无机活性元素对皮肤创面愈合的生物诱导作用

目的观察并论证无机活性元素(商品名德莫林)对上皮细胞增殖、分化的诱导作用以及对皮肤创面愈合的促进作用。方法(1)细胞实验:将正常人皮肤上皮细胞分为实验组(培养液中含20g/L德莫林)和对照组(常规培养)。培养12、20d时检测两组细胞的增殖倍数以及培养上清液中Ⅳ型胶原和表皮生长因子(EGF)的含量。(2)动物实验:在60只SD大鼠背部制作对称性的10%TBSA浅Ⅱ、深Ⅱ度烫伤创面(各30只60个)。采用自身同体对照法,治疗组创面用1g/100cm2德莫林治疗,对照组创面常规涂抹磺胺嘧啶银(SD-Ag)冷霜。观察治疗3、5、7、10、14、18d时创面皮肤的病理学改变并计算创面愈合率。(3)临床应用:采用随机、双盲、同体对照法,选择浅Ⅱ、深Ⅱ度烧伤创面和供皮区创面各30例60个,治疗组创面用1g/100cm2德莫林治疗,对照组创面常规应用碘伏或SD-Ag冷霜。另对60例糖尿病足部溃疡创面应用同剂量德莫林。观察各创面的愈合情况,检测患者血、尿常规及肝、肾功能等指标有无改变。结果(1)细胞实验:培养12、20d时,实验组细胞的增殖倍数及培养上清液中Ⅳ型胶原、EGF的含量均明显高于对照组(P<0.01).(2)动物实验:浅Ⅱ、深Ⅱ度治疗组创面肉芽组织增生或上皮覆盖的时间均明显早于同深度对照组创面。浅Ⅱ度治疗组创面伤后7、10、14d的愈合率以及深Ⅱ度治疗组创面伤后5、10、18d的愈合率均明显高于同深度对照组创面(P<0.05).(3)临床应用:浅Ⅱ、深Ⅱ度治疗组创面治疗5、10d时的创面愈合率均明显高于同深度对照组创面(P<0.05),其创面愈合时间以及供皮区治疗组创面愈合时间均早于各自的对照组创面(P<0.05).60例糖尿病足患者治疗前足部溃疡面积为(39±28)cm2,治疗2周后缩小为(19±23)cm2,总有效率达62.5%。各患者治疗前后血常规及肝、肾功能等指标无明显改变。结论无机活性元素对上皮细胞的增殖、分化及创面愈合有明显的促进作用。

Bio-inductive effects of inorganic elements on skin wound healing

OBJECTIVE: To explore the bio-inductive effects of inorganic elements (Dermlin) on the human epithelial proliferation and differentiation and their promoting effects on skin wound healing. METHODS: 1 ). 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. RESULTS: 1). 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. CONCLUSION: The inorganic element (Dermlin) is beneficial to wound healing and to the proliferation and differentiation of epithelial cells.