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前列腺体积是否可预测有轻度至无当前症状的男性中出现下尿路症状的发展?来自 REDUCE 试验的结果。

Does Prostate Size Predict the Development of Incident Lower Urinary Tract Symptoms in Men with Mild to No Current Symptoms? Results from the REDUCE Trial.

机构信息

Duke Prostate Center, Division of Urology, Department of Surgery and Pathology, Duke University School of Medicine, Durham, NC, USA; Urology Section, Veterans Affairs Medical Center, Durham, NC, USA.

Urology Section, Veterans Affairs Medical Center, Durham, NC, USA; Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, NC, USA.

出版信息

Eur Urol. 2016 May;69(5):885-91. doi: 10.1016/j.eururo.2015.12.002. Epub 2015 Dec 24.

DOI:10.1016/j.eururo.2015.12.002
PMID:26724841
Abstract

BACKGROUND

It has been shown that increased prostate size is a risk factor for lower urinary tract symptom (LUTS) progression in men who currently have LUTS presumed due to benign prostatic hyperplasia (BPH).

OBJECTIVE

To determine if prostate size is a risk factor for incident LUTS in men with mild to no symptoms.

DESIGN, SETTING, AND PARTICIPANTS: We conducted a post hoc analysis of the REDUCE study, which contained a substantial number of men (n=3090) with mild to no LUTS (International Prostate Symptom Score [IPSS] <8).

OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS

Our primary outcome was determination of the effect of prostate size on incident LUTS presumed due to BPH defined as two consecutive IPSS values >14, or receiving any medical (α-blockers) or surgical treatment for BPH throughout the study course. To determine the risk of developing incident LUTS, we used univariable and multivariable Cox models, as well as Kaplan-Meier curves and the log-rank test.

RESULTS AND LIMITATIONS

Among men treated with placebo during the REDUCE study, those with a prostate size of 40.1-80ml had a 67% higher risk (hazard risk 1.67, 95% confidence interval 1.23-2.26, p=0.001) of developing incident LUTS compared to men with a prostate size 40.0ml or smaller. There was no association between prostate size and risk of incident LUTS in men treated with 0.5mg of dutasteride. The post hoc nature of our study design is a potential limitation.

CONCLUSIONS

Men with mild to no LUTS but increased prostate size are at higher risk of incident LUTS presumed due to BPH. This association was negated by dutasteride treatment.

PATIENT SUMMARY

Benign prostatic hyperplasia (BPH) is a very common problem among older men, which often manifests as lower urinary tract symptoms (LUTS), and can lead to potentially serious side effects. In our study we determined that men with mild to no current LUTS but increased prostate size are much more likely to develop LUTS presumed due to BPH in the future. This association was not seen in men treated with dutasteride, a drug approved for treatment of BPH. Our study reveals that men with a prostate size of 40.1-80ml are potential candidates for closer follow-up.

摘要

背景

研究表明,前列腺体积增大是目前患有下尿路症状(LUTS)的良性前列腺增生(BPH)患者发生 LUTS 进展的危险因素。

目的

确定前列腺体积是否是轻度至无症状男性发生 LUTS 的危险因素。

设计、地点和参与者:我们对 REDUCE 研究进行了事后分析,该研究包含大量轻度至无 LUTS(国际前列腺症状评分[IPSS] <8)的男性(n=3090)。

结局测量和统计分析

我们的主要结局是确定前列腺体积对因 BPH 导致的新发 LUTS 的影响,定义为连续两次 IPSS 值>14,或在整个研究过程中因 BPH 接受任何药物(α-受体阻滞剂)或手术治疗。为了确定发生新发 LUTS 的风险,我们使用单变量和多变量 Cox 模型,以及 Kaplan-Meier 曲线和对数秩检验。

结果和局限性

在 REDUCE 研究中接受安慰剂治疗的男性中,前列腺体积为 40.1-80ml 的男性发生新发 LUTS 的风险增加 67%(危险比 1.67,95%置信区间 1.23-2.26,p=0.001)与前列腺体积为 40.0ml 或更小的男性相比。在接受 0.5mg 达特罗terone 治疗的男性中,前列腺体积与新发 LUTS 风险之间无关联。我们的研究设计的事后性质是一个潜在的局限性。

结论

轻度至无 LUTS 但前列腺体积增大的男性发生 BPH 导致的新发 LUTS 的风险较高。这种关联被 dutasteride 治疗所否定。

患者总结

良性前列腺增生(BPH)是老年男性中非常常见的问题,常表现为下尿路症状(LUTS),并可能导致潜在的严重副作用。在我们的研究中,我们确定了目前轻度至无 LUTS 但前列腺体积增大的男性在未来更有可能患上 BPH 引起的 LUTS。在接受 dutasteride 治疗的男性中未观察到这种关联,dutasteride 是一种批准用于治疗 BPH 的药物。我们的研究表明,前列腺体积为 40.1-80ml 的男性可能是密切随访的候选者。

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