精神分裂症数字标记物与数字疗法的研究进展
Research Progress on Digital Biomarkers and Digital Therapeutics for Schizophrenia
DOI: 10.12677/ap.2026.161028, PDF,    科研立项经费支持
作者: 张 超, 解魏卫：宁波大学附属康宁医院精神科，浙江 宁波；吴向平：宁波大学附属妇女儿童医院心理科，浙江 宁波；黄辉敏：温州医科大学附属三院精神卫生科，浙江 温州；吕海龙*：浙江大学医学院附属第一医院精神卫生科，浙江 杭州
关键词: 精神分裂症；数字标记物；数字疗法；机器学习；Schizophrenia； Digital Biomarker； Digital Therapeutics； Machine Learning
摘要: 精神分裂症病程迁延，社会负担沉重。传统药物与心理干预在阴性症状控制、复发预测及功能康复方面仍存在显著局限。近五年的初步研究表明：基于被动传感(如活动模式、社交频率)和语音特征等数字标记物，可能有助于早期识别复发风险；而数字疗法(如III期验证的CT-155、虚拟现实训练等)在改善阴性症状、社会回避及服药依从性方面展现出可靠疗效，且安全性与耐受性俱佳。然而，该领域仍面临数据隐私保护、偏倚、循证证据薄弱及监管标准缺失等关键挑战。文章系统综述了数字标记物与数字疗法的定义及其在临床应用中的进展，探讨了人工智能与机器学习的技术支撑作用，以及闭环整合干预的前景。同时，深入剖析了其在伦理、监管与临床转化中的难点，呼吁开展多中心随机对照试验与国际标准化合作，以推动精准精神病学从概念走向临床实践，切实改善患者的长期预后。
Abstract: Schizophrenia is a chronic and highly disabling disorder with a substantial societal burden. Conventional pharmacological and psychosocial interventions remain limited in managing negative symptoms, predicting relapse, and promoting functional recovery. Preliminary evidence from the past five years suggests that digital biomarkers—derived from passive sensing (e.g., mobility patterns, social interaction frequency) and speech features—may aid in the early identification of relapse risk. Meanwhile, digital therapeutics, including the recently Phase III-validated CT-155, virtual reality-based interventions, and prescription-grade applications, have demonstrated reliable efficacy in alleviating negative symptoms, reducing social avoidance, and improving medication adherence, with favorable safety and tolerability profiles. Nevertheless, critical challenges persist, including data privacy concerns, fairness, a lack of high-quality evidence, and the absence of harmonized regulatory standards. This review systematically examines the definitions and clinical applications of digital biomarkers and therapeutics, the role of artificial intelligence and machine learning as enabling technologies, and the prospects for closed-loop integrated interventions. It further analyzes key ethical, regulatory, and implementation barriers and calls for large-scale multicenter randomized controlled trials and international standardization efforts to advance precision psychiatry from concept to clinical reality and ultimately improve long-term patient outcomes.
文章引用：张超, 解魏卫, 吴向平, 黄辉敏, 吕海龙 (2026). 精神分裂症数字标记物与数字疗法的研究进展. 心理学进展, 16(1), 226-234. https://doi.org/10.12677/ap.2026.161028

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