Comparison of the Therapeutic Effects Recombinant Human Acidic and Basic Fibroblast Growth Factors in Wound Healing in Diabetic Patients

概要

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To explore an optimal improvement of diabetic wound healing we have comparatively studied the effects of recombinant human acidic and basic fibroblast growth factors (rhaFGF and rhbFGF) on the healing impaired skin wounds in diabetic patients. Before using rhaFGF in diabetic patients, its pharmacokinetic features and possible toxic effects were evaluated using a rabbit model. For the 139 diabetic patients, 25% of them were divided into the group to receive topical rhbFGF daily at the dose of 100 U/0.1 ml/cm^2 as positive control (n = 35), and the remainder to receive topical rhaFGF at the same dose as rhbFGF (n = 104). Pharmacokinetic studies showed that plasma concentration of rhaFGF rapidly increased and reached to peak levels at 0.5 hr and then quickly decreased to normal levels at 3 hr after topical application on the wounds. No detectable toxic effects were found by examining multiple organs of the rabbits at 28 days after applying rhaFGF at 900 U/cm^2. Topical application of either rhbFGF or rhaFGF at 100 U/cm^2 effectively cured the skin wounds in the diabetic patients. Although there was no remarkable difference between groups, rhaFGF provided a slightly better healing rate and efficiency than rhbFGF did. Therefore rhaFGF will become an alternative candidate for diabetic wounds, especially when diabetic wounds were in acidic environment due to bacterial infection.
公益社団法人日本薬学会の論文
2008-08-01