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首页> 外文期刊>BJU international >Serenoa repens Serenoa repens + selenium + lycopene vs tadalafil 5 mg for the treatment of lower urinary tract symptoms secondary to benign prostatic obstruction: a Phase IV IV , non‐inferiority, open‐label, clinical study ( SPRITE SPRITE study)
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Serenoa repens Serenoa repens + selenium + lycopene vs tadalafil 5 mg for the treatment of lower urinary tract symptoms secondary to benign prostatic obstruction: a Phase IV IV , non‐inferiority, open‐label, clinical study ( SPRITE SPRITE study)

机译：Serenoa Repens Serenoa Repens +硒+番茄红素VS达拉非5毫克用于治疗尿路症状中的良性症状，良性前列腺梗阻：IV阶段IV，非劣势，开放标签，临床研究（Sprite Sprite研究）

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Objective To compare in a randomised, open‐label, non‐inferiority clinical study, the efficacy and tolerability of Serenoa repens (SeR) + selenium (Se) + lycopene (Ly) (SeR‐Se‐Ly) therapy vs tadalafil 5 mg in men with lower urinary tract symptoms ( LUTS ). Patients and methods From May 2015 to January 2017, 427 patients were enrolled in 21 different centres (International Standard Randomised Controlled Trial Number Register [ ISRCTN ] 73316039). Inclusion criteria included: age between 50 and 80 years, International Prostate Symptom Score ( IPSS ) ≥12, maximum urinary flow rate ( Q max ) ≤ 15 mL /s, and post‐void residual ( PVR ) 100 mL . Patients were randomised into two groups in a 2:1 ratio: Group A (SeR‐Se‐Ly, 1 tablet daily for 6 months) and Group B (tadalafil 5 mg, 1 tablet daily for 6 months). The primary endpoint of the study was the non‐inferior variation in the IPSS and Q max in Group A vs Group B after 6 months of treatment. Results In all, 404 patients completed the full protocol. When comparing both therapies, Group A was statistically not inferior to Group B considering the median change in IPSS (?3.0 vs ?3.0; P 0.01), IPSS quality of life (?2.0 vs ?2.0; P 0.05), and Q max (2.0 vs 2.0 mL /s; P 0.01). We found statistically significant differences in the increase of at least 3 points in Q max (38.2% vs 28.1%; P = 0.04) and of at least 30% of Q max (39.2% vs 27.3%; P 0.01) in Group A compared to Group B. The percentage of patients with an increase of at least 3 points in the IPSS and a decrease of at least 25% of the IPSS was not statistically different between the two groups. For adverse events, four patients in Group A (1.44%) and 10 in Group B (7.81%) ( P 0.05) reported side‐effects. Conclusion We have shown that treatment with SeR‐Se‐Ly was not inferior to tadalafil 5 mg for improving IPSS and Q max in men with LUTS .
机译：目的在随机，开放标签，非劣升性临床研究中比较塞蛋白repens（Ser）+硒（Se）+番茄红素（SER-SE-LY）治疗与Tadalafil 5毫克的疗效和耐受性尿路症状下降的男性（LUT）。从2015年5月到2017年1月的患者和方法，427名患者参加了21个不同的中心（国际标准随机对照编号寄存器[ISRCTN] 73316039）。包含标准包括：50至80岁之间的年龄，国际前列腺症状评分（IPS）≥12，最大尿流率（Q max）≤15ml/ s，和后空隙残留（Pvr）＆ 100 ml。患者在2：1的比例中随机分为两组：A组（SER-SE-LY，每日6个月，1种片）和B组（Tadalafil 5mg，每日1片6个月，6个月）。该研究的主要终点是在治疗6个月后A组A族B组中的IPS和Q Max的非较差变化。结果所有，404名患者完成了完整的协议。考虑IPS中的中位变化（α3.0; 0.01），IPS的生命质量（α3.0; 2.0 vs？2.0; 2.0; p＆ 0.05），统计上的统计上没有统计而不是统计和q max（2.0 vs 2.0 ml / s; p＆ 0.01）。我们发现Q max中至少3点的统计学显着差异（38.2％vs28.1％; p = 0.04），并且q max的至少30％（39.2％vs27.3％; p <0.01）与B组相比。IPS中增加至少3点的患者的百分比和至少25％的IPS在两组之间没有统计学不同。对于不良事件，B组（1.44％）和B组中的四个患者（7.81％）（P <0.05）报告副作用。结论我们已经表明，Ser-Se-Ly的治疗不逊于Tadalafil 5毫克，以改善IPS和Q Max在带有LUT的男性。

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