重组人酸性成纤维细胞生长因子皮肤用药的长期毒性研究  

Study on Long-term Toxicity of Recombinant Human Acidic Fibroblast Growth Factor in Rabbits

作　　者：许华[1] 李校堃[1] 郑青[1] 杨晓明[1] 黄亚东[1] 赵文[1] 姚成灿[1] 吴晓萍[1] 黄芝瑛[2] 

机构地区：[1]暨南大学药学院医药生物技术研究开发中心,广州510632 [2]广州市医药工业研究所,广州510240

出　　处：《中国药科大学学报》2003年第1期46-50,共5页Journal of China Pharmaceutical University

基　　金：国家高技术研究发展计划 (十五 863)项目 (编号 2 0 0 1AA2 15 131)~~

摘　　要：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AIM:To investigate the long tern toxicity of recombinant human acidic fibroblast growth factor (rhaFGF) in rabbits.METHOD:The long term toxicity was tested in rabbits by daubed rhaFGF to scathe skin at the dose of 3600,1800,900 U/cm 2 respectively, once daily for 28 successive days. The hematological, blood biochemical, pathological examination and so on were conducted at 28 days after treatment or at 14 days after stopping administration. RESULT:No abnormal hematological, blood biochemical, pathological index were found in the group of 900 U/ cm 2. The hyperplasia of lymph gland, splenic white pulp, lamina propria of roundlet vesicular organ,and thymus follicles could be observed in a few of rabbits in the group of 1800 U/cm 2. In the group of 3600 U/cm 2, the hyperplasia above mentioned was observed in moiety rabbits, lymphocyte infiltration all round the brain blood could be seen occasionally, and the count of seminiferous tubule testis increased in a modicum of rabbits. The pathologic changes above mentioned were lessenod after stopping treatment of two weeks. The postpone toxic reaction of rhaFGF was not observed. CONCLUSION:rhaFGF used by skin administration at the dose of efficacy and at the most 15 fold of effective dose is safe.

关 键 词：重组人酸性成纤维细胞生长因子 皮肤用药 长期毒性 

分 类 号：R99[医药卫生—毒理学]