{"title":"补充烟酰胺对荷兰透析患者磷酸盐浓度的影响:随机交叉试验。","authors":"","doi":"10.1053/j.jrn.2024.02.005","DOIUrl":null,"url":null,"abstract":"<div><h3>Objective</h3><p>Hyperphosphatemia is a common complication in patients with kidney failure, despite the use of phosphate binders. Vitamin B3, either in the form of niacin or niacinamide (NAM), shows potential as “add-on” treatment to reduce serum phosphate concentrations in this population. NAM seems to lack many of the side effects that are observed with niacin. The aim of this study was to investigate whether NAM is an effective and acceptable treatment in reducing serum phosphate concentrations in patients with kidney failure.</p></div><div><h3>Methods</h3><p>DiaNia was a double-blind placebo-controlled randomized crossover trial, comparing NAM (250-500 mg/day) to placebo as “add-on” treatment to an individual treatment with approved phosphate binders for 12 weeks in patients receiving hemodialysis. The primary outcome was serum phosphate concentrations, and the secondary outcomes were platelet counts as well as drop-outs due to side effects. Data were analyzed using both per-protocol and intention-to-treat analyses.</p></div><div><h3>Results</h3><p>Mean age of the per-protocol population (n = 26) was 63.6 ± 17.2 years and 53.8% were men. NAM treatment significantly reduced serum phosphate with 0.59 mg/dL (p = .03). Linear mixed-effects models demonstrated superiority of 12 weeks NAM over 12 weeks placebo with a between-treatment difference of 0.77 mg/dL (95% CI 0.010, 1.43; <em>P</em> = .03). Similar results, although not significant, were found in the intention-to-treat population. We found no between-treatment differences in platelet counts and during the NAM treatment we observed 3 drop-outs due to side effects (8.6%).</p></div><div><h3>Conclusion</h3><p>NAM is effective in reducing serum phosphate concentrations in patients with kidney failure receiving hemodialysis. In addition, NAM is well-tolerated and seems not to increase the risk of thrombocytopenia. Thus, NAM can be valuable as “add-on” treatment to combat hyperphosphatemia in patients with kidney failure. However, more research in larger populations is needed to confirm this.</p></div>","PeriodicalId":50066,"journal":{"name":"Journal of Renal Nutrition","volume":null,"pages":null},"PeriodicalIF":3.4000,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1051227624000360/pdfft?md5=7837abd9936820eacbf5849f93af8335&pid=1-s2.0-S1051227624000360-main.pdf","citationCount":"0","resultStr":"{\"title\":\"The Effect of Niacinamide Supplementation on Phosphate Concentrations in Dutch Dialysis Patients: A Randomized Crossover Trial\",\"authors\":\"\",\"doi\":\"10.1053/j.jrn.2024.02.005\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Objective</h3><p>Hyperphosphatemia is a common complication in patients with kidney failure, despite the use of phosphate binders. Vitamin B3, either in the form of niacin or niacinamide (NAM), shows potential as “add-on” treatment to reduce serum phosphate concentrations in this population. NAM seems to lack many of the side effects that are observed with niacin. The aim of this study was to investigate whether NAM is an effective and acceptable treatment in reducing serum phosphate concentrations in patients with kidney failure.</p></div><div><h3>Methods</h3><p>DiaNia was a double-blind placebo-controlled randomized crossover trial, comparing NAM (250-500 mg/day) to placebo as “add-on” treatment to an individual treatment with approved phosphate binders for 12 weeks in patients receiving hemodialysis. The primary outcome was serum phosphate concentrations, and the secondary outcomes were platelet counts as well as drop-outs due to side effects. Data were analyzed using both per-protocol and intention-to-treat analyses.</p></div><div><h3>Results</h3><p>Mean age of the per-protocol population (n = 26) was 63.6 ± 17.2 years and 53.8% were men. NAM treatment significantly reduced serum phosphate with 0.59 mg/dL (p = .03). Linear mixed-effects models demonstrated superiority of 12 weeks NAM over 12 weeks placebo with a between-treatment difference of 0.77 mg/dL (95% CI 0.010, 1.43; <em>P</em> = .03). Similar results, although not significant, were found in the intention-to-treat population. We found no between-treatment differences in platelet counts and during the NAM treatment we observed 3 drop-outs due to side effects (8.6%).</p></div><div><h3>Conclusion</h3><p>NAM is effective in reducing serum phosphate concentrations in patients with kidney failure receiving hemodialysis. In addition, NAM is well-tolerated and seems not to increase the risk of thrombocytopenia. Thus, NAM can be valuable as “add-on” treatment to combat hyperphosphatemia in patients with kidney failure. 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引用次数: 0
摘要
目的:尽管使用了磷酸盐结合剂(PBs),高磷血症仍是肾衰竭患者的常见并发症。烟酸或烟酰胺(NAM)形式的维生素 B3 具有 "附加 "治疗的潜力,可降低这类人群的血清磷酸盐浓度。烟酰胺似乎没有烟酸的许多副作用。本研究旨在探讨 NAM 是否是一种有效且可接受的治疗方法,以降低肾衰竭患者的血清磷酸盐浓度:DiaNia 是一项双盲安慰剂对照随机交叉试验,该试验比较了 NAM(250-500 毫克/天)和安慰剂,作为血液透析患者使用已获批准的 PBs 单独治疗 12 周的 "附加 "治疗。主要结果是血清磷酸盐浓度,次要结果是血小板计数以及因副作用而退出治疗的人数。数据分析采用了每方案(PP)分析和意向治疗(ITT)分析:PP人群(26人)的平均年龄为63.6±17.2岁,53.8%为男性。NAM治疗可使血清磷酸盐明显降低0.59 mg/dL(p=0.03)。线性混合模型(LMMs)显示,12 周 NAM 优于 12 周安慰剂,治疗间差异为 0.77 mg/dL (95% CI 0.010, 1.43; p=0.03)。在 ITT 群体中也发现了类似的结果,尽管并不显著。我们没有发现血小板计数在治疗间存在差异,在 NAM 治疗期间,我们观察到有 3 人因副作用而退出治疗(8.6%):结论:NAM 能有效降低接受血液透析的肾衰竭患者的血清磷酸盐浓度。此外,NAM 的耐受性良好,似乎不会增加血小板减少的风险。因此,NAM 可以作为 "附加 "治疗,用于治疗肾衰竭患者的高磷酸盐血症。不过,还需要在更大的人群中进行更多的研究来证实这一点。
The Effect of Niacinamide Supplementation on Phosphate Concentrations in Dutch Dialysis Patients: A Randomized Crossover Trial
Objective
Hyperphosphatemia is a common complication in patients with kidney failure, despite the use of phosphate binders. Vitamin B3, either in the form of niacin or niacinamide (NAM), shows potential as “add-on” treatment to reduce serum phosphate concentrations in this population. NAM seems to lack many of the side effects that are observed with niacin. The aim of this study was to investigate whether NAM is an effective and acceptable treatment in reducing serum phosphate concentrations in patients with kidney failure.
Methods
DiaNia was a double-blind placebo-controlled randomized crossover trial, comparing NAM (250-500 mg/day) to placebo as “add-on” treatment to an individual treatment with approved phosphate binders for 12 weeks in patients receiving hemodialysis. The primary outcome was serum phosphate concentrations, and the secondary outcomes were platelet counts as well as drop-outs due to side effects. Data were analyzed using both per-protocol and intention-to-treat analyses.
Results
Mean age of the per-protocol population (n = 26) was 63.6 ± 17.2 years and 53.8% were men. NAM treatment significantly reduced serum phosphate with 0.59 mg/dL (p = .03). Linear mixed-effects models demonstrated superiority of 12 weeks NAM over 12 weeks placebo with a between-treatment difference of 0.77 mg/dL (95% CI 0.010, 1.43; P = .03). Similar results, although not significant, were found in the intention-to-treat population. We found no between-treatment differences in platelet counts and during the NAM treatment we observed 3 drop-outs due to side effects (8.6%).
Conclusion
NAM is effective in reducing serum phosphate concentrations in patients with kidney failure receiving hemodialysis. In addition, NAM is well-tolerated and seems not to increase the risk of thrombocytopenia. Thus, NAM can be valuable as “add-on” treatment to combat hyperphosphatemia in patients with kidney failure. However, more research in larger populations is needed to confirm this.
期刊介绍:
The Journal of Renal Nutrition is devoted exclusively to renal nutrition science and renal dietetics. Its content is appropriate for nutritionists, physicians and researchers working in nephrology. Each issue contains a state-of-the-art review, original research, articles on the clinical management and education of patients, a current literature review, and nutritional analysis of food products that have clinical relevance.