Efficacy and Safety of High-Dose Vitamin D Supplementation vs Solifenacin or Standard Urotherapy for Overactive Bladder Dry in Children: A Randomized Clinical Trial
Efficacy and Safety of High-Dose Vitamin D Supplementation vs Solifenacin or Standard Urotherapy for Overactive Bladder Dry in Children: A Randomized Clinical Trial
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DOI：
10.1097/ju.0000000000003763
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发表时间：
2024-01-01
影响因子：
6.6
通讯作者：
Wei，Guanghui
中科院分区：
文献类型：
--
作者：
Chen，Hongsong;Zhang，Zhicheng;Wei，Guanghui
目的：探讨大剂量维生素 D 补充剂 (VDS) 联合标准尿疗法 (SU) 治疗儿童膀胱过度活动症干燥症 (OAB-dry) 的有效性和安全性。材料和方法：2023 年 1 月至 2023 年 6 月在中国的一个学术中心进行了一项 3 组随机临床试验。符合条件的患者 (n = 303) 被随机接受 8 周：高剂量 VDS（维生素 D3 滴剂）封装为软胶囊，2400 IU/d）加 SU（VDS+ SU 组）（n= 100），索利那新（5-10 mg/d）加 SU（SOL+ SU 组）（n= 102）；或单独使用 SU（SU 组）（n= 101）。排尿频率减少是主要结果。次要结局包括尿急、夜尿、生活质量（QoL）评分、儿科下尿路症状（PLUTS）评分和参与者满意度的改善。记录每组内治疗引起的不良事件 (TEAE)。结果：参与者的中位年龄为 82.0 个月，基线平均维生素 D 水平为 22.64 ng/mL。干预后，VDS+ SU 组的每日排尿次数比 SOL+ SU 组（中位差 3.0；95% CI 2.0 至 3.5；P<. 001）和 SU 组（中位差 4.0；95% CI 3.0 至 5.0；P<. 001）有更大的改善。 VDS+ SU 组的 QoL 和 PLUTS 分数也显示出最大的改善。 SOL+ SU 组和 SU 组的患者满意度相似。与其他组相比，VDS+ SU 组没有表现出较高的 TEAE 风险。结论：高剂量 VDS 加 SU 在治疗儿童 OAB-dry 方面有效且耐受性良好，表明其作为该人群的新型治疗选择的潜力。
Purpose:To investigate the efficacy and safety of high-dose vitamin D supplementation (VDS) plus standard urotherapy (SU) in managing overactive bladder dry (OAB-dry) in children.Materials and Methods:A 3-arm, randomized clinical trial was performed at an academic center in China between January 2023 to June 2023. Eligible patients (n= 303) were randomized to receive 8 weeks of: high-dose VDS (vitamin D3 drops encapsulated as soft capsules, 2400 IU/d) plus SU (VDS+ SU group)(n= 100), solifenacin (5-10 mg/d) plus SU (SOL+ SU group)(n= 102); or SU alone (SU group)(n= 101). Reduction in voiding frequency was the primary outcome. Secondary outcomes encompassed improvement in urgency, nocturia, quality of life (QoL) score, pediatric lower urinary tract symptom (PLUTS) score, and participant satisfaction. Treatment-emergent adverse events (TEAEs) were recorded within each group.Results:Participants had a median age of 82.0 months and their baseline mean vitamin D level was 22.64 ng/mL. The VDS+ SU group showed greater improvements in voids/d than the SOL+ SU group (median difference 3.0; 95% CI 2.0 to 3.5; P<. 001) and the SU group (median difference 4.0; 95% CI 3.0 to 5.0; P<. 001) after intervention. The VDS+ SU group also showed the greatest improvement in QoL and PLUTS scores. Patient satisfaction was similar between the SOL+ SU and SU groups. The VDS+ SU group did not exhibit a heightened risk of TEAEs compared to the other groups.Conclusions:High-dose VDS plus SU was effective and well-tolerated in managing OAB-dry in children, suggesting its potential as a novel therapeutic option for this population.