| Objectives:1. To evaluate the clinical effectiveness, safety and patients’ satisfaction of Xiao Yin Lotion for the treatment of skin lesions induced by psoriasis vulgaris, and observe its effect on single symptoms of skin lesions (erythema, scale, infiltration and area) and itching;2.To evaluate the effectiveness of Xiao Yin Lotion in treatment of psoriasis vulgaris through investigating its influence on the process of epidermal keratinization of skin scales in mice tails, and explore its mechanism through the detection the expression of skin scale of mice tails and proliferation and apoptosis related factors by immunohistochemical techniques.Methods:1.Through a prospective, randomized, single-bind, placebo controlled trial, evaluated the curative effects, safety and patients’ satisfaction of Xiao Yin Lotion in the treatment of skin lesions induced by psoriasis vulgaris.2. Through the skin scale of mice tails model, observed the pathological change of skin scale tissue at light microscopic level of the Xiao Yin Lotion group, Vitamin A acid cream group, placebo group and blank group respectively and counted the number of scales with granular layer.3. Through immunohistochemical staining Envision method technology of Cyclin D1, Survivin, Ki67, detected the expression of scales of mice tai Is of Xiao Yin Lotion group, Vitamin A acid cream group and blank group.Results:A total of70patients were enrolled in the study. Patients were divided randomly to Xiao Yiin Lotion treatment group (n=35) and control group (n=35).66patients completed the8-week treatment. One patient was lost in treatment group and three patients in control group. No significant differences on baseline characteristics between the two groups. After the8-week treatment, PASI scores of the two groups has a statistically significant difference (P<0.05). The effect of Xiao Yin Lotion group was superior to that of control group. The markedly effective rate and the total effective rate of treatment group was20.59%and100%respectively, and the control group was9.38%and84.38%respectively. There was no significant difference between the two groups in markedly effective rate and the total effective rate (P>0.05).For the score of single symptoms, statistical analyses showed that there was marked improvement of erythema, scaling, infiltration symptoms in both the treatment group and control group before and after treatment (P<0.05). For the treatment of scales and skin lesions area, the effect of Xiao Yin Lotion group is better than that of control group (P<0.05). For erythema, infiltration, and the area, there was no significant difference between groups (P>0.05).Before the treatment, there was no significant difference in itching scores (P=0.340), however, there was significant differences after the treatment (P<0.05). The effect of Xiao Yin Lotion group is better than that of the control group in improving the itching score.After8-week treatment, the satisfaction rate of the treatment group (91.18%) is higher than that of the control group (75%), but there was no significant difference between the two groups (P>0.05).The results of HE staining of mouse models:The results of experiment showed that the numbers of the granular layer cells in Xiao Yin Lotion group and Vi tamin A acid were significantly more than that of other groups, and the number of Xiao Yin Lotion group is more than that of control group and blank group (P<0.05). The number of Xiao Yin Lot ion group i s more than than of the dilution group (P<0.05). It demonstrated that the effect of Xiao Yin Lotion would be better in a higher concentration.Experiment of immunohistochemical mouse model showed:there was a high expression of Cyclin D1in Vitamin A acid cream group and Xiao Yin Lotion group, while in blank group there was a lower expression. It showed the highest expression of Survivin in the Xiao Yin Lotion group, followed by Vitamin A acid cream group and control group. Conclusion:Xiao Yin Lotion can decrease PASI score of skin lesions in patients with psoriasis vulgaris and improved the itching symptom, with conclusive effect and good safety.The animal model experiments proved that Xiao Yin Lotion can promote the formation of the granular layer of epidermal scale in mice tails. Further study on the reasons of the granular layer formation is needed. |
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