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脊髓损伤患者神经原性下尿路功能障碍的治疗:抗胆碱能药物与米拉贝隆对照评估认知影响和疗效的开放性标签、初步研究。

The treatment of neurogenic lower urinary tract dysfunction in persons with spinal cord injury: An open label, pilot study of anticholinergic agent vs. mirabegron to evaluate cognitive impact and efficacy.

机构信息

Department of Rehabilitation Medicine, University of Texas Health San Antonio, San Antonio, TX, USA.

Spinal Cord Injury Service, South Texas Veteran's Health Care System, San Antonio, TX, USA.

出版信息

Spinal Cord Ser Cases. 2021 Jun 10;7(1):50. doi: 10.1038/s41394-021-00413-6.

DOI:10.1038/s41394-021-00413-6
PMID:34112758
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8192499/
Abstract

STUDY DESIGN

Pre-post intervention.

OBJECTIVES

  1. To test whether replacement of oral anticholinergic (AC) agents with mirabegron for neurogenic lower urinary tract dysfunction (NLUTD) yields improved cognitive function in older persons with spinal cord injury (SCI). 2. To test whether mirabegron is safe and as efficacious as AC.

SETTING

USA.

METHODS

Pilot study: Twenty older (>60 y/o) persons with SCI taking chronic (>6 months) AC medication for NLUTD were enrolled. All participants were first studied on AC at baseline then switched to mirabegron for 6 months. Primary outcomes were cognitive tests of (1) executive function (TEXAS, SDMT); (2) attention (SCWT); and (3) memory (SLUMS and WMS-IV Story A/B). Secondary outcomes assessed efficacy and safety including Neurogenic Bladder Symptom Score (NBSS), bladder diary, neurogenic bowel dysfunction (NBD) survey, heart rate (HR), electrocardiogram (EKG), and mean arterial pressure (MAP).

RESULTS

When switching from AC to mirabegron for NLUTD, older persons with SCI exhibited statistically significant improvements in immediate Story A recall (p = 0.01), delayed story A and B recall (p = 0.01, 0.004), and in TEXAS (p = 0.04). Three subscores within NBSS significantly improved (p = 0.001) and the frequency of incontinence decreased (p = 0.03) on mirabegron. NBD, HR, MAP, and EKGs were unchanged.

CONCLUSIONS

Older persons with SCI on AC for NLUTD demonstrated improved short-term and delayed memory (WMS-IV Story A/B) as well as executive function (TEXAS) when switched to mirabegron. Efficacy of mirabegron for NLUTD symptoms was superior to AC with no adverse effects on bowel or cardiovascular function.

SPONSORSHIP

Claude D. Pepper Older Americans Independence Center.

摘要

研究设计

干预前后。

目的

  1. 测试对于患有脊髓损伤(SCI)的老年人,用米拉贝隆代替口服抗胆碱能(AC)药物治疗神经源性下尿路功能障碍(NLUTD)是否能改善认知功能。2. 测试米拉贝隆是否安全且与 AC 一样有效。

地点

美国。

方法

初步研究:招募了 20 名年龄大于 60 岁(>60 岁)、患有 SCI、长期(>6 个月)服用 AC 药物治疗 NLUTD 的老年人。所有参与者首先接受 AC 治疗的基线研究,然后切换至米拉贝隆治疗 6 个月。主要结果是认知测试(1)执行功能(TEXAS,SDMT);(2)注意力(SCWT);和(3)记忆(SLUMS 和 WMS-IV 故事 A/B)。次要结果评估疗效和安全性,包括神经源性膀胱症状评分(NBSS)、膀胱日记、神经源性肠功能障碍(NBD)调查、心率(HR)、心电图(EKG)和平均动脉压(MAP)。

结果

当从 AC 切换到米拉贝隆治疗 NLUTD 时,患有 SCI 的老年人在即时故事 A 回忆方面表现出统计学上的显著改善(p=0.01),延迟故事 A 和 B 回忆(p=0.01,0.004)和在 TEXAS 中(p=0.04)。NBSS 的三个亚评分显著改善(p=0.001),且失禁频率降低(p=0.03)。NBD、HR、MAP 和 EKG 无变化。

结论

患有 SCI 的老年人因 NLUTD 服用 AC 治疗时,切换至米拉贝隆后,短期和延迟记忆(WMS-IV 故事 A/B)以及执行功能(TEXAS)均得到改善。米拉贝隆治疗 NLUTD 症状的疗效优于 AC,对肠道或心血管功能无不良影响。

赞助

Claude D. Pepper 美国老年人独立中心。

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Mirabegron: a decade of study.米拉贝隆:十年研究历程。
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Motor demands of cognitive testing may artificially reduce executive function scores in individuals with spinal cord injury.认知测试的运动需求可能会人为降低脊髓损伤患者的执行功能评分。
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