Van der Linden Lorenz, Hias Julie, Vanassche Thomas
Pharmacy Department, University Hospitals Leuven, Leuven, Belgium.
Department of Cardiovascular Sciences, University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium.
Eur Heart J Suppl. 2022 Feb 14;24(Suppl A):A32-A41. doi: 10.1093/eurheartj/suab153. eCollection 2022 Feb.
The class of new oral anticoagulants (NOACs) has been developed to provide reliable oral anticoagulation without the need for therapeutic drug monitoring. Based on phase I and II trials and pharmacokinetic and pharmacodynamic modeling, fixed drug doses have been selected for large phase III clinical trials for each currently available NOAC. In these trials, the use of the fixed dose without plasma level assessments was shown to be at least as effective and at least as safe as vitamin K antagonists with continuous therapeutic drug monitoring. Real world evidence reaffirms that the use of a fixed NOAC dose without plasma level assessment is safe and effective in a large variety of patients. Nevertheless, measurement of NOAC plasma levels can add information that may be useful in some clinical scenarios. This review discusses the possible use cases, the limitations, and the practical implementation of measuring NOAC plasma concentrations.
新型口服抗凝药（NOACs）的研发目的是在无需治疗药物监测的情况下提供可靠的口服抗凝作用。基于I期和II期试验以及药代动力学和药效学模型，已为每种目前可用的NOAC选择了固定药物剂量用于大型III期临床试验。在这些试验中，未进行血浆水平评估而使用固定剂量被证明至少与持续进行治疗药物监测的维生素K拮抗剂一样有效且一样安全。真实世界证据再次证实，在众多患者中，不进行血浆水平评估而使用固定的NOAC剂量是安全有效的。尽管如此，测定NOAC血浆水平可提供在某些临床情况下可能有用的信息。本综述讨论了测定NOAC血浆浓度的可能应用情况、局限性及实际操作。
