| Objective:This study aims to observe the clinical efficacy and safety of Daihuang Xiaobi Cream and Calcipotriol Ointment in the treatment of mild to moderate psoriasis,and to explore the feasibility of Daihuang Xiaobi Cream in treat mild to moderate psoriasis in order to provide a theoretical basis foundation for seeking an effective and safe traditional Chinese medicine as an external preparation for the treatment of mild to moderate psoriasis.Methods:Screening for patients with psoriasis vulgaris in the dermatology clinic of the Traditional Chinese Medicine Hospital affiliated to the Southwest Medical University,at least 58 patients should be included in the group based on the random selection.The patients were randomly divided into the treatment group and the control group.In order to make clinical observations.The treatment group was treated with Daihuang Xiaobi Cream external rub,and the control group was treated with Calcipotriol Ointment.The two groups were applied topically.Each time,the cream was taken for about 1FTU for adults,10mg/cm~2,the thickness is about 1mm.After application,rub bing gently for a while to promote absorption.Administering it twice a day,and using it continuously for 4 weeks as a period of treatment from the test day.The PASI scores(erythema,scaly,infiltration,area)of the two groups were recorded before treatment,2 weeks after treatment,and 4-week after treatment.The laboratory test results of the two groups were recorded before and after 4weeks of treatment.The ELISA method was applied.The serum inflammatory factor IL-17 in the two groups of subjects was measured before treatment and 4weeks after treatment.Side effects were recorded during the medication period.After treatment,the two groups of patients were followed up for 4 weeks to understand the short-term recurrence.SPSS 22.0 statistical software should be used to statistically analyze the data obtained during the trial,and compare the general baseline data,various scores before and after treatment,IL-17 levels,adverse reactions and efficacy and so on between the treatment group and the control group.Results:(1)A total of 70 cases were included in the clinical study,and 65cases were completed,including 33 in the treatment group and 32 in the control group.There was no statistically significant difference in general data such as gender,age,family history,course of disease,clinical stage of skin lesions,grade of skin lesion severity,and PASI score before treatment between the two groups(P>0.05),and they were comparable..(2)The erythema and scaly scores of the treatment group and the control group decreased after 2 and 4weeks of treatment,but the degree of decline in the control group was more significant than that of the treatment group,and the control group was better than the treatment group(P<0.05).(3)After treatment,the infiltration and area scores of the treatment group were not significantly different from those before treatment at 2 and 4 weeks.The infiltration and area scores of the control group were significantly lower than before treatment.(P<0.05).(4)The PASI scores of the treatment group and the control group were lower than those before treatment at 2 and 4 weeks after treatment,but there was no significant difference between the two(P>0.05).(5)There was no significant difference in IL-17 levels between the two groups before treatment(P>0.05).IL-17 in both groups decreased after 4 weeks of treatment,a statistical difference(P<0.05),but between the two groups after treatment.No statistically significant difference(P>0.05).(6)During the treatment period,no adverse reactions related to the test drug occurred in the treatment group,and 2 adverse reactions related to the test drug occurred in the control group.(7)The total effective rates of the treatment group and control group were 60.61%and 93.75%,respectively.The overall efficacy of the control group was better than that of the treatment group.Conclusion:(1)Daihuang Xiaobi Cream has a certain effect on the improvement of erythema and scaly skin lesions in patients with mild to moderate psoriasis,but there is no significant improvement in the extent and area of skin lesion infiltration in this type of patients;Calcipotriol Ointment has exert certain effects on improving erythema,scales,infiltration degree,and area scores in patients with mild to moderate psoriasis vulgaris.The degree of improvement in erythema and scales is better than Daihuang Xiaobi Cream,and the overall effectiveness is higher than Daihuang Xiaobi Cream.(2)Daihuang Xiaobi Cream and Calcipotriol Ointment can both affect the inflammatory factor IL-17,both of which can reduce the level of IL-17.(3)During the whole test,there were no drug-related adverse reactions in the Daihuang Xiaobi Cream group,and there were no abnormal changes in laboratory indicators related to the test drug before and after the administration,while 2 adverse reactions occurred in the Calcipotriol Ointment group.Daihuang Xiaobi Cream is safer than Calcipotriol.(4)The short-term recurrence rate of Daihuang Xiaobi Cream and Calcipotriol Ointment is low. |
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