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目的 :研究重组人酸性成纤维细胞生长因子 (rhaFGF)皮肤用药的长期毒性。方法 :对新西兰兔破损皮肤连续给药 2 8d ,剂量分别为 3 60 0 ,180 0 ,90 0U/cm2 ,观察rhaFGF用药期间和停药后对动物血液学、血液生化学、组织学等方面的影响。结果 :rhaFGF的无毒剂量为 90 0U/cm2 ;rhaFGF180 0U/cm2 用药可见个别动物出现淋巴结、脾白髓、圆小囊固有层及胸腺滤泡增生 ;3 60 0U/cm2 用药可见半数以上动物淋巴结出现淋巴等器官滤泡增生 ,偶见大脑血管周围出现少量淋巴细胞浸润 ,个别动物睾丸生精小管精子细胞数量增加。停药 2周 ,上述病理改变减轻。未观察到rhaFGF的延迟性毒性反应。结论 :rhaFGF在有效剂量及大于有效 15倍的剂量下皮肤外用是安全的
OBJECTIVE: To study the long-term toxicity of recombinant human acidic fibroblast growth factor (rhaFGF) to skin. Methods: The damaged skin of New Zealand rabbits was continuously treated for 28 days with dosages of 3 60 0, 180 0 and 90 0 U / cm2 respectively. The effects of rhaFGF on the hematology, blood biochemistry and histology influences. Results: rhaFGF non-toxic dose of 90 0U / cm2; rhaFGF180 0U / cm2 drug can be seen in individual animals showed lymph nodes, splenic white pulp, lamina propria and thymic follicular hyperplasia; 3 60 0U / cm2 medication can be seen in more than half of animal lymph nodes Appear lymphoid follicular hyperplasia and other organs, occasionally seen a small amount of cerebral blood vessels around the infiltration of lymphocytes, individual animal testicular seminiferous tubule sperm cells increased. After stopping for 2 weeks, the above pathological changes were alleviated. No delayed toxic effects of rhaFGF were observed. Conclusions: rhaFGF is safe for topical application at doses greater than 15 times its effective dose