中国数字疗法的发展现状与趋势：基于国家药品监督管理局批准产品的多维度分析

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【中图分类号】R319【文献标识码】A DOI：10.12114/j.issn.1007-9572.2025.0167

【Abstract】BackgroundDigital Therapeutics （DTx），asaninnovativedigital interventionalmethod，isinterationally regardedasaprescription"digitaldrug"withsignificantpotentialinchronicdiseasemanagementand mental health.China's "Healthy China 2030"strategysupports healthcare digital ransformation.However，there'salack of systematicanalysison DTx productsapprovedbyChina'sNationalMedical ProductsAdministration（NMPA）.Also，therearechalengessuchasanimperfect regulatoryframeworkand insuffcientclinicalevidence.ObjectiveConductasystematicanalysisof thecharacteristicsof DTx productsapprovedbytheNMPA，systematicalleviewapprovaltrends，indicationdistribution，andindustriallandscapeto provideevidenceforregulatory policyoptimizationandindustrial development.MethodsResearchdata were primarilysourced fromeightmedicaldevicedatabasesoftheNMPA.Using independentkeywordsearches，atotalof20107candidatedevices were generated.Afterscreening，235deviesmetingthedefiitionofDTxwereidentified.Seventeenproductfeatureswereextracted， andstatisticalanalysiswasperformedusingSPSS25.0softare.ResultsAsofDecember2O24，NMPAhadapproved235devices that mee thedefinitionofDTx.Thenumberof approvalshad increased yearlysince2O18，withasignificantincreasing n 2022. Most were domestically produced （ n =227， 96.60% ）andapproved （ scriptstylen=219 93.19% ）by local medical products administrations. The majority were ClassII medical devices （ n =224， 95.32% ），with core functionsmostly focused on disease treatment （ n =207， （204 88.09% ），widely used for nervous system diseases （ n =108，45.96 % ）.Nearlyall require prescriptions （ n =227，96.60 % ） and often used guided behavioral intervention techniques （n=135，57.45 % ）.Digital technologies mainly involved online medical services 1 n=145 ， 61.70% ） and primarily targeted the adult population （ n=163 ，69.36 % ）.Manufacturers were mostly in economically developedregions.ConclusionChina's DTxindustry is growingdue topolicysupport.Butthere areobstacleslikeancomplete regulatoryframerk，insuicietevidenegeneationdlckofusinesodels.I'ssuggestedtoncereglatorylis， emphasize real world evidence，and raise academic attention to support wider DTx adoption.

【Key Words】Digital therapeutics;Medical devices; Regulatory approval; Policy; National Medical Products Administration

数字疗法（DTx）是一种基于循证医学的高质量软件程序驱动的、以患者为中心的干预方案，旨在预防、管理或治疗疾病[1]。（剩余13346字）