银屑灵优化方(PSORI-CM02)治疗寻常型银屑病的疗效和安全性观察

Efficacy and Safety of Optimized Yinxieling Formula(PSORI-CM02)in the Treatment of Psoriasis Vulgaris

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。

Objective To evaluate the efficacy and long-term safety of PSORI-CM02 decoction for patients with psoriasis vulgaris and to provide basic data of PSORI-CM02 for clinical application.Method This is a single center,open-label pilot study.31 participants with psoriasis vulgaris received PSORI-CM02 decoction orally for 24 weeks.Skin conditions,symptoms and quality of life were assessed every 2 weeks and safety was evaluated throughout the trial.The primary outcome was the mean score changes of Psoriasis Area and Severity Index(PASI).The secondary parameters were the improvement rate of PASI,the changes of PGA(Physician′s Global Assessment),Body Surface Area(BSA)and Pruritus Scores on the Visual Analogue Scale(VAS),Dermatology Life Quality Index(DLQI),Skindex,Psoriasis Vulgaris Main Symptom Scale.Safety was evaluated by recording adverse events and serious adverse events throughout the trial.Result A total of 31 subjects participated in the trial,and 27 completed the trial.The average change of PASI score after treatment at 24 week was 2.59,and the average PASI improvement rate was 45.60%.There were statistically significant differences in changes of PASI,BSA,VAS,Psoriasis Vulgaris Main Symptom Scale scores and the emotion domain of Skindex-16 from baseline(P<0.05).Meanwhile,there was no statistically significant difference in score changes of DLQI and other domains of Skindex.For safety,Only 1 patient(1.6%)had erythema on the skin,which was considered to be allergic to PSORI-CM02 Subject’s erythema disappeared after PSORI-CM02 withdrawal.No other serious adverse events or adverse events were observed related to PSORI-CM02.Conclusion PSORI-CM02 can improve lesion condition,relieve skin itching,and improve symptoms in psoriasis patients.PSORI-CM02 is effective and safe for long-term usage for psoriasis vulgaris and further researches for application are needed.