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已发表论文
高他克莫司暴露对肾移植受者移植物功能的影响及预测模型的建立：一项单中心回顾性队列研究
Authors Yang W, Xia R, Zhao P, Du J, Liu R, Zeng W, Chen Y, Luo X, Zheng P, Li Y, Mo L
Received 14 August 2025
Accepted for publication 24 December 2025
Published 31 December 2025 Volume 2025:19 Pages 12035—12047
DOI https://doi.org/10.2147/DDDT.S560652
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Dr Solomon Tadesse Zeleke
Wenyu Yang,1,2,* Renfei Xia,3,* Peijin Zhao,1,2 Juanhua Du,4 Rumin Liu,3 Wenli Zeng,3 Yan Chen,1,2 Xin Luo,1,2 Ping Zheng,1,2 Yilei Li,1,2 Liqian Mo1,2
1Department of Pharmacy, Nanfang Hospital, Southern Medical University, Guangzhou, People’s Republic of China; 2Clinical Pharmacy Center, Nanfang Hospital, Southern Medical University, Guangzhou, People’s Republic of China; 3Department of Transplantation, Nanfang Hospital, Southern Medical University, Guangzhou, People’s Republic of China; 4Department of Cardiology, Nanfang Hospital, Southern Medical University, Guangzhou, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Yilei Li, Department of Pharmacy, Nanfang Hospital, Southern Medical University, Guangzhou, People’s Republic of China, Email lei@smu.edu.cn Liqian Mo, Department of Pharmacy, Nanfang Hospital, Southern Medical University, Guangzhou, People’s Republic of China, Email moliqian@smu.edu.cn
Purpose: To evaluate the association between early supratherapeutic tacrolimus exposure (trough concentration > 20 ng/mL within the first postoperative week) and graft outcomes in kidney transplant recipients, and to develop a prediction model for this early high exposure.
Patients and Methods: This single-center retrospective cohort study included 210 kidney transplant recipients (105 exposed, 105 non-exposed) after propensity score matching. Renal function (eGFR, cystatin C) and infection rates over the first year were compared using linear mixed-effects models with multiple imputation. A Cox proportional hazards model with LASSO variable selection was developed to predict the risk of high exposure.
Results: The exposed group had significantly lower eGFR at 7 days, 1, and 3 months (adjusted mean differences: − 11.32, − 10.20, − 10.75 mL/min/1.73 m2) and higher cystatin C (0.83, 0.36, 0.36 mg/L). At 1 year, eGFR remained lower (− 7.54 mL/min/1.73 m2, P=0.038) and cystatin C higher (0.40 mg/L, P=0.043) in the exposed group. The 1-year infection rate was higher in the exposed group (80.0% vs 52.3%; adjusted OR=4.27, P< 0.001). The prediction model identified CYP3A5 *3/*3 genotype (HR=2.19), elevated C-reactive protein on day 1 (HR=1.27), and higher weight-adjusted tacrolimus dose (HR=1.58) as key predictors (C-index=0.716; optimism-corrected C-index=0.728).
Conclusion: Early high tacrolimus exposure is associated with impaired renal function and increased infection risk in the first year after transplantation. A prediction model incorporating genetic, inflammatory, and dosing factors could aid in early risk stratification.
Keywords: therapeutic drug monitoring, pharmacogenomics, predictive model, early exposure, risk prediction
1Department of Pharmacy, Nanfang Hospital, Southern Medical University, Guangzhou, People’s Republic of China; 2Clinical Pharmacy Center, Nanfang Hospital, Southern Medical University, Guangzhou, People’s Republic of China; 3Department of Transplantation, Nanfang Hospital, Southern Medical University, Guangzhou, People’s Republic of China; 4Department of Cardiology, Nanfang Hospital, Southern Medical University, Guangzhou, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Yilei Li, Department of Pharmacy, Nanfang Hospital, Southern Medical University, Guangzhou, People’s Republic of China, Email lei@smu.edu.cn Liqian Mo, Department of Pharmacy, Nanfang Hospital, Southern Medical University, Guangzhou, People’s Republic of China, Email moliqian@smu.edu.cn
Purpose: To evaluate the association between early supratherapeutic tacrolimus exposure (trough concentration > 20 ng/mL within the first postoperative week) and graft outcomes in kidney transplant recipients, and to develop a prediction model for this early high exposure.
Patients and Methods: This single-center retrospective cohort study included 210 kidney transplant recipients (105 exposed, 105 non-exposed) after propensity score matching. Renal function (eGFR, cystatin C) and infection rates over the first year were compared using linear mixed-effects models with multiple imputation. A Cox proportional hazards model with LASSO variable selection was developed to predict the risk of high exposure.
Results: The exposed group had significantly lower eGFR at 7 days, 1, and 3 months (adjusted mean differences: − 11.32, − 10.20, − 10.75 mL/min/1.73 m2) and higher cystatin C (0.83, 0.36, 0.36 mg/L). At 1 year, eGFR remained lower (− 7.54 mL/min/1.73 m2, P=0.038) and cystatin C higher (0.40 mg/L, P=0.043) in the exposed group. The 1-year infection rate was higher in the exposed group (80.0% vs 52.3%; adjusted OR=4.27, P< 0.001). The prediction model identified CYP3A5 *3/*3 genotype (HR=2.19), elevated C-reactive protein on day 1 (HR=1.27), and higher weight-adjusted tacrolimus dose (HR=1.58) as key predictors (C-index=0.716; optimism-corrected C-index=0.728).
Conclusion: Early high tacrolimus exposure is associated with impaired renal function and increased infection risk in the first year after transplantation. A prediction model incorporating genetic, inflammatory, and dosing factors could aid in early risk stratification.
Keywords: therapeutic drug monitoring, pharmacogenomics, predictive model, early exposure, risk prediction