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Population pharmacokinetic study of tacrolimus in pediatric patients with primary nephrotic syndrome
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Ling-fei HUANG1, 2, Chen-yan ZHAO2, Zheng JIAO2, *, Yi-xi LIU2, 3, Hui-fen ZHANG1, Jue WANG1, Jian-hua MAO4
Acta Pharmaceutica Sinica | 2018, 53(2) : 263 - 270
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Acta Pharmaceutica Sinica | 2018, 53(2): 263-270
• ORIGINAL ARTICLES •
Population pharmacokinetic study of tacrolimus in pediatric patients with primary nephrotic syndrome
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Ling-fei HUANG1, 2, Chen-yan ZHAO2, Zheng JIAO2, *, Yi-xi LIU2, 3, Hui-fen ZHANG1, Jue WANG1, Jian-hua MAO4
Affiliations
  • 1. Department of Pharmacy, Children's Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China
  • 2. Department of Pharmacy, Huashan Hospital, Fudan University, Shanghai 200040, China
  • 3. School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing 211198, China
  • 4. Department of Nephrology, Children's Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China
Published: 2018-02-12 doi: 10.16438/j.0513-4870.2017-0639
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Tacrolimus is commonly used in the treatment for the refractory primary nephrotic syndrome (PNS) in the pediatric patients. Data were retrospectively obtained from 100 children with 357 tacrolimus trough concentrations in our center between May 2010 and March 2016. Information of age, sex, body weight, drug dose, co-therapy medications, laboratory tests and sampling time were collected. The population pharmacokinetic model was developed using nonlinear mixed effect modeling (NONMEM) software. A one-compartment model with first-order absorption and elimination best described the data. The population estimate of apparent clearance (CL/F) and apparent volume of distribution (V/F) was 6.54 L·h-1 and 86.2 L, respectively. Body weight (WT, kg), daily dose of tacrolimus (DD, mg·day-1) and co-therapy azole antifungal agent have a significant impact on the CL/F. The final PPK model of CL/F was:CL/F=6.54×${\left( {\frac{{{\rm{WT}}}}{{25}}} \right)^k}$×${\left( {\frac{{{\rm{DD}}}}{{1.5}}} \right)^{0.293}}$×0.657Azole, K=$\frac{{{\rm{W}}{{\rm{T}}^{ - 30.9}}}}{{{\rm{W}}{{\rm{T}}^{ - 30.9}} + {{10.4}^{ - 30.9}}}} $. When combined with azole antifungal agents, Azole was 1, whereas vice versa was 0. This is the first PPK study of tacrolimus conducted in pediatric patients with PNS, which may facilitate individualized drug therapy of tacrolimus.

tacrolimus  /  children  /  primary nephrotic syndrome  /  population pharmacokinetic  /  nonlinear mixed effect model
Ling-fei HUANG, Chen-yan ZHAO, Zheng JIAO, Yi-xi LIU, Hui-fen ZHANG, Jue WANG, Jian-hua MAO. Population pharmacokinetic study of tacrolimus in pediatric patients with primary nephrotic syndrome[J]. Acta Pharmaceutica Sinica, 2018 , 53 (2) : 263 -270 . DOI: 10.16438/j.0513-4870.2017-0639
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Article Info
doi: 10.16438/j.0513-4870.2017-0639
  • Receive Date：2017-07-15
  • Online Date：2026-01-15
  • Published：2018-02-12
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History
  • Received：2017-07-15
  • Accepted：2017-08-30
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Affiliations
    1. Department of Pharmacy, Children's Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China
    2. Department of Pharmacy, Huashan Hospital, Fudan University, Shanghai 200040, China
    3. School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing 211198, China
    4. Department of Nephrology, Children's Hospital, School of Medicine, Zhejiang University, Hangzhou 310003, China
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表12种不同金属材料的力学参数
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小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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