肾移植受者早期霉酚酸暴露量估算模型研究

R969; 目的 建立肾移植早期受者体内霉酚酸(MPA)暴露量[以12 h内血药浓度-时间曲线下面积(AUC0-12 h)计]的估算模型.方法 选择20例接受吗替麦考酚酯(MMF)+他克莫司+甲泼尼龙三联免疫抑制治疗的肾移植受者,分别于术后第15天口服吗替麦考酚酯分散片(750 mg,q12 h)前及服药后0.5、1.0、1.5、2.0、3.0、4.0、6.0、8.0、12.0 h采集血样,测定MPA血药浓度,计算MPA的药动学参数;采用多元线性逐步回归分析法,拟合估算受者人群体内MPA-AUC0-12 h的有限采样法简化计算公式,并采用Bland-Altman方法评价该公式与经典药动学方法之...

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Published in中国药房 Vol. 34; no. 20; pp. 2530 - 2534
Main Authors 张寒娟, 丁建强, 韩文超, 陈永妍, 王高彪, 丁蕊, 袁冬冬
Format Journal Article
LanguageChinese
Published 郑州市第七人民医院药学部,郑州 450016%武警河南总队医院药学部,郑州 450052 01.10.2023
Subjects
肾移植
exposure
暴露量
有限采样法
renal transplantation
mycophenolic acid
pharmacokinetics
estimation model
药动学
预测模型
霉酚酸
limited sampling strategy
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ISSN1001-0408
DOI10.6039/j.issn.1001-0408.2023.20.15

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Abstract R969; 目的 建立肾移植早期受者体内霉酚酸(MPA)暴露量[以12 h内血药浓度-时间曲线下面积(AUC0-12 h)计]的估算模型.方法 选择20例接受吗替麦考酚酯(MMF)+他克莫司+甲泼尼龙三联免疫抑制治疗的肾移植受者,分别于术后第15天口服吗替麦考酚酯分散片(750 mg,q12 h)前及服药后0.5、1.0、1.5、2.0、3.0、4.0、6.0、8.0、12.0 h采集血样,测定MPA血药浓度,计算MPA的药动学参数;采用多元线性逐步回归分析法,拟合估算受者人群体内MPA-AUC0-12 h的有限采样法简化计算公式,并采用Bland-Altman方法评价该公式与经典药动学方法之间的一致性.结果 20例受者MPA的给药前血药浓度(c0)为(1.53±0.84)μg/mL,药峰浓度(cmax)为(12.07±5.97)μg/mL,半衰期(t1/2)为(5.41±3.67)h,药峰时间(tmax)为(1.58±0.75)h,fAUC0-12 h(按经典药动学方法计算出的AUC0-12 h)为(33.95±13.40)μg·h/mL.使用"4.0、8.0、12.0 h"三点采样估算MPA-AUC0-12 h的简化计算公式为AUC0-12 h= 12.058+2.819c4.0+7.045c8.0+3.879c12.(0R 2=0.934),预测值与fAUC0-12 h有很好的相关性及一致性,95.0%的预测值在x±1.96SD(标准差)范围内.结论 成功建立了肾移植受者早期MPA暴露量估算模型,且该模型有较好的预测精度,并具有采样点少的优势.
AbstractList R969; 目的 建立肾移植早期受者体内霉酚酸(MPA)暴露量[以12 h内血药浓度-时间曲线下面积(AUC0-12 h)计]的估算模型.方法 选择20例接受吗替麦考酚酯(MMF)+他克莫司+甲泼尼龙三联免疫抑制治疗的肾移植受者,分别于术后第15天口服吗替麦考酚酯分散片(750 mg,q12 h)前及服药后0.5、1.0、1.5、2.0、3.0、4.0、6.0、8.0、12.0 h采集血样,测定MPA血药浓度,计算MPA的药动学参数;采用多元线性逐步回归分析法,拟合估算受者人群体内MPA-AUC0-12 h的有限采样法简化计算公式,并采用Bland-Altman方法评价该公式与经典药动学方法之间的一致性.结果 20例受者MPA的给药前血药浓度(c0)为(1.53±0.84)μg/mL,药峰浓度(cmax)为(12.07±5.97)μg/mL,半衰期(t1/2)为(5.41±3.67)h,药峰时间(tmax)为(1.58±0.75)h,fAUC0-12 h(按经典药动学方法计算出的AUC0-12 h)为(33.95±13.40)μg·h/mL.使用"4.0、8.0、12.0 h"三点采样估算MPA-AUC0-12 h的简化计算公式为AUC0-12 h= 12.058+2.819c4.0+7.045c8.0+3.879c12.(0R 2=0.934),预测值与fAUC0-12 h有很好的相关性及一致性,95.0%的预测值在x±1.96SD(标准差)范围内.结论 成功建立了肾移植受者早期MPA暴露量估算模型,且该模型有较好的预测精度,并具有采样点少的优势.
Author 韩文超
丁蕊
丁建强
王高彪
袁冬冬
陈永妍
张寒娟
AuthorAffiliation 郑州市第七人民医院药学部,郑州 450016%武警河南总队医院药学部,郑州 450052
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HAN Wenchao
YUAN Dongdong
DING Jianqiang
ZHANG Hanjuan
CHEN Yongyan
DING Rui
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DocumentTitle_FL Estimation model for the exposure of mycophenolic acid in early renal transplant recipients
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Issue 20
Keywords 肾移植
exposure
暴露量
有限采样法
renal transplantation
mycophenolic acid
pharmacokinetics
estimation model
药动学
预测模型
霉酚酸
limited sampling strategy
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