| Objective: In order to observe the treatment effect of TSQBG on Melasma and to explore the treatment mechanism, and to provide scientific basis for clinical application of TSQBG.Methods: Including two parts. The clinical study was done in part one : 66 cases with melasma were divided randomly into the test group treated with TSQBG and the control group treated with SJG. The survey was conducted on clinical effect after a period of therapy. The experimental studies were done in part two : the first, the experiment of the inhibition effects of TSQBG on the activities of mushroom tyrosinase in vitro was done, tyrosinase activities were determined by the dopachrome method using L-Dopa as the substrate and the amount of dopachrome in the reaction mixture was measured as absorbance; the second, the experiment of the biological effects of TSQBG on melanocytes was done, cytology,enzymology and seropharmacological methods were used, the intervention of TSQBG medicated serum on the cell proliferation, melanin content and tyrosinase activity of melanocytes after UVA radiation in vitro were observed, the primary cultured human skin melanocytes from foreskin were selected as target cells in this study.Results: 1.The Clinical study showed that, TSQBG had a good clinical curative effect on melasma that the total effective rates were respectively 93.94%, but, in the control group treated with SJG, the total effective rates were only respectively 72.73%, comparison between the two groups showed significant statistical difference (P <0.05). 2.The experimental study results of, (1) different dose (high,middle,lower)test groups of TSQBG all showed that TSQBG could inhibit significantly the activities of mushroom tyrosinase in vitro. Among which, the function of inhibition was better when middle or high concentration was given(P<0.01 ). And more, there was certain relation between concentration and function which TSQBG inhibited the activities of mushroom tyrosinase in vitro.(2) The different concentration of TSQBG has a potential effect on decreasing the melanin content of the primary cultured human skin melanocytes in vitro which increased by UVA, the tyrosinase activities of melanocytes was inhibited significantly. In addition, the cell proliferation of the melanocytes was also decreased with the increasing of TSQBG concentration. and the intervention effects of TSQBG on the skin melanocytes after Ultraviolet A radiation was somewhat different from different treatment concentrations (doses) and time of TSQBG, the effect relative with the dosage, and stronger effect was showed in the middle, high concentration or dose group(P<0.05或P<0.01 ),and were parallel with each other in a time-dependent manner.Conclusion: Our results suggested that (1)TSQBG, which was according to HuoZaoJieZhi, has a good effect in treating melasma, its clinical effect was remarkable than that of ShaJi Granule. (2)the main important pathway of the biological effect of TSQBG on human skin melanocytes were decreasing the cell proliferation, melanin content and tyrosinase activities, and it is the possible mechanism of the effect of TSQBG on Melasma. (3)It recommended that the usage of the dose (15g,Tid) of clinical study was the safe and effective dose on skin melanocytes of patients with melasma. (4) It was also indicaded that as longer time and higher dose use of TSQBG as better effect of treatment of melasma. (5)the results may be the scientific foundation that make TSQBG valid in clinical treatment of melasma. |
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