Clinical Observation And Experimental Study Of Compound Coptis Ointment In The Treatment Of Mild To Moderate Psoriasis Vulgaris

Objective:To observe the clinical efficacy and safety of Compound Huanglian Ointment in the treatment of mild to moderate psoriasis vulgaris,and to establish a mouse psoriasis animal model to study the feasibility and effect of Compound Huanglian Ointment in the treatment of mild to moderate psoriasis vulgaris The mechanism provides a theoretical basis for seeking a safe and effective external preparation of traditional Chinese medicine in clinical use.Methods:1.Clinical trial: 70 patients with mild to moderate psoriasis vulgaris who met the inclusion criteria and exclusion criteria were randomly divided into observation group and control group according to the order of out-patient visit,with 35 patients in each group.The observation group was given compound coptis ointment twice a day,while the control group was given capitriol ointment twice a day for 4 consecutive weeks.PASI score was performed on the affected skin lesions before and during the treatment period(Week 2 and Week 4),and the shape of the rash(erythema,infiltration and scale)and the degree of pruritus were scored.Aderse reactions were monitored during the treatment.During the follow-up period(6 weeks,8 weeks),the subjects who were clinically cured,significantly effective and effective were evaluated and recorded for recurrence through telephone follow-up.2.Animal experiment: 52 BALB/c mice were randomly divided into two groups: blank group(8 mice)and model group(44 mice).Model group by the combined approach is proposed to build in vitro in vivo animal models of psoriasis,2 weeks after random 4,only under a microscope to observe the histopathological changes,prompt after the success of the building,the remaining 40 mice were randomly divided into 5 groups,each group of eight,model group,positive control group respectively(card berth three alcohol group)and compound coptis chinensis cream high dose group,middle dose group,low dose group,After1 week of drug intervention,the morphological and histomathological changes of the dorsal skin lesions of mice were observed,as well as the changes of IL-23,TNF-α content and organ index in the dorsal skin lesions of mice were detected.Results:1.Clinical Trials:(1)(1)Intra-group comparison: After 2 weeks and 4 weeks of treatment,scores of the observation group and the control group decreased,respectively,compared with before treatment,with statistical significance(P<0.05).(2)Comparison between groups: After 2weeks of treatment,there were no statistically significant differences in PASI score and skin rash shape score between the observation group and the control group(P>0.05),but there were statistically significant differences in pruritus score(P<0.05),and the decrease was more obvious in the observation group;After 4 weeks of treatment,there was no statistically significant difference in erythema score between the observation group and the control group(P>0.05),and there were statistically significant differences in other scores(P<0.05),and the control group was better than the observation group,but in the pruritus score,the observation group was better than the control group in the downward trend.(2)During the whole experiment,the observation group did not have any adverse reactions related to the trial drug;2 patients in the control group had uncomfortable symptoms,but none of them affected daily life,so the medication was continued.(3)The total effective rate of patients in the observation group was 61.76%,the total effective rate of patients in the control group was 87.87%,and the overall curative effect of the control group was better than that of the observation group(P<0.05).(4)After the drug intervention,the two clinically effective subjects were followed up by telephone for 4 weeks,and no recurrence cases were found.2.Animal experiment:(1)Skin lesion morphology: Compared with the model group,the positive control group and the compound huanglian ointment group had reduced back skin lesions,erythema subsided,scaly reduced,and skin lesions thinned,especially in the positive control group and compound huanglian ointment.In the high-dose ointment group,the skin lesions basically returned to normal.(2)Histopathology: Compared with the model group,the thickness of the epidermis of the positive control group and each dose group of compound huanglian ointment was thinner,and the number of inflammatory infiltration and blood vessels decreased.Among them,each dose group of compound huanglian ointment increased with the increase of drug concentration.,The improvement in the high-dose group was the most obvious.(3)Changes in IL-23 and TNF-α levels: Compared with the model group,the levels of IL-23 and TNF-α in the back skin lesions of mice in the positive control group and the compound Huanglian ointment groups in each dose group were significantly reduced.There was statistical significance(P<0.05),but the decrease was most obvious in the high-dose compound Huanglian Ointment group.(4)Changes in spleen and thymus index: Compared with the model group,the spleen index and thymus index of mice in each medication group decreased to varying degrees,and the difference was statistically significant(P<0.05),but the decrease was most obvious in the high-dose compound Huanglian Ointment group.Conciusion:(1)Compound Huanglian ointment and calcipotriol ointment are effective in treating mild to moderate psoriasis vulgaris.In terms of overall efficacy,the efficacy of calcipotriol ointment is higher than that of compound huanglian ointment;in terms of adverse reactions and recurrence rate,compound huanglian ointment has high safety and low short-term recurrence rate.(2)The mechanism of action of Fufang Huanglian Ointment in the treatment of psoriasis vulgaris may be related to the regulation of the content of IL-23 and TNF-α in the skin lesions.It inhibits the content of pro-inflammatory factors IL-23 and TNF-α,thereby To achieve the effect of controlling inflammation and regulating immunity.