OBJECTIVETo explore the bio-inductive effects of inorganic elements (Dermlin) on the human epithelial proliferation and differentiation and their promoting effects on skin wound healing.

METHODS1 ). Cellular test: Normal human skin epithelial cells were cultured with 20 g/L Dermlin supplemented culture medium (E group) and regular culture medium (C group), respectively. The cell proliferation rate and the expressions of type IV collagen and epidermal growth factor (EGF) in the supernatant were determined in 12 and 20 post culture days (PCD). (2). Animal test: Self-consubstantiality control was employed in the study. Sixty Sprague - Dawley rats were inflicted with two symmetric 10% TBSA of superficial or deep partial thickness scald on the back of each rat, and were divided into control[ C, with topical application of silver sulfadiazine (SD - Ag) cream to the wounds] and treatment (T, with 1 g/100 cm2 Dermlin topical application to the wounds) groups. The pathological changes in wound skin were observed and the wound healing rate was calculated on 3, 5, 7, 10, 14 and 18 post treatment day (PTD). (3). Randomized, double-blinded and consubstantiality control method was employed in the clinical trial. Ninety patients were enrolled in the clinical study, among them 30 cases with 60 donor site wounds, 30 with 60 superficial and 30 with 60 deep partial thickness burn wounds were included. Dermlin in dose of 1 g/100 cm2 was applied to the wounds in T group and SD - Ag cream in C group for up to 18 days. Furthermore, sixty patients with diabetic foot ulcers were included for 1 g/100 cm2 Dermlin treatment. The wound healing rate was observed. And the blood and urine test and the indices of hepatic and renal function were determined.

RESULTS1). Cellular test: The cell proliferation rate and the expression of type IV collagen and EGF in the culture supernatant were obviously higher than those in control group at the same time points (P < 0.01). 2). Animal test: Hyperplastic granulation tissue occurred in the rat wound in the T group since 5 PTD, while that occurred in the C group since 7 PTD. The healing rate of superficial thickness wound in T group on 7, 10, 14 PTD, and that of deep partial thickness wound in T group on 5, 10, 18 PTD were obviously higher than that in the C group (P <0.05). 3). Clinical study indicated that the wound healing rate of the patients with superficial or deep partial thickness scald in the T group was evidently higher than that in the C group on 5 and 10 PTD (P <0.05), but the wound healing time of the superficial, deep partial thickness wound and donor site wound in the T group was significantly shorter than that in the C group (P < 0.05). Before treatment, the square of the ulcers on the foot of the patients with diabetic was (39 +/- 28) cm2, and it was reduced to (19 +/- 23) cm2 2 weeks later, with the therapeutic efficacy reaching 62.5% . For all patients, no obvious change was found in the blood test and hepatic and renal function indices.

CONCLUSIONThe inorganic element (Dermlin) is beneficial to wound healing and to the proliferation and differentiation of epithelial cells.