Wason Suman, Mount David, Faulkner Robert
Mutual Pharmaceutical Company, Inc., Philadelphia, PA, 19124, USA.
Clin Drug Investig. 2014 Dec;34(12):845-55. doi: 10.1007/s40261-014-0238-6.
The effect of renal impairment on colchicine pharmacokinetics in patients with chronic kidney disease (CKD) has not been studied previously. We evaluated the effect of renal impairment on colchicine pharmacokinetics in patients with CKD.
The pharmacokinetics and safety of a single, oral 0.6-mg dose of colchicine was evaluated in an open-label study in eight healthy subjects with normal renal function; eight subjects each with mild, moderate, or severe renal impairment; and eight subjects with end-stage renal disease (ESRD) who received a single dose prior to receiving, and again following, hemodialysis.
Colchicine exposure was similar for subjects with normal renal function, mild impairment, or ESRD prior to and during hemodialysis (24.7-31.7 ng·h/mL), but was up to twofold higher in subjects with moderate or severe renal impairment (48.9 and 48.0 ng·h/mL, respectively). A very small amount of the colchicine dose (mean of 5.2 %) was recovered in dialysate.
It appears that patients with mild or moderate renal impairment or those actively receiving hemodialysis do not show accumulation of colchicine, whereas those with severe renal impairment show a doubling of exposure. All patients with renal impairment taking colchicine should be closely monitored, especially as many patients taking colchicine often have other comorbidities and may be taking other medications.
既往尚未研究肾功能损害对慢性肾脏病（CKD）患者秋水仙碱药代动力学的影响。我们评估了肾功能损害对CKD患者秋水仙碱药代动力学的影响。
在一项开放标签研究中，对8名肾功能正常的健康受试者、8名轻度、中度或重度肾功能损害受试者以及8名终末期肾病（ESRD）受试者进行了评估，这些ESRD受试者在血液透析前和透析后分别接受了单次口服0.6 mg秋水仙碱剂量，并评估了其药代动力学和安全性。
肾功能正常、轻度损害或血液透析前及透析期间的ESRD受试者的秋水仙碱暴露量相似（24.7 - 31.7 ng·h/mL），但中度或重度肾功能损害受试者的暴露量高出两倍（分别为48.9和48.0 ng·h/mL）。透析液中回收的秋水仙碱剂量非常少（平均为5.2%）。
轻度或中度肾功能损害患者或正在接受血液透析的患者似乎未出现秋水仙碱蓄积，而重度肾功能损害患者的暴露量增加了一倍。所有服用秋水仙碱的肾功能损害患者均应密切监测，尤其是因为许多服用秋水仙碱的患者往往还有其他合并症，可能正在服用其他药物。
