Abstract: AIM: To investigate the therapeutic effects of recombinant human basic fibroblast growth factor (rh-bFGF) on duodenal ulcers in rats and to evaluate its preclinical safety. METHODS: The duodenal ulcer was induced by cysteamine s. c. in rats. The acute and chronic toxicity was observed in mice and Beagle dogs. The chronic toxicity was investigated in rats and Beagle dogs for 90 days. RESULTS: In rats treated by rh-bFGF, the area of duodenal ulcerwas reduced, and the proliferation velocity of surface glandular epithelium of duodenal ulcer was increased significantly compared with that of control group. The ulcers entirely covered by epithelium were nearly 60 % in rh-bFGF treated groups as contrast to 13 % in famotidine group. The maximum tolerable dose of mice or Beagle dogs was more than 2 ×10⁶AU/kg or 3.5 ×10⁵AU/kg when rh-bFGF was given intravenously or orally, which was 4167 or 729 times of clinic dose, respectively. After treatment with rh-bFGF by mouth for 90 days, the appearance, general behavior, growth and development of rats and Beagle dogs were not affected. And the hematological and blood biochemical indices in rh-bFGF treated group had no obvious difference compared with those of control group. It also did not affect the haematogenesis function of bone marrow in rats and dogs. And the pathohistological change was not found in all organs of dogs and rats. CONCLUSION: The rh-bFGF obviously promotes the ulcer healing as well as glandular epithelium reconstruction of duodenal ulcers in rats. And there is no obviously acute and chronic toxicity reaction during this experiment.

Key words: basic fibroblast growth factor, duodenal ulcer, Beagle dogs, rats, toxicity