慢性肾脏病中的药物处置问题：对药物研发及监管审批的影响
Drug Disposition Issues in CKD: Implications for Drug Discovery and Regulatory Approval.
作者信息
Tieu Alvin, House Andrew A, Urquhart Bradley L
机构信息
Department of Physiology and Pharmacology, Schulich School of Medicine and Dentistry, The University of Western Ontario, London, Ontario, Canada; Division of Nephrology, Department of Medicine, Schulich School of Medicine and Dentistry, The University of Western Ontario; Lawson Health Research Institute, London, Ontario, Canada; and Department of Physiology and Pharmacology, Schulich School of Medicine and Dentistry, The University of Western Ontario; Division of Nephrology, Department of Medicine, Schulich School of Medicine and Dentistry, The University of Western Ontario; Lawson Health Research Institute, London, Ontario, Canada.
Department of Physiology and Pharmacology, Schulich School of Medicine and Dentistry, The University of Western Ontario, London, Ontario, Canada; Division of Nephrology, Department of Medicine, Schulich School of Medicine and Dentistry, The University of Western Ontario; Lawson Health Research Institute, London, Ontario, Canada; and Department of Physiology and Pharmacology, Schulich School of Medicine and Dentistry, The University of Western Ontario; Division of Nephrology, Department of Medicine, Schulich School of Medicine and Dentistry, The University of Western Ontario; Lawson Health Research Institute, London, Ontario, Canada.
出版信息
Adv Chronic Kidney Dis. 2016 Mar;23(2):63-6. doi: 10.1053/j.ackd.2016.01.013.
Patients with chronic kidney disease (CKD) have several comorbidities that require pharmacologic intervention including hypertension, diabetes, anemia, and cardiovascular disease. Advanced CKD patients (eg, treated with hemodialysis) take an average of 12 medications concurrently and are known to suffer from an increased number of medication-related adverse drug events. Recent basic and clinical research has identified altered renal and nonrenal drug clearance in CKD as one mediator of the increased adverse drug events observed in this patient population. This review will briefly describe pharmacokinetic considerations in CKD, review the Food and Drug Administration guidelines for performing pharmacokinetic studies in CKD patients, and outline the roles of academia, industry, and regulatory agencies in improving drug safety in CKD patients.
慢性肾脏病（CKD）患者存在多种需要药物干预的合并症，包括高血压、糖尿病、贫血和心血管疾病。晚期CKD患者（如接受血液透析治疗的患者）平均同时服用12种药物，且已知会遭受更多与药物相关的不良药物事件。最近的基础和临床研究已确定CKD患者肾脏和非肾脏药物清除率的改变是该患者群体中观察到的不良药物事件增加的一个介导因素。本综述将简要描述CKD患者的药代动力学注意事项，回顾美国食品药品监督管理局关于在CKD患者中进行药代动力学研究的指南，并概述学术界、制药行业和监管机构在提高CKD患者用药安全性方面的作用。
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