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首页> 外文期刊>BJU international >Safety and efficacy of alfuzosin 10 mg once-daily in the treatment of lower urinary tract symptoms and clinical benign prostatic hyperplasia: a pooled analysis of three double-blind, placebo-controlled studies.
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Safety and efficacy of alfuzosin 10 mg once-daily in the treatment of lower urinary tract symptoms and clinical benign prostatic hyperplasia: a pooled analysis of three double-blind, placebo-controlled studies.

机译：每天一次10 mg阿夫唑嗪治疗下尿路症状和临床良性前列腺增生的安全性和有效性：对三项双盲，安慰剂对照研究的汇总分析。

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OBJECTIVES: To examine the efficacy and safety of a once-daily formulation of alfuzosin in a pooled analysis of three parallel, randomized, double-blind, placebo-controlled 3-month studies of patients with lower urinary tract symptoms (LUTS) consistent with clinical benign prostatic hyperplasia. PATIENTS AND METHODS: Patients were randomized to receive alfuzosin, 10 mg once-daily (473) or placebo (482) for 12 weeks. Primary efficacy criteria were improvements in the International Prostate Symptom Score (IPSS) and peak urinary flow rate (PFR). RESULTS: Alfuzosin significantly improved the mean (sd) IPSS, by - 6.0 (5.1) vs - 4.2 (5.7) with placebo (P < 0.005) and the PFR, by + 2.3 (3.8) vs + 1.1 (3.1) ml/s with placebo (P < 0.001), irrespective of prostate size. The significant improvement in LUTS included the irritative and the obstructive subscore of the IPSS and the nocturia criterion; the PFR increased rapidly and significantly, from the first visit (14 days). The quality-of-life score also improved significantly in alfuzosin-treated patients. Alfuzosin was well tolerated; the number of withdrawals for adverse events was comparable in both treatment groups. The most frequently reported adverse event was dizziness (placebo 2.9%, alfuzosin 6.1%). There were no significant changes in blood pressure with alfuzosin compared with placebo, including in elderly and hypertensive patients. Sexual adverse events were rare (abnormal ejaculation, 0.6%). CONCLUSIONS: The once-daily formulation of alfuzosin, administered at 10 mg with no dose titration is effective, with a good safety profile, especially in elderly and hypertensive patients.
机译：目的：在对三项平行，随机，双盲，安慰剂对照，为期三个月的下尿路症状（LUTS）患者进行的3个月平行临床研究的汇总分析中，检查每日一次阿夫唑嗪制剂的疗效和安全性良性前列腺增生症。患者与方法：患者随机接受阿夫唑嗪，每日一次10 mg（473）或安慰剂（482）12周。主要疗效标准是国际前列腺症状评分（IPSS）和尿峰值流速（PFR）的改善。结果：使用安慰剂（P <0.005）和PFR，阿夫唑嗪显着改善了平均（sd）IPSS，分别为-6.0（5.1）和-4.2（5.7），分别为+ 2.3（3.8）和+ 1.1（3.1）ml / s安慰剂组（P <0.001），与前列腺大小无关。 LUTS的显着改善包括IPSS的刺激性和阻塞性子评分以及夜尿标准;从首次访视（14天）开始，PFR迅速且显着增加。阿夫唑嗪治疗的患者的生活质量得分也显着提高。阿夫唑嗪的耐受性良好。在两个治疗组中，因不良事件而退出的人数相当。最常见的不良事件是头晕（安慰剂为2.9％，阿夫唑嗪为6.1％）。与安慰剂相比，阿夫唑嗪的血压没有明显变化，包括老年和高血压患者。性不良事件很少见（射精异常，为0.6％）。结论：每日一次的阿夫唑嗪制剂，剂量为10 mg，无剂量滴定是有效的，并且具有良好的安全性，特别是在老年和高血压患者中。

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