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补充肌酸对青少年皮肌炎的疗效和安全性:一项随机、双盲、安慰剂对照交叉试验。

Efficacy and safety of creatine supplementation in juvenile dermatomyositis: A randomized, double-blind, placebo-controlled crossover trial.

作者信息

Solis Marina Yazigi, Hayashi Ana Paula, Artioli Guilherme Giannini, Roschel Hamilton, Sapienza Marcelo Tatit, Otaduy Maria Concepción, De Sã Pinto Ana Lucia, Silva Clovis Artur, Sallum Adriana Maluf Elias, Pereira Rosa Maria R, Gualano Bruno

机构信息

School of Medicine, University of São Paulo, Sao Paulo, Brazil.

School of Physical Education and Sport, University of São Paulo, Sao Paulo, Brazil.

出版信息

Muscle Nerve. 2016 Jan;53(1):58-66. doi: 10.1002/mus.24681. Epub 2015 Nov 23.

DOI:10.1002/mus.24681
PMID:25899989
Abstract

INTRODUCTION

It has been suggested that creatine supplementation is safe and effective for treating idiopathic inflammatory myopathies, but no pediatric study has been conducted to date. The objective of this study was to examine the efficacy and safety of creatine supplementation in juvenile dermatomyositis (JDM) patients.

METHODS

In this study, JDM patients received placebo or creatine supplementation (0.1 g/kg/day) in a randomized, crossover, double-blind design. Subjects were assessed at baseline and after 12 weeks. The primary outcome was muscle function. Secondary outcomes included body composition, aerobic conditioning, health-related quality of life, and muscle phosphocreatine (PCr) content. Safety was assessed by laboratory parameters and kidney function measurements.

RESULTS

Creatine supplementation did not affect muscle function, intramuscular PCr content, or any other secondary outcome. Kidney function was not affected, and no side effects were reported.

CONCLUSIONS

Twelve weeks of creatine supplementation in JDM patients were well-tolerated and free of adverse effects, but treatment did not affect muscle function, intramuscular PCr, or any other parameter.

摘要

引言

有人认为补充肌酸对治疗特发性炎性肌病是安全有效的,但迄今为止尚未进行过儿科研究。本研究的目的是检验补充肌酸对青少年皮肌炎(JDM)患者的疗效和安全性。

方法

在本研究中,JDM患者采用随机、交叉、双盲设计接受安慰剂或补充肌酸(0.1克/千克/天)。在基线和12周后对受试者进行评估。主要结局是肌肉功能。次要结局包括身体成分、有氧调节、健康相关生活质量和肌肉磷酸肌酸(PCr)含量。通过实验室参数和肾功能测量评估安全性。

结果

补充肌酸不影响肌肉功能、肌肉内PCr含量或任何其他次要结局。肾功能未受影响,且未报告任何副作用。

结论

JDM患者补充肌酸12周耐受性良好且无不良反应,但治疗未影响肌肉功能、肌肉内PCr或任何其他参数。

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