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左旋肉碱治疗自闭症谱系障碍儿童的疗效:一项随机对照试验的系统评价和荟萃分析。

Effect of L-Carnosine in children with autism spectrum disorders: a systematic review and meta-analysis of randomised controlled trials.

机构信息

Department of Pharmacy Practice, Sri Ramachandra Faculty of Pharmacy, Sri Ramachandra Institute of Higher Education and Research, Chennai, 600116, Tamil Nadu, India.

Department of Pharmacy Practice, National Institute of Pharmaceutical Education and Research, Guwahati, India.

出版信息

Amino Acids. 2021 Apr;53(4):575-585. doi: 10.1007/s00726-021-02960-6. Epub 2021 Mar 11.

Abstract

Autism spectrum disorders (ASD) are an emerging health problem worldwide. So far, no definite cure for ASD exists. L-Carnosine is an amino acid containing β-alanine and L-histidine which has been proposed to have neuroprotective, antioxidant and anti-convulsive properties that may benefit affected children with this disorder. This review aimed to assess the effect of L-Carnosine in the management of ASD in children. We systematically reviewed randomised controlled trials (RCTs) which documented the effect of L-Carnosine in children with ASD. A literature search was performed in PubMed, Cochrane Library, Google Scholar, ClinicalTrials.gov, Clinical Trial Registry-India databases from inception to December 20, 2020. Articles were selected based on pre-set inclusion/exclusion criteria. The primary outcomes were changes in social, communication and behavioural responses and the secondary outcomes were improvement in sleep disorders, gastrointestinal problems, oxidative stress markers and adverse effects. Jadad scale was used to assess the quality of RCTs and modified Cochrane risk of bias tool was used to check the risk of bias of the included studies. The meta-analysis was reported based on the fixed-effects model. Four double-blinded, placebo-controlled, RCTs and one open label trial with a total of 215 participants were selected for the review. All the trials were methodological of high quality according to the Jadad scale. The modified Cochrane risk of bias tool showed a low to high risk of bias. Results from the meta-analysis of three studies showed no significant difference between L-Carnosine and placebo groups in the Gilliam autism rating scale (GARS) (MD = - 2.57; 95% CI - 10.30, 5.16, p = 0.52) and in its socialisation (MD = - 1.51; 95% CI - 6.16, 3.14, p = 0.53), behaviour (MD = - 0.48; 95% CI - 4.82, 3.87, p = 0.83) and communication (MD = - 3.94; 95% CI - 10.00, 2.11, p = 0.20) subscales as well as the childhood autism rating scale (CARS) (MD = - 0.88; 95% CI - 6.96, 5.20; p = 0.78). Current data do not support the use of L-Carnosine in the management of children with ASD due to a low number of studies and sample size available. Further studies are warranted to know the effect of L-Carnosine for ASD management.

摘要

自闭症谱系障碍 (ASD) 是全球日益严重的健康问题。到目前为止,还没有针对 ASD 的明确治疗方法。L-肉碱是一种含有 β-丙氨酸和 L-组氨酸的氨基酸,它具有神经保护、抗氧化和抗惊厥特性,可能有益于患有这种疾病的受影响儿童。本综述旨在评估 L-肉碱在儿童 ASD 管理中的作用。我们系统地综述了记录 L-肉碱对 ASD 儿童影响的随机对照试验 (RCT)。在 PubMed、Cochrane 图书馆、Google Scholar、ClinicalTrials.gov 和 Clinical Trial Registry-India 数据库中进行了文献检索,检索时间从开始到 2020 年 12 月 20 日。根据预先设定的纳入/排除标准选择文章。主要结果是社会、沟通和行为反应的变化,次要结果是睡眠障碍、胃肠道问题、氧化应激标志物和不良反应的改善。Jadad 量表用于评估 RCT 的质量,改良的 Cochrane 偏倚风险工具用于检查纳入研究的偏倚风险。根据固定效应模型报告了荟萃分析结果。共纳入 4 项双盲、安慰剂对照 RCT 和 1 项开放标签试验,共 215 名参与者。根据 Jadad 量表,所有试验均为高质量的方法学研究。改良的 Cochrane 偏倚风险工具显示存在低到高的偏倚风险。3 项研究的荟萃分析结果显示,L-肉碱组和安慰剂组在吉尔曼自闭症评定量表 (GARS) (MD=-2.57;95%CI-10.30,5.16;p=0.52) 和社交 (MD=-1.51;95%CI-6.16,3.14;p=0.53)、行为 (MD=-0.48;95%CI-4.82,3.87;p=0.83) 和沟通 (MD=-3.94;95%CI-10.00,2.11;p=0.20) 亚量表以及儿童自闭症评定量表 (CARS) (MD=-0.88;95%CI-6.96,5.20;p=0.78) 方面无显著差异。由于可用的研究数量和样本量较少,目前的数据不支持在 ASD 儿童管理中使用 L-肉碱。需要进一步的研究来了解 L-肉碱对 ASD 管理的影响。

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