每日 8 毫克与每日 4 毫克两次服用西洛多辛治疗下尿路症状提示良性前列腺增生症患者的安全性和疗效（SILVER 研究）：一项为期 12 周、双盲、随机、平行、多中心研究。
Safety and efficacy of 8-mg once-daily vs 4-mg twice-daily silodosin in patients with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (SILVER Study): a 12-week, double-blind, randomized, parallel, multicenter study.
机构信息
Department of Urology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
Department of Urology, Yonsei University College of Medicine, Severance Hospital, Seoul, Korea.
出版信息
Urology. 2014 Apr;83(4):875-81. doi: 10.1016/j.urology.2013.11.013. Epub 2014 Feb 12.
OBJECTIVE
To show the noninferiority of silodosin 8-mg once-daily (QD) to 4-mg twice-daily (BID) in efficacy and safety in patients with lower urinary tract symptoms or benign prostatic hyperplasia in the Korean population.
METHODS
A prospective, multicenter, double-blind, randomized, comparative study was conducted. A total of 532 male patients aged ≥50 years with lower urinary tract symptoms or benign prostatic hyperplasia were included. All patients received silodosin QD or BID for 12 weeks. The primary end point was the change from baseline in total International Prostate Symptom Score (IPSS) at 12 weeks. Adverse drug reactions, vital signs, and laboratory tests were recorded.
RESULTS
A total of 424 patients were randomized to the silodosin QD or BID groups. These groups were not significantly different in baseline characteristics. The mean total IPSS change in QD group was not inferior to that in BID group (-6.70 and -6.94, respectively; 95% confidence interval, -0.88 to 1.36). The QD and BID groups did not significantly differ in the following: percentages of patients with ≥25% (63.41% and 67.82%, respectively; P = .349) or ≥4-point improvement in total IPSS (65.85% and 69.31%, respectively; P = .457), maximum urinary flow rate improvement ≥30% (47.32% and 40.59%, respectively; P = .172), changes in IPSS voiding subscore (-4.42 ± 4.93 and -4.65 ± 4.77; P = .641), IPSS storage subscore (-2.05 ± 3.07 and -2.52 ± 2.97; P = .117), quality of life (-1.19 ± 1.49 and -1.40 ± 1.42; P = .136), maximum urinary flow rate (3.55 ± 5.93 and 3.74 ± 6.79 mL/s; P = .768), International Continence Society male questionnaire score, Patient Goal Achievement Score, or Treatment Satisfaction Question. The 2 groups had similar frequencies of adverse drug reactions.
CONCLUSION
QD administration of silodosin was not inferior to BID in efficacy. The 2 groups had similar adverse drug reaction profiles.
目的
在韩国人群中，显示索利那新 8 毫克每日 1 次（QD）与 4 毫克每日 2 次（BID）在疗效和安全性方面非劣效性。
方法
进行了一项前瞻性、多中心、双盲、随机、对照研究。共纳入 532 名年龄≥50 岁的患有下尿路症状或良性前列腺增生的男性患者。所有患者接受索利那新 QD 或 BID 治疗 12 周。主要终点是 12 周时总国际前列腺症状评分（IPSS）的基线变化。记录药物不良反应、生命体征和实验室检查结果。
结果
共有 424 名患者被随机分配至索利那新 QD 或 BID 组。两组在基线特征方面无显著差异。QD 组的平均总 IPSS 变化与 BID 组无显著差异（分别为-6.70 和-6.94；95%置信区间，-0.88 至 1.36）。QD 组和 BID 组在以下方面无显著差异：≥25%（分别为 63.41%和 67.82%；P=0.349）或总 IPSS 改善≥4 分（分别为 65.85%和 69.31%；P=0.457）、最大尿流率改善≥30%（分别为 47.32%和 40.59%；P=0.172）、IPSS 排尿症状评分的变化（-4.42±4.93 和-4.65±4.77；P=0.641）、IPSS 储存症状评分（-2.05±3.07 和-2.52±2.97；P=0.117）、生活质量评分（-1.19±1.49 和-1.40±1.42；P=0.136）、最大尿流率（分别为 3.55±5.93 和 3.74±6.79 mL/s；P=0.768）、国际尿控协会男性问卷评分、患者目标达成评分或治疗满意度评分。两组不良反应的发生频率相似。
结论
QD 给药的索利那新在疗效方面不劣于 BID。两组不良反应谱相似。
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