A Randomized Double-blind Controlled Clinical Study Of Modified Qufeng Runmian Powder In The Treatment Of Acne Vulgaris Caused By Damp Toxin And Blood Stasis

This dissertation is composed of two parts:literature review and clinical trial.The part of literature review:The first literature review:In this paper,we refer to the relevant papers about the law of traditional chinese medicine(TCM)Syndromes of acne vulgaris in recent years,and make a systematic review from the distribution law and constitution,the severity of the disease,the regional differences,the characteristics of skin lesions,the law of drug use,sex hormones,immune indicators,Helicobacter pylori,and summarize the results to explore the law of TCM syndromes of acne vulgaris for the treatment of TCM and provide more comprehensive guidance.The second literature review:Recent papers on the pathogenesis of acne vulgaris and modern medical treatment methods were consulted.The research hotspots in the pathogenesis of acne vulgaris in recent years were listed,such as P.acnes,immunity and free insulin-like growth factor-1.Therapeutic aspects are reviewed from three aspects:pHysiotherapy,systemic therapy and local therapy.Experimental research part:Objective:To evaluate the efficacy and safety of TCM powder modified QufengRunmian(???????,MQFRM)in the treatment of acne vulgaris with syndrome of wet and blood stasis.Method:A multicenter,randomized,double-blind,placebo-controlled clinical trial was designed.Based on the order of inclusion,the acne vulgaris patients with syndrome of wet and blood stasis were randomly assigned to the treatment group or the placebo control group,administrated with MQFRM or placebo,145g/bag,1 time daily,for 4 weeks.The primary indice of efficacy was the effective rates of acne severity score(ASS).The secondary indexes of efficacy included the changes in scores of the dermatology life quality indexscales(DLQI)and spots,pores,brown spots,porypHyrins and red areas from VISIA;skin pH;sebum and hydration from SOFT skin multianalyser.Results:A total of 220 patients were included,with 110 in the treatment group and 110 in the control group,and finally 204 accomplished the follow-up.The total effective rate was 84.50%and 31.68%for the treatment and control groups respectively.The difference of total effective rate between the two groups and the 95%confidence interval(CI)were 57.84%(39.26%-66.38%).Two cases of mild drug allergy were found in treatment group.Conclusion:Modified QufengRunmian powder was more effective than placebo in the treatment of acne vulgaris with syndrome of wet and blood stasis,also no serious adverse reactions.