Anti-cicatrix Triamcinolone Acetonide Acetate/Silicong Gel Sheeting: Manufacture And Primary Observation Of Its Effects On Hypertrophic Scar

Scar is the inevitable result of wound healing. Hypertrophic scarring is a pathological phenomenon of excessive repair in tissue after dermal injuries. Because hypertrophic scar (HS) protrudes from normal skin surface, patients suffer from itch,pricking pain,contracture. Those symptoms often affects appearance and functions of patients. Prevention and cure of hypertrophic scarring is a tough and urgent problem to be solved in the field of medcine. HS is the most familiar pathological scar. It is a pathological state which is characterized by proliferation and activation of firbroblast. Much collagen is produced and more extracellar matrix deposit in tissue, which is mainly including ? ? ? type collagen and can not be absorbed by body. It is believed that the formation mechanism of hypertrophic scarring is related to heterogeneity of fibroblast and adjusting abnormality of cytokine. Corticosteroid is one kind of effective drug in the non-surgery therapy of scar now, especially triamcinolone acetonide acetate (TA), which inhibite synthesization of collagen and enhance the activity of collagenase to reduce it. The use method is interlesional injection. But there are a few shortcoming as followings: ①pain;②difussion asymmetry after injection;③now the dosage and use method of TA is difficult to control , total body side effects will appear after long-time use; ④interlesional injection is fit for small area scar, enlarging the injecton area is limited by TA dose for one time. A painless,topical application of minimal dosage is a perfect way to solve such problems. It is proved that silicone gel sheeting(SGS) is able to reduce hypertrophic scarring. In some researches , drug, such as prostaglandin E,antibiotics, is added to SGS to improve livability percent of transplanting flap and be used as anti-infection dressing. It is believed that the added drug can be released slowly from SGS. To combine TA and SGS to make a drug sheeting(TA-SGS) , which is used in scar therapy, is possible. There is no same research now. In order to manufacture TA-SGS and observe its clinic effects on HS, the contents and methods of this study are as followings: 1,to manufacture TA-SGS: ①manufacture;②to detect releasing condition of TA-SGS by using high-performance　liquid　chromatographic　(HPLC)　method;③to detect the transdermal dosage of TA-SGS and finish the manufacture; 2,to study the effects of TA-SGS on hypertrophic scar,fibroblast,collagen deposition,cytokine and their correlation with clinical observation,histomorphology and immunohistochemistry. To primarily evaluate clinical efficacy of this new drug membrane. The main results in the experiment are followings: 1,In 2 weeks study ,when the TA dose in TA-SGS is up to 1.39mg/cm2,the releasing dosage of TA is 0.30-0.40mg/cm2 , the transdermal dosage is 0.20mg/cm2 , which accord with the clinical therapy dose. 2,Research and clinical application showed that TA-SGS is capable of preventing and treating HS effectively and have remarkable effects on softening, thinning and smoothing scar. Histological observation showed that: after application of TA-SGS, the collagen deposition reduced, microcirculation improved, the arrangement of collagen fibers and histological structure of scar transformed to normal. The collagen fiber area density of TA-SGS was lower than the control group and SGS group after 2-3 months. The expression of positive cell of TGF-β1,α-SM actin in scar tissue were significantly decreased more than SGS group. Conclusion: 1,It is proved the TA-SGS is a new combining method to prevent and therapy hypertrophic scarring. By using it , the deficiencies of present clinical application method of TA are made up. Besides being used easily, it combine and enhance the effects of TA and SGS on scar. 2,From a series of TA dosage adding study , it is concluded that C type TA-SGS accords with request of clinical therapy. when the TA dose in TA-SGS is up to about 1.39mg/cm2,the releasing dosage of TA is 0.30-0.40mg/cm2 , the transdermal dosage is 0.20mg/cm2 , which accord with the clinical therapy dose. Drug in the TA-SGS is released slowly to fit for topical application of minimal dosage. The TA dose and using time of TA-SGS can be changed to fit for children scar patients.3,It is showed from study that: after application of TA-SGS, microcirculation improved, the collagen deposition reduced, the arrangement of collagen fibers and histological structure of scar transformed to normal. The expression of positive cell of TGF-β1,α-SM actin in scar tissue were significantly decreased more than SGS group. 4,This study is to observe the effects of TA-SGS on HS, but the further study is needed to observe the effects of TA-SGS on the scar after burn and keloid.