基于MRI的人工智能技术在阿尔茨海默病中的应用进展及审批现状

Application and Approvals of MRI-Based Artificial Intelligence Technology for the Detection of Alzheimer’s Disease

阿尔茨海默病(Alzheimer’s Disease,AD)发病率随着社会人口老龄化加剧呈上升趋势,给社会带来沉重公共卫生资源负担,《阿尔茨海默病创新药物临床试验中国专家共识》强调AD应着力于早期发现和预防,而临床现状是AD的诊断率低且漏诊率高。临床中对AD诊断首选的影像学检查方法是磁共振成像(Magnetic Resonance Imaging,MRI),而人工智能应用于影像诊断近年来一直是全球医疗器械业界的热点。为此着重回顾AD各模态MRI影像学表现和基于MRI的人工智能在AD辅助诊断的应用研究,以及国内外相关人工智能软件审批现状,以期为我国AD辅助诊断软件监管的完善带来参考。

The aging of the social population is increasing,and the incidence of Alzheimer’s disease(AD)is also rising,which brings a heavy burden of public health resources to the society.The Consensus of Chinese Experts on Clinical Trials of Innovative Drugs for Alzheimer’s disease has already been published which emphasizes that AD should focus on early detection and prevention,while the clinical status of AD is that the diagnosis rate of AD is low and the rate of missed diagnosis is high.The preferred imaging method for AD diagnosis in clinical practice is MRI,and the application of artificial intelligence to imaging diagnosis has been a hot spot in the global medical device industry in recent years.Therefore,this paper focuses on reviewing the MRI imaging performance of various modalities of AD and the application research of MRI-based artificial intelligence in AD auxiliary diagnosis,including the approval state of relevant artificial intelligence software in the world,in order to bring reference for the improvement of supervision on Alzheimer’s auxiliary diagnosis software.