Buzelin J M, Roth S, Geffriaud-Ricouard C, Delauche-Cavallier M C
Department of Urology, CHU Hôtel-Dieu, Nantes, France.
Eur Urol. 1997;31(2):190-8. doi: 10.1159/000474449.
To assess the efficacy and safety of a sustained-release (SR) formulation of alfuzosin, a selective alpha(1)-blocker, in patients with symptomatic benign prostatic hyperplasia (BPH).
A total of 390 men were randomly assigned to receive SR-alfuzosin (n = 194), 5 mg twice daily without dose titration, or placebo (n = 196) for 12 weeks. Of the patients included, 47% had concomitant cardiovascular disease, mainly hypertension or coronary heart disease.
SR-alfuzosin significantly improved urinary symptoms versus placebo assessed using the I-PSS (-31 vs. -18%, p = 0.007) and Boyarsky (-30 vs. -16%, p < 0.001) scores, with a direct correlation between both scores. Maximum flow rate increased significantly with SR-alfuzosin (+2.4 ml/s, i.e. +29%) compared with placebo (+1.1 ml/s, i.e. +14%, p = 0.006). Residual urine was also significantly reduced with SR-alfuzosin. Overall, SR-alfuzosin was as well tolerated as placebo. Nine patients dropped out for adverse events with SR-alfuzosin (4.6%) and 14 (7.1%) with placebo. The incidence of vasodilation-related events (dizziness, postural symptoms, headache) with SR-alfuzosin (3.1%) was similar to that of placebo (3.6%). No first-dose effect was observed compared with placebo. The reduction in supine blood pressure with SR-alfuzosin was minor (< or = 5 mm Hg), both in normotensive and hypertensive patients.
SR-alfuzosin is an effective treatment of symptoms related to BPH that shows a good safety profile in normotensive and hypertensive patients, without the need of dose titration.
评估选择性α1受体阻滞剂阿夫唑嗪缓释制剂（SR-阿夫唑嗪）治疗有症状的良性前列腺增生（BPH）患者的疗效和安全性。
总共390名男性被随机分配接受SR-阿夫唑嗪（n = 194），每日两次，每次5mg，无需剂量滴定，或接受安慰剂（n = 196）治疗12周。纳入的患者中，47%伴有心血管疾病，主要是高血压或冠心病。
与安慰剂相比，SR-阿夫唑嗪使用国际前列腺症状评分（I-PSS）（-31%对-18%，p = 0.007）和博亚尔斯基评分（-30%对-16%，p < 0.001）评估，能显著改善尿路症状，且两个评分之间存在直接相关性。与安慰剂相比，SR-阿夫唑嗪使最大尿流率显著增加（+2.4ml/s，即+29%），而安慰剂增加+1.1ml/s，即+14%（p = 0.006）。SR-阿夫唑嗪也使残余尿量显著减少。总体而言，SR-阿夫唑嗪的耐受性与安慰剂相当。9名患者因SR-阿夫唑嗪的不良事件退出（4.6%），14名（7.1%）因安慰剂退出。SR-阿夫唑嗪引起的血管舒张相关事件（头晕、体位性症状、头痛）发生率（3.1%）与安慰剂（3.6%）相似。与安慰剂相比，未观察到首剂效应。在血压正常和高血压患者中，SR-阿夫唑嗪使仰卧位血压降低幅度较小（≤5mmHg）。
SR-阿夫唑嗪是治疗与BPH相关症状的有效药物，在血压正常和高血压患者中显示出良好的安全性，无需剂量滴定。
