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目的确定中国肿瘤患者静脉滴注重组人类抗血管内皮生长因子单克隆抗体贝伐单抗后的药动学参数。比较中国肿瘤患者与高加索肿瘤患者静脉滴注贝伐单抗的药动学参数。方法本次试验为开放性,3阶段(筛查期,治疗期,随访期)试验。所有受试者根据入组先后依次分配至3个剂量组,分别给予5、10、15mg·kg-1贝伐单抗。每个剂量组均在试验的第1天单剂量静脉滴注贝伐单抗,在随后的20d进行安全性评价。能够耐受第1次静脉滴注的受试者在第22、36、50、64天(5mg.kg-1和10mg·kg-1剂量组),或第22、43、64、85天(15mg·kg-1剂量组)给予相同剂量的贝伐单抗。采用酶联免疫法(ELISA)测定贝伐单抗的血清药物浓度。结果多剂量静脉滴注贝伐单抗(给药间隔为每2周/3周)与其单剂量给药后的药动学参数相似。结论本次试验与在高加索患者中进行的Ⅰ期临床研究观察到的药动学参数相似。
Objective To determine the pharmacokinetic parameters of intravenous infusion of recombinant human anti-vascular endothelial growth factor monoclonal antibody bevacizumab in Chinese cancer patients. The pharmacokinetic parameters of intravenous bevacizumab in Chinese cancer patients and Caucasian cancer patients were compared. Methods This test is open, 3 stages (screening period, treatment period, follow-up period) test. All subjects were assigned to 3 dose groups according to the groups, and were given 5,10,15 mg · kg-1 bevacizumab respectively. Each dose group was given a single intravenous infusion of bevacizumab on the first day of the experiment and a safety evaluation was performed on the next 20 days. Subjects who were able to tolerate the first intravenous drip were on days 22, 36, 50, 64 (5 mg.kg-1 and 10 mg.kg-1 dose groups), or 22, 43, 64, 85 15 mg · kg-1 dose group) were given the same dose of bevacizumab. Serum drug concentrations of bevacizumab were determined by enzyme-linked immunosorbent assay (ELISA). Results Multi-dose intravenous bevacizumab (dosing interval every 2 weeks / 3 weeks) was similar to the pharmacokinetic parameters after single dose administration. Conclusions This trial is similar in pharmacokinetic parameters observed in Phase I clinical studies in Caucasians.