| ObjectiveThis study intends to observe the clinical efficacy of Wen’s Dahuang Kushen decoction bath in the treatment of psoriasis vulgaris in progress period with blood-heat syndrome,so as to explore the excellent treatment scheme of Wen’s Dahuang Kushen decoction bath.Through the mechanism research to explore the possible mechanism of Wen’s Dahuang Kushen decoction bath in the treatment of psoriasis vulgaris.MethodsClinical research: The temperatures and concentrations of Chinese herbal bath were determined by consulting literature,and they were divided into six Chinese herbal bath groups by different combinations of temperature and concentration.At the same time,the basic treatment group and the ozone hydrotherapy group were set as the control.Patients with psoriasis vulgaris in progress period with blood-heat syndrome who met the inclusion criteria were recruited as the research subjects.They were randomly divided into basic treatment group,ozone hydrotherapy group,Chinese herbal bath group 1,Chinese herbal bath group2,Chinese herbal bath group3,Chinese herbal bath group 4,Chinese herbal bath group 5 and Chinese herbal bath group 6.Thirty-six participants will be assigned to each group.The basic treatment group will be given oral co-qingdai capsule and compound glycyrrhizin tablet,as well as external use jojoba Oil.The ozone group will be given ozone hydrotherapy at the same time as the basic treatment.The Chinese herbal bath group will be given Wen’s Dahuang Kushen decoction bath at the same time as the basic treatment.Different Chinese herbal bath groups were treated according to their corresponding bath temperatures and concentrations.The course of treatment was two weeks.The PASI score,BSA score,VAS score,DLQI score,SAS score,and SDS score were performed on the included patients before and after treatment.Through the evaluation of safety indicators and adverse events,the safety of the study was evaluated.Mechanism research: According to the diagnostic criteria,inclusion criteria and exclusion criteria in the clinical research,72 patients were recruited and randomly divided into observation group and control group,with 36 cases in each group.The observation group adopted the excellent treatment scheme of Wen’s Dahuang Kushen decoction bath in clinical research,while the control group adopted the basic treatment plan in the clinical research,and the course of treatment was two weeks.At the same time,20 healthy volunteers were recruited as the healthy control.The expression levels of Th17 cell,Treg cell,RORγt,Foxp3,IL-17,TNF-α,IL-10 and TGF-β1 in peripheral blood of healthy volunteers and patients with psoriasis vulgaris were detected before and after treatment.Results1.The general situation of clinical studyA total of 273 patients completed treatment,including 186 males(68.1%),87females(31.9%),guttate psoriasis 118 cases(43.2%),plaque psoriasis 155 cases(56.8%),moderate psoriasis 192 cases(70.3%),severe psoriasis 81 cases(29.7%),269 cases with recurrence(98.5%)and 4 cases with the first episode(1.5%).2.The evaluation of clinical indexes(1)The PASI score of each group after treatment was significantly different from that before treatment(P<0.01).The group comparisons showed that the differences in Chinese herbal bath group 3 and Chinese herbal bath group 4 compared with basic treatment group,ozone hydrotherapy group,Chinese herbal bath group 1,Chinese herbal bath group 2,Chinese herbal bath group 5 and Chinese herbal bath group 6 were statistically significant(P<0.01).(2)The differential value of PASI score in each group showed that the differences in Chinese herbal bath group 1,Chinese herbal bath group 2,Chinese herbal bath group3,Chinese herbal bath group 4,Chinese herbal bath group 5 and Chinese herbal bath group 6 were statistically significant compared with those in basic treatment group(P<0.01).The differences in Chinese herbal bath group 1,Chinese herbal bath group 2,Chinese herbal bath group 3,Chinese herbal bath group 4,Chinese herbal bath group 5and Chinese herbal bath group 6 were statistically significant compared with those in the ozone hydrotherapy group(P<0.05).The differences in Chinese herbal bath group3 and Chinese herbal bath group 4 compared with Chinese herbal bath group 1,Chinese herbal bath group 2,Chinese herbal bath group 5 and Chinese herbal bath group 6 were statistically significant(P<0.01).(3)The comparison of the arrival rate of PASI-50 in each group showed that the differences were statistically significant in Chinese herbal bath group 3 compared with basic treatment group and ozone hydrotherapy group(P<0.05),and the difference was statistically significant in Chinese herbal bath group 4 compared with basic treatment group(P<0.05).(4)The BSA score after treatment were no significantly differences from those before treatment in basic treatment group and ozone hydrotherapy group(P>0.05).The BSA score after treatment were significantly differences from those before treatment in Chinese herbal bath group 1～Chinese herbal bath group 6(P<0.05).The group comparisons showed that the differences in Chinese herbal bath group 3 compared with basic treatment group,ozone hydrotherapy group,Chinese herbal bath group 1,Chinese herbal bath group 2,Chinese herbal bath group 5 and Chinese herbal bath group 6 were statistically significant(P<0.05).(5)The VAS score of each group after treatment was significantly different from that before treatment(P<0.01).The group comparisons showed that the differences in Chinese herbal bath group 3 compared with basic treatment group,ozone hydrotherapy group,Chinese herbal bath group 1,Chinese herbal bath group 2,Chinese herbal bath group 5 and Chinese herbal bath group 6 were statistically significant(P<0.05).The differences in Chinese herbal bath group 4 compared with basic treatment group,ozone hydrotherapy group,Chinese herbal bath group 1 and Chinese herbal bath group 2 were statistically significant(P<0.05).(6)The DLQI score,SAS score,and SDS score after treatment were significantly differences from those before treatment in each group(P<0.01).The group comparisons showed that there were no significant difference among all groups(P>0.05).(7)There were no significant differences in the number of adverse events among all groups(P>0.05).(8)The multifactor analysis of variance showed that different temperatures of Wen’s Dahuang Kushen decoction bath had significant effects on PASI score and its differential value,as well as BSA score and VAS score(P<0.01),but had no significant effects on DLQI score,SAS score and SDS score(P>0.05).The multifactor analysis of variance showed that different concentrations of Wen’s Dahuang Kushen decoction bath had no significant effects on PASI score and its differential value,as well as BSA score,VAS score,DLQI score,SAS score and SDS score(P>0.05).3.The mechanism research(1)The PASI score of observation group and control group after treatment were significantly different from those before treatment(P<0.01),as well as the group comparisons(P<0.01).The comparison of the arrival rate of PASI-50 showed that the difference was statistically significant in the two groups(P<0.05).(2)The expression levels of Th17 cell,RORγt,IL-17 and TNF-α in peripheral blood of patients with psoriasis vulgaris were higher than those in healthy group(P<0.01),while the expression levels of Treg cell,Foxp3,IL-10 and TGF-β1 were lower than those in healthy group(P<0.01).(3)The comparison of peripheral blood indexes between observation group and control group before and after treatment showed that there were no significant differences in Th17 cell,Treg cells RORγt,Foxp3,IL-17,TNF-α,IL-10,and TGF-β1,as well as the group comparisons(P>0.05).Conclusions1.Wen’s Dahuang Kushen decoction bath has significant clinical effect in the treatment of psoriasis vulgaris in progress period with blood-heat syndrome.2.The scheme of Wen’s Dahuang Kushen decoction bath with the combination of temperature and concentration(38～40℃,1/10)is the excellent treatment scheme for this study.3.During the treatment for two consecutive weeks,the concentration had no significant effects on the clinical outcome indexes of Wen’s Dahuang Kushen decoction bath in the treatment of psoriasis vulgaris in progress period with blood-heat syndrome,while the temperature had significant effects on the clinical outcome indexes.The clinical effect of temperature of 38～40°C was the most significant,but it had no significant intervention effects on the related immune inflammatory indexes.The specific mechanism needs to be further explored by our research group.4.Wen’s Dahuang Kushen decoction bath is safe in the treatment of psoriasis vulgaris. |
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