摘要
OBJECTIVE:To evaluate the efficacy and safety of flesh-moistening paste for treating psoriasis vulgaris in patients with blood stasis pattern in terms of Traditional Chinese Medicine(TCM).METHODS:Eudipleural rashes on both the left and right side of the same patients with psoriasis vulgaris,diagnosed via TCM as blood stasis pattern,were selected as the targeted skin lesions.A randomized,double-blind,parallel-controlled,multicenter controlled trial was conducted.The targeted skin lesions were categorized into either the treatment or control group.The treatment group used the flesh-moistening paste;the control group used a placebo.Both the paste and the placebo were topically applied twice daily for eight weeks.The patients were examined biweekly to evaluate the effects.The two groups were compared in terms of the psoriasis area and severity index(PASI)of the targeted skin lesions,which is scored according to erythema,desquamation,infiltration,area,pruritus,and improvement of skin barrier function.Adverse events were recorded during the study period.SPSS 21.0 was used to analyze the data.RESULTS:Fifty-six patients were enrolled between February 2016 and October 2017.Two were complicated by cardio-cerebrovascular disease and were excluded;thus,54 outpatients were finally enrolled in the study.Four dropped out during the study period:three failed to complete their follow-up visits for unknown reasons,and one exited due to an adverse event.The final trial comprised 50 of the 56 originally selected patients,with a 92.6%completion rate.After 8 weeks of treatment,the targeted skin lesion scores differed significantly(P<0.05).The PASI scores of the targeted skin lesions differed significantly beginning at week 6(P<0.05).The treatment group presented better results than those of the control group.Only one patient had an adverse reaction associated with the treatment.Improvements in skin barrier function differed significantly(P<0.05).CONCLUSION:The flesh-moistening paste demonstrated a reliable curative effect and safety for treating psoriasis vulgaris in patients with blood stasis patterns.The topical paste improved the barrier function of the skin lesions.
基金
Supported by the Clinical Characteristics Application of Beijing Municipal Science and Technology Commission(No.Z161100000516108)a Randomized Controlled Clinical Study on the Indications of TCM External Treatment for Psoriasis with"Analogic Drug Selection"
the Project of Ten Diseases and Ten Drugs funded by the Beijing Municipal Science and Technology Commission(No.Z161100001816024)Research and Development of Traditional Chinese Medicine Preparation for Treatment of Sunburn By Hao Qin Huaban Granule
the project supported by the National Natural Science Foundation of China(No.81673975 Study on the Mechanism of Hui Yang Sheng Ji Gao Promoting Ulcer Angiogenesis in Type 2 Diabetes Mellitus and 81774309 Study on the Immune Regulation Mechanism of PI3K/Akt/m TOR Signaling Pathway Mediated by tlrs-4 in Light Sensitive Skin Diseases by Clearing Heat,Cooling Blood and Detoxification)
the Beijing Key Laboratory of Clinic and Basic Research with TCM on Psoriasis(No.BZ0375)。
