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目的应用两点法估算环孢素A患者的血药浓度,制定个体化给药方案。方法研究对象为肾移植患者32例,干细胞移植患者8例;男性26例,女性14例;年龄26～65岁,平均年龄(42.4±11.1)岁;体质量45～72 kg,平均体质量(59.2±7.6)kg;给药剂量(3.42±1.11)mg.kg-.1d-1。患者的肝、肾功能均正常。用荧光偏振免疫分析法测定40例器官移植患者环孢素A的2个不同稳态谷浓度。用米-曼氏模型拟合药动学参数Vm与Km,估算环孢素A的血药浓度(目标浓度),并与实测值进行比较。结果药动学参数Vm为(463±87)mL,Km为(147±16)mg.L-1。实测血药浓度值与估算血药浓度值之间无显著性差异(P>0.05)。结论利用两点法估算环孢素A的血药浓度与实测血药浓度相近,可用于预测血药浓度及优化个体化给药方案。
Objective To estimate the plasma concentration of cyclosporin A by two-point method and to develop a personalized drug delivery regimen. Methods: The subjects were 32 renal transplant recipients and 8 stem cell transplant recipients. There were 26 males and 14 females, aged from 26 to 65 years with an average age of (42.4 ± 11.1) years. The body weight was 45 to 72 kg, mean body mass 59.2 ± 7.6) kg; the dose (3.42 ± 1.11) mg.kg-.1d-1. Patients with liver and kidney function are normal. Fluorescence polarization immunoassay was used to determine the two different steady state trough concentrations of cyclosporin A in 40 patients with organ transplantation. The pharmacokinetic parameters, Vm and Km, were fitted using the Michelson model to estimate the plasma concentration of cyclosporin A (target concentration) and compared with the measured values. Results Pharmacokinetic parameters Vm was (463 ± 87) mL and Km was (147 ± 16) mg.L-1. There was no significant difference between the measured plasma concentration and the estimated plasma concentration (P> 0.05). Conclusion The two-point method for the determination of cyclosporin A blood concentration and the measured plasma concentration is similar, can be used to predict plasma concentration and optimize individualized dosing regimen.