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Long-term toxicity of modified recombinant human tumor necrosis factor in Macaca mulatta
1Centre of New Drug Evaluation, Second Military Medical University, Shanghai, China.
Aim:
To study the long-term toxicity of modified recombinant human tumor necrosis factor (rhTNF-NC) in Macaca mulatta compared with recombinant human tumor necrosis factor (rhTNF).
Methods:
rhTNF-NC 93, 9.3 GU/m2, and rhTNF 62 GU/m2 were injected i.v. daily to 16 Macaca mulatta for 1 month and 10 d, respectively. Hematologic, chemical, urinalysis values, ECG, specific antibody, bone marrow, and pathologic profile of organs were measured.
Results:
No more adverse effects of rhTNF-NC were found in spite of anorexia in 4 monkeys and palpebral edema in 2 monkeys of 93 GU/m2 group. Besides, in rhTNF group, the injury of liver and kidneys, the decrease of erythron, the phlebitis, and thrombosis at injection site occurred. Both drugs caused the production of specific antibody.
Conclusion:
No serious adverse effects of rhTNF-NC were found in Macaca mulatta. The toxicity of rhTNF-NC was much lower than that of rhTNF.