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一项用于提高重症精神障碍患者依从性的数字药物系统的随机临床试验。

Randomized clinical trial of a digital medication system to enhance adherence in patients with severe mental disorders.

作者信息

Zhou Jia, Zhai Qian, Qi Han, Jin Xiaolei, Xiao Cunli, Li Wenxiu, Song Junwei, Feng Lei, Wang Haibo, Dong Chengcheng, Yu Zibo, Feng Yuan, Wang Gang, Yan Fang

机构信息

Beijing Key Laboratory of Mental Disorders, National Clinical Research Center for Mental Disorders & National Center for Mental Disorders, Beijing Anding Hospital, Capital Medical University, Beijing, China.

Advanced Innovation Center for Human Brain Protection, Capital Medical University, Beijing, China.

出版信息

NPJ Digit Med. 2025 Jun 5;8(1):333. doi: 10.1038/s41746-025-01748-2.

DOI:10.1038/s41746-025-01748-2
PMID:40467762
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12137551/
Abstract

To evaluate the effectiveness of a digital medication system in improving adherence among patients with serious mental disorders (SMD), we conducted a cluster-randomized controlled trial across 30 communities in Beijing. Participants, aged 18-65 years, were diagnosed with schizophrenia or bipolar disorder and either received intermittent medication or refused treatment. Recruitment occurred from September 2, 2022, to January 12, 2023. The intervention group received a digital medication system. The control group used an online medication diary. The primary outcome was poor adherence, defined as missing 20% or more of prescribed doses at 12 months. Among 216 recruited patients, 206 completed the study. The intervention group showed significantly higher adherence (84/108 vs. 23/108), with an adjusted risk difference of 52.34% (95% CI: 34.65%-70.03%; P < 0.0001). This trial provides the first robust evidence that the digital medication system can significantly improve medication adherence in patients with SMD. Trial Registration: The trial was registered on the Chinese Clinical Trial Registry (chictr.org.cn) on May 29, 2022 (ChiCTR-ICR-2200060359).

摘要

为评估数字药物系统在提高严重精神障碍(SMD)患者服药依从性方面的有效性,我们在北京的30个社区开展了一项整群随机对照试验。参与者年龄在18至65岁之间,被诊断为精神分裂症或双相情感障碍,且要么接受间歇性药物治疗,要么拒绝治疗。招募时间为2022年9月2日至2023年1月12日。干预组使用数字药物系统,对照组使用在线服药日记。主要结局为依从性差,定义为在12个月时漏服20%或更多规定剂量的药物。在招募的216例患者中,206例完成了研究。干预组的依从性显著更高(84/108 vs. 23/108),调整后的风险差异为52.34%(95%CI:34.65%-70.03%;P < 0.0001)。本试验提供了首个有力证据,表明数字药物系统可显著提高严重精神障碍患者的服药依从性。试验注册:该试验于2022年5月29日在中国临床试验注册中心(chictr.org.cn)注册(ChiCTR-ICR-2200060359)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5b7/12137551/c6cd1e51e630/41746_2025_1748_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5b7/12137551/64581af5c6bc/41746_2025_1748_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5b7/12137551/568e20c4cd8c/41746_2025_1748_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5b7/12137551/a95626ecb9a4/41746_2025_1748_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5b7/12137551/c6cd1e51e630/41746_2025_1748_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5b7/12137551/64581af5c6bc/41746_2025_1748_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5b7/12137551/568e20c4cd8c/41746_2025_1748_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5b7/12137551/a95626ecb9a4/41746_2025_1748_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/b5b7/12137551/c6cd1e51e630/41746_2025_1748_Fig4_HTML.jpg

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本文引用的文献

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