二甲双胍辅助治疗自闭症谱系障碍儿童易激惹症的有效性和安全性:随机、双盲、安慰剂对照试验。

IF 4.5 3区 医学 Q1 CLINICAL NEUROLOGY
Zahra Bazrafshan, Parsa Mohammadi, Alireza Hasanzadeh, Mohammad Sanjari Moghaddam, Maryam Kabiri, Hossein Sanjari Moghaddam, Amir Hossein Abdolghaffari, Mohammad-Reza Mohammadi, Shahin Akhondzadeh
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引用次数: 0

摘要

背景:抗糖尿病药物对减轻自闭症症状有一定疗效。然而,关于二甲双胍对自闭症相关易激惹性的影响还缺乏临床研究。本研究旨在评估二甲双胍作为利培酮的辅助治疗药物对控制自闭症谱系障碍(ASD)儿童易激惹性的有效性和安全性:这是一项为期10周的随机、双盲、安慰剂对照试验,于2024年3月至2024年5月在Roozbeh医院(伊朗德黑兰)的儿童自闭症诊所进行。参与者被分为利培酮加二甲双胍(每天500毫克)和利培酮加安慰剂两组,并在基线、第5周和第10周接受异常行为核对表-社区量表(ABC-C)评估:共有 55 名患者被纳入最终分析。与安慰剂组相比,二甲双胍组的易激惹性(主要结果指标)急剧下降(p = 0.008)。在 ABC-C 的其他四个分量表中,多动/不遵医嘱得分在基线至第 5 周期间显著下降(p = 0.021)。此外,与安慰剂组相比,二甲双胍组的不恰当言语分量表从基线到第 5 周显著下降(p = 0.045)。在嗜睡/社会退缩或刻板行为分量表的ABC-C评分中未观察到其他重大发现:结论:二甲双胍在减轻 ASD 患者的易激惹性方面表现出良好的效果,这与之前的研究结果一致。然而,在提出广泛的临床建议之前,还需要进一步的研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Metformin efficacy and safety as an adjunctive treatment for irritability in children with autism spectrum disorder: A randomized, double-blind, placebo-controlled trial.

Background: Antidiabetic medications have shown efficacy in alleviating autism symptoms. However, there is a lack of clinical research on the impact of metformin on irritability associated with autism. This study aimed to assess the efficacy and safety of metformin as an adjuvant therapy with risperidone for managing irritability in children diagnosed with Autism Spectrum Disorder (ASD).

Methods: This is a randomized, 10-week, double-blind, placebo-controlled trial conducted at the children's autism clinic of Roozbeh Hospital (Tehran, Iran) from March 2024 to May 2024. Participants were divided into two groups of risperidone plus metformin (500 mg per day) and risperidone plus placebo and were assessed at baseline, weeks 5 and 10 with the aberrant behavior checklist-community scale (ABC-C).

Results: A total of 55 patients were included in the final analysis. Irritability (primary outcome measure) sharply decreased in the metformin compared to the placebo group (p = 0.008). Among the other four subscales of ABC-C, the hyperactivity/noncompliance score showed a significant drop during the baseline-to-week-5 period (p = 0.021). In addition, inappropriate speech subscales decreased significantly from baseline-to-week 5 in the metformin compared to the placebo group (p = 0.045). No other significant finding was observed among ABC-C scores for lethargy/social withdrawal or stereotypic behavior subscales.

Conclusion: Metformin demonstrated promising results in reducing irritability in ASD patients, which is in concordance with previous studies. However, further studies are required before any broad clinical recommendation.

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来源期刊
Journal of Psychopharmacology
Journal of Psychopharmacology 医学-精神病学
CiteScore
8.60
自引率
4.90%
发文量
126
审稿时长
3-8 weeks
期刊介绍: The Journal of Psychopharmacology is a fully peer-reviewed, international journal that publishes original research and review articles on preclinical and clinical aspects of psychopharmacology. The journal provides an essential forum for researchers and practicing clinicians on the effects of drugs on animal and human behavior, and the mechanisms underlying these effects. The Journal of Psychopharmacology is truly international in scope and readership.
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