Departments of, Department of, Urology, Christian Medical College, Vellore, India.
Department of, Biostatistics, Christian Medical College, Vellore, India.
BJU Int. 2020 May;125(5):718-724. doi: 10.1111/bju.15027. Epub 2020 Feb 27.
To compare the efficacy and safety of tamsulosin vs the combination of tamsulosin and tadalafil in male lower urinary tract symptoms (LUTS).
This was a double-blinded, parallel-arm randomised controlled trial. Men aged >45 years with moderate LUTS and a maximum urinary flow rate (Q ) of 5-15 mL/s were included. One arm received 0.4 mg tamsulosin only (Group-A), while the second received 5 mg tadalafil with tamsulosin (Group-B). The primary outcome was the International Prostate Symptom Score (IPSS). Secondary outcomes were IPSS quality of life (QoL) score, five-item version of the International Index of Erectile Function (IIEF-5) score, Q , and post-void residual urine (PVR). Block randomisation was used. Placebo was used for blinding and allocation concealment. Intention-to-treat analysis was used for outcome measures.
Of the 183 men screened, 140 were randomised (71 in Group-A, 69 in Group-B); 116 (82.85%) (61 in Group-A, 55 in Group-B) completed the study. Baseline characteristics were comparable. The improvements in the IPSS, IPSS QoL score, IIEF score and Q were -1.69 (95% confidence interval [CI] -1.4 to -2.0), -0.70 (95% CI -0.60 to -0.80), 3.8 (95% CI 3.4-4.2) and 1.8 mL/s (95% CI 1.1-2.4) respectively, in favour of the combination group. The difference in PVR was not significant. There were no serious adverse events (AEs). The dropout rate due to AEs was 2.85%. Myalgia (five patients) was the commonest AE in the combination group.
The combination of tamsulosin and tadalafil produced significantly better improvements in LUTS, QoL, erectile function and Q compared to monotherapy with tamsulosin, without an increase in AEs.
比较坦索罗辛与坦索罗辛联合他达拉非治疗男性下尿路症状（LUTS）的疗效和安全性。
这是一项双盲、平行臂随机对照试验。纳入年龄>45 岁、中度 LUTS 且最大尿流率（Q ）为 5-15ml/s 的男性。一组接受 0.4mg 坦索罗辛（A 组），另一组接受坦索罗辛联合 5mg 他达拉非（B 组）。主要结局是国际前列腺症状评分（IPSS）。次要结局是 IPSS 生活质量（QoL）评分、国际勃起功能指数（IIEF-5）五分量表评分、Q 和残余尿量（PVR）。采用区组随机化。安慰剂用于双盲和分组隐匿。意向治疗分析用于评估结局。
在筛选的 183 名男性中，有 140 名被随机分配（A 组 71 名，B 组 69 名）；116 名（82.85%）（A 组 61 名，B 组 55 名）完成了研究。基线特征相似。IPSS、IPSS QoL 评分、IIEF 评分和 Q 的改善分别为-1.69（95%置信区间 [CI] -1.4 至-2.0）、-0.70（95% CI -0.60 至-0.80）、3.8（95% CI 3.4-4.2）和 1.8ml/s（95% CI 1.1-2.4），组合组更优。PVR 差异无统计学意义。无严重不良事件（AE）。因 AE 导致的退出率为 2.85%。组合组最常见的 AE 是肌痛（五例）。
与坦索罗辛单药治疗相比，坦索罗辛联合他达拉非治疗 LUTS、QoL、勃起功能和 Q 可显著改善，且 AE 无增加。
