评估辅酶Q10在儿童血液透析患者中的有效性和安全性:一项随机对照试验

IF 3.4 Q2 PHARMACOLOGY & PHARMACY
Salma A. Rahman Sharaf, Sarah Farid Fahmy, Heba M. Adel Abou Zaghla, Ahmed Hussein Hassan, Sara Mahmoud Zaki
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引用次数: 0

摘要

临床试验证据表明,辅酶Q10可显著改善成人血液透析患者的线粒体功能,降低氧化应激和心血管疾病。然而,我们从未充分研究过它在儿科患者中的作用。本研究旨在评估补充辅酶Q10对儿科血液透析患者氧化应激和炎症标志物的影响。这是一项前瞻性、随机、双盲、安慰剂对照试验。招募了36名儿童血液透析患者,随机分为每天口服辅酶Q10 (3-5 mg/kg)或安慰剂,持续12周。结果采用Mann-Whitney检验,干预组儿童的血尿素氮变化中位数较基线显著降低,为- 58.18,而安慰剂组为- 9.6 (p = 0.002)。干预组血清丙二醛变化的中位数百分比显著降低了- 55.68,而安慰剂组升高了39.75 (p < 0.001)。此外,干预组血清肿瘤坏死因子-α水平较基线变化的中位数百分比显著降低- 46.69,而安慰剂组升高8.5% (p = 0.03)。结论补充口服辅酶Q10可能对儿童血液透析患者的氧化应激和炎症指标有有益的影响。本研究强调了辅酶Q10平均剂量为4 mg/kg/天对儿童血液透析患者的潜在疗效;这为其他研究人员自信地评估更大剂量以控制该患者群体的全身性炎症开了绿灯。需要进一步的研究来确定辅酶Q10治疗是否能改善儿科血液透析患者的临床结果,如感染、住院、心血管事件和死亡率。临床试验。gov, NCT05170893,注册于2021年12月28日,https://clinicaltrials.gov/study/NCT05170893?cond=NCT05170893&rank=1.Graphical摘要
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluation of efficacy and safety of coenzyme Q10 in pediatric hemodialysis patients: a randomized controlled trial

Background

There is evidence from clinical trials that coenzyme Q10 significantly improves mitochondrial function and decreases oxidative stress and cardiovascular disease in adult hemodialysis patients. However, we have never fully investigated its role in pediatric patients before. This study aimed to assess the effects of coenzyme Q10 supplementation on oxidative stress and inflammatory markers in pediatric hemodialysis patients. This was a prospective, randomized, double-blinded, placebo-controlled trial. Thirty-six pediatric hemodialysis patients were recruited and simply randomized to receive either oral coenzyme Q10 (3–5 mg/kg) daily or placebo daily for 12 weeks.

Results

Using the Mann–Whitney test, children in the intervention group showed a significant reduction in the median percent change of blood urea nitrogen from baseline of − 58.18 versus − 9.6 in the placebo group (p = 0.002). The median percent change of serum malondialdehyde significantly decreased by − 55.68 in the intervention group, while it increased by 39.75 in the placebo group (p < 0.001). Additionally, the median percent change from baseline in serum tumor necrosis factor-α levels significantly decreased by − 46.69 in the intervention group and increased by 8.5 in the placebo group (p = 0.03).

Conclusion

Supplementation of oral coenzyme Q10 may have beneficial effects on oxidative stress and inflammatory markers in pediatric hemodialysis patients. This study emphasized the potential efficacy of an average coenzyme Q10 dose of 4 mg/kg/day in pediatric hemodialysis patients; this gives the green light for other researchers to confidently evaluate larger doses as an attempt to control the systemic inflammation in this patient population. Further research is needed to determine whether coenzyme Q10 treatment improves clinical outcomes such as infection, hospitalization, cardiovascular events, and mortality in pediatric hemodialysis patients.

Trial Registration Clinical trials.gov, NCT05170893, Registered 28 December 2021, https://clinicaltrials.gov/study/NCT05170893?cond=NCT05170893&rank=1.

Graphical abstract

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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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