重组人肿瘤坏死因子-NC在肿瘤患者体内的药代动力学研究

The pharmacokinetics of recombinant human tumor necrosis factor in patients with cancer

目的 :研究重组人肿瘤坏死因子 (rhTNF NC)在肿瘤患者体内的药代动力学。方法 :入选 9例患者 ,单剂量静脉注射rhTNF NC 1.0× 10 6 IU·m- 2 。应用酶联免疫反应 (ELISA)检测rhTNF NC的血药浓度。结果 :rhTNF NC的量 时曲线符合二室模型。主要的药代动力学参数如下 :Cmax 为 (2 .2 73± 3.5 4 9)ng·L- 1 ,AUC( 0～t) 为(71.4 3± 82 .4 1)ng·min·L- 1 ,t1 2 α为 (1.6 2± 1.6 5 )min ,t1 2 β为 (6 0 .94± 5 0 .6 0 )min。Cl为 (11.2 2± 12 .2 0 )L·min- 1 。结论 :本品药代动力学参数的个体差异较大 ,不同患者应根据药代动力学特性调整给药剂量和间隔时间。

Objective:To investigate the pharmacokinetics of recombinant human tumor necrosis factor (rhTNF NC) in patients with cancer.Methods:9 patients were administered inravenously 1.0×10 6 IU·m -2 rhTNF NC.The concentration in plasma were determined by Enzyme linked immuosorbent assay(ELISA).Results:The concentration time curves of rhTNF NC fitted to a two compartment open model.The main pharmacokinetics parameters were as follows: C max (2.273±3.549) ng·L -1 , AUC (0～t) (71.43±82.41) ng·min -1 , t 1/2 α(1.62±1.65)min, t 1/2 β (60.94± 50.60)min, Cl (11.22±12.20)L·min -1 .Conclusion:There were significant differences in pharmacokinetics of rhTNF NC among individuals,which suggested that the dose and interval of administration should be adjusted as the pharmacokinetics of each patient.