Objective：To explore the therapeutic effect of auricular therapy combined with optimized Yinxieling Formula（银屑灵优化方） on psoriasis vulgaris.Methods：A randomized controlled single-blind clinical trial on 84 out...Objective：To explore the therapeutic effect of auricular therapy combined with optimized Yinxieling Formula（银屑灵优化方） on psoriasis vulgaris.Methods：A randomized controlled single-blind clinical trial on 84 outpatients with psoriasis vulgaris was conducted.The patients were randomized to a treatment group（43 cases treated by auricular therapy combined with optimized Yinxieling Formula） and a control group （41 cases treated by optimized Yinxieling Formula alone） according to a random number generated by SPSS 17.0 software.The treatment duration for both groups was 8 weeks.The therapeutic effect was comprehensively measured by the primary outcome measure[Psoriasis Area and Severity Index（PASI） reduction rate]and the secondary outcome measure[PASI,Visual Analogue Scale（VAS）,Dermatology Life Quality Index（DLQI）, Self-rating Depression Scale（SDS）,and Self-rating Anxiety Scale（SAS）].The outcomes of both groups were obtained and compared before and after the intervention.Results：The PASI reduction rate in the treatment group was 74.4%（32/43）,which was higher than that in the control group（36.6%,15/41,P0.01）.The PASI scores decreased in both groups after treatment and was lower in the treatment group compared with the control group （P0.01）.With stratified analysis,there were significant differences between the PASI scores in the following subgroups：age 18-30,baseline PASI10 and stable stage（P0.05）.DLQI decreased in both groups on some categories after treatment,but there were no significant differences between the two groups in SDS,SAS and VAS（P0.05）.No obvious adverse reactions were found in either group.Conclusion：The therapeutic effect of auricular therapy combined with Optimized Yinxieling Formula was superior to Optimized Yinxieling Formula alone with no obvious adverse reaction.展开更多
目的评价PSORI-CM02汤剂治疗寻常型银屑病的临床疗效和长期服用的安全性,为进一步开发PSORI-CM02方治疗寻常型银屑病提供临床疗效和安全性数据。方法采用单臂的临床观察,给予寻常型银屑病患者口服银屑灵优化方(PSORI-CM02)中药汤剂共24...目的评价PSORI-CM02汤剂治疗寻常型银屑病的临床疗效和长期服用的安全性,为进一步开发PSORI-CM02方治疗寻常型银屑病提供临床疗效和安全性数据。方法采用单臂的临床观察,给予寻常型银屑病患者口服银屑灵优化方(PSORI-CM02)中药汤剂共24周,嘱患者每2周复诊,并记录皮损严重程度、瘙痒情况、患者主要症状、生活质量等,同时进行安全性指标监测。主要结局指标为自身治疗前后的银屑病皮损面积与严重程度指数(Psoriasis Area and Severity Index,PASI)下降的分数值;次要结局指标包括治疗24周PASI改善率、医生总体评价PGA(Physician’s Global Assessment)、皮损体表面积BSA(Body Surface Area)、视觉模拟瘙痒评分VAS(Pruritus Scores on the Visual Analogue Scale)、皮肤病生活质量指数(Dermatology Life Quality Index,DLQI)、Skindex以及寻常型银屑病主症量表;安全性评价包括血常规、肝肾功等实验室指标,以及治疗过程中不良事件和严重不良事件的发生人次、比例。结果本研究共招募了31例受试者,其中27例完成了试验。治疗前后PASI评分下降平均分值为2.59分,平均PASI改善率为45.60%,PASI、BSA、VAS、主症量表、Skindex-16的情感维度得分治疗后均较治疗前明显下降,具有统计学意义(P<0.05);DLQI以及Skindex其他维度得分治疗前后差异未见统计学差异。安全性方面,仅有1例(1.6%)患者皮肤出现红斑考虑为中药过敏而导致停药,停药后红斑消失,无其他药物相关不良事件和严重不良事件。结论PSORI-CM02能改善银屑病患者的皮损和减轻皮肤瘙痒,改善银屑病患者的症状,长期使用安全性好,可作为治疗寻常型银屑病的一个有效验方,具有推广应用潜力,值得进一步研究和开发。展开更多
基金Supported by the Financial Industry Technology Research and Development Program of Guangdong Province(No.201105)
文摘Objective：To explore the therapeutic effect of auricular therapy combined with optimized Yinxieling Formula（银屑灵优化方） on psoriasis vulgaris.Methods：A randomized controlled single-blind clinical trial on 84 outpatients with psoriasis vulgaris was conducted.The patients were randomized to a treatment group（43 cases treated by auricular therapy combined with optimized Yinxieling Formula） and a control group （41 cases treated by optimized Yinxieling Formula alone） according to a random number generated by SPSS 17.0 software.The treatment duration for both groups was 8 weeks.The therapeutic effect was comprehensively measured by the primary outcome measure[Psoriasis Area and Severity Index（PASI） reduction rate]and the secondary outcome measure[PASI,Visual Analogue Scale（VAS）,Dermatology Life Quality Index（DLQI）, Self-rating Depression Scale（SDS）,and Self-rating Anxiety Scale（SAS）].The outcomes of both groups were obtained and compared before and after the intervention.Results：The PASI reduction rate in the treatment group was 74.4%（32/43）,which was higher than that in the control group（36.6%,15/41,P0.01）.The PASI scores decreased in both groups after treatment and was lower in the treatment group compared with the control group （P0.01）.With stratified analysis,there were significant differences between the PASI scores in the following subgroups：age 18-30,baseline PASI10 and stable stage（P0.05）.DLQI decreased in both groups on some categories after treatment,but there were no significant differences between the two groups in SDS,SAS and VAS（P0.05）.No obvious adverse reactions were found in either group.Conclusion：The therapeutic effect of auricular therapy combined with Optimized Yinxieling Formula was superior to Optimized Yinxieling Formula alone with no obvious adverse reaction.
文摘目的评价PSORI-CM02汤剂治疗寻常型银屑病的临床疗效和长期服用的安全性,为进一步开发PSORI-CM02方治疗寻常型银屑病提供临床疗效和安全性数据。方法采用单臂的临床观察,给予寻常型银屑病患者口服银屑灵优化方(PSORI-CM02)中药汤剂共24周,嘱患者每2周复诊,并记录皮损严重程度、瘙痒情况、患者主要症状、生活质量等,同时进行安全性指标监测。主要结局指标为自身治疗前后的银屑病皮损面积与严重程度指数(Psoriasis Area and Severity Index,PASI)下降的分数值;次要结局指标包括治疗24周PASI改善率、医生总体评价PGA(Physician’s Global Assessment)、皮损体表面积BSA(Body Surface Area)、视觉模拟瘙痒评分VAS(Pruritus Scores on the Visual Analogue Scale)、皮肤病生活质量指数(Dermatology Life Quality Index,DLQI)、Skindex以及寻常型银屑病主症量表;安全性评价包括血常规、肝肾功等实验室指标,以及治疗过程中不良事件和严重不良事件的发生人次、比例。结果本研究共招募了31例受试者,其中27例完成了试验。治疗前后PASI评分下降平均分值为2.59分,平均PASI改善率为45.60%,PASI、BSA、VAS、主症量表、Skindex-16的情感维度得分治疗后均较治疗前明显下降,具有统计学意义(P<0.05);DLQI以及Skindex其他维度得分治疗前后差异未见统计学差异。安全性方面,仅有1例(1.6%)患者皮肤出现红斑考虑为中药过敏而导致停药,停药后红斑消失,无其他药物相关不良事件和严重不良事件。结论PSORI-CM02能改善银屑病患者的皮损和减轻皮肤瘙痒,改善银屑病患者的症状,长期使用安全性好,可作为治疗寻常型银屑病的一个有效验方,具有推广应用潜力,值得进一步研究和开发。
