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西洛多辛治疗老年良性前列腺增生男性夜间多尿的有效性:一项多中心研究。

The Effectiveness of Silodosin for Nocturnal Polyuria in Elderly Men With Benign Prostatic Hyperplasia: A Multicenter Study.

作者信息

Kim Young Won, Park Jinsung, Chung Hong, Kim Hong-Wook, Kim Hyung Joon, Jung Jae Hung, Kim Won Tae

机构信息

Department of Urology, Chungbuk National University College of Medicine, Cheongju, Korea.

Department of Urology, Eulji University School of Medicine, Daejeon, Korea.

出版信息

Int Neurourol J. 2015 Sep;19(3):190-6. doi: 10.5213/inj.2015.19.3.190. Epub 2015 Sep 22.

Abstract

PURPOSE

To investigate improvement in nocturia and nocturnal polyuria in nocturnal polyuria patients after silodosin administration by using a 3-day frequency volume chart.

METHODS

This was a prospective multicenter study. We enrolled nocturnal polyuria patients (nocturnal polyuria index [NPi]>0.33), aged ≥60 years, diagnosed with the 3-day frequency volume charts of patients with benign prostatic hyperplasia taking α-blockers. Of the 54 patients, 30 (55.6%) completed the study according to the study protocol (per-protocol group), and 24 dropped out (dropout group).

RESULTS

Of the 24 patients in the dropout group, 5 withdrew consent due to side effects or lack of efficacy, 7 were lost to follow-up at 4 weeks, 8 were lost to follow-up at 12 weeks, and 4 dropped out due to failure to complete 3-day frequency volume charts at 12 weeks. In the per-protocol group, there was significant improvement in the International Prostate Symptom Score (IPSS), especially question numbers 1, 3, 4, 5, 6, 7, and the quality of life question (P=0.001, P=0.007, P<0.001, P=0.003, P=0.049, P<0.001, and P<0.001, respectively). The Leeds sleep evaluation questionnaire (LSEQ) score for the sleep question improved from 64.36 to 70.43 (P=0.039). The NPi reduced from 0.4005 to 0.3573 (P=0.027); however, in many cases, there was no improvement in nocturnal polyuria itself. In intention-to-treat analysis, there were significant improvements in IPSS and LSEQ in 45 patients.

CONCLUSIONS

In elderly nocturnal polyuria patients, silodosin monotherapy exhibits good efficacy in improving nocturia and nocturnal polyuria; however, the mean NPi was still >0.33. Considering the high dropout rate of our study due to no implementation of 3-day frequency volume charts, prospective and large-scale studies are needed to confirm our results.

摘要

目的

通过使用3天频率尿量图表,研究西洛多辛给药后夜尿症患者夜尿和夜间多尿的改善情况。

方法

这是一项前瞻性多中心研究。我们纳入了年龄≥60岁、夜间多尿指数(NPi)>0.33的夜尿症患者,这些患者通过服用α受体阻滞剂的良性前列腺增生患者的3天频率尿量图表进行诊断。54例患者中,30例(55.6%)按照研究方案完成了研究(符合方案组),24例退出(退出组)。

结果

在退出组的24例患者中,5例因副作用或缺乏疗效而撤回同意书,7例在4周时失访,8例在12周时失访,4例因未在12周完成3天频率尿量图表而退出。在符合方案组中,国际前列腺症状评分(IPSS)有显著改善,尤其是问题1、3、4、5、6、7以及生活质量问题(分别为P = 0.001、P = 0.007、P < 0.001、P = 0.003、P = 0.049、P < 0.001和P < 0.001)。睡眠问题的利兹睡眠评估问卷(LSEQ)评分从64.36提高到70.43(P = 0.039)。NPi从0.4005降至0.3573(P = 0.027);然而,在许多情况下,夜间多尿本身并无改善。在意向性分析中,45例患者的IPSS和LSEQ有显著改善。

结论

在老年夜尿症患者中,西洛多辛单药治疗在改善夜尿和夜间多尿方面显示出良好疗效;然而,平均NPi仍>0.33。考虑到由于未实施3天频率尿量图表,我们的研究退出率较高,需要进行前瞻性大规模研究来证实我们的结果。

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