA水平是否 与前列腺上皮细胞总数直接相关； 确定前列腺癌是否可以可靠地排除在基础上 直肠指诊和血清PSA水平。特拉唑嗪和 非那雄胺被选为药理药物，因为这两种药物 已经在男性BPH患者身上进行了广泛的研究。共有100名受试者 将参加4个ARM随机安慰剂对照试验 学习。主要结果衡量标准将包括AUA症状评分和 生活质量评分。纳入和排除标准将定义 一组有临床意义的良性前列腺增生症患者缺乏绝对 干预的适应症。前列腺组织将按顺序进行分析 提供与前列腺癌检测和预测相关的见解 对药物治疗的治疗反应。

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.