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度他雄胺可改善夜尿症但不会改善睡眠:来自 REDUCE 临床试验的结果。

Dutasteride Improves Nocturia but Does Not Lead to Better Sleep: Results from the REDUCE Clinical Trial.

机构信息

Division of Urology, Department of Surgery, Cedars-Sinai Medical Center, Los Angeles, California.

Duke Cancer Institute, Duke University School of Medicine, Durham, North Carolina.

出版信息

J Urol. 2021 Jun;205(6):1733-1739. doi: 10.1097/JU.0000000000001640. Epub 2021 Feb 19.

DOI:10.1097/JU.0000000000001640
PMID:33605791
Abstract

PURPOSE

In men, complaints of nocturia causing poor sleep are often attributed to benign prostatic hyperplasia and treated with benign prostatic hyperplasia medications. We assessed whether treating lower urinary tract symptoms with dutasteride altered either nocturia or sleep quality using data from REDUCE.

MATERIALS AND METHODS

REDUCE was a 4-year randomized, multicenter trial comparing dutasteride 0.5 mg/day vs placebo for prostate cancer chemoprevention. Study participants were men considered at increased risk for prostate cancer. Eligibility included age 50-75 years, prostate specific antigen 2.5-10 ng/ml, and 1 negative prostate biopsy. At baseline, 2 years and 4 years, men completed the International Prostate Symptom Score and Medical Outcomes Study Sleep Scale, a 6-item scale assessing sleep. To test differences in nocturia and Medical Outcomes Study Sleep Scale over time, we used linear mixed models adjusted for baseline confounders. Subanalyses were conducted in men symptomatic from lower urinary tract symptoms, nocturia, poor sleep, or combinations thereof.

RESULTS

Of 6,914 men with complete baseline data, 80% and 59% were assessed at 2 and 4-year followup, respectively. Baseline characteristics were balanced between treatment arms. Dutasteride improved nocturia at 2 (-0.15, 95% CI -0.21, -0.09) and 4 years (-0.24, 95% CI -0.31, -0.18) but did not improve sleep. When limited to men symptomatic from lower urinary tract symptoms, nocturia, poor sleep or combinations thereof, results mirrored findings from the full cohort.

CONCLUSIONS

In men with poor sleep who complain of nocturia, treatment of lower urinary tract symptoms with dutasteride modestly improves nocturia but has no effect on sleep. These results suggest men with poor sleep who complain of nocturia may not benefit from oral benign prostatic hyperplasia treatment.

摘要

目的

在男性中,因夜尿症导致睡眠质量差而引起的抱怨通常归因于良性前列腺增生,并使用治疗良性前列腺增生的药物进行治疗。我们评估了使用度他雄胺治疗下尿路症状是否会改变夜尿症或睡眠质量,数据来自 REDUCE。

材料和方法

REDUCE 是一项为期 4 年的随机、多中心试验,比较了度他雄胺 0.5mg/天与安慰剂在前列腺癌化学预防中的作用。研究参与者为被认为患有前列腺癌风险增加的男性。入选标准包括年龄 50-75 岁,前列腺特异性抗原 2.5-10ng/ml,以及 1 次阴性前列腺活检。在基线、2 年和 4 年时,男性完成了国际前列腺症状评分和医疗结局研究睡眠量表,这是一个评估睡眠的 6 项量表。为了测试随时间变化的夜尿症和医疗结局研究睡眠量表的差异,我们使用了线性混合模型,根据基线混杂因素进行了调整。在有下尿路症状、夜尿症、睡眠不佳或其组合症状的男性中进行了亚分析。

结果

在 6914 名有完整基线数据的男性中,分别有 80%和 59%在 2 年和 4 年随访时进行了评估。治疗组之间的基线特征平衡。度他雄胺在 2 年(-0.15,95%置信区间-0.21,-0.09)和 4 年(-0.24,95%置信区间-0.31,-0.18)时改善了夜尿症,但没有改善睡眠。当仅限于有下尿路症状、睡眠不佳或其组合症状的男性时,结果与全队列的结果一致。

结论

在睡眠不佳且抱怨夜尿症的男性中,用度他雄胺治疗下尿路症状可适度改善夜尿症,但对睡眠没有影响。这些结果表明,睡眠不佳且抱怨夜尿症的男性可能不会受益于口服良性前列腺增生症治疗。

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引用本文的文献

1
Modeling study of the effect of placebo and medical therapy on storage and voiding symptoms, nocturia, and quality of life in men with prostate enlargement at risk for progression.前列腺增生进展风险男性的储存和排尿症状、夜尿症和生活质量的安慰剂和医学治疗效果的建模研究。
Prostate Cancer Prostatic Dis. 2024 Sep;27(3):469-477. doi: 10.1038/s41391-023-00731-w. Epub 2023 Oct 4.