PROGRESSION OF BPH ON MEDICAL THERAPY

良性前列腺增生症(BPH)是男性最常见的疾病 年龄在50岁以上。传统上相关的症状被认为是 继发于膀胱出口梗阻的平滑肌张力 前列腺癌或先天性膀胱功能障碍。一大堆替代方案 在过去5年中的文献中描述了治疗方案 好几年了。然而，这些研究主要集中在相对疗效和 这些疗法的副作用简介。几乎没有什么长期的 对患有以下两种疾病的人的良性前列腺增生症进展自然史的研究 在那些被治疗或被警觉等待的人中。此外， 不同年龄和种族的前列腺增生症的自然病史一直很差。 特色化的。最后，到目前为止，还没有长期的研究 膀胱功能与前列腺梗阻、前列腺的关系 采用的是大小、症状和治疗。 这项为期7年的全面试验将提供对 未经治疗的前列腺肥大和症状的进展 另有一名患者接受药物治疗。这是特别的 之所以重要，是因为药物治疗的效果可以真正确定 只有在了解良性前列腺增生症未经治疗的自然历史的情况下。这个 药物缩小前列腺大小的效果 5α还原酶抑制剂、非那雄胺和/或生理性还原 使用α1受体拮抗剂的尿路出口阻力， 多沙唑嗪对膀胱症状、排尿参数和可逆性的影响 将对功能障碍进行评估。将研究四个治疗组，L) 安慰剂，2)5毫克非那雄胺(普罗卡)，3)8毫克多沙唑嗪(卡杜拉) 和4)5毫克非那雄胺和8毫克多沙唑嗪。疾病的进展 将通过基线AUA症状评分上升4来衡量 积分、尿潴留、大小便失禁或复发 尿路感染或基线血肌酐上升50%。 通过这次全面的BPH试验，我们希望确定：a)最佳 时间介入治疗良性前列腺增生症，B)是否缩小 前列腺的大小会导致疾病进程的真正消退吗？c) 预测疾病严重程度的先验前列腺组织特征 或对药物治疗的优惠反应，D)是否特定种族 群体表现出不同形式的BPH，导致不同的比率 进展和对治疗的不同反应？以及，E)是否 伴随而来的前列腺癌或前列腺炎也会受到影响。 通过药物干预治疗良性前列腺增生症？

Benign prostatic hyperplasia (BPH) is the most common affliction of men over the age of 50. Traditionally associated symptoms are felt to be secondary to bladder outlet obstruction, dynamic tone of the smooth muscle of the prostate or inherent bladder dysfunction. A host of alternative therapeutic options have been described in the literature over the past 5 years. However, these studies have focused on the relative efficacy and side effect profile of these therapies. There have been few long term studies of the natural history of BPH progression in those who are either treated or in those who are followed by watchful waiting. Moreover, the natural history of BPH in various age and ethnic groups have been poorly characterized. Finally, to date, there have been no long term studies of the association between bladder function, prostatic obstruction, prostate size, symptoms and therapy employed. This full scale, 7 year trial, will provide enormous insight into the progression of prostate enlargement and symptoms in both an untreated population and one treated with medication. This is of particular importance because efficacy of medical therapy can be truly determined only with an understanding of the untreated natural history of BPH. The effects of pharmacologic reduction in the size of the prostate utilizing the 5alpha reductase inhibitor, finasteride, and/or physiologic reduction of urethral outlet resistance using the alpha1 receptor antagonist, doxazosin, on symptoms, voiding parameters and reversibility of bladder dysfunction will be assessed. Four treatment groups will be studied, l) placebo, 2) 5 mg of finasteride (PROSCAR), 3) 8 mg of doxazosin (CARDURA) and, 4) 5 mg finasteride and 8 mg of doxazosin. Progression of disease will be measured by either a rise in baseline AUA Symptom Score of 4 points, development of urinary retention, incontinence or recurrent urinary tract infections or a rise in baseline serum creatinine of 50%. Through this full scale BPH trial, we hope to ascertain: A) the optimal temporal intervention in the treatment of BPH, B) whether reduction in the size of the prostate result in true regression of the disease process? C) a priori prostate tissue characteristics which predict severity of disease or preferential response to medical therapy, D) whether specific ethnic groups manifest various forms of BPH resulting in different rates of progression and differential response to therapy? and, E) whether concomitant prostate conditions such as cancer or prostatitis are effected by pharmacologic intervention for BPH?