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复方草药制剂Subap Plus对复发性草酸钙结石形成者24小时尿液分析及晨尿pH值的影响:一项初步研究

Effectiveness of Subap Plus, a Polyherbal Medicine, on 24-Hour Urinalysis and Early Morning Urine pH in Recurrent Calcium Oxalate Stone Formers: A Pilot Study.

作者信息

Patankar Prakash G, Palnitkar Devdatta, Patankar Suresh B

机构信息

Department of General Surgery, Patankar Nursing Home, Chiplun, IND.

Department of General Surgery, Ace Hospital and Research Centre, Pune, IND.

出版信息

Cureus. 2025 Jul 12;17(7):e87764. doi: 10.7759/cureus.87764. eCollection 2025 Jul.

DOI:10.7759/cureus.87764
PMID:40792340
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12337062/
Abstract

Introduction Calcium oxalate stone formation is driven by urinary supersaturation, pH, and imbalances in promoters and inhibitors, with acidic nighttime urine (pH <6) promoting crystal nucleation due to low citrate levels. Hence, the purpose of this pilot study was to evaluate the effectiveness of Subap Plus capsule, a polyherbal Ayurvedic formulation, for its preventive effects on early morning pH, 24-hour urinalysis parameters, and supersaturation indices in recurrent calcium oxalate stone formers. Methodology A two-week nonrandomized, uncontrolled pilot study was conducted at Ace Hospital, Pune, India, with 58 patients (20-60 years) with confirmed recurrent calcium oxalate stones. Patients received Subap Plus capsules twice daily alongside dietary advice. Baseline and post-intervention assessments included early morning urinary pH, 24-hour urinalysis (uric acid, oxalate, calcium, citrate, sodium, phosphorus, potassium, and magnesium), and supersaturation indices of calcium oxalate, calcium phosphate, and uric acid. Paired t-tests compared pre- and post-intervention values, and the statistical significance was set to p ≤ 0.05. Results Significant improvements included increased early morning pH (5.55 ± 0.39 to 5.80 ± 0.51, p = 0.001), decreased uric acid (311.38 ± 161.87 mg/day to 275.12 ± 149.82 mg/day, p = 0.017), increased potassium (28.09 ± 14.58 mmol/day to 35.16 ± 16.30 mmol/day, p = 0.002), and decreased uric acid supersaturation (0.53 ± 0.45 to 0.37 ± 0.38, p = 0.006). Citrate showed a trend toward an increase (623.16 ± 429.93 mg/day to 702.99 ± 429.50 mg/day, p = 0.068), and calcium oxalate supersaturation decreased nonsignificantly (2.87 ± 3.27 to 2.37 ± 1.66, p = 0.206). Calcium phosphate supersaturation increased in 37 (63.79%) of patients (p = 0.263). Conclusions The study concluded that the Subap Plus capsule demonstrated effectiveness in modulating early morning pH and urinary parameters to prevent calcium oxalate stone recurrence. The current study supports the role of Ayurvedic polyherbal formulations in urolithiasis management. However, large, randomized controlled trials are essential to confirm efficacy and address limitations, such as the short intervention duration. Hence, future research should optimize the formulation to enhance preventive effects.

摘要

引言 草酸钙结石的形成受尿液过饱和度、pH值以及促进剂和抑制剂失衡的驱动,夜间酸性尿液(pH <6)由于柠檬酸盐水平低而促进晶体成核。因此,本初步研究的目的是评估一种阿育吠陀多草药配方Subap Plus胶囊对复发性草酸钙结石形成者清晨pH值、24小时尿液分析参数和过饱和度指数的预防效果。

方法 在印度浦那的Ace医院进行了一项为期两周的非随机、无对照的初步研究,纳入58例确诊为复发性草酸钙结石的患者(年龄20 - 60岁)。患者每天服用两次Subap Plus胶囊,并接受饮食建议。基线和干预后评估包括清晨尿液pH值、24小时尿液分析(尿酸、草酸盐、钙、柠檬酸盐、钠、磷、钾和镁)以及草酸钙、磷酸钙和尿酸的过饱和度指数。配对t检验比较干预前后的值,统计学显著性设定为p≤0.05。

结果 显著改善包括清晨pH值升高(从5.55±0.39升至5.80±0.51,p = 0.001)、尿酸降低(从311.38±161.87毫克/天降至275.12±149.82毫克/天,p = 0.017)、钾升高(从28.09±14.58毫摩尔/天升至35.16±16.30毫摩尔/天,p = 0.002)以及尿酸过饱和度降低(从0.53±0.45降至0.37±0.38,p = 0.006)。柠檬酸盐呈升高趋势(从623.16±429.93毫克/天升至702.99±429.50毫克/天,p = 0.068),草酸钙过饱和度无显著降低(从2.87±3.27降至2.37±1.66,p = 0.206)。37例(63.79%)患者的磷酸钙过饱和度升高(p = 0.263)。

结论 该研究得出结论,Subap Plus胶囊在调节清晨pH值和尿液参数以预防草酸钙结石复发方面显示出有效性。本研究支持阿育吠陀多草药配方在尿石症管理中的作用。然而,大型随机对照试验对于确认疗效和解决局限性(如干预持续时间短)至关重要。因此,未来的研究应优化配方以增强预防效果。

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