| Objective:By comparing symptom scores and VAS scores,the therapeutic effects of Compound oleum lithospermi,Kangfuxin Solution and Sesame oil in the treatment of skin lesions and symptoms and the degree of self-perceived symptoms of Chronic Cheilitis exfoliativa were explored,so as to provide theory support for clinical application in the later stage.Methods:This trial was a three-arm,randomized,double-control clinical trial with superior efficacy.The random sequence was selected by querying the random number table,and then the random sequence was hidden by the envelope,so that the subjects were randomly divided into three groups:the experimental group,the positive control group and the negative control group.Sample size was estimated using PASS software.The experimental group was externally coated with Compound oleum lithospermi,the positive control group was externally coated with Kangfuxin Solution,and the negative control group was externally coated with sesame oil.The subjects were asked to follow the unified and standardized application method,for a course of 28 days.The subjects’ symptom score and VAS score,which measured the perceived symptom level,were recorded at three time points before treatment,14 days after treatment,and 28 days after treatment.Adverse reactions were recorded and treated during the study.Results:Among the 148 subjects who completed the study,there were 3 times as many female participants as men;The mean age was 29.70 years.Unmarried persons accounted for the majority;The mean BMI of 21.02 showed no significant statistical difference.The disease is prone to recurrent attacks,the average course of disease is 2-3 years,the disease is more than 10 years in 4 cases;30 of the subjects had a known and definite history of allergy;The subjective symptom distribution pain was about 1.53 times higher than pruritus.The intra-group comparison showed that the objective symptom scores of the experimental group 0,14 and 28 days of treatment were 11.37,6.33 and 3.65,respectively,P<0.05.VAS scores of subjective symptoms were 3.29,1.94 and 1.13,respectively,P<0.05.There were statistically significant differences in the objective symptom efficacy and subjective symptom efficacy between 14 days and 28 days of treatment.The objective symptom scores of the positive control group before,14 and 28 days of treatment were 10.67,8.23 and 7.12,respectively,P<0.05,and the difference was statistically significant.The VAS scores of subjective symptoms were 3.73,2.73 and 2.42,respectively.There was a statistical difference between the VAS scores of subjective symptoms before treatment and those at 14 and 28 days of treatment,respectively.However,there was no statistical difference between the VAS scores at 14 days of treatment and 28 days of treatment.There were statistical differences in the objective symptom efficacy and subjective symptom efficacy between 14 days and 28 days of treatment.In the negative control group,the objective symptom scores were 10.46,8.42 and 7.04 before,14 and 28 days of treatment,and the subjective symptom VAS scores were 4.04,2.71 and 1.96,respectively,P<0.05,the difference was statistically significant.There were statistical differences in the objective symptom efficacy and subjective symptom efficacy between 14 days and 28 days of treatment.For objective skin lesions,the total effective rate at 14 days of treatment was 82.60%in the experimental group,27.10%in the positive control group and 8.30%in the negative control group,P<0.05.The total effective rate after 28 days of treatment was 94.20%in the test group,58.40%in the positive control group and 37.50%in the negative control group,P<0.05.For subjective pain/pruritus symptoms,the total effective rate of 14 days treatment was 61.60%in the experimental group,52.10%in the positive control group and 29.20%in the negative control group,P=0.032<0.05.The total effective rate after 28 days of treatment was 80.80%in the test group,60.40%in the positive control group and 66.6%in the negative control group(P=0.078>0.05),and the difference was not statistically significant.Conclusion:The treatment of Chronic Cheilitis exfoliativa with Compound oleum lithospermi,Kangfuxin solution and sesame oil was found to be effective,and the therapeutic effect was continuously increasing within 28 days.To improve the symptoms and symptoms of skin lesions,the effect of Compound oleum lithospermi was obviously better than that of Kangfuxin solution and sesame oil.For the improvement of subjective pain/pruritus symptoms,the efficacy of Compound oleum lithospermi was slightly better than that of Kangfuxin solution and sesame oil,but the difference was not statistically significant.There were no reports of adverse reactions,and the drugs were safe and stable.Therefore,it is proved that the Compound oleum lithospermi is effective,safe and stable in the treatment of Chronic Cheilitis exfoliativa,and is suitable for clinical application and promotion research. |
PDF Full Text Request