A randomized controlled trial evaluating the impact of curcumin versus pentoxifylline on patients with chronic kidney disease

IF 4.5 Q2 PHARMACOLOGY & PHARMACY
Nada M. Kamel, Ahmed Elkoraie, Tarek M. Mostafa, Fedaa A. Kotkata
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引用次数: 0

Abstract

Background

Chronic kidney disease (CKD) is a long-term, progressive disorder marked by a steady decline in renal function. It is frequently associated with complications such as anemia, bone and mineral imbalances, oxidative stress, and systemic inflammation. The buildup of uremic toxins, particularly p-cresyl sulfate (pCS), increases cardiovascular risk and mortality. Early diagnosis and timely treatment are essential to slow disease progression and enhance quality of life. This study investigates the nephroprotective roles of curcumin (–) and pentoxifylline (PTX) as adjunctive therapies alongside standard CKD management. Ninety-four CKD patients were randomized into three groups: control (standard care), – (500 mg twice daily), and PTX (400 mg twice daily) for 6 months. Renal function, electrolytes, and quality of life (KDQOL-SF™ v1.3) were assessed at baseline, 1, 3, and 6 months, while biomarkers (pCS, MDA, and Hs-CRP) were measured at baseline and after 6 months.

Results

After 6 months, – significantly reduced pCS (5.79 ± 3.74 to 5.02 ± 3.41 μg/mL, p = 0.011) and MDA levels (11.26 ± 7.37 to 10.43 ± 8.84 nmol/mL, p = 0.016), while the PTX group showed significant improvement in Hs-CRP levels (7.13 ± 3.53 to 5.52 ± 3.43 mg/L, p = 0.019) and albuminuria (p = 0.034 of ACR). Both treatments favorably affected creatinine, urea, and eGFR compared with control. After 6 months, serum creatinine showed improvement in both intervention groups, decreasing (3.58 ± 2.21 to 3.12 ± 2.18 mg/dL) in the – group and (2.75 ± 1.48 to 2.34 ± 1.17 mg/dL) in the PTX group (both p < 0.001), BUN significantly decreased (41.03 ± 18.38 to 29.96 ± 13.46 mg/dL) and (35.29 ± 12.94 to 28.50 ± 14.59 mg/dL), respectively, compared with worsening values in the control group (both p < 0.001) and eGFR increased (23.77 ± 13.35 to 28.50 ± 15.93 mL/min/1.73m2) and (30.29 ± 14.07 to 35.57 ± 15.40 mL/min/1.73m2), respectively (both p < 0.001). Only mild gastrointestinal side effects were reported across all study groups, with no statistically significant differences between groups and no serious adverse events observed.

Conclusions

– and PTX treatment may provide adjunctive benefits in CKD by improving selected secondary outcomes related to oxidative stress, inflammation, and renal function.

Clinical trial registration

This study was retrospectively registered on ClinicalTrials.gov on June 12, 2024 (Identifier: NCT06458465) on https://clinicaltrials.gov/study/NCT06458465.

一项评估姜黄素与己酮茶碱对慢性肾病患者影响的随机对照试验
背景:慢性肾脏疾病(CKD)是一种长期的进行性疾病,以肾功能的稳定下降为特征。它通常与贫血、骨和矿物质失衡、氧化应激和全身炎症等并发症有关。尿毒症毒素的积累,特别是对甲酚硫酸盐(pCS),增加心血管风险和死亡率。早期诊断和及时治疗对于减缓疾病进展和提高生活质量至关重要。本研究探讨了姜黄素(-)和己酮茶碱(PTX)作为标准CKD治疗的辅助疗法的肾保护作用。94名CKD患者被随机分为三组:对照组(标准护理),- (500 mg每日两次)和PTX (400 mg每日两次),为期6个月。在基线、1、3和6个月时评估肾功能、电解质和生活质量(KDQOL-SF™v1.3),同时在基线和6个月后测量生物标志物(pCS、MDA和Hs-CRP)。结果6个月后,PTX组血清pCS(5.79±3.74 ~ 5.02±3.41 μg/mL, p = 0.011)、MDA水平(11.26±7.37 ~ 10.43±8.84 nmol/mL, p = 0.016)、Hs-CRP水平(7.13±3.53 ~ 5.52±3.43 mg/L, p = 0.019)、蛋白尿水平(ACR p = 0.034)均显著改善。与对照组相比,两种治疗均对肌酐、尿素和eGFR有良好影响。6个月后,两组患者血清肌酐均有所改善,其中-组(3.58±2.21)mg/dL降至3.12±2.18 mg/dL, PTX组(2.75±1.48)mg/dL降至2.34±1.17 mg/dL (p均为0.001),BUN分别显著降低(41.03±18.38 ~ 29.96±13.46 mg/dL)和(35.29±12.94 ~ 28.50±14.59 mg/dL)。与对照组相比,eGFR分别升高(23.77±13.35 ~ 28.50±15.93 mL/min/1.73m2)和(30.29±14.07 ~ 35.57±15.40 mL/min/1.73m2) (p均为0.001)。所有研究组仅报告了轻微的胃肠道副作用,组间无统计学差异,未观察到严重不良事件。结论:通过改善与氧化应激、炎症和肾功能相关的次要结局,PTX治疗可为CKD提供辅助益处。临床试验注册本研究于2024年6月12日在ClinicalTrials.gov上回顾性注册(标识符:NCT06458465),网址为https://clinicaltrials.gov/study/NCT06458465。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
自引率
0.00%
发文量
44
审稿时长
23 weeks
期刊介绍: Future Journal of Pharmaceutical Sciences (FJPS) is the official journal of the Future University in Egypt. It is a peer-reviewed, open access journal which publishes original research articles, review articles and case studies on all aspects of pharmaceutical sciences and technologies, pharmacy practice and related clinical aspects, and pharmacy education. The journal publishes articles covering developments in drug absorption and metabolism, pharmacokinetics and dynamics, drug delivery systems, drug targeting and nano-technology. It also covers development of new systems, methods and techniques in pharmacy education and practice. The scope of the journal also extends to cover advancements in toxicology, cell and molecular biology, biomedical research, clinical and pharmaceutical microbiology, pharmaceutical biotechnology, medicinal chemistry, phytochemistry and nutraceuticals.
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