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目的 研究一种新型基因工程人肿瘤坏死因子－α（ｎｒｈＴＮＦ－α）的临床前药理、毒理和药代动力学特性。方法观察ｎｒｈＴＮＦ－α对动物移植性肿瘤的抑制作用、毒副作用（如急性中毒反应和死亡情况，过敏反应，以及对神经系统、呼吸系统、心血管系统、造血系统和免疫系统的影响）及药代动力学变化。结果ｎｒｈＴＮＦ－α具有明显的抑瘤作用且呈剂量依赖性。对动物的急性中毒表现及病理变化与ｒｈＴＮＦ－α相似，未见其他不良反应。结论ｎｒｈＴＮＦ－α的抑瘤作用明显，毒副反应低，具有良好的临床应用前景。
Objective To study the preclinical pharmacological, toxicological and pharmacokinetic properties of a novel recombinant human tumor necrosis factor-α (nrhTNF-α). Methods To observe the inhibitory effect of nrhTNF-α on the transplanted tumor of animals, the toxic and side effects (such as acute poisoning and death, allergic reaction, and effects on the nervous system, respiratory system, cardiovascular system, hematopoietic system and immune system) and drugs Dynamic changes. Results nrhTNF-α had obvious anti-tumor effect in a dose-dependent manner. Acute poisoning of animals and pathological changes and rhTNF-α similar, no other adverse reactions. Conclusion nrhTNF-α has obvious anti-tumor effect, low toxicity and good clinical application prospect.