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坦索罗辛和阿夫唑嗪治疗良性前列腺增生症所致排尿障碍的随机交叉比较。

Randomized crossover comparison of tamsulosin and alfuzosin in patients with urinary disturbances caused by benign prostatic hyperplasia.

机构信息

Urology Department, Yüksek İhtisas Education and Research Hospital, Bursa, Turkey.

出版信息

Int Urol Nephrol. 2011 Dec;43(4):949-54. doi: 10.1007/s11255-011-9949-2. Epub 2011 Apr 8.

Abstract

PURPOSE

The aim of this study was to compare the efficacy and safety of alfuzosin (Alf) and tamsulosin (Tam) in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH).

MATERIALS AND METHODS

One hundred men with benign prostatic hyperplasia (BPH) who were admitted to our urology department with lower urinary tract symptoms (LUTS) were enrolled in this randomized cross-over study. At enrollment, detailed medical history was recorded, and International Prostate Symptom Score (IPSS), digital rectal examination, urinary ultrasound, prostate specific antigen (PSA) level, and uroflowmetry were determined. BPH patients with IPSS greater than 8 and maximum urinary flow rate (Q(max)) lower than 15 ml/s were randomly divided into a Alf-Tam group (Alf for 8 weeks, followed by Tam for 8 weeks) or a Tam-Alf group (Tam for 8 weeks, followed by Alf for 8 weeks). There was no withdrawal period (washout) when switching drugs.

RESULTS

In the first treatment period, each drug significantly improved IPSS and Q(max). In both the Alf-Tam and Tam-Alf groups, cross-over was effective in improving IPSS and Q(max). Alf and Tam significantly lowered IPSS and significantly increased Q(max) from baseline (P < 0.001). Neither drug affected serum PSA levels.

CONCLUSIONS

Tam and Alf, which were used during different time frames in the same individuals, are associated with similarly favorable outcomes. When one alpha-blocker does not provide a desired effect in the treatment of BPH, switching to another alpha-blocker seems to be beneficial.

摘要

目的

本研究旨在比较坦索罗辛(Tam)和阿夫唑嗪(Alf)治疗下尿路症状(LUTS)相关良性前列腺增生(BPH)的疗效和安全性。

材料和方法

本随机交叉研究纳入了 100 名因 LUTS 而到我院泌尿科就诊的 BPH 患者。入组时,详细记录了患者的病史,并进行了国际前列腺症状评分(IPSS)、直肠指检、超声检查、前列腺特异抗原(PSA)水平和尿流率测定。将 IPSS >8 且最大尿流率(Qmax)<15ml/s 的 BPH 患者随机分为 Alf-Tam 组(Alf 治疗 8 周,随后是 Tam 治疗 8 周)或 Tam-Alf 组(Tam 治疗 8 周,随后是 Alf 治疗 8 周)。在换药时,没有停药期(洗脱期)。

结果

在第一个治疗期,每种药物均显著改善了 IPSS 和 Qmax。在 Alf-Tam 和 Tam-Alf 组中,交叉治疗均有效改善了 IPSS 和 Qmax。Alf 和 Tam 均显著降低了 IPSS,且与基线相比显著增加了 Qmax(P<0.001)。两种药物均未影响血清 PSA 水平。

结论

在同一患者中不同时间段使用坦索罗辛(Tam)和阿夫唑嗪(Alf),均能获得相似的良好效果。当一种α-受体阻滞剂在治疗 BPH 时不能达到理想效果时,换用另一种α-受体阻滞剂似乎是有益的。

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