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首个基于证据的高血压数字化治疗临床实践的医疗器械软件。

The first software as medical device of evidence-based hypertension digital therapeutics for clinical practice.

机构信息

Division of Cardiovascular Medicine, School of Medicine, Jichi Medical University, Tochigi, Japan.

出版信息

Hypertens Res. 2022 Dec;45(12):1899-1905. doi: 10.1038/s41440-022-01016-w. Epub 2022 Oct 7.

DOI:10.1038/s41440-022-01016-w
PMID:36207530
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9540047/
Abstract

In 2021, the open-label randomized HERB-Digital Hypertension 1 (HERB-DH1) trial showed for the first time that hypertension digital therapeutics (a hypertension treatment app) successfully reduced blood pressure (BP) in patients with hypertension. Patients in the digital therapeutics group who used the app and home BP monitoring (HBPM) showed significant and persistent decreases in office, home and ambulatory BP values compared with the control group (who were under physician management using HBPM and lifestyle modifications). The results of the pivotal study led to the first global approval of this app for the treatment of hypertension in Japan in 2022, including medical insurance reimbursement. As a result, this hypertension app is expected to become widely used in the clinical management of all stages of hypertension. The most important remaining research issues include the identification of patients likely to respond to this therapeutic approach and the development of clinical efficacy indices. In addition, guidelines for the appropriate use of hypertension apps in the treatment of hypertension are needed. Next steps include the development and research of digital tools to facilitate the behavioral modifications required to prevent hypertension.

摘要

2021 年,开放标签随机 HERB-Digital Hypertension 1(HERB-DH1)试验首次表明,高血压数字疗法(一种高血压治疗应用程序)可成功降低高血压患者的血压(BP)。与对照组(在医生的管理下使用家庭血压监测(HBPM)和生活方式改变)相比,使用该应用程序和家庭血压监测(HBPM)的数字治疗组患者的诊室、家庭和动态血压值均显著且持续降低。这项关键性研究的结果导致该应用程序于 2022 年在日本获得全球首个高血压治疗批准,包括医疗保险报销。因此,这种高血压应用程序有望在高血压的所有阶段的临床管理中得到广泛应用。最重要的遗留研究问题包括识别可能对这种治疗方法有反应的患者,以及开发临床疗效指标。此外,还需要制定用于高血压治疗的高血压应用程序的适当使用指南。下一步包括开发和研究数字工具,以促进预防高血压所需的行为改变。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4bed/9540047/962a8c6d61a7/41440_2022_1016_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4bed/9540047/bb7c2f427eab/41440_2022_1016_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4bed/9540047/2792bfb9135f/41440_2022_1016_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4bed/9540047/4c89a0d199ca/41440_2022_1016_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4bed/9540047/9d4344b6057a/41440_2022_1016_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4bed/9540047/e03ac4ecbda8/41440_2022_1016_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4bed/9540047/962a8c6d61a7/41440_2022_1016_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4bed/9540047/bb7c2f427eab/41440_2022_1016_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4bed/9540047/2792bfb9135f/41440_2022_1016_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4bed/9540047/4c89a0d199ca/41440_2022_1016_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4bed/9540047/9d4344b6057a/41440_2022_1016_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4bed/9540047/e03ac4ecbda8/41440_2022_1016_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4bed/9540047/962a8c6d61a7/41440_2022_1016_Fig6_HTML.jpg

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