Sebastianelli Arcangelo, Spatafora Pietro, Frizzi Jacopo, Saleh Omar, Sessa Maurizio, De Nunzio Cosimo, Tubaro Andrea, Vignozzi Linda, Maggi Mario, Serni Sergio, McVary Kevin T, Kaplan Steven A, Gravas Stavros, Chapple Christopher, Gacci Mauro
Department of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, University of Florence, 50134 Florence, Italy.
Department of Experimental Medicine, Section of Pharmacology "L. Donatelli", University of Campania "L. Vanvitelli", 80138 Naples, Italy.
J Clin Med. 2019 Jul 29;8(8):1126. doi: 10.3390/jcm8081126.
Tadalafil 5 mg represents the standard for men with Erectile dysfunction (ED) and lower urinary tract symptoms (LUTS)/benign prostatic enlargement (BPE). We carried out an observational trial aiming to assess the efficacy and safety of Tadalafil compared with Tadalafil plus Tamsulosin. Seventy-five patients complaining of ED and LUTS were treated for 12-weeks with Tadalafil plus placebo (TAD+PLA-group) or with combination therapy tadalafil plus tamsulosin (TAD+TAM-group). Efficacy variables were: International Index of Erectile Function (IIEF), International Prostate Symptom Score (IPSS), maximum urinary flow rate (Qmax) and safety assessments. Data were evaluated using paired samples -test (baseline vs. 12-weeks) and analysis of variance (Δgroup-TAD+PLA vs. Δgroup-TAD+TAM). At baseline, both groups presented similar characteristics and symptoms scores (all: > 0.05). From baseline to 12-weeks, all the subjects showed a significant improvement of IIEF, total-IPSS, storage-IPSS, Qmax (all: < 0.001). Conversely, a significant improvement of voiding-IPSS was observed in TAD+TAM-group (-3.5 points, < 0.001). Indeed, TAD+PLA-group showed a not significant improvement of voiding-IPSS (-2.0 points, = 0.074). When we compared between-groups differences at 12-weeks, IIEF ( = 0.255), total-IPSS ( = 0.084) and storage-IPSS ( = 0.08) did not show any statistically significant differences, whereas, voiding-IPSS and Qmax were significantly better in TAD+TAM-group ( = 0.006 and = 0.027, respectively). No severe treatment adverse events (TAEs) were reported in both groups. Tadalafil achieved the same improvements of IIEF, total-IPSS, storage-IPSS when compared to combination therapy. Instead, Qmax and voiding-IPSS were better managed with combination therapy, without change of TAEs.
他达拉非5毫克是治疗勃起功能障碍（ED）和下尿路症状（LUTS）/良性前列腺增生（BPE）男性患者的标准药物。我们开展了一项观察性试验，旨在评估他达拉非与他达拉非联合坦索罗辛相比的疗效和安全性。75名主诉ED和LUTS的患者接受了为期12周的治疗，其中一组接受他达拉非加安慰剂治疗（TAD + PLA组），另一组接受他达拉非联合坦索罗辛的联合治疗（TAD + TAM组）。疗效变量包括：国际勃起功能指数（IIEF）、国际前列腺症状评分（IPSS）、最大尿流率（Qmax）以及安全性评估。数据采用配对样本t检验（基线与12周时）和方差分析（TAD + PLA组变化值与TAD + TAM组变化值）进行评估。在基线时，两组呈现出相似的特征和症状评分（所有P值均>0.05）。从基线到12周，所有受试者的IIEF、总IPSS、储尿期IPSS、Qmax均有显著改善（所有P值均<0.00）。相反，在TAD + TAM组中观察到排尿期IPSS有显著改善（-3.5分，P<0.0）。实际上，TAD + PLA组排尿期IPSS改善不显著（-2.0分，P = 0.074）。当我们比较12周时两组之间的差异时，IIEF（P = 0.255）、总IPSS（P = 0.084）和储尿期IPSS（P = 0.08）均未显示出任何统计学上的显著差异，然而，排尿期IPSS和Qmax在TAD + TAM组中显著更好（分别为P = 0.006和P = 0.027）。两组均未报告严重治疗不良事件（TAEs）。与联合治疗相比，他达拉非在IIEF、总IPSS、储尿期IPSS方面取得了相同的改善。相反，联合治疗在Qmax和排尿期IPSS方面管理得更好，且TAEs无变化。
