基于来自韩国多个中心的电子医疗记录的积极药监框架的开发和应用
Seon Choe1, Suehyun Lee2, Chan Hee Park1
1Division of Biomedical Informatics, Systems Biomedical Informatics Research Centre, Seoul National University College of Medicine, 103 Daehak-ro, Jongno-gu, Seoul, 03080, Republic of Korea.
Drug safety
|May 27, 2023
概括
这项研究开发了一种韩国常用数据模型 (K-CDM) 用于药物监测,使药物不良反应 (ADR) 的多机构分析成为可能. K-CDM在检测药物风险方面证明了可行性,例如NSAID和抗凝剂.
科学领域:
- 药监和药物安全 药监和药物安全
- 医疗信息学 医疗信息学
- 临床数据管理 临床数据管理
背景情况:
- 追溯的药监数据可以通过共同数据模型 (CDM) 进行多中心分析.
- 为个别医疗系统和分析应用程序建立合适的CDM仍然是一个挑战.
研究的目的:
- 为药监系统构建一个专门的韩国共同数据模型 (K-CDM).
- 使用基于临床场景的方法检测药物不良反应 (ADR).
主要方法:
- 从13个机构转换到K-CDM的非识别患者记录 (n=5,402,129).
- 将本地电子医疗记录 (EMR) 代码映射到标准词汇库,并开发了分布式查询.
- 通过去中心化或分布式网络对K-CDM进行应用查询进行分析.
主要成果:
- 分析显示,非类固醇抗炎药物 (NSAIDs) 与阿司匹林相比,胃肠道出血风险翻了一番.
- 非维生素K抗凝剂降低了0.18倍的脑血管出血风险,与华法林相比.
结论:
- K-CDM是可行的药物监测,产生结果与以前的研究相比较.
- 数据质量,映射完整性和机构异质性需要持续校准以提高有效性.
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