环孢素联合阿维A治疗中重度银屑病疗效和安全性的临床研究  

Clinical study on the efficacy and safety of cyclosporine combined with acitretin in the treatment of moderate to severepsoriasis

作　　者：徐康 孙洁 朱超 龚春燕 XU Kang;SUN Jie;ZHU Chao;GONG Chunyan(Department of Pharmacy,Hospital of Skin Diseases and Institute of Dermatology,Chinese Academy of Medical Sciences&Peking Union Medical College,Nanjing 210042,China)

机构地区：[1]中国医学科学院皮肤病医院药剂科,江苏南京210042

出　　处：《临床皮肤科杂志》2023年第9期536-540,共5页Journal of Clinical Dermatology

摘　　要：目的:评价环孢素联合阿维A和两种药物单用治疗银屑病的疗效和不良反应。方法:将患者随机分为联合组(环孢素联合阿维A)、环孢素组和阿维A组共3组。评估治疗前后银屑病皮损面积和严重程度指数(PASI)评分和体表面积(BSA)评分的变化,监测药物不良反应(ADR)。结果:共196例患者入组,治疗4周后联合组的PASI评分(8.31±5.23)分,低于阿维A组(14.04±6.81)分和环孢素组(11.47±6.12)分。皮损改善达PASI75(PASI基线分数降低≥75%)的患者中联合组37例(54.4%),阿维A组5例(8.1%),环孢素组17例(25.8%),联合组与其他2组比较,差异均有统计学意义(P<0.05)。治疗12周后,皮损改善达PASI75患者中,联合组63例(92.6%)、阿维A组38例(61.3%)、环孢素组58例(87.9%),联合组与其他2组比较,差异有统计学意义(P<0.05)。联合组环孢素血药浓度(100.01±37.93)mg/L,环孢素组(154.49±67.84)mg/L,两组比较差异有统计学意义(P<0.05)。联合组的不良反应以高血压为主(8/68,11.8%),低于环孢素组(13/66,19.7%)。阿维A组口唇炎、干眼症和(或)皮肤干燥发生率16.1%(10/62),联合组1.5%(1/68),两组比较差异有统计学意义(P<0.05)。结论:环孢素联合阿维A治疗银屑病较环孢素和阿维A单独使用能够更快改善皮损。同时,联合用药降低了环孢素的用量,降低了高血压和口唇炎等的发生率。Objective:To evaluate the efficacy and adverse reactions of cyclosporine,acitretin,and their combination in the treatment of psoriasis,to provide evidence for the clinical use of cyclosporine combined with acitretin.Methods:Patients were randomly divided into three groups:combined group(cyclosporine combined with acitretin),cyclosporine group,and acitretin group.Psoriasis area and severity index(PASI)score and body surface area(BSA)score were assessed,and adverse drug reactions(ADRs)were monitored.Results:A total of 196 patients were enrolled and randomized.After four weeks of treatment,PASI score in the combined group(8.31±5.23)was lower than those in the acitretin group(14.046.81)and cyclosporine group(11.47±6.12).Of the patients reaching PASI75(≥75%reduction in baseline PASI score),37(54.4%)were in the combined group,more than the 5(8.1%)in the acitretin group and 17(25.8%)in the cyclosporine group(P<0.05).Afer 12 weeks of treatment,63(92.6%)patients reached PASI75 in the combined group,more than the 38(61.3%)in the acitretin group and 58(87.9%)in the cyclosporine group(P<0.05).Serum concentration of cyclosporine was 100.01±37.93 mg/L in the combined group,lower than the 154.49±67.84 mg/L in the cyclosporine group(P<0.05).The ADRs in the combined group were mainly hypertension(8/68,11.8%),less than those in the cyclosporine group(13/66,19.7%).The incidence of cheilitis,dry eye and/or dry skin in the acitretin group(10/62,16.1%)was higher than that in the combined group(1/68,1.5%)(P<0.05).Conclusion:The combined cyclosporine with acitretin was more effective and safer in treating the skin lesions than cyclosporine or acitretin monotherapy in psoriasis.Moreover,the combined therapy reduced the usage dose of cyclosporine,and decreased the incidences of hypertension and cheilitis.

关 键 词：银屑病 环孢素 阿维A 银屑病面积及严重程度指数(PASI) 体表面积(BSA) 药物不良反应(ADR) 皮肤生活质量指数(DLQI) 

分 类 号：R758.63[医药卫生—皮肤病学与性病学]