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数字疗法与临床药理学。

Digital therapeutics and clinical pharmacology.

作者信息

Chung Jae-Yong

机构信息

Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Bundang Hospital, Seongnam 13620, Korea.

出版信息

Transl Clin Pharmacol. 2019 Mar;27(1):6-11. doi: 10.12793/tcp.2019.27.1.6. Epub 2019 Mar 27.

DOI:10.12793/tcp.2019.27.1.6
PMID:32055575
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6989269/
Abstract

Digital therapeutics (DTx) is a new subsection of digital health that is primarily driven by software and will be of great interest to clinical pharmacologists. In this article, an overview of DTx, including definition, position in the landscape of therapeutics, product categories, benefits, and challenges, is provided. Discussions from the point of view of clinical pharmacology are presented, as DTx should have exposure-response relationships. The principles of clinical pharmacology can be applied to DTx as they are comparable to pharmacotherapy. Clinical pharmacology has great potential in the development, application, and regulation of DTx.

摘要

数字疗法(DTx)是数字健康的一个新分支,主要由软件驱动,临床药理学家将对其产生浓厚兴趣。本文提供了数字疗法的概述,包括定义、在治疗领域的地位、产品类别、益处和挑战。从临床药理学的角度进行了讨论,因为数字疗法应具有暴露-反应关系。临床药理学的原理可应用于数字疗法,因为它们与药物治疗具有可比性。临床药理学在数字疗法的开发、应用和监管方面具有巨大潜力。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa38/6989269/759c4f2f4271/tcp-27-6-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa38/6989269/7760c2826e15/tcp-27-6-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa38/6989269/759c4f2f4271/tcp-27-6-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa38/6989269/7760c2826e15/tcp-27-6-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/aa38/6989269/759c4f2f4271/tcp-27-6-g002.jpg

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U.S. Food and Drug Administration Precertification Pilot Program for Digital Health Software: Weighing the Benefits and Risks.美国食品和药物管理局数字健康软件预认证试点计划:权衡利弊。
Ann Intern Med. 2018 May 15;168(10):730-732. doi: 10.7326/M17-2715. Epub 2018 Apr 10.
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Digital Therapeutics: An Integral Component of Digital Innovation in Drug Development.
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JMIR Ment Health. 2025 Jan 27;12:e64959. doi: 10.2196/64959.
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Evaluating the Efficacy of a Digital Therapeutic (CT-152) as an Adjunct to Antidepressant Treatment in Adults With Major Depressive Disorder: Protocol for the MIRAI Remote Study.评估数字疗法(CT-152)作为成人重度抑郁症抗抑郁治疗辅助手段的疗效:MIRAI 远程研究方案。
JMIR Res Protoc. 2024 Aug 20;13:e56960. doi: 10.2196/56960.
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Redesigning Pharmacy to Improve Public Health Outcomes: Expanding Retail Spaces for Digital Therapeutics to Replace Consumer Products That Increase Mortality and Morbidity Risks.重新设计药房以改善公共卫生成果:扩大数字疗法的零售空间,取代那些增加死亡和发病风险的消费品。
Pharmacy (Basel). 2024 Jul 12;12(4):107. doi: 10.3390/pharmacy12040107.
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Digital therapeutics as an emerging new therapy for diabetes mellitus: potentials and concerns.数字疗法作为糖尿病的一种新兴治疗方法:潜力与担忧。
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