肾移植受者麦考酚钠肠溶片药代动力学特征及其影响因素分析

doi:10.3969/j.issn.1006298X.2021.02.007

肾脏病与透析肾移植杂志 ›› 2021, Vol. 30 ›› Issue (2): 136-142.DOI: 10.3969/j.issn.1006298X.2021.02.007

肾移植受者麦考酚钠肠溶片药代动力学特征及其影响因素分析

出版日期:2021-04-28 发布日期:2021-06-06

Pharmacokinetics features and influencing factors of entericcoated mycophenolate sodium in renal allograft recipients

Online:2021-04-28 Published:2021-06-06

摘要/Abstract

摘要： 目的：观察肾移植受者麦考酚钠肠溶片(ECMPS)药代动力学特征及其影响因素。
方法：67例肾移植受者均接受ECMPS联合他克莫司、泼尼松的三联免疫抑制方案,根据24h尿蛋白定量结果将患者分为阴性组和蛋白尿组。采用EMIT法测定服药前及服药后05h、1h、15h、2h、4h、6h、8h、10h、12h的血浆霉酚酸(MPA)浓度(分别为C05、C1、C15、C2、C4、C6、C8、C10、C12)。
结果：蛋白尿组血清肌酐(SCr)、血尿素氮(BUN)、估算的肾小球滤过率(eGFR)、血清白蛋白(Alb)、血红蛋白(Hb)与阴性组之间存在显著差异。蛋白尿组受者C0显著高于阴性组[(486±234) mg／L vs (356±189) mg／L,P=0014],但均与MPAAUC0～12h正相关(r=0547,P=0001;r=0856,P=0000)。二组MPAAUC0～12h分别为(6616±2708) mg·h／L和(5881±2048) mg·h／L,具有显著统计学差异(T=-1259,P=0021)。SCr水平与MPAAUC0～12h正相关,Hb、Alb以及eGFR、与MPAAUC0～12h负相关。蛋白尿组受者MPA高暴露组MPAAUC0～12h显著高于阴性组[(9398±2011) mg·h／L vs (8169±1821) mg·h／L,P=0026]。MPA高暴露受者Hb水平低于低暴露组与目标暴露组(P=0029),而SCr水平均高于低暴露组和目标暴露组(P=0014)。
结论：移植肾功能、Hb、Alb与MPAAUC0～12h具有显著的相关性,术后蛋白尿增加肾移植受者MPA高暴露风险。

关键词: 蛋白尿, 肾移植, 霉酚酸钠肠溶片, 估算的肾小球滤过率

Abstract: Ｏｂｊｅｃｔｉｖｅ：To observe pharmacokinetic features and influencing factors of entericcoated mycophenolate sodium (ECMPS)in renal allograft recipients.
Ｍｅｔｈｏｄｏｌｏｇｙ：sixtyseven kidney transplant recipients treated with ECMPS in combination with tacrolimus and prednisone were enrolled and divided into negative proteinuria (negative)group and proteinuria group according to 24hour quantitative of urine protein.Plasma mycophenolic acid (MPA) concentrations were determined by EMIT method at premedcation, 05, 1, 15,2,4,6,8,10 and 12 hours (C05, C1, C15, C2, C4, C6, C8, C10 and C12) after oral administration.
Ｒｅｓｕｌｔｓ：There were significant differences among serum creatinine (SCr),blood urea nitrogen (BUN), estimated glomerular filtration rate (eGFR), serum albumin (Alb), hemoglobin (Hb) between the two groups. The value of C0 and MPAAUC0～12h in proteinuria group was significantly higher than that of negative group［(486±234) mg／L vs (356±189) mg／L,P=0014), (6616±2708) mg·h／L vs (5881±2048) mg·h／L,P=0021)］.SCr was positively correlated with MPAAUC0～12h, while Hb,Alb and eGFR were negatively correlated with MPAAUC0～12h. The MPAAUC0～12h in the high eposure group with proteinuria was 9368 mg.h／L, which was significantly higher than the negative group with 8169 mg.h／L(P=0026). Hb level of MPA high eposure recipients was lower than that of low eposure group and target eposure group (P=0029), while SCr level was higher than that of the other two groups (P=0014).
Ｃｏｎｃｌｕｓｉｏｎ：
There was a significant correlation between renal allograft function, Hb, Alb and MPAAUC0～12h. Postoperativeproteinuria increased the risk of MPA high eposure in the renal allograft recipients.

Key words: proteinuria, kidney transplantation, enteric-coated mycophenolate sodium, estimated glomerular filtration rate

赵纪强, 赵济全, 吴艳琴, 李玉珍, 何朝辉. 肾移植受者麦考酚钠肠溶片药代动力学特征及其影响因素分析[J]. 肾脏病与透析肾移植杂志, 2021, 30(2): 136-142.

ZHAO Jiqiang, ZHAO Jiquan, WU Yanqin, LI Yuzhen, HE Zhaohui. Pharmacokinetics features and influencing factors of entericcoated mycophenolate sodium in renal allograft recipients[J]. Chinese Journal of Nephrology, Dialysis & Transplantation, 2021, 30(2): 136-142.

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ISSN 1006-298X CN 32-1425/R

肾移植受者麦考酚钠肠溶片药代动力学特征及其影响因素分析

Pharmacokinetics features and influencing factors of entericcoated mycophenolate sodium in renal allograft recipients

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