Carson C C, Rosenberg M, Kissel J, Wong D G
University of North Carolina, Chapel Hill, NC, USA.
Int J Clin Pract. 2014 Jan;68(1):94-103. doi: 10.1111/ijcp.12305.
BACKGROUND/AIMS: Men with signs of benign prostatic hyperplasia (BPH) may experience lower urinary tract symptoms (LUTS) such as urinary frequency, urgency, intermittence, nocturia, straining, incomplete emptying or a weak urinary stream. The effective management of LUTS suggestive of BPH (BPH-LUTS) requires careful consideration of several factors, including the severity of a patient's symptoms, concurrent or other coexisting medical conditions, the ability to improve symptoms and impact quality of life (QOL), as well as the potential side effects of available treatment options. Several clinical studies have assessed phosphodiesterase type 5 (PDE5) inhibitors in reducing LUTS; however, tadalafil is the only PDE5 inhibitor approved for the treatment of signs and symptoms of BPH, as well as in men with both erectile dysfunction (ED) and the signs and symptoms of BPH. This review examined articles that assessed tadalafil in patients with signs and symptoms of BPH, with or without erectile dysfunction (ED), which led to regulatory approval in the United States and Europe.
In dose-ranging and confirmatory studies, results demonstrate that tadalafil significantly improved total International Prostate Symptom Score (IPSS) following 12 weeks of treatment with once daily tadalafil 5 mg. Statistically significant improvements in Benign Prostatic Hyperplasia Impact Index (BII), IPSS subscores, IPSS QOL and International Index of Erectile Function (IIEF) were also observed. Improvement in urinary symptoms occurred regardless of age, previous treatment with an α1 -adrenergic blocker, BPH-LUTS severity at baseline or ED status.
While tadalafil is most frequently recognised as a standard treatment option for men with ED, it also represents a well-tolerated and effective treatment option in men with moderate to severe BPH-LUTS.
背景/目的:有良性前列腺增生(BPH)体征的男性可能会出现下尿路症状(LUTS),如尿频、尿急、尿间断、夜尿、排尿费力、尿不尽或尿流无力。对提示BPH的LUTS(BPH-LUTS)进行有效管理需要仔细考虑多个因素,包括患者症状的严重程度、并发或其他共存的医疗状况、改善症状和影响生活质量(QOL)的能力,以及现有治疗选择的潜在副作用。多项临床研究评估了5型磷酸二酯酶(PDE5)抑制剂在减轻LUTS方面的作用;然而,他达拉非是唯一被批准用于治疗BPH体征和症状以及患有勃起功能障碍(ED)且有BPH体征和症状男性的PDE5抑制剂。本综述研究了评估他达拉非在有或无勃起功能障碍(ED)的BPH体征和症状患者中的文章,这些文章促成了其在美国和欧洲的监管批准。
在剂量范围研究和验证性研究中,结果表明,每日一次服用5mg他达拉非治疗12周后,他达拉非显著改善了国际前列腺症状总评分(IPSS)。还观察到良性前列腺增生影响指数(BII)、IPSS子评分、IPSS生活质量评分和国际勃起功能指数(IIEF)有统计学意义的改善。无论年龄、既往是否使用α1 -肾上腺素能阻滞剂治疗、基线时BPH-LUTS严重程度或ED状态如何,尿路症状均有改善。
虽然他达拉非最常被认为是ED男性的标准治疗选择,但它也是中重度BPH-LUTS男性耐受性良好且有效的治疗选择。