【摘要】 目的动态监测鼠抗人T淋巴细胞CD25抗原单克隆抗体(WuTac)在健康人中与CD25抗原结合的饱和度及其对外周血淋巴细胞亚群的影响,评价WuTac临床应用的安全性,并预测其有效性。方法静脉恒速滴注WuTac0.05、0.1、0.2mg/kg,在用药前和停药后的1、24和72h经肘静脉采血,通过流式细胞术动态监测T淋巴细胞亚群及与CD25抗原结合的饱和度。结果不同剂量组的T淋巴细胞亚群用药前后差异均无统计学意义;停药后1h开始,CD25+淋巴细胞的比例明显降低,且一直持续至停药后72h,CD25+淋巴细胞的比例均明显低于用药前。不同剂量组的CD25抗原的饱和度均达96%以上。结论WuTac单抗用药后,对健康人T淋巴细胞亚群均无影响,能迅速与CD25高效结合,持续时间72h以上,为其Ⅱ、Ⅲ期临床研究奠定了基础。更多还原

【Abstract】 Objective To monitor the binding saturation of mouse-derived McAb WuTac against human T lymphocyte CD25 to CD25 antigen in healthy persons as well as its effect on peripheral blood lymphocyte subsets, evaluate the safety and predict the effectiveness of WuTac in clinic. Methods Thirty-six healthy volunteers were divided into three groups and injected with WuTac at dosages of 0. 05, 0. 1 and 0. 2 mg / kg body weight respectively by intravenous drip within 60 min at a constant rate, and their venous blood samples were collected before injection and 1, 24 and 72 h after withdrawal of injection for dynamic monitoring of T lymphocyte subset and binding saturation to CD25 antigen by flow cytometry. Results The T lymphocyte subsets before and after injection showed no significant difference in various groups. The percentage of CD25+ lymphocytes decreased significantly staring from 1 h until 72 h after withdrawal of injection, which was significantly lower than that before injection. All the binding saturations of WuTac to CD25 antigen in various groups were more than 96%. Conclusion WuTac showed no significant effect on T lymphocyte subsets of healthy persons, and bound to CD25 rapidly and effectively, which maintained for more than 72 h. It laid a foundation of phases Ⅱ and Ⅲ of clinical trial of WuTac.更多还原