数字疗法产品的应用及质量评价现状研究

Study on clinical application and quality evaluation of digital therapeutics

随着数字技术的不断发展,数字疗法(Digital therapeutics,DTx)作为一种新兴的医疗手段已经成功应用于精神疾病与部分慢性疾病的管理与防治之中。近年来,随着DTx产品不断获批上市,国际上对于产品的标准化工作已经有了一些初步的探索,但是我国的相关工作仍然还处于准备阶段。本文从此类产品的临床应用入手,介绍其质量评价,包括标准化和临床评价的现状,尤其是重点介绍了美国药典会和英国国家健康与护理卓越研究所的相关工作,希望对我国下一步标准化工作提供思路。

As digital technology develops,digital therapeutics(DTx)has already been successfully applied to the treatment and management of mental disorders and some chronic diseases.In recent years,as DTx products have been approved and listed on the market,some international organizations have carried out some preliminary exploration on the standardization of products,but the relevant work in China is still in the stage of preparation.This essay would zoom in on such DTx products,and introduce their current situation of quality assessments,including standardization and clinical evaluation.Further,this essay especially focuses on the relative work done by The United States Pharmacopeia and National Institute for Health and Care Excellence,in the hope to provide ideas for standardization work of DTx in China.