Efficacy and safety of creatine supplementation in childhood-onset systemic lupus erythematosus: a randomized, double-blind, placebo-controlled, crossover trial
Efficacy and safety of creatine supplementation in childhood-onset systemic lupus erythematosus: a randomized, double-blind, placebo-controlled, crossover trial
复制标题
DOI：
10.1177/0961203314546017
复制
发表时间：
2014-12-01
期刊：
影响因子：
2.6
通讯作者：
Gualano, B.
中科院分区：
文献类型：
--
作者：
Hayashi, A. P.;Solis, M. Y.;Gualano, B.
简介：肌酸补充已成为一种有前途的非药物治疗策略，以抵消肌肉功能障碍和低瘦质量在各种情况下，包括在儿科和风湿病。本研究的目的是检查补充肌酸治疗儿童系统性红斑狼疮（C-SLE）的有效性和安全性。方法：具有轻度疾病活动性的C-SLE患者（n = 15）采用交叉、双盲、重复测量设计，以随机方式接受安慰剂或肌酸补充剂。在基线和每组12周后对参与者进行评估，中间穿插8周的洗脱期。主要结果是肌肉功能，通过一系列测试进行评估，包括一次最大重复（1-RM）测试、起跑计时测试、站立计时测试和握力测试。次要结局包括身体组成、骨重塑生化指标、有氧调节、生活质量和身体能力。通过三次24小时的饮食回顾来评估饮食摄入量可能存在的差异。采用磷磁共振波谱法（31 P-MRS）测定肌肉磷酸肌酸含量。通过实验室参数评估干预的安全性，并通过51 Cr-EDTA清除率测量肾功能。此外，在整个试验过程中记录了自我报告的不良事件。结果：干预前后肌酸和安慰剂组肌内磷酸肌酸含量无显著差异（肌酸前：20.5 +/- 2.6，后：20.4 +/- 4.1，安慰剂前：19.8 +/- 2.0，后：20.2 +/- 3.2 mmol/kg湿肌；两组间相互作用p = 0.70）。此外，可能是肌内磷酸肌酸含量没有变化的结果，安慰剂组和肌酸组在任何肌肉功能和有氧调节参数、瘦质量、脂肪质量、骨量和生活质量评分方面没有显著变化（p < 0.05）。51 Cr-EDTA清除率没有因补充肌酸而改变，也没有发现副作用。结论：在非活动期C-SLE患者中，以0.1 g/kg/d的速度补充12周肌酸方案耐受性良好且无不良反应，但不影响肌内磷酸肌酸、肌肉功能、游离脂肪量或生活质量。
Introduction: Creatine supplementation has emerged as a promising non-pharmacological therapeutic strategy to counteract muscle dysfunction and low lean mass in a variety of conditions, including in pediatric and rheumatic diseases. The objective of this study was to examine the efficacy and safety of creatine supplementation in childhood systemic lupus erythematosus (C-SLE). Methods: C-SLE patients with mild disease activity (n = 15) received placebo or creatine supplementation in a randomized fashion using a crossover, double-blind, repeated-measures design. The participants were assessed at baseline and after 12 weeks in each arm, interspersed by an eight-week washout period. The primary outcomes were muscle function, as assessed by a battery of tests including one-maximum repetition (1-RM) tests, the timed-up-and-go test, the timed-stands test, and the handgrip test. Secondary outcomes included body composition, biochemical markers of bone remodeling, aerobic conditioning, quality of life, and physical capacity. Possible differences in dietary intake were assessed by three 24-hour dietary recalls. Muscle phosphorylcreatine content was measured through phosphorus magnetic resonance spectroscopy (31 P-MRS). The safety of the intervention was assessed by laboratory parameters, and kidney function was measured by 51 Cr-EDTA clearance. Additionally, self-reported adverse events were recorded throughout the trial. Results: Intramuscular phosphorylcreatine content was not significantly different between creatine and placebo before or after the intervention (creatine-Pre: 20.5 +/- 2.6, Post: 20.4 +/- 4.1, placebo-Pre: 19.8 +/- 2.0; Post: 20.2 +/- 3.2 mmol/kg wet muscle; p = 0.70 for interaction between conditions). In addition, probably as a consequence of the lack of change in intramuscular phosphorylcreatine content, there were no significant changes between placebo and creatine for any muscle function and aerobic conditioning parameters, lean mass, fat mass, bone mass, and quality of life scores (p > 0.05). The 51 Cr-EDTA clearance was not altered by creatine supplementation and no side effects were noticed. Conclusion: A 12-week creatine supplementation protocol at 0.1 g/kg/d is well tolerated and free of adverse effects but did not affect intramuscular phosphorylcreatine, muscle function, free-fat mass or quality of life in non-active C-SLE patients.