Urology Research Center, Guilan University of Medical Sciences, Iran.
Int Braz J Urol. 2012 Jan-Feb;38(1):33-9. doi: 10.1590/s1677-55382012000100005.
To evaluate safety and efficacy of tadalafil on lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in patients treated with standard medication.
In this case-controlled randomized clinical trial, from November 2008 to August 2009, 132 patients with obstructive and irritative urinary tract symptoms due to BPH, IPSS ≥ 8, no indication for surgical intervention and that reached plateau levels of response to treatment were selected. These patients were randomly allocated in two groups (each containing 66 patients). The treatment group received standard treatment of BPH and tadalafil (10 mg nightly); the placebo group received only standard treatment of BPH. IPSS, maximum urinary flow rate (Qmax) and quality of life were assessed before and after a 3-month period of study.
Before treatment, mean IPSS, Qmax and quality of life values in the treatment and placebo groups were 13.06 ± 4.37 and 13.66 ± 4.25, 8.92 ± 2.96 mL/s and 9.09 ± 2.91 mL/s, 2.93 ± 0.86 and 2.66 ± 0.78, respectively. After treatment, mean IPSS, Qmax, and quality of life values in treatment group were 7.66 ± 3.99, 9.99 ± 4.76 mL/s and 1.80 ± 0.98, respectively. These findings were compared to corresponding values of the placebo group (11.37 ± 3.64, 8.73 ± 2.22 mL/s and 2.19 ± 0.53, respectively): IPSS and quality of life were significantly different but Qmax didn't show a significant change.
Tadalafil improves quality of life and urinary symptoms in patients with LUTS suggestive of BPH, but doesn't have any significant effect on Qmax. Therefore, this drug may be effectively used in combination with standard medical therapies for BPH.
评估他达拉非在接受标准药物治疗的下尿路症状（LUTS）提示良性前列腺增生（BPH）患者中的安全性和疗效。
在这项病例对照随机临床试验中，我们于 2008 年 11 月至 2009 年 8 月，选择了 132 例因 BPH 导致阻塞性和刺激性尿路症状、IPSS≥8、无手术干预指征且对治疗反应达到平台水平的患者。这些患者被随机分为两组（每组 66 例）。治疗组接受标准 BPH 治疗和他达拉非（每晚 10mg）；安慰剂组仅接受标准 BPH 治疗。在研究的 3 个月期间前后评估 IPSS、最大尿流率（Qmax）和生活质量。
治疗前，治疗组和安慰剂组的平均 IPSS、Qmax 和生活质量值分别为 13.06±4.37 和 13.66±4.25、8.92±2.96 mL/s 和 9.09±2.91 mL/s、2.93±0.86 和 2.66±0.78。治疗后，治疗组的平均 IPSS、Qmax 和生活质量值分别为 7.66±3.99、9.99±4.76 mL/s 和 1.80±0.98。与安慰剂组（11.37±3.64、8.73±2.22 mL/s 和 2.19±0.53）相比，这些发现有显著差异：IPSS 和生活质量有显著改善，但 Qmax 无显著变化。
他达拉非可改善 LUTS 提示 BPH 患者的生活质量和尿路症状，但对 Qmax 无显著影响。因此，该药物可能与 BPH 的标准药物治疗联合有效使用。
