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首页> 外文期刊>Journal of Pharmacy and Pharmaceutical Sciences >Mining Small Routine Clinical Data: A Population Pharmacokinetic Model and Optimal Sampling Times of Capecitabine and its Metabolites
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Mining Small Routine Clinical Data: A Population Pharmacokinetic Model and Optimal Sampling Times of Capecitabine and its Metabolites

机译：小型常规临床数据的挖掘：卡培他滨及其代谢物的种群药代动力学模型和最佳采样时间

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Abstract Purpose : The present study was performed to demonstrate that small amounts of routine clinical data allow to generate valuable knowledge. Concretely, the aims of this research were to build a joint population pharmacokinetic model for capecitabine and three of its metabolites (5-DFUR, 5-FU and 5-FUH2) and to determine optimal sampling times for therapeutic drug monitoring. Methods: We used data of 7 treatment cycles of capecitabine in patients with metastatic colorectal cancer. The population pharmacokinetic model was built as a multicompartmental model using NONMEM and was internally validated by visual predictive check. Optimal sampling times were estimated using PFIM 4.0 following D-optimality criterion. Results: The final model was a multicompartmental model which represented the sequential transformations from capecitabine to its metabolites 5-DFUR, 5-FU and 5-FUH2 and was correctly validated. The optimal sampling times were 0.546, 0.892, 1.562, 4.736 and 8 hours after the administration of the drug. For its correct implementation in clinical practice, the values were rounded to 0.5, 1, 1.5, 5 and 8 hours after the administration of the drug. Conclusions: Capecitabine, 5-DFUR, 5-FU and 5-FUH2 can be correctly described by the joint multicompartmental model presented in this work. The aforementioned times are optimal to maximize the information of samples. Useful knowledge can be obtained for clinical practice from small databases.
机译：摘要目的：本研究旨在证明少量常规临床数据可产生有价值的知识。具体而言，本研究的目的是建立卡培他滨及其三种代谢物（5-DFUR，5-FU和5-FUH2）的联合种群药代动力学模型，并确定用于治疗药物监测的最佳采样时间。方法：我们使用了卡培他滨治疗转移性大肠癌患者的七个治疗周期的数据。使用NONMEM将群体药代动力学模型构建为多室模型，并通过视觉预测检查进行了内部验证。遵循D优化准则，使用PFIM 4.0估算了最佳采样时间。结果：最终模型是一个多室模型，代表了从卡培他滨到其代谢物5-DFUR，5-FU和5-FUH2的顺序转化，并得到了正确验证。给药后的最佳采样时间为0.546、0.892、1.562、4.736和8小时。为了在临床实践中正确实施，在给药后将值四舍五入到0.5、1、1.5、5和8小时。结论：卡培他滨，5-DFUR，5-FU和5-FUH2可以通过本研究提出的联合多室模型正确描述。前述时间是最佳的以最大化样本信息。可以从小型数据库中获得有用的知识以用于临床实践。

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