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目的 评估治疗药物监测平台中5个英夫利西单抗模型用于预测克罗恩病患者英夫利西单抗谷浓度的准确性。方法 纳入2023年10月至2025年3月使用英夫利西单抗进行诱导治疗的36例克罗恩病病例为研究对象。基于首次给药后第2周和/或第2次给药后第4周的英夫利西单抗谷浓度，评估治疗药物监测平台中的5个英夫利西单抗模型(Aubourg 2015、Ternant 2008、Passot2016、Dreesen 2021和权重模型)预测第3次给药后第8周英夫利西单抗谷浓度的准确性。结果 基于首次给药后第2周的谷浓度，预测误差在±30%内的病例占比(F30)最高、预测误差中位数最低、预测浓度与实测浓度差距在±1μg·mL-1内的病例占比最高的模型均为Aubourg 2015，分别为56.67%,-3.12%和43.33%。基于第2次给药后第4周谷浓度，F30较高的模型为权重模型和Passot 2016(均为66.67%)、Aubourg 2015和Ternant 2008(均占58.33%)，预测误差中位数较低的模型为权重模型(4.81%)和Aubourg 2015(-13.36%)，预测浓度与实测浓度差距在±1μg·mL-1内的病例占比较高的模型为Aubourg 2015和Passot 2016(均占50.00%)。基于首次给药后第2周及第2次给药后第4周谷浓度，F30最高的模型为Aubourg 2015和Passot 2016(均占65.22%)，预测误差中位数最低的模型为Aubourg 2015(-8.52%)，预测浓度与实测浓度差距在±1μg·mL-1内的病例占比较高的模型为Passot2016(占52.17%)和Aubourg 2015(占47.83%)。结论 基于第2次英夫利西单抗给药后第4周谷浓度预测第3次给药后第8周谷浓度，Aubourg 2015和权重模型是预测效能较高的模型，临床可接受。
Abstract：AIM To evaluate the predictive accuracy of 5 infliximab population pharmacokinetic models in the therepeutic drug monitoring platform for predicting infliximab trough concentrations in patients with Crohn disease. METHODS A total of 36 patients with Crohn disease in the induction remission phase who received infliximab treatment from October 2023 to March 2025 were enrolled. The predictive accuracy of the 5 infliximab models in TDMx(Aubourg 2015, Ternant 2008, Passot 2016, Dreesen 2021, and Model average) was evaluted by calculating the difference between the measured and predicted concentrations at the 8 th week after the third infusion, based on the trough concentrations at the 2 nd week after the first infusion and/or the 4 th week after the second infusion. RESULTS Based on the trough concentrations at the 2 nd week after the first infusion, the Aubourg model achieved the highest proportion of predictions within ±30% of the observed values(F30: 56.67%), the lowest median prediction error(MDPE:-3.12%) and the highest proportion of predictions within ± 1 μg·mL-1 of the measured values(43.33%). Based on the trough concentration at the 4 th week after the second infusion, the models achieving a higher proportion of F30 in descending order were Model average and Passot 2016(both at 66.67%), followed by Aubourg 2015 and Ternant 2008(both at 58.33%). The models with the lowest MDPE were Model average(4.81%) and Aubourg 2015(-13.36%). The models with the highest proportion of predicted values within ± 1 μg·mL-1 of the measured values were Aubourg 2015 and Passot 2016(both at 50.00%). Based on the trough concentrations at the 2 nd week after the first infusion and the 4 th week after the second infusion, the models with the highest F30 proportion were Aubourg 2015 and Passot 2016(both at 65.22%). The model with the lowest MDPE was Aubourg 2015(-8.52%). The models with a relatively high proportion of predicted values within ±1 μg·mL-1 of the measured values were Passot 2016(52.17%) and Aubourg 2015(47.83%). CONCLUSION Based on the trough concentration at the 4 th week after the second infusion of inftiximab, Aubourg 2015 and Model average are considered clinically acceptable for estimating the trough concentration at the 8 th week after the third infusion.
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基本信息:
DOI：10.19577/j.1007-4406.2026.03.004
中图分类号:R969.1
引用信息:
[1]李玉,王燕,周丹丽,等.治疗药物监测平台预测克罗恩病患者英夫利西单抗谷浓度的准确性评估[J].中国临床药学杂志,2026,35(03):212-216.DOI:10.19577/j.1007-4406.2026.03.004.
基金信息:
江苏省研究型医院学会精益化用药科研基金资助（编号SYHKJ-JY-2025-40）; 无锡市科学技术协会2025立项课题（编号KX-25-212）; 无锡市儿童医院博士科研启动基金（编号2023BSQD-ZKZ）; 无锡市卫健委青年项目（编号Q202162）