塞来昔布治疗良性前列腺增生引起的夜尿症：一项前瞻性、随机、双盲、安慰剂对照研究。

Celecoxib for treatment of nocturia caused by benign prostatic hyperplasia: a prospective, randomized, double-blind, placebo-controlled study.

作者信息

Falahatkar Siavash, Mokhtari Gholamreza, Pourreza Farshid, Asgari Seyed Alaeddin, Kamran Alireza Noshad

机构信息

Urology Research Center, Razi Hospital, Guilan University of Medical Sciences, Rasht, Islamic Republic of Iran.

出版信息

Urology. 2008 Oct;72(4):813-6. doi: 10.1016/j.urology.2008.04.069. Epub 2008 Aug 9.

DOI:10.1016/j.urology.2008.04.069

PMID:18692876

Abstract

OBJECTIVES

Nocturia is a well-recognized symptom of benign prostatic hyperplasia (BPH), which is commonly treated by alpha(1)-blockers and/or 5alpha-reductase inhibitors. However, the effectiveness of these drugs for nocturia has been reported to be only 25%-39%. The aim of this study was to investigate the efficacy of celecoxib, a cyclooxygenase-2 inhibitor, in the treatment of patients with BPH complaining of nocturia.

METHODS

This was a prospective, randomized, double-blind, placebo-controlled study. A total of 80 men with lower urinary tract symptoms and BPH were entered into the study and were randomized to receive celecoxib, 100 mg at 9 pm vs placebo for 1 month. The inclusion criteria also included a total International Prostate Symptom Score >8 and complaints of >or=2 voids nightly. The efficacy and safety of the treatment were assessed by changes in the urinary flow and symptoms between baseline and 1 month of follow-up.

RESULTS

In the celecoxib group (n = 40), the mean nocturnal frequency (+/-SD) decreased from 5.17 +/- 2.1 to 2.5 +/- 1.9 (P < .0001), and the mean International Prostate Symptom Score (+/-SD) decreased from 18.2 +/- 3.4 to 15.5 +/- 4.2 (P < .0001). In the control group (n = 40), the mean nocturnal frequency (+/-SD) decreased from 5.30 +/- 2.4 to 5.12 +/- 1.9 (P > .05), and the mean International Prostate Symptom Score (+/-SD) decreased from 18.4 +/- 3.1 to 18 +/- 3.9 (P > .05). A statistically significant difference was found between the 2 groups (P < .0001). No statistically significant differences were found in the changes in the peak flow rate between the celecoxib and control groups or in celecoxib group between baseline and 1 month (P > .05). No significant side effects were reported.

CONCLUSIONS

Celecoxib is effective in the treatment of patients with BPH complaining of refractory nocturia. Our results suggest a novel treatment option for this common condition.

摘要

目的

夜尿症是良性前列腺增生（BPH）的一个公认症状，通常用α1受体阻滞剂和/或5α还原酶抑制剂进行治疗。然而，据报道这些药物治疗夜尿症的有效率仅为25%-39%。本研究的目的是调查环氧化酶-2抑制剂塞来昔布治疗主诉夜尿症的BPH患者的疗效。

方法

这是一项前瞻性、随机、双盲、安慰剂对照研究。共有80名有下尿路症状和BPH的男性纳入研究，随机分为两组，一组在晚上9点服用100毫克塞来昔布，另一组服用安慰剂，为期1个月。纳入标准还包括国际前列腺症状评分总分>8分以及每晚排尿≥2次。通过比较基线和随访1个月时尿流和症状的变化来评估治疗的疗效和安全性。

结果

在塞来昔布组（n = 40），平均夜尿次数（±标准差）从5.17±2.1降至2.5±1.9（P <.0001），国际前列腺症状评分均值（±标准差）从18.2±3.4降至15.5±4.2（P <.0001）。在对照组（n = 40），平均夜尿次数（±标准差）从5.30±2.4降至5.12±1.9（P>.05），国际前列腺症状评分均值（±标准差）从18.4±3.1降至18±3.9（P>.05）。两组之间存在统计学显著差异（P <.0001）。塞来昔布组和对照组之间的最大尿流率变化以及塞来昔布组基线和1个月之间的最大尿流率变化均无统计学显著差异（P>.05）。未报告明显的副作用。