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根据国际前列腺症状评分严重程度将良性前列腺增生相关下尿路症状患者分为亚组,比较每日一次使用4毫克与8毫克西洛多辛的疗效和安全性。

Comparative efficacy and safety profile of 4 vs 8 mg of silodosin once daily usage in patients with benign prostatic hyperplasia-related lower urinary tract symptoms divided into subgroups according to International Prostate Symptom Score severity.

作者信息

Gul Abdullah, Coban Soner, Turkoglu Ali Riza, Guzelsoy Muhammet, Ozturk Murat, Kankilic Nazim Abdulkadir

机构信息

University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital, Department of Urology, Bursa, Turkey.

University of Health Sciences, Van Education and Research Hospital, Department of Urology, Van, Turkey.

出版信息

Prostate Int. 2020 Dec;8(4):152-157. doi: 10.1016/j.prnil.2020.04.002. Epub 2020 May 19.

DOI:10.1016/j.prnil.2020.04.002
PMID:33425792
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7767940/
Abstract

BACKGROUND

The purpose of this study was to compare once daily (QD) usage of 4 and 8 mg of silodosin in patients divided as those with moderate and with severe lower urinary tract symptoms (LUTSs) according to International Prostate Symptom Score (IPSS) categories in terms of effectiveness and adverse events.

METHODS

A total of 234 patients aged ≥ 40 years were evaluated prospectively. All participants were divided firstly into two groups according to their IPSS severity as moderate and severe. They were further allocated to receive 4 mg of silodosin and 8 mg of silodosin QD. Demographic features and laboratory tests were recorded. The patients were questioned with International Index of Erectile Function-5 and IPSS along with quality of life index. Uroflowmetric measurements were applied to the patients. All tests and measurements were repeated at the 3rd month, and changes from pretreatment to posttreatment were analyzed by SPSS 21.0 Program. The statistical significance level was set at p < 0.05.

RESULTS

Both treatments provided benefit in patients with both moderate and severe LUTSs. While results did not differ among 4 mg and 8 mg of silodosin in patients with moderate LUTSs, 8 mg of silodosin was significantly better than 4mg in those with severe LUTSs in terms of improvement of the total IPSS, IPSS voiding subtotal score, and quality of life score (p = 0.015, 0.030, <0.001, respectively). Both treatments did not affect erectile functions. Adverse events were seen more frequently in patients receiving 8 mg of silodosin than those treated with 4 mg of silodosin (p = 0.024).

CONCLUSION

Our study revealed that 4 mg of silodosin QD was as effective as 8 mg of silodosin QD in patients with moderate LUTSs but not with severe LUTSs. It can be inferred from this study that prescription of 4 and 8 mg of silodosin may be chosen to treat the patients with moderate and severe LUTSs due to benign prostatic heperplasia, respectively.

摘要

背景

本研究的目的是比较每日一次(QD)服用4毫克和8毫克西洛多辛对根据国际前列腺症状评分(IPSS)分类为中度和重度下尿路症状(LUTS)的患者在有效性和不良事件方面的影响。

方法

前瞻性评估了总共234名年龄≥40岁的患者。所有参与者首先根据其IPSS严重程度分为中度和重度两组。他们进一步被分配接受4毫克西洛多辛和8毫克西洛多辛每日一次治疗。记录人口统计学特征和实验室检查结果。使用国际勃起功能指数-5、IPSS以及生活质量指数对患者进行询问。对患者进行尿流率测量。所有测试和测量在第3个月重复进行,并使用SPSS 21.0程序分析治疗前至治疗后的变化。统计学显著性水平设定为p<0.05。

结果

两种治疗方法对中度和重度LUTS患者均有益。在中度LUTS患者中,4毫克和8毫克西洛多辛的治疗效果无差异,但在重度LUTS患者中,就总IPSS、IPSS排尿总分和生活质量评分的改善而言,8毫克西洛多辛明显优于4毫克(分别为p = 0.015、0.030、<0.001)。两种治疗方法均不影响勃起功能。接受8毫克西洛多辛治疗的患者比接受4毫克西洛多辛治疗的患者更频繁出现不良事件(p = 0.024)。

结论

我们的研究表明,每日一次服用4毫克西洛多辛对中度LUTS患者的效果与8毫克西洛多辛相同,但对重度LUTS患者则不然。从本研究可以推断,对于因良性前列腺增生导致中度和重度LUTS的患者,可分别选择开具4毫克和8毫克西洛多辛进行治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2fc/7767940/1488ec5b491a/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2fc/7767940/1488ec5b491a/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a2fc/7767940/1488ec5b491a/gr1.jpg

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