数字医学：创新的药物-器械组合作为药物依从性的新衡量标准。
Digital Medicine: Innovative Drug-Device Combination as New Measure of Medication Adherence.
作者信息
Vallejos Ximena, Wu Christine
机构信息
Miami VA Healthcare System, Miami, FL, USA.
出版信息
J Pharm Technol. 2017 Aug;33(4):137-139. doi: 10.1177/8755122517704212. Epub 2017 Apr 28.
Abstract
In September 2015, the Food and Drug Administration accepted the first digital medicine new drug application for a drug-device combination of Otsuka's Abilify® (aripiprazole) and an ingestible sensor embedded in the tablet that digitally records ingestion. When this digital medicine is taken, it sends a signal to a patch worn by the patient. The information is recorded, time-stamped, and relayed to any Bluetooth-enabled device and, with patients' consent, to their physicians and/or their caregivers. An encapsulation model in which a tablet is co-encapsulated with the ingestible sensor has been successfully used in the setting of renal transplant, diabetes, hypertension, and hypercholesterolemia.
摘要
2015年9月，美国食品药品监督管理局受理了首个数字药物新药申请，该药物为大冢制药的阿立哌唑（Abilify®）与嵌入片剂中的可摄入传感器的药物-器械组合，可对药物摄入进行数字记录。服用这种数字药物时，它会向患者佩戴的贴片发送信号。信息被记录、加盖时间戳，并转发到任何支持蓝牙的设备，经患者同意后，还会转发给他们的医生和/或护理人员。一种将片剂与可摄入传感器共同封装的封装模型已成功应用于肾移植、糖尿病、高血压和高胆固醇血症的治疗中。
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