作为自闭症谱系障碍辅助疗法的Altibrain®的有效性和安全性:针对核心症状的开放性试验
Sidharth Mehan1, Aakash Kumar1, Prashant R Utage2
1Division of Neuroscience, Department of Pharmacology, ISF College of Pharmacy, Moga, Punjab, India (Affiliated to IK Gujral Punjab Technical University, Jalandhar, Punjab, 144603, India).
Current pharmaceutical design
|January 27, 2025
概括
阿尔提布莱恩®显著改善了自闭症谱系障碍 (ASD) 儿童的社交互动,并减少了重复性行为. 这种治疗方案对自闭症患者及其家人来说是有前途的.
科学领域:
- 神经科学是一个神经科学.
- 发展心理学 发展心理学
- 药理学 药理学是指药理学的学科.
背景情况:
- 自闭症谱系障碍 (ASD) 是一种复杂的神经发育状况,其特点是社会沟通缺陷和限制性,重复性行为.
- 目前用于ASD的标准治疗方法提供症状缓解,但在解决核心缺陷方面往往存在局限性.
- 需要新的治疗干预措施来改善ASD患者的治疗结果.
研究的目的:
- 评估Altibrain®在与标准自闭症谱系障碍 (ASD) 治疗一起使用时的疗效和安全性.
- 为了比较标准ASD治疗单独对比Altibrain®加标准ASD治疗在被诊断为ASD的个体的结果.
主要方法:
- 一个随机的,开放的标签试验,涉及120名参与者 (年龄3至17岁),确诊ASD诊断.
- 参与者被分配给接受单独标准ASD治疗或Altibrain®加标准ASD治疗口服每天一次,持续24周.
- 主要结局包括核心ASD症状的变化 (通过ADOS测量) 和安全评估;次要结局侧重于社会沟通,重复行为和整体功能.
主要成果:
- 与单独标准治疗相比,Altibrain®显著改善了社交互动,并减少了重复性行为 (p < 0.0001).
- 组合组在社会功能,意识,认知,沟通和动机方面表现出显著的改善 (p < 0.0001).
- 阿尔提布莱恩®在减少过度活跃,易怒,昏迷和异常行为 (p < 0.0001) 方面表现出卓越的疗效,具有良好的安全性.
结论:
- 阿尔蒂布雷恩®作为自闭症谱系障碍 (ASD) 患者的有价值的治疗选择具有前途.
- 需要进一步的研究,包括使用更大的队列进行长期研究,以证实这些发现并探索潜在的机制.
- 该研究的局限性包括缺乏神经成像和生物标志物分析.
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