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将医生排除在外:患者自我控制的居家他克莫司治疗药物自我监测

Removing the physician from the equation: Patient-controlled, home-based therapeutic drug self-monitoring of tacrolimus.

作者信息

Hazenbroek Marinus, Pengel Liset H M, Sassen Sebastiaan D T, Massey Emma K, Reinders Marlies E J, de Winter Brenda C M, Hesselink Dennis A

机构信息

Erasmus MC Transplant Institute, University Medical Center Rotterdam, Rotterdam, the Netherlands.

Department of Internal Medicine, Division of Nephrology and Transplantation, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.

出版信息

Br J Clin Pharmacol. 2025 Jun;91(6):1560-1568. doi: 10.1111/bcp.16121. Epub 2024 Jun 3.

Abstract

The dosing of tacrolimus, which forms the backbone of immunosuppressive therapy after kidney transplantation, is complex. This is due to its variable pharmacokinetics (both between and within individual patients), narrow therapeutic index, and the severe consequences of over- and underexposure, which may cause toxicity and rejection, respectively. Tacrolimus is, therefore, routinely dosed by means of therapeutic drug monitoring (TDM). TDM is performed for as long as the transplant functions and frequent and often lifelong sampling is therefore the rule. This puts a significant burden on patients and transplant professionals and is associated with high healthcare-associated costs. Furthermore, by its very nature, TDM is reactive and has no predictive power. Finally, the current practice of TDM does not foresee in an active role for patients themselves. Rather, the physician or pharmacist prescribes the next tacrolimus dose after obtaining the concentration measurement test results. In this article, we propose a strategy of patient-controlled, home-based, self-TDM of the immunosuppressant tacrolimus after transplantation. We argue that with the combined use of population tacrolimus pharmacokinetic models, home-based sampling by means of dried blood spotting and implementation of telemedicine, this may become a feasible approach in the near future.

摘要

他克莫司是肾移植后免疫抑制治疗的核心药物,其给药方式复杂。这是因为它的药代动力学存在个体间和个体内差异、治疗指数窄,以及暴露过量和不足会分别导致毒性和排斥反应等严重后果。因此,他克莫司通常通过治疗药物监测(TDM)来给药。只要移植肾功能正常,就会进行TDM,因此频繁且往往是终身采样是惯例。这给患者和移植专业人员带来了巨大负担,并与高昂的医疗相关成本相关。此外,就其本质而言,TDM是反应性的,没有预测能力。最后,目前TDM的做法没有预见到患者自身的积极作用。相反,医生或药剂师在获得浓度测量测试结果后开出下一次他克莫司剂量。在本文中,我们提出了一种移植后患者自控、居家、自我TDM免疫抑制剂他克莫司的策略。我们认为,通过联合使用群体他克莫司药代动力学模型、借助干血斑进行居家采样以及实施远程医疗,这在不久的将来可能会成为一种可行的方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0960/12122133/9dec6be8f5ac/BCP-91-1560-g002.jpg

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