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
黄英，万永玲，高洪志，吕焕章，吴德政
(北京市北太平路医院临床药理科， 北京 100039)
[摘要] 目的：观察重组人肿瘤坏死因子(rhTNF-NC)在肿瘤患者体内的药代动力学特点。方法：入选9例患者，单剂量静脉注射rhTNF-NC 1.0´106 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(2.273±3.549)ng.L-1,AUC(0~t)为(71.43±82.41)ng.min.L-1, t1/2a为(1.62±1.65)min，t1/2b为(60.94±50.60)min。Cl为(11.22±12.20)L.min-1。结论：本品在不同患者之间药代动力学参数个体差异较大，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。
[关键词] 重组人肿瘤坏死因子；药代动力学；酶联免疫反应
, 百拇医药
[中图分类号]R730.3 [文献标识码]A [文章编码]1003-3734(2001)
Pharmacokinetics of recombinant human tumor necrosis factor in patients with cancer
HUANG ying,WAN Yong-ling, GAO Hong-zhi ,LV Huang-zhang, Wu De-zheng
(Department of Clinical pharmacology ,Beijing North Taiping Road Hospital, Beijing 100039,China)
[Abstract] Objiective:To investigate the pharmacokinetics of recombinant human tumor necrosis factor (rhTNF-NC) in patients with cancer . Methods:9 patients were enrolled for 1.0´104 IU.m-2.d-1rhTNF-NC for one day. The concentration in plasma were determined by Enyme-linked immuosorbent assay(ELISA). Results: The results showed that concentration-time curves of rhTNF-NC fitted to a two-compartment open model.The main pharmacokinetics parameters were as follows :Cmax=(2.273±3.549)pg.L1, AUC(0~t)=(71.43±82.41) pg.min-1,t1/2a=(1.62±1.65)min,t1/2b=(60.94±50.60)min.Cl=(11.22±12.20)L.min-1.Conclusion: There were significant differencs of pharmacolineties for rhTNF-NC among individuals, which suggested that the dose and interval of administration should be adjusted as the pharmacokinetics of each patient.
, 百拇医药
[Key Words] rhTNF-NC; pharmacokinetics; ELISA
[作者简介]黄 英(1970—)，女，实验师，主要从事药效学与药代动力学研究。联系电话：(010)66874965。
[参考文献]
[1] Chai BX,Tang ZM, Liu XW, et al.Tissue distribution of recombinant human tumor necrosis factor alpha derivative in mice[J].Acta Pharmacol Sina, 1999 ,20(4):371-374.
[2] Fung KP, Lam WP, Choy YM.Human tumour necrosis factor-alpha inhibits glucose transport in culturedEhrlich ascites tumour cells[J].Life Sci, 1995,57(1): PL1-6.
[3] Pessina GP, Paulesu L, Corradeschi F,et al. Bocci V.Pharmacokinetics and catabolism of tumor necrosis factor-alpha in rat lungs[J]. Immunopharmacology, 1995, 29(3):245-50., 百拇医药
(北京市北太平路医院临床药理科， 北京 100039)
[摘要] 目的：观察重组人肿瘤坏死因子(rhTNF-NC)在肿瘤患者体内的药代动力学特点。方法：入选9例患者，单剂量静脉注射rhTNF-NC 1.0´106 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(2.273±3.549)ng.L-1,AUC(0~t)为(71.43±82.41)ng.min.L-1, t1/2a为(1.62±1.65)min，t1/2b为(60.94±50.60)min。Cl为(11.22±12.20)L.min-1。结论：本品在不同患者之间药代动力学参数个体差异较大，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。
[关键词] 重组人肿瘤坏死因子；药代动力学；酶联免疫反应
, 百拇医药
[中图分类号]R730.3 [文献标识码]A [文章编码]1003-3734(2001)
Pharmacokinetics of recombinant human tumor necrosis factor in patients with cancer
HUANG ying,WAN Yong-ling, GAO Hong-zhi ,LV Huang-zhang, Wu De-zheng
(Department of Clinical pharmacology ,Beijing North Taiping Road Hospital, Beijing 100039,China)
[Abstract] Objiective:To investigate the pharmacokinetics of recombinant human tumor necrosis factor (rhTNF-NC) in patients with cancer . Methods:9 patients were enrolled for 1.0´104 IU.m-2.d-1rhTNF-NC for one day. The concentration in plasma were determined by Enyme-linked immuosorbent assay(ELISA). Results: The results showed that concentration-time curves of rhTNF-NC fitted to a two-compartment open model.The main pharmacokinetics parameters were as follows :Cmax=(2.273±3.549)pg.L1, AUC(0~t)=(71.43±82.41) pg.min-1,t1/2a=(1.62±1.65)min,t1/2b=(60.94±50.60)min.Cl=(11.22±12.20)L.min-1.Conclusion: There were significant differencs of pharmacolineties for rhTNF-NC among individuals, which suggested that the dose and interval of administration should be adjusted as the pharmacokinetics of each patient.
, 百拇医药
[Key Words] rhTNF-NC; pharmacokinetics; ELISA
[作者简介]黄 英(1970—)，女，实验师，主要从事药效学与药代动力学研究。联系电话：(010)66874965。
[参考文献]
[1] Chai BX,Tang ZM, Liu XW, et al.Tissue distribution of recombinant human tumor necrosis factor alpha derivative in mice[J].Acta Pharmacol Sina, 1999 ,20(4):371-374.
[2] Fung KP, Lam WP, Choy YM.Human tumour necrosis factor-alpha inhibits glucose transport in culturedEhrlich ascites tumour cells[J].Life Sci, 1995,57(1): PL1-6.
[3] Pessina GP, Paulesu L, Corradeschi F,et al. Bocci V.Pharmacokinetics and catabolism of tumor necrosis factor-alpha in rat lungs[J]. Immunopharmacology, 1995, 29(3):245-50., 百拇医药