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Carswell等1975年曾报道用BCG致敏的小鼠经内毒素刺激,在其血清中产生一种可引起其它动物肿瘤坏死的因子,此因子被命名为肿瘤坏死因子(TNF).最近人体TNF基因已被克隆,并表达于大肠杆菌(E coli).基于此物质在动物中具有强的选择性抗肿瘤活性,1985年开始对临床Ⅰ期进行了试验.用于此项研究的重组人体肿瘤坏死因子(rH-TNF)是来源于E coli的人体蛋白,对某些类型的肿瘤有明显的细胞毒作用,但对正常人二倍体细胞在体外无任何毒性作用.本文对29名患者进行了临床Ⅰ期试验及药代动力学研究.患者共接受1～48×10~4
Carswell et al. Reported in 1975 that mice sensitized with BCG were stimulated with endotoxin and produced in their serum a factor that causes tumor necrosis in other animals, which is termed tumor necrosis factor (TNF). Recently, the human TNF gene Has been cloned and expressed in E. coli Based on its strong selective antitumor activity in animals, clinical Phase I trials were initiated in 1985. Recombinant human tumor necrosis used in this study Factor (rH-TNF) is a human protein derived from E. coli that has significant cytotoxic effects on certain types of tumors but has no toxic effect on normal human diploid cells in vitro. In this paper, 29 patients Phase Ⅰ clinical trials and pharmacokinetic studies in patients with a total of 1 ~ 48 × 10 ~ 4