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首页> 外文期刊>The journal of sexual medicine >A Comparative Randomized Prospective Study to Evaluate Efficacy and Safety of Combination of Tamsulosin and Tadalafil vs. Tamsulosin or Tadalafil Alone in Patients with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia
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A Comparative Randomized Prospective Study to Evaluate Efficacy and Safety of Combination of Tamsulosin and Tadalafil vs. Tamsulosin or Tadalafil Alone in Patients with Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia

机译：评价坦索罗辛和他达拉非与单独使用坦索罗辛或他达拉非联合治疗良性前列腺增生引起的下尿路症状的疗效和安全性的比较随机前瞻性研究

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Introduction: Lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) and erectile dysfunction are common disorders of advancing age. Aim: To evaluate the efficacy and safety of tamsulosin and tadalafil in patients with LUTS due to BPH. Methods: In this prospective randomized study, 133 men complaining of LUTS due to BPH were included. Forty-five patients received tamsulosin 0.4mg/day alone (Group A), 44 patients received tadalafil 10mg/day (Group B), and combination therapy (tamsulosin and tadalafil both) was instituted in 44 patients (Group C). After a 2-week medication free run-in period, they were evaluated for International Prostatic Symptom Score (IPSS), International Index of Erectile Function score (IIEF5), quality of life (IPSS QoL), maximum urinary flow rate (Qmax), post-void residual urine (PVR) volume, and safety parameters before and at 3 months of treatment. Main Outcome Measures: There were primary (IPSS, IPSS QoL index, Qmax, and PVR) and secondary (erectile function [EF] domain scores from IIEF5) efficacy end points. Safety assessment included laboratory tests and patient's reporting of adverse event. Results: A significant improvement in IPSS score was observed in all the 3 groups A, B, and C (-50.90%, P<0.05; -33.50%, P<0.05; and -53.90%, P<0.05, respectively). IIEF5 score increased significantly in these three groups (+39.28%, P<0.05; +45.96%, P<0.05; and +60.23%, P<0.05, respectively). A significant increase in Qmax and decrease in PVR were also observed (33.99%, P<0.05; 29.78%, P<0.05; and 37.04%, P<0.05) and (-60.90%, P<0.05; -49.45%, P<0.05; and -62.97%, P<0.05, respectively). The QoL scores improved significantly (-73.35%, P<0.05; -70.26%, P<0.05; and -79.65%, P<0.05, respectively). Side effects were dyspepsia, heartburn, headache, flushing, myalgia, and backache. Adverse effect dropout was 3.7%. No participant experienced any severe or serious adverse events. Conclusions: In patients with LUTS due to BPH, tamsulosin and tadalafil alone or in combination cause a significant improvement in patients with LUTS. Their EF also improves with these medications. The improvement is better with combination therapy compared with single agent alone.
机译：简介：与良性前列腺增生（BPH）和勃起功能障碍相关的下尿路症状（LUTS）是年龄增长的常见疾病。目的：评价坦索罗辛和他达拉非对BPH引起的LUTS患者的疗效和安全性。方法：在这项前瞻性随机研究中，纳入了133名因BPH引起LUTS不适的男性。四十五名患者接受坦索罗辛0.4mg /天（A组），44名患者接受他达拉非10mg /天（B组），并且在44名患者中开始联合治疗（坦索罗辛和他达拉非两者）（C组）。经过2周的无药物磨合期后，对他们进行国际前列腺症状评分（IPSS），国际勃起功能指数评分（IIEF5），生活质量（IPSS QoL），最大尿流率（Qmax），治疗前和治疗三个月时的术后排尿残留量（PVR）和安全性参数。主要结果指标：有主要（IPSS，IPSS QoL指数，Qmax和PVR）和次要（IIEF5提供的勃起功能[EF]域评分）功效终点。安全性评估包括实验室检查和患者不良事件报告。结果：在A，B和C的所有三个组中，IPSS评分均得到了显着改善（分别为-50.90％，P <0.05; -33.50％，P <0.05;和-53.90％，P <0.05）。在这三组中，IIEF5评分显着增加（分别为+ 39.28％，P <0.05; + 45.96％，P <0.05;和+ 60.23％，P <0.05）。还观察到Qmax显着增加和PVR降低（33.99％，P <0.05; 29.78％，P <0.05;和37.04％，P <0.05）和（-60.90％，P <0.05; -49.45％，P <0.05;和-62.97％，P <0.05）。 QoL得分显着提高（分别为-73.35％，P <0.05; -70.26％，P <0.05;和-79.65％，P <0.05）。副作用有消化不良，烧心，头痛，潮红，肌痛和腰酸。不良反应辍学率为3.7％。没有参与者经历任何严重或严重的不良事件。结论：在因BPH导致的LUTS患者中，坦洛新和他达拉非单独或联合使用可显着改善LUTS患者。这些药物还可改善他们的EF。与单独使用单一药物相比，联合治疗的改善更好。

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