Department of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, Careggi Hospital, University of Florence, Florence, Italy.
Department of Minimally Invasive and Robotic Urologic Surgery and Kidney Transplantation, Careggi Hospital, University of Florence, Florence, Italy -
Minerva Urol Nephrol. 2021 Dec;73(6):836-844. doi: 10.23736/S2724-6051.20.04099-0. Epub 2020 Nov 17.
The aim of this study was to assess the impact of tadalafil 5 mg/die plus tamsulosin 0.4 mg/die combination therapy on lower urinary tract symptoms (LUTS) and erectile dysfunction (ED), according to presence vs. absence of metabolic syndrome (MetS).
Seventy-five consecutive men presenting with ED and LUTS were enrolled. Patients were divided into two groups according to MetS presence. All subjects were treated with combination therapy for 12 weeks. Patients were re-evaluated after treatment with uroflowmetry and post-void residual volume (PVR), International Prostate Symptoms Score (IPSS), IPSS Quality of Life (QoL), overactive bladder questionnaire (OAB-q) and International Index Erectile Function-5 (IIEF-5) Score.
After enrollment, 50 patients were included: 31 (62.0%) with MetS and 19 (38.0%) without MetS. At baseline, patients without MetS showed a significantly better IPSS, IIEF and OAB-q, as compared to those with MetS. After 12 weeks of combination therapy LUTS, ED and flowmetry significantly improved in both groups (P<0.001). The improvement after 12 weeks was similar between groups in all parameters (P>0.05), except for ∆OAB-q that was significantly better for patients with MetS (P=0.028). Nevertheless, total IPSS, all IPSS subscores and OAB-q were significantly better at 12 weeks in men without MetS (P<0.05). Despite IIEF-5 was significantly different at baseline, after 12 weeks of combination therapy, erectile function was similar in men with or without METS: 16.3±3.8 vs. 17.7±4.7 (P=0.238). No serious adverse event (AE) was reported, and complications were comparable between groups (P>0.05).
Patients with MetS have worse LUTS and ED profiles. However, tadalafil plus tamsulosin combination treatment provided them a similar ED profile and a greater relief of overactive bladder (OAB) symptoms at the end of the trial. Combination therapy had the same safety profile in men besides MetS. Further randomized controlled trials are needed.
本研究旨在评估他达拉非 5 毫克/天联合坦索罗辛 0.4 毫克/天的联合治疗对下尿路症状（LUTS）和勃起功能障碍（ED）的影响，根据是否存在代谢综合征（MetS）。
连续招募了 75 名患有 ED 和 LUTS 的男性患者。根据 MetS 的存在情况，将患者分为两组。所有患者均接受联合治疗 12 周。治疗后，通过尿流率和残余尿量（PVR）、国际前列腺症状评分（IPSS）、IPSS 生活质量评分（QoL）、膀胱过度活动症问卷（OAB-q）和国际勃起功能指数-5（IIEF-5）评分对患者进行再次评估。
入组后，共纳入 50 例患者：31 例（62.0%）存在 MetS，19 例（38.0%）不存在 MetS。基线时，无 MetS 的患者的 IPSS、IIEF 和 OAB-q 评分明显优于有 MetS 的患者。联合治疗 12 周后，两组患者的 LUTS、ED 和尿流率均明显改善（P<0.001）。但两组患者在所有参数上的改善程度在治疗 12 周后无明显差异（P>0.05），但 OAB-q 的改善程度除外，有 MetS 的患者改善更为显著（P=0.028）。然而，在 12 周时，无 MetS 的患者的总 IPSS、所有 IPSS 子评分和 OAB-q 评分均明显改善（P<0.05）。尽管 IIEF-5 在基线时存在显著差异，但在联合治疗 12 周后，有或无 METS 的男性勃起功能相似：16.3±3.8 vs. 17.7±4.7（P=0.238）。未报告严重不良事件（AE），且组间并发症相当（P>0.05）。
患有 MetS 的患者的 LUTS 和 ED 严重程度更差。然而，他达拉非联合坦索罗辛联合治疗为这些患者提供了相似的 ED 严重程度，并在试验结束时更大程度地缓解了膀胱过度活动（OAB）症状。该联合治疗在除 MetS 以外的男性中具有相同的安全性。还需要进一步的随机对照试验。
