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高剂量维生素 D 补充剂与索利那新或标准尿路治疗对儿童膀胱过度活动症(无湿)的疗效比较:一项随机临床试验的二次分析。

Efficacy of high-dose vitamin D supplementation vs. solifenacin or standard urotherapy for overactive bladder dry in children: a secondary analysis of a randomized clinical trial.

机构信息

Department of Urology, Children's Hospital of Chongqing Medical University, 136 Zhongshan Road, Chongqing, 400014, PR China.

Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing, 400014, PR China.

出版信息

World J Urol. 2024 Oct 22;42(1):586. doi: 10.1007/s00345-024-05296-4.

DOI:10.1007/s00345-024-05296-4
PMID:39436468
Abstract

PURPOSE

To investigate the efficacy of high-dose vitamin D supplementation (VDS) plus standard urotherapy (SU) in managing pediatric overactive bladder dry (OAB-dry), specifically in children with (1) vitamin D levels between 20 and 35 ng/mL and (2) heightened baseline symptom severity.

METHODS

In this secondary analysis of a randomized controlled trial, eligible children (n = 303) were assigned to 8 weeks of VDS + SU group, solifenacin (SOL) + SU group, or SU alone group. The primary outcome was voiding frequency; secondary outcomes included urgency, nocturia, quality of life (QoL), pediatric lower urinary tract symptoms scores, and patient satisfaction.

RESULTS

Among 303 participants, 197 (65%) had vitamin D levels between 20 and 35 ng/mL, and 119 (39%) exhibited heightened baseline symptom severity. In both subgroups, VDS + SU resulted in significantly greater improvements in voiding frequency compared to SOL + SU and SU alone. In the vitamin D subgroup (20-35 ng/mL), the median difference in voids/day between VDS + SU and SOL + SU was 2.0 (95% CI, 1.0 to 3.0; P = 0.003) and 3.2 compared to SU alone (P < 0.001). In the heightened symptom subgroup, the median difference was 3.0 (95% CI, 2.0 to 4.0; P < 0.001) vs. SOL + SU and 5.0 (95% CI, 4.0 to 6.0; P < 0.001) vs. SU alone. The VDS + SU group generally outperformed the other groups in various secondary outcome measures.

CONCLUSION

High-dose VDS plus SU has significant therapeutic benefit in children with OAB-dry in those with vitamin D levels between 20 and 35 ng/mL and with more severe symptoms, compared to SOL + SU or SU alone.

摘要

目的

研究大剂量维生素 D 补充(VDS)联合标准尿路治疗(SU)治疗小儿膀胱过度活动症(OAB)干性(OAB-dry)的疗效,特别是针对(1)维生素 D 水平在 20 至 35ng/ml 之间,(2)基线症状严重程度较高的患儿。

方法

本研究为一项随机对照试验的二次分析,纳入的患儿(n=303)被分为 8 周 VDS+SU 组、索利那新(SOL)+SU 组和 SU 单药组。主要结局为排尿频率;次要结局包括尿急、夜尿、生活质量(QoL)、小儿下尿路症状评分和患者满意度。

结果

在 303 名参与者中,有 197 名(65%)维生素 D 水平在 20 至 35ng/ml 之间,119 名(39%)基线症状严重程度较高。在这两个亚组中,与 SOL+SU 和 SU 单药组相比,VDS+SU 均显著改善了排尿频率。在维生素 D 亚组(20-35ng/ml)中,VDS+SU 与 SOL+SU 相比,每日排尿次数的中位数差异为 2.0(95%CI,1.0 至 3.0;P=0.003),与 SU 单药组相比为 3.2(P<0.001)。在症状加重亚组中,中位数差异为 3.0(95%CI,2.0 至 4.0;P<0.001)与 SOL+SU 相比,与 SU 单药组相比为 5.0(95%CI,4.0 至 6.0;P<0.001)。VDS+SU 组在各种次要结局指标上总体优于其他组。

结论

与 SOL+SU 或 SU 单药相比,高剂量 VDS 联合 SU 对维生素 D 水平在 20 至 35ng/ml 之间且症状更严重的小儿 OAB-dry 患儿具有显著的治疗益处。

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本文引用的文献

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J Urol. 2024 Jan;211(1):26-36. doi: 10.1097/JU.0000000000003763. Epub 2023 Oct 23.
2
The effect of vitamin D on urgent urinary incontinence in postmenopausal women.维生素 D 对绝经后女性急迫性尿失禁的影响。
Int Urogynecol J. 2023 Aug;34(8):1955-1960. doi: 10.1007/s00192-023-05486-5. Epub 2023 Feb 24.
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Effect of Vitamin D Supplementation on Overactive Bladder and Urinary Incontinence Symptoms in Older Men: Ancillary Findings From a Randomized Trial.
维生素 D 补充对老年男性膀胱过度活动症和尿失禁症状的影响:一项随机试验的辅助结果。
J Urol. 2023 Jan;209(1):243-252. doi: 10.1097/JU.0000000000002942. Epub 2022 Sep 6.
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The effect of vitamin D deficiency in children with overactive bladder related urinary incontinence.儿童维生素 D 缺乏与膀胱过度活动症相关尿失禁的关系。
Int Braz J Urol. 2022 Mar-Apr;48(2):316-325. doi: 10.1590/S1677-5538.IBJU.2021.0645.
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The effect of vitamin D deficiency and supplementation on urinary incontinence: scoping review.维生素 D 缺乏和补充对尿失禁的影响:范围综述。
Int Urogynecol J. 2022 May;33(5):1083-1090. doi: 10.1007/s00192-021-04963-z. Epub 2021 Sep 7.
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Systematic Review and Meta-Analysis of the Association between Vitamin D Status and Lower Urinary Tract Symptoms.系统评价和荟萃分析维生素 D 状态与下尿路症状之间的关系。
J Urol. 2021 Jun;205(6):1584-1594. doi: 10.1097/JU.0000000000001441. Epub 2020 Nov 18.
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Nocebo Response in the Pharmacological Management of Overactive Bladder: A Systematic Review and Meta-analysis.药物治疗过度膀胱的厌恶反应:系统评价和荟萃分析。
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