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已发表论文
伏立康唑初始谷浓度和降钙素原对肝毒性不良事件的预测价值
Authors Chen L, Wang X, Wu X, Qin H, Zhu H
Received 15 August 2025
Accepted for publication 17 November 2025
Published 26 November 2025 Volume 2025:19 Pages 10507—10518
DOI https://doi.org/10.2147/DDDT.S560753
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Professor Anastasios Lymperopoulos
Lijuan Chen,1 Xinwen Wang,1 Xiaoli Wu,1 Haiyan Qin,1 Hongchao Zhu2
1Department of Pharmacy, The Affiliated Huaian No. 1 People’s Hospital of Nanjing Medical University, Huaian, Jiangsu Province, People’s Republic of China; 2Department of Nuclear Medicine, The Affiliated Huaian No. 1 People’s Hospital of Nanjing Medical University, Huaian, Jiangsu Province, People’s Republic of China
Correspondence: Hongchao Zhu, Department of Nuclear Medicine, The Affiliated Huaian No. 1 People’s Hospital of Nanjing Medical University, Huaian, Jiangsu Province, 223300, People’s Republic of China, Email zhuhongchao366@126.com
Purpose: This study aimed to evaluate the predictive value of initial trough concentration (Cmin) of voriconazole (VCZ) and procalcitonin (PCT) in hepatotoxic adverse events.
Patients and Methods: A retrospective analysis was performed on clinical data from 170 patients administered VCZ at our institution between January 2021 and July 2025. Risk factors associated with VCZ-induced hepatotoxicity were identified through binary logistic regression analysis. The diagnostic performance of initial VCZ-Cmin and PCT in predicting hepatotoxicity was evaluated using receiver operating characteristic (ROC) curve analysis.
Results: The mean loading dose of VCZ was 9.48 mg/kg, with a maintenance dose of 6.62 mg/kg, and an average initial Cmin of 5.58 mg/L. Hepatotoxicity was observed in 20.59% (35/170) of patients during the treatment period. Multivariate logistic regression analysis, adjusted for confounding factors including weight, maintenance dose, and proton pump inhibitors use, revealed that elevated initial VCZ-Cmin and high PCT levels were significantly associated with hepatotoxicity. ROC curve analysis identified critical thresholds for hepatotoxicity risk: an initial VCZ-Cmin of 5.035 mg/L (AUC=0.663, P=0.003) and a PCT level of 0.835 ng/mL (AUC=0.754, P< 0.001), the predictive probability of their combination was 0.184 (AUC=0.744, P< 0.001). After grouping according to the threshold level of PCT, there was a significant difference in the initial VCZ-Cmin between patients with high PCT levels and those with low PCT levels (P=0.005).
Conclusion: VCZ-induced hepatotoxicity is the common adverse reaction, exhibiting significant associations with elevated initial VCZ-Cmin and increased PCT levels. Both the initial VCZ-Cmin and PCT levels are independent risk factors, and either alone or in combination can predict the occurrence of hepatotoxicity. Among these, PCT levels have the most significant predictive value.
Keywords: voriconazole, initial trough concentration, procalcitonin, hepatotoxicity, therapeutic drug monitoring
1Department of Pharmacy, The Affiliated Huaian No. 1 People’s Hospital of Nanjing Medical University, Huaian, Jiangsu Province, People’s Republic of China; 2Department of Nuclear Medicine, The Affiliated Huaian No. 1 People’s Hospital of Nanjing Medical University, Huaian, Jiangsu Province, People’s Republic of China
Correspondence: Hongchao Zhu, Department of Nuclear Medicine, The Affiliated Huaian No. 1 People’s Hospital of Nanjing Medical University, Huaian, Jiangsu Province, 223300, People’s Republic of China, Email zhuhongchao366@126.com
Purpose: This study aimed to evaluate the predictive value of initial trough concentration (Cmin) of voriconazole (VCZ) and procalcitonin (PCT) in hepatotoxic adverse events.
Patients and Methods: A retrospective analysis was performed on clinical data from 170 patients administered VCZ at our institution between January 2021 and July 2025. Risk factors associated with VCZ-induced hepatotoxicity were identified through binary logistic regression analysis. The diagnostic performance of initial VCZ-Cmin and PCT in predicting hepatotoxicity was evaluated using receiver operating characteristic (ROC) curve analysis.
Results: The mean loading dose of VCZ was 9.48 mg/kg, with a maintenance dose of 6.62 mg/kg, and an average initial Cmin of 5.58 mg/L. Hepatotoxicity was observed in 20.59% (35/170) of patients during the treatment period. Multivariate logistic regression analysis, adjusted for confounding factors including weight, maintenance dose, and proton pump inhibitors use, revealed that elevated initial VCZ-Cmin and high PCT levels were significantly associated with hepatotoxicity. ROC curve analysis identified critical thresholds for hepatotoxicity risk: an initial VCZ-Cmin of 5.035 mg/L (AUC=0.663, P=0.003) and a PCT level of 0.835 ng/mL (AUC=0.754, P< 0.001), the predictive probability of their combination was 0.184 (AUC=0.744, P< 0.001). After grouping according to the threshold level of PCT, there was a significant difference in the initial VCZ-Cmin between patients with high PCT levels and those with low PCT levels (P=0.005).
Conclusion: VCZ-induced hepatotoxicity is the common adverse reaction, exhibiting significant associations with elevated initial VCZ-Cmin and increased PCT levels. Both the initial VCZ-Cmin and PCT levels are independent risk factors, and either alone or in combination can predict the occurrence of hepatotoxicity. Among these, PCT levels have the most significant predictive value.
Keywords: voriconazole, initial trough concentration, procalcitonin, hepatotoxicity, therapeutic drug monitoring