Pudilan Xiaoyan Oral Liquid(蒲地蓝消炎口服液)in Treatment of Moderate Acne Vulgaris(Syndrome of Damp-Heat Accumulation):A Multicenter,Randomized,Double-blind and Placebo-controlled Trial
Objective To observe the efficacy and safety of Pudilan Xiaoyan Oral Liquid(蒲地蓝消炎口服液)in the treat-ment of moderate acne vulgaris with damp-heat accumulation syndrome.Methods A multicenter,randomized,double blind and controlled study was conducted.The study was carried out in 5 centers which included a total of 240 patients with moderate acne vulgaris of damp-heat accumulation syndrome.The patients were screened and randomly divided into an experimental group and a control group,with 120 patients in each group.The experimental group was given Pudilan Xiaoyan Oral Liquid and the control group was given Pudilan Xiaoyan Oral Liquid simulant.Both groups were treated with topical clindamycin phosphate gel which was applied to affected area after cleansing,twice a day.The treatment course was 4 weeks.The numbers of skin lesions(papules,pus-tules,pimples),and TCM symptoms(red face,itchy and painful skin rash,thick and greasy tongue coating,yellow urine and con-stipation)scores were evaluated.Adverse reactions were recorded.Results A total of 229 patients completed the trial,with 117 ca-ses in the experimental group and 112 cases in the control group.After 4 weeks,the numbers of papules and pustules decreased greatly in both groups,the number of pimples and TCM symptoms scores decreased greatly in the experimental group compared with those at the baseline(P＜0.05).Compared with those in the control group,the indexes mentioned-above were better in the experimental group(P＜0.05).The acne lesions improvement efficiency was 87.2％in the experimental group,which was higher than that of 58.0％in the control group(P＜0.05).There was only one irritant reaction to ointment for external use in the experi-mental group.Conclusion Pudilan Xiaoyan Oral Liquid is effective in reducing the numbers of skin lesions and improving clinical TCM syndromes for moderate acne vulgaris of damp-heat accumulation syndrome,which is worthy of clinical application.
Pudilan Xiaoyan Oral Liquid(蒲地蓝消炎口服液)acne vulgarissyndrome of damp-heat accumulationinte-grated traditional Chinese and western medicine therapyrandomized controlled study
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维普
