Department of Clinical Pharmacy and Translational Science, The University of Tennessee Health Science Center, Memphis, TN; Department of Medicine (Division of Nephrology), The University of Tennessee Health Science Center, Memphis, TN; Department of Pharmacy and Therapeutics, Center for Clinical Pharmaceutical Sciences, University of Pittsburgh Schools of Pharmacy and Medicine, Pittsburgh, PA; and Department of Medicine, Renal-Electrolyte Division, University of Pittsburgh Schools of Pharmacy and Medicine, Pittsburgh, PA.
Department of Clinical Pharmacy and Translational Science, The University of Tennessee Health Science Center, Memphis, TN; Department of Medicine (Division of Nephrology), The University of Tennessee Health Science Center, Memphis, TN; Department of Pharmacy and Therapeutics, Center for Clinical Pharmaceutical Sciences, University of Pittsburgh Schools of Pharmacy and Medicine, Pittsburgh, PA; and Department of Medicine, Renal-Electrolyte Division, University of Pittsburgh Schools of Pharmacy and Medicine, Pittsburgh, PA.
Adv Chronic Kidney Dis. 2018 Jan;25(1):14-20. doi: 10.1053/j.ackd.2017.10.003.
Creatinine clearance has been the most common method of estimating kidney function for the purpose of drug dosing for decades. The availability and extensive clinical use of estimated glomerular filtration rate (eGFR) now provides clinicians a potential alternative. Currently, data demonstrating the validity of eGFR-based drug dosing is limited, but proof of principle has been established and the tide related to use of eGFR for drug dosing appears to be turning. Use of the same kidney function estimate for management of kidney disease, drug development and dosing, and harmonization in all clinical arenas would be ideal. Use of multiple equations can lead to differences in kidney function estimates and corresponding drug dosing regimens, which necessitates clinical judgment and a pragmatic approach when rendering drug dosing decisions. Careful consideration of the risk-benefit ratio of individual drugs and dosing regimens within each patient is warranted. Going forward, FDA guidance will likely incentivize pharmaceutical manufacturers to generate eGFR-based dosing recommendations in addition to creatinine clearance for inclusion in the label of newly approved drugs. However, dosing information for currently approved drugs will continue to be based on creatinine clearance alone, so clinicians must be vigilant in the assessment of kidney function in order to provide optimal pharmacotherapy.
几十年来，肌酐清除率一直是最常用的估计肾功能的方法，目的是为药物剂量调整提供依据。目前，估算肾小球滤过率（eGFR）的可用性和广泛的临床应用为临床医生提供了一种潜在的替代方法。目前，基于 eGFR 的药物剂量调整的有效性数据有限，但已确立了原理证明，并且与 eGFR 用于药物剂量调整相关的趋势似乎正在发生转变。在所有临床领域中，使用相同的肾功能估计值来管理肾脏疾病、药物开发和剂量调整以及实现协调将是理想的。使用多个方程可能会导致肾功能估计值和相应的药物剂量方案存在差异，因此在制定药物剂量决策时需要临床判断和务实的方法。在每个患者中，仔细考虑个体药物和剂量方案的风险-效益比是必要的。展望未来，FDA 指南可能会鼓励制药商生成基于 eGFR 的剂量建议，除了肌酐清除率之外，还将其纳入新批准药物的标签中。然而，目前批准的药物的剂量信息仍将仅基于肌酐清除率，因此临床医生必须警惕肾功能评估，以提供最佳的药物治疗。
