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阿夫唑嗪治疗有症状的良性前列腺增生的α受体阻滞治疗:与哌唑嗪的对比研究。PRAZALF研究组

Alpha-blocking treatment with alfuzosin in symptomatic benign prostatic hyperplasia: comparative study with prazosin. The PRAZALF Group.

作者信息

Buzelin J M, Hebert M, Blondin P

机构信息

Synthélabo Pharmacie, Le Plessis-Robinson, France.

出版信息

Br J Urol. 1993 Dec;72(6):922-7. doi: 10.1111/j.1464-410x.1993.tb16298.x.

DOI:10.1111/j.1464-410x.1993.tb16298.x
PMID:7508331
Abstract

Alfuzosin, a selective alpha 1-adrenoceptor antagonist which is effective in the symptomatic treatment of benign prostatic hyperplasia (BPH), was compared with prazosin, another drug commonly used for the same purpose. After a 1-week placebo run-in period, 103 patients with day-time frequency > or = 7 or nocturia > or = 2 and peak flow rate < 15 ml/s were randomised to receive either alfuzosin (2.5 mg tid) or prazosin (2 mg bid) for 3 weeks, with a gradual dose increase during the first week, in a double-blind, parallel group, multicentre study. Voiding symptoms, assessed on the basis of the Boyarsky scale and a micturition diary, were significantly improved in both groups, as were urinary flow rates. However, neither the clinical improvement nor the increase in flow rates differed significantly between the 2 groups. The peak flow rate increased similarly with alfuzosin (2.6 +/- 0.6 ml/s) and prazosin (2.9 +/- 0.7 ml/s); the mean flow rate and voided volume increase tended to be more marked with alfuzosin (30 and 22.2% respectively) than with prazosin (20.6 and 6.5%). Clinical safety was good in both groups. All 4 adverse events in the prazosin group but only 1 of the 4 adverse events in the alfuzosin group were related to a decrease in blood pressure. It was concluded that alfuzosin was at least as effective as prazosin in the treatment of symptomatic patients with BPH and the incidence of adverse events related to their vasodilatory properties was lower with alfuzosin.

摘要

阿夫唑嗪是一种选择性α1肾上腺素能受体拮抗剂,对良性前列腺增生(BPH)的症状治疗有效,将其与另一种常用于相同目的的药物哌唑嗪进行比较。在为期1周的安慰剂导入期后,103例白天排尿次数≥7次或夜尿≥2次且峰值流速<15 ml/s的患者被随机分为两组,在一项双盲、平行组、多中心研究中,一组接受阿夫唑嗪(2.5 mg,每日3次)治疗,另一组接受哌唑嗪(2 mg,每日2次)治疗,为期3周,第一周逐渐增加剂量。根据博亚尔斯基量表和排尿日记评估的排尿症状在两组中均有显著改善,尿流率也是如此。然而,两组之间的临床改善和流速增加均无显著差异。阿夫唑嗪组(2.6±0.6 ml/s)和哌唑嗪组(2.9±0.7 ml/s)的峰值流速增加相似;阿夫唑嗪组的平均流速和排尿量增加(分别为30%和22.2%)比哌唑嗪组(20.6%和6.5%)更明显。两组的临床安全性均良好。哌唑嗪组的4例不良事件均与血压下降有关,而阿夫唑嗪组的4例不良事件中只有1例与血压下降有关。得出的结论是,在治疗有症状的BPH患者时,阿夫唑嗪至少与哌唑嗪一样有效,且阿夫唑嗪与血管舒张特性相关的不良事件发生率较低。

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