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α1肾上腺素能受体拮抗剂在接受低剂量率近距离放射治疗的前列腺癌患者中的应用——西洛多辛与萘哌地尔的随机对照试验

Use of alpha-1 adrenoceptor antagonists in patients who underwent low-dose-rate brachytherapy for prostate cancer - a randomized controlled trial of silodosin versus naftopidil.

作者信息

Tanaka Nobumichi, Torimoto Kazumasa, Asakawa Isao, Miyake Makito, Anai Satoshi, Hirayama Akihide, Hasegawa Masatoshi, Konishi Noboru, Fujimoto Kiyohide

机构信息

Departments of Urology, Nara Medical University, 840 Shijo-cho, Kashihara, Nara, 634-8522, Japan.

Radiation Oncology, Nara Medical University, Kashihara, Nara, 634-8522, Japan.

出版信息

Radiat Oncol. 2014 Dec 29;9:302. doi: 10.1186/s13014-014-0302-7.

DOI:10.1186/s13014-014-0302-7
PMID:25544509
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4300048/
Abstract

BACKGROUND

To evaluate the effect of two different alpha-1 adrenoceptor antagonists on lower urinary tract symptoms in patients who underwent LDR-brachytherapy.

METHODS

A total of 141 patients who had been clinically diagnosed with localized prostate cancer and underwent LDR-brachytherapy were enrolled. Patients were randomized and allocated to two groups (silodosin 8 mg vs. naftopidil 75 mg). The primary endpoint was a change in the international prostate symptom score (IPSS) at 3 months after seed implantation. Secondary endpoints included the recovery rate of IPSS at 12 months after seed implantation, the change in IPSS and overactive bladder symptom score, uroflowmetric parameters, and frequency volume chart (FVC). To determine independent variables that can predict IPSS recovery, logistic regression analysis was carried out.

RESULTS

The mean change in the IPSS at 3 months after seed implantation in both groups was ⊿10.6 (naftopidil) and ⊿10.4 (silodosin), respectively. There was not a significant difference between the two groups (p=0.728). An increase in urinary frequency and a decrease in total urinated volume and mean voided volume were observed in FVC for 12 months after seed implantation. Multivariate analysis revealed that the urethral dose (UD30) was an independent predictive parameter of IPSS recovery. Patients with UD30 < 200Gy showed a higher recovery rate of IPSS at 12 months after seed implantation.

CONCLUSION

There was no significant difference of serial change in IPSS between silodosin and naftopidil during the first year after seed implantation. A lower dose on the urethra was an independent predictor of IPSS recovery at 12 months after seed implantation.

摘要

背景

评估两种不同的α-1肾上腺素能受体拮抗剂对接受低剂量率近距离放射治疗患者下尿路症状的影响。

方法

共纳入141例临床诊断为局限性前列腺癌并接受低剂量率近距离放射治疗的患者。患者被随机分为两组(西洛多辛8毫克组与萘哌地尔75毫克组)。主要终点是种子植入后3个月时国际前列腺症状评分(IPSS)的变化。次要终点包括种子植入后12个月时IPSS的恢复率、IPSS和膀胱过度活动症症状评分的变化、尿流率参数以及频率-尿量图(FVC)。为确定可预测IPSS恢复的独立变量,进行了逻辑回归分析。

结果

两组种子植入后3个月时IPSS的平均变化分别为⊿10.6(萘哌地尔组)和⊿10.4(西洛多辛组)。两组之间无显著差异(p = 0.728)。种子植入后12个月的FVC显示尿频增加,总尿量和平均排尿量减少。多变量分析显示尿道剂量(UD30)是IPSS恢复的独立预测参数。UD30<200Gy的患者在种子植入后12个月时IPSS恢复率较高。

结论

种子植入后的第一年,西洛多辛和萘哌地尔在IPSS的系列变化上无显著差异。较低的尿道剂量是种子植入后12个月时IPSS恢复的独立预测因素。

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25-Year disease-free survival rate after irradiation for prostate cancer calculated with the prostate specific antigen definition of recurrence used for radical prostatectomy.基于用于根治性前列腺切除术的前列腺特异性抗原复发定义,计算前列腺癌放疗后 25 年无病生存率。
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