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首页> 外文期刊>Research and Reports in Urology >Effect of silodosin on specific urinary symptoms associated with benign prostatic hyperplasia: analysis of international prostate symptom scores in 2 phase III clinical studies
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Effect of silodosin on specific urinary symptoms associated with benign prostatic hyperplasia: analysis of international prostate symptom scores in 2 phase III clinical studies

机译：西洛多辛对与良性前列腺增生相关的特定泌尿症状的影响：2项III期临床研究中国际前列腺症状评分的分析

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Purpose: Pooled results from 2 randomized, placebo-controlled, US phase III studies (NCT00224107, NCT00224120) showed that silodosin, a uroselective α-blocker, significantly improved International Prostate Symptom Scores (IPSS) in men with symptomatic benign prostatic hyperplasia (BPH). This analysis evaluated the effect of silodosin on each symptom assessed by IPSS questionnaire.Materials and methods: Study participants (N = 923) were men aged ≥50 years with IPSS ≥13 and Qmax 4–15 mL/s. They received silodosin 8 mg or placebo once daily for 12 weeks. Patient responses to 7 IPSS questions were collected at weeks 0 (baseline), 0.5, 1, 2, 4, and 12 and scored on a 6-point scale. Efficacy of silodosin versus placebo was assessed by analysis of covariance.Results: For each symptom, the 2 treatment groups had similar mean baseline scores. Decrease in score from baseline (mean ± standard deviation) to last observation was significantly greater with silodosin than with placebo for all symptoms (P < 0.005); symptom improvement with silodosin (versus placebo) was greatest for weak stream (silodosin, -1.1 ± 1.4 versus placebo, -0.5 ± 1.2; P < 0.0001) and smallest for nocturia (silodosin, -0.6 ± 1.1 versus placebo, -0.4 ± 1.2; P = 0.0037). Compared with placebo, silodosin significantly improved nocturia within 1 week (silodosin, -0.5 ± 1.07 versus placebo, -0.3 ± 1.05; P = 0.009) and all other symptoms within 3 to 4 days (P < 0.01).Conclusions: Silodosin significantly improved all BPH-associated symptoms assessed by IPSS questionnaire within the first week of treatment. All improvements were maintained over the 12-week study period.
机译：目的：来自两项随机，安慰剂对照的美国III期研究（NCT00224107，NCT00224120）的汇总结果表明，尿嘧啶（一种尿素选择性α受体阻滞剂）可明显改善有症状的前列腺增生（BPH）男性的国际前列腺症状评分（IPSS）。 。该分析通过IPSS问卷评估了西洛多辛对每种症状的影响。材料和方法：研究参与者（N = 923）为年龄≥50岁的男性，IPSS≥13，Qmax为4-15 mL / s。他们每天接受一次西洛多辛8 mg或安慰剂，持续12周。在第0周（基线），0.5、1、2、4和12周时收集患者对7个IPSS问题的回答，并以6分制进行评分。通过协方差分析评估西洛多辛与安慰剂的疗效。结果：对于每种症状，两个治疗组的平均基线评分相似。对于所有症状，西洛多辛从基线（均值±标准差）到最后一次观察的得分降低幅度明显大于安慰剂组（P <0.005）;西洛多辛（安慰剂）的症状改善在弱流中最大（西洛多辛，-1.1±1.4与安慰剂，-0.5±1.2; P <0.0001），夜尿症最小（西洛多辛，-0.6±1.1与安慰剂，-0.4±1.2） ; P = 0.0037）。与安慰剂相比，西洛多辛在1周内显着改善夜尿（西洛多辛-0.5±1.07，而安慰剂为-0.3±1.05; P = 0.009）以及所有其他症状在3-4天内（P <0.01）。在治疗的第一周内，通过IPSS问卷评估了所有与BPH相关的症状。在为期12周的研究期内，所有改进均得以维持。

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