IIS-Fundación Jiménez Díaz-Universidad Autónoma de Madrid, Spain; REDINREN, Madrid, Spain.
IIS-Fundación Jiménez Díaz-Universidad Autónoma de Madrid, Spain.
Am J Med. 2016 Dec;129(12):1259-1263. doi: 10.1016/j.amjmed.2016.08.019. Epub 2016 Sep 6.
Direct oral anticoagulants (DOACs) may require dose reduction or avoidance when glomerular filtration rate is low. However, glomerular filtration rate is not usually measured in routine clinical practice. Rather, equations that incorporate different variables use serum creatinine to estimate either creatinine clearance in mL/min or glomerular filtration rate in mL/min/1.73 m. The Cockcroft-Gault equation estimates creatinine clearance and incorporates weight into the equation. By contrast, the Modification of Diet in Renal Disease and Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equations estimate glomerular filtration rate and incorporate ethnicity but not weight. As a result, an individual patient may have very different renal function estimates, depending on the equation used. We now highlight these differences and discuss the impact on routine clinical care for anticoagulation to prevent embolization in atrial fibrillation. Pivotal DOAC clinical trials used creatinine clearance as a criterion for patient enrollment, and dose adjustment and Federal Drug Administration recommendations are based on creatinine clearance. However, clinical biochemistry laboratories provide CKD-EPI glomerular filtration rate estimations, resulting in discrepancies between clinical trial and routine use of the drugs.
直接口服抗凝剂(DOAC)在肾小球滤过率较低时可能需要减少剂量或避免使用。然而,肾小球滤过率在常规临床实践中通常不进行测量。相反,包含不同变量的公式使用血清肌酐来估计肌酐清除率(以毫升/分钟计)或肾小球滤过率(以毫升/分钟/1.73 平方米计)。 Cockcroft-Gault 方程估计肌酐清除率并将体重纳入方程。相比之下,改良肾脏病饮食研究(MDRD)和慢性肾脏病流行病学合作(CKD-EPI)方程估计肾小球滤过率并纳入种族因素但不纳入体重因素。因此,根据所使用的公式,个体患者的肾功能估计可能会有很大差异。我们现在强调这些差异,并讨论其对预防心房颤动栓塞的抗凝常规临床护理的影响。关键的 DOAC 临床试验将肌酐清除率作为患者入组的标准,剂量调整和美国食品和药物管理局的建议基于肌酐清除率。然而,临床生化实验室提供 CKD-EPI 肾小球滤过率估计值,导致临床试验和药物常规使用之间存在差异。