Pharmacopoeias. China includes monographs for recombinant human epidermal growth factor suitable for external use.
Urogastrone is a polypeptide first isolated from human urine. Two forms have been identified, p and y urogastrone. The p form consists of 53 amino acids and is distinguishable from the y form by an additional terminal arginine residue. The p form is reported to be identical to human epidermal growth factor and this term is widely used in the literature.
Urogastrone inhibits gastric acid secretion and has been tried in the treatment of peptic ulcer disease and other gastrointestinal disorders but its rapid destruction in the stomach has limited its clinical use.
It is a potent stimulator of cellular proliferation and has also been used as an aid to wound healing.
Intravenous infusion of urogastrone 250 nanograms/kg over 1 hour has been reported to reduce the secretion of gastric acid in patients with duodenal ulcer or the Zollinger-Ellison syndrome. Ulcer pain was relieved 30 to 60 minutes after the start of the infusion. A dose of 100 nanograms/kg per hour by intravenous infusion has been used with partial success in an infant with microvillous atrophy and was apparently beneficial in an infant with necro-tising enteritis.
Human epidermal growth factor has also shown some promise in the treatment of active ulcerative colitis. In a small study, patients received daily enemas containing either recombinant human epidermal growth factor (5 micrograms in 100 mL) or placebo all patients also received oral mesalazine. Ten of the 12 patients in the urogastrone group were in remission after 2 weeks treatment compared with 1 of the 12 patients in the placebo group, and this benefit was maintained for up to 12 weeks.
For a general discussion of the management of wounds and ulcers.
In a randomised double-blind study in 61 patients with diabetic foot ulcers, adding human epidermal growth factor 0.04% to an ulcer cream containing protein-free bovine blood extract was shown to significantly enhance wound healing and reduce healing time compared with either the cream alone or the cream plus human epidermal growth factor 0.02%. Topical application of recombinant human epidermal growth factor 0.02% has also been reported to reduce pain and promote healing of exfoliated skin lesions in a patient with drug-induced Stevens-Johnson syndrome.
The effect on the rate of wound healing of a cream containing sulfadiazine silver plus recombinant human epidermal growth factor (10 micrograms/mL) was compared with sulfadiazine silver alone in 12 patients each requiring skin grafts at 2 donor sites. The cream containing epidermal growth factor accelerated the rate of epidermal regeneration in all patients and reduced the average time to 100% healing by about 1.5 days. Patients were followed up for a maximum of 1 year after cessation of therapy and no complications or clinical evidence of neoplasia at the healed donor sites occurred.
In contrast, recombinant human epidermal growth factor as an ophthalmic solution containing 30 or 100 micrograms/mL was investigated in patients who had undergone keratoplasty, but the weaker solution had no effect on the rate of re-epithelialisation, and the more concentrated one was actually associated with slower healing.
Chile: FCE; Hebermin.