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Pharmacokinetics of tacrolimus converted from twice-daily formulation to once-daily formulation in Chinese stable liver transplant recipients

文献类型：期刊论文

作者Zhang, Yi-fan1; Chen, Xiao-yan1; Dai, Xiao-jian1; Leng, Xi-sheng2; Zhong, Da-fang1
刊名ACTA PHARMACOLOGICA SINICA
出版日期2011-11
卷号32期号:11页码:1419-1423
关键词tacrolimus modified release clinical pharmacokinetics liver transplantation
ISSN号1671-4083
DOI10.1038/aps.2011.125
文献子类Article
英文摘要Aim: To evaluate the pharmacokinetics of tacrolimus in Chinese stable liver transplant recipients converted from immediate release (IR) tacrolimus-based immunosuppression to modified release (MR) tacrolimus-based immunosuppression. Methods: Open-label, multi-center study with a one-way conversion design was conducted. Eighty-three stable liver recipients (6-24 months post-transplant) with normal renal and stable hepatic function were converted from IR tacrolimus twice-daily treatment to MR tacrolimus once-daily treatment on a 1:1 (mg:mg) total daily dose basis. Twenty-four hour pharmacokinetic studies were carried out on d 0 (pre-conversion), d 1, and d 84 (post-conversion). Results: The area under the blood concentration-time curve of MR tacrolimus from 0 to 24 h (AUC(0-24)) on d 1 was comparable to that of IR tacrolimus on d 0, with a 90% confidence interval (CI) for MR/IR tacrolimus of 92%-97%. The AUC(0-24) value for MR tacrolimus on d 84 with the daily dose increased by 14% was approximately 17% lower than that for IR tacrolimus. The 90% CI was 77%-90%, outside the bioequivalence range of 80%-125%. There was a good correlation between AUC(0-24) and concentration at 24 h (C(24)) for IR tacrolimus (d 0, r=0.930) and MR tacrolimus (d 1, r=0.936; d 84, r=0.903). Conclusion: The exposure to tacrolimus when administered MR tacrolimus once daily is not equivalent to that for IR tacrolimus twice daily after an 84-day conversion in Chinese stable liver transplant recipients. The dose should be adjusted on the basis of trough levels. The therapeutic drug monitoring for patients treated with IR tacrolimus is considered to be applicable to MR tacrolimus.
WOS关键词MODIFIED-RELEASE TACROLIMUS ; SOLID-ORGAN TRANSPLANTATION ; PROGRAF-BASED REGIMEN ; OPEN-LABEL TRIAL ; CLINICAL-EXPERIENCE ; CONVERSION
WOS研究方向Chemistry ; Pharmacology & Pharmacy
语种英语
CSCD记录号CSCD:4364875
WOS记录号WOS:000296739400016
出版者ACTA PHARMACOLOGICA SINICA
源URL[http://119.78.100.183/handle/2S10ELR8/278357]  
专题上海药物代谢研究中心
通讯作者Zhong, Da-fang
作者单位1.Chinese Acad Sci, Shanghai Inst Mat Med, Shanghai 201203, Peoples R China;
2.Peking Univ, Peoples Hosp, Beijing 100871, Peoples R China
推荐引用方式
GB/T 7714		 Zhang, Yi-fan,Chen, Xiao-yan,Dai, Xiao-jian,et al. Pharmacokinetics of tacrolimus converted from twice-daily formulation to once-daily formulation in Chinese stable liver transplant recipients[J]. ACTA PHARMACOLOGICA SINICA,2011,32(11):1419-1423.
APA Zhang, Yi-fan,Chen, Xiao-yan,Dai, Xiao-jian,Leng, Xi-sheng,&Zhong, Da-fang.(2011).Pharmacokinetics of tacrolimus converted from twice-daily formulation to once-daily formulation in Chinese stable liver transplant recipients.ACTA PHARMACOLOGICA SINICA,32(11),1419-1423.
MLA Zhang, Yi-fan,et al."Pharmacokinetics of tacrolimus converted from twice-daily formulation to once-daily formulation in Chinese stable liver transplant recipients".ACTA PHARMACOLOGICA SINICA 32.11(2011):1419-1423.

入库方式： OAI收割

来源：上海药物研究所

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