2013-08-012024-05-14https://scholars.lib.ntu.edu.tw/handle/123456789/660553摘要：背景 臺灣慢性腎臟疾病人口眾多。雖測量血中肌氨酸酐（creatinine）有諸多影響因子，但由此評估腎功能已廣被接受。常用於劑量調整的 Cockcroft-Gault 計算的肌氨酸酐廓清率（creatinine clearance；ClCr）和用於慢性腎臟疾病分級的Modification of Diet in Renal Disease 估計的腎絲球過濾率（estimated glomerular filtration rate；eGFR）不僅單位不同，兩者計算結果在不同人種及個體上也沒有一定關係，因此 2010 年起美國食品及藥物管理局要求進行藥動試驗時，對於腎臟功能不全病人除了提供常見的 ClCr計算對藥動學的影響外，還要提供以 MDRD計算的 eGFR 對藥動學參數影響。多數藥品須經腎臟排除，了解 ClCr 和 eGFR的關係對於病人用藥的安全性及效用幫助極大，找出影響其間差值的因素也可提供更多臨床評估腎功能時的參考。 目的 本計劃的目的包括分析 ClCr 和 eGFR 計算公式間的關係，以準確給予腎臟劑量。也希望分析兩者間的差值會受到哪些病人因素影響。 方法 本研究將先回顧文獻資料，並比較估算 ClCr 和 eGFR 之各種公式的研究族群、適用範圍等。利用臺大醫院病人電腦資料找出 ClCr 和 eGFR 之間的關係；分析哪些病人因素對於兩數值差距的影響。利用病人族群中有測量尿中creatinine 並完整收集 12 或 24 小時尿液所計算得到的腎功能，驗證這些公式（包括本所研究所得的 ClCr 公式）在臺灣人的應用性，並依據藥動學原理剖析腎功能單位的選擇。<br> Abstract: Background The prevalence of chronic kidney disease (CKD) is high in Taiwan. Though there are many factors that may affect the measurement of serum creatinine, it is a well-accepted marker for renal function assessment. The creatinine clearance (ClCr) estimated by Cockroft-Gault is commonly used as a reference for dosage adjustment; while the estimated glomerular filtration rate (eGFR) by Modification of Diet in Renal Disease (MDRD) is used in CKD staging. ClCr and eGFR not only have different units, but the results of estimation from the two varied among races and individuals. Since 2010, US Food and Drug Administration required both the influences of ClCr and eGFR on the pharmacokinetics of a drug in renal insufficient patients during pharmacokinetic studies. Because most drugs are excreted through kidney, an understanding on the relationship between ClCr and eGFR is important to dose safely and effectively. Furthermore, identifying the factors that may influence the difference between ClCr and eGFR can provide in-depth consideration during clinical renal function assessment. Purpose The purpose of this study is to analyze the correlation between different ClCr and eGFR equations in order to provide better renal dose. We also want to find the factors that may cause the differences between them. Methods This study will conduct literature review to understand study population during the development of different ClCr and eGFR equations, as well as their scope of application. National Taiwan University Hospital electronic patient database will be used to analyze the correlation between ClCr and eGFR and to identify factors that may influence the difference between ClCr and eGFR. The data from patients who have completed 12-hr or 24-hr urine collection with calculated renal function will be used to verify the applicability of these equations (including a ClCr equation developed by our institute) in Taiwanese. Pharmacokinetic principles will be used to analyze the appropriate unit to be used for renal function while dosing a patient.肌氨酸酐腎絲球過濾率慢性腎功能不全creatinineglomerular filtration raterenal insufficiencychronic