昆仙胶囊治疗进行期寻常型银屑病的单中心随机双盲安慰剂对照临床试验研究

A Single-center,randomized,double-blind,placebo-controlled clinical trial of Kunxian capsule in the treatment of psoriasis vulgaris

目的:评价昆仙胶囊治疗进行期寻常型银屑病的疗效及安全性。方法:按照入选和排除标准将进行期寻常型银屑病患者随机分成昆仙胶囊治疗组及安慰剂对照组,治疗周期为4周,采用PASI评分评价药物疗效。结果:共纳入病例60例,每组30例,治疗组脱落3例,对照组脱落1例。治疗组达到PASI 50、PASI 75、PASI 90的患者比例分别为74.1%、29.6%和14.8%,对照组各组患者均为0%,两组各PASI组均存在显著差异(P值分别为0.001,0.002,0.048)。治疗组和对照组中分别出现不良事件6例和1例。结论:昆仙胶囊治疗进行期寻常型银屑病疗效优于安慰剂。

Objective:To evaluate the efficacy and safety of Kunxian capsule in the treatment of psoriasis vulgaris.Methods:The patients were randomly divided into the Kunxian capsule treatment group and the placebo control group according to the predetermined inclusion and exclusion criteria.The PASI score was used to evaluate the drug efficacy.Results:Sixty patients were collected,30 in each group.The off cases in the treatment group and control group were 3 and 1.The proportion of patients recovered to PASI 50,PASI 75,and PASI 90 in the treatment group was 74.1%,29.6%,and 14.8%respectively.No any patients recovered to PASI 50,PASI 75 or PASI 90 in the control group.The proportion of the patients with PASI 50,PASI 75 and PASI 90 was significant difference between the two groups(P=0.001,0.002,0.048).Adverse events occurred in 6 patients in the treatment group and 1 patient in the control group.The incidence of total adverse event in the treatment group and control group were 20%and 3.3%,with no significant difference(P>0.05).Conclusion:Kunxian capsule is effective and safe in the treatment of psoriasis vulgaris.