人类可穿戴的心电图装置的特性,用于在自由移动的非动物中持续收集数据
Christopher P Regan1, Alysia A Chaves1, Theodore Detwiler1
1Safety & Exploratory Pharmacology, Merck & Co., Inc., Rahway, NJ, USA.
Journal of pharmacological and toxicological methods
|June 21, 2025
概括
人类可穿戴的心电图设备可以可靠地收集狗和非人类灵长类动物的非临床安全数据. 这证实了它们在毒理学研究中的内心电图测量中的使用.
科学领域:
- 药理学和毒理学 药理学和毒理学
- 生物医学工程 生物医学工程
- 兽医医学 兽医医学 兽医医学
背景情况:
- 可穿戴设备在个人健康中很常见,但由于设计和数据访问问题,在非临床研究中受到限制.
- 由于技术的局限性,临床创新在非临床环境中面临着挑战.
研究的目的:
- 评估在非临床安全研究中使用人类心电图 (ECG) 可穿戴设备 (WRB) 的可行性.
- 将WRB的心电图数据与犬类和非人类灵长类动物 (NHPs) 的植入式遥测 (TEL) 设备进行比较.
主要方法:
- 从WRB和TEL同时进行24小时的心电图记录,用于犬和NHP.
- 使用多菲提利德或载体,然后对心率和心电图间隔进行分析.
- 布兰德-阿尔特曼分析以确定设备之间的偏差和一致性极限.
主要成果:
- 在WRB和TEL之间的数据大小和资料的定性一致性.
- 设备之间的偏差为HR,PR,QRS和狗QT<2ms;NHPQT<6.6ms,具有可接受的协议限制.
- 多菲提利德诱导的QT变化在设备之间是可比的,在QTci建模中差异很小.
结论:
- 人类心电图可穿戴设备可用于收集非临床安全药理学和毒理学终点.
- 这项技术扩大了在非临床研究中对内心电图数据收集的选择.
- 经过验证的可穿戴设备可以支持在非临床研究中采用临床创新.
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