Abstract:

Objective To evaluate the efficacy and safety of triethanolamine cream in the treatment of skin ulcer. Methods A multicenter, single-blind, randomized, positive-control study was conducted. One-hundred and twenty patients aging 18－65 years with skin ulcer were randomly classified into the test and control group at a ratio of 2︰1 to be treated with triethanolamine cream and recombinant bovine basic fibroblast growth factor gel respectively for 4 weeks. The healing rate of ulcer, granulation tissue production rate and epithelialization rate were calculated. Results After the beginning of treatment, the condition of all patients was improved with time. In total, 76 out of 80 triethanolamine-treated patients and 38 out of 40 basic fibroblast growth factor gel-treated patients completed the 4-week trial. Significant differences were observed in the healing rate of ulcer, epithelialization rate and granulation tissue production rate between the test and control group （71.05% vs. 34.21%, P = 0.0002; 85% vs. 50%, P = 0.0001; 66.25% vs. 37.5%, P = 0.0035）. No adverse events occurred in any of the patients. Conclusions Triethanolamine cream seems superior to recombinant bovine basic fibroblast growth factor gel with regard to the healing rate of ulcer, epithelialization rate and granulation tissue production rate, and may be a promising drug for the treatment of skin ulcer.

Key words: Key words: skin, ulcer, triethanolamine, recombinant bovine basic fibroblast growth factor