Periyar College of Pharmaceutical Sciences, 620021 Tiruchirappalli, Tamil Nadu, India.
Karthikeyan Child Development Unit, Sri Ramachandra Institute of Higher Education and Research, 600116 Chennai, Tamil Nadu, India.
Front Biosci (Landmark Ed). 2024 Oct 23;29(10):365. doi: 10.31083/j.fbl2910365.
Literature indicates that L-carnosine may be deficient in autism spectrum disorder (ASD) children. The aim of the present study was to estimate the level of L-carnosine in plasma and correlate it with the Autism Treatment Evaluation Checklist (ATEC) and Childhood Autism Rating Scale 2nd Edition, Standard Version (CARS2-ST) scores. To measure L-carnosine level, a bio-analytical method was developed using reverse phase high- liquid chromatography and validated as per International Conference on Harmonization guidelines.
Children were supplemented with L-carnosine (10-15 mg/kg) along with standard care therapies for 2 months. Before and after supplementation, scores on the ATEC, CARS2-ST, BEARS sleep screening tool, 6-item Gastrointestinal Severity Index, and Parental Stress Scale were evaluated, and L-carnosine was measured at the end of the trial.
The calibration curve was linear in the range of 100-600 ng/mL (R = 0.998). The level of L-carnosine quantified was 33.7 ± 0.2 ng/mL. There was no significant difference found in any of the outcome measures ( > 0.05).
Despite the fact that L-carnosine is detectable in the blood, it was found to be ineffective in the management of ASD in children.
The study was registered in the Clinical Trial Registry-India, registration number: CTRI/2019/07/020102.
文献表明，肉毒碱可能在自闭症谱系障碍（ASD）儿童中缺乏。本研究旨在评估血浆中肉毒碱的水平，并将其与自闭症治疗评估检查表（ATEC）和儿童自闭症评定量表第二版，标准版（CARS2-ST）评分相关联。为了测量肉毒碱的水平，开发了一种反相高效液相色谱的生物分析方法，并按照国际协调会议的指导方针进行了验证。
儿童在标准治疗的基础上补充肉毒碱（10-15mg/kg），持续 2 个月。在补充前后，评估 ATEC、CARS2-ST、BEARS 睡眠筛查工具、6 项胃肠道严重程度指数和父母压力量表的评分，并在试验结束时测量肉毒碱水平。
校准曲线在 100-600ng/mL 范围内呈线性（R=0.998）。定量的肉毒碱水平为 33.7±0.2ng/mL。在任何结果指标上都没有发现显著差异（>0.05）。
尽管肉毒碱在血液中可检测到，但它在儿童 ASD 的治疗中并不有效。
该研究在印度临床试验注册处注册，注册号：CTRI/2019/07/020102。
