The Clinical Study Of Xiaojin Capsule In The Treatment Of Moderate To Severe Acne (phlegm And Blood Stasis Aggregation)

Objective:Comparing the clinical efficacy of Xiaojin capsule combined with the Chinese herbal mask and Tanshinone capsule combined with the Chinese herbal mask in the treatment of moderate and severe acne(syndrome of phlegm and blood stasis),and evaluating the correlation between the efficacy of the two groups of drugs and the grade(?,? and ?)of acne,and observing the occurrence of adverse reactions of the two groups during the study.Method:The trial is a prospective randomized positive parallel-controlled clinical trial,in which,80 subjects were randomly assigned to the treatment group and the control group,40 cases for each group.The treatment group was given Xiaojin capsule orally,5 pills each time,2 times a day.The control group was given Tanshinone capsule orally,4 pills each time,3 times a day.At the same time,the two groups were given external application of Chinese herbal mask,30 minutes each time,2 times a week for 4 weeks.Then,the patients were interviewed before treatment,at 2 weeks after treatment and 4 weeks after treatment,respectively.The scores of skin lesions,TCM syndromes and quality of life were recorded by the evaluation scale.Meanwhile,the adverse reactions were recorded and treated in time After the observation,the collected data were analyzed by SPSS 22.0.Result:In this study,73 effective cases were collected,including 38 cases in the treatment group and 35 cases in the control group.At 2 weeks of treatment,the total effective rate of skin lesions was 68.4%in the treatment group and 14.3%in the control group,the total effective rate of TCM syndromes was 55.3%in the treatment group and 25.7%in the control group.At 4 weeks of treatment,the total effective rate of skin lesions was 92.1%in the treatment group and 68.6%in the control group,the total effective rate of TCM syndromes was 94.7%in the treatment group and 68.6%in the control group,respectively.Therapeutic effect analysis:by within-group comparison,there were statistical differences in the scores of skin lesions,TCM syndromes and life quality between the two groups before and at 4 weeks after treatment.By between-group comparison,there was no statistical difference in the scores of skin lesions,TCM syndromes and quality of life between the two groups before treatment.There was no statistical difference in the scores of skin lesions,TCM syndromes and quality of life between the two groups at 2 weeks of treatment.There were statistical differences in the scores of skin lesions,TCM syndromes and quality of life between the two groups at 4 weeks of treatment,and the scores of skin lesions,TCM syndromes and life quality in the treatment group were lower than those in the control group.Correlation analysis:by within-group comparison,there was no statistical difference in the change rate of skin lesions score and life quality score between the experimental group and the control group in different acne grades after 4 weeks of treatment.There was no statistical difference in the change rate of TCM syndrome score of different acne grades in the control group,and there was statistical difference in the change rate of TCM syndrome score of different acne grades in the treatment group.Among the above,the change rate of grade ?was higher than that of grade ?,the change rate of grade ? was higher than that of grade ?,and there was no statistical difference between grade ? and grade ?.Case of adverse reactions:during the trial,there were no adverse reactions in the treatment group but 2 cases of adverse reactions in the control group,symptom relief after discontinuation.Conclusion:Xiaojin capsule combined with Chinese herbal mask and Tanshinone capsule combined with Chinese herbal mask are effective in treating moderate and severe acne which belongs to phlegm and blood stasis,and the effect of Xiaojin capsule combined with Chinese herbal mask is slightly better than Tanshinone capsule combined with Chinese herbal mask in improving skin lesions,TCM syndromes and life quality.At 4 weeks of treatment,for Xiaojin capsule treated group,there was no relationship between the therapeutic effect of skin lesions and life quality and acne grade,but there was relationship between TCM syndromes and acne grade.The therapeutic effect of grade ? and ? patients was more obvious than that of grade ? patients.For Tanshinone capsule treated group,there was no relationship between skin lesions,TCM syndromes,life quality and acne grade.Moreover,there was no adverse reactions in Xiaojin capsule treated group during the trial,which demonstrated that it was worthy of clinical application.