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体积吸收微采样在 COVID-19 大流行期间临床试验和治疗药物监测中的采样替代方法:综述。

Volumetric Absorptive Microsampling as a Sampling Alternative in Clinical Trials and Therapeutic Drug Monitoring During the COVID-19 Pandemic: A Review.

机构信息

Faculty of Pharmacy, Universitas Indonesia, Depok, West Java 16424, Indonesia.

Functional Medical Staff of Surgical Oncology, Dharmais Cancer Hospital, Jakarta 11420, Indonesia.

出版信息

Drug Des Devel Ther. 2020 Dec 31;14:5757-5771. doi: 10.2147/DDDT.S278892. eCollection 2020.

Abstract

An infectious disease, COVID-19, caused by a new type of coronavirus, has been discovered recently. This disease can cause respiratory distress, fever, and fatigue. It still has no drug and vaccine for treatment and prevention. Therefore, WHO recommends that people should stay at home to reduce disease transmission. Due to the quarantine, FDA stated that this could hamper drug development clinical trial protocols. Hence, an alternative sampling method that can be applied at home is needed. Currently, volumetric absorptive microsampling (VAMS) has become attention in its use in clinical and bioanalytical fields. This paper discusses the advantages and challenges that might be found in the use of VAMS as an alternative sampling tool in clinical trials and therapeutic drug monitoring (TDM) during the COVID-19 pandemic. VAMS allows easy sampling, can be done at home, storage and delivery at room temperature, and the volume taken is small and minimally invasive. VAMS is also able to absorb a fixed volume that can increase the accuracy and precision of analytical methods, and reduce the hematocrit effects (HCT). The use of VAMS is expected to be implemented immediately in clinical trials and TDM during this pandemic considering the benefits it has.

摘要

一种由新型冠状病毒引起的传染病,COVID-19,最近被发现。这种疾病会导致呼吸困难、发热和疲劳。它仍然没有治疗和预防的药物和疫苗。因此,世界卫生组织建议人们呆在家里以减少疾病传播。由于隔离,美国食品药品监督管理局表示,这可能会阻碍药物开发临床试验方案。因此,需要一种可以在家中应用的替代采样方法。目前,容量吸收微采样(VAMS)在临床和生物分析领域的应用引起了关注。本文讨论了在 COVID-19 大流行期间,将 VAMS 用作临床试验和治疗药物监测(TDM)中的替代采样工具可能存在的优势和挑战。VAMS 允许轻松采样,可以在家中进行,在室温下储存和运输,并且采集的体积小,微创。VAMS 还能够吸收固定体积,从而提高分析方法的准确性和精密度,并减少血细胞比容效应(HCT)。考虑到 VAMS 的优势,预计它将在此次大流行期间立即在临床试验和 TDM 中得到应用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1bcd/7783192/1feeb8a9d289/DDDT-14-5757-g0001.jpg

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