益赛普联合甲氨蝶呤治疗中重度斑块型银屑病的有效性和安全性  

Efficacy and safety of etanercept combined with methotrexate in treatment of moderate to severe plaque psoriasis

作　　者：张玲玲[1] 龚瑜[1] 于倩[1] 王瑶[1] 史玉玲[1] ZHANG Ling-ling;GONG Yu;YU Qian;WANG Yao;SHI Yu-ling(Dept. of Dermatology, Tenth People＇s Hospital, Tongji University, Shanghai 200072, Chin)

机构地区：[1]同济大学附属第十人民医院皮肤科,上海200072

出　　处：《同济大学学报（医学版）》2018年第2期7-11,共5页Journal of Tongji University(Medical Science)

基　　金：国家自然科学基金(81301356);上海市自然科学基金(13ZR1432200;16ZR1426800);上海市科委引导项目基金(13411960700)

摘　　要：目的探讨益赛普联合甲氨蝶呤(methotrexate,MTX)治疗中重度斑块型银屑病的有效性和安全性。方法筛选中重度斑块型银屑病患者30例,随机分为益赛普联合MTX治疗组(联合用药组)和单用益赛普治疗组(单药组)。两组患者用药24周。治疗第2、6、12、18、24周时记录银屑病严重程度指数(psoriasis area and severity index,PASI)评分,分别统计达到PASI 50、PASI 75、PASI 90的患者比例,记录医生对病情的总体评价(physician's global assessment,PGA)、患者对病情的总体评价(patient's global assessment,Pt GA)和皮肤病生活质量指数(dermatology life quality index,DLQI),同时检查血、尿常规、肝肾功能、血沉和C反应蛋白,评价患者不良反应(adverse event,AE)的发生率。结果治疗前,联合用药组和单药组PASI评分分别为(28.97±7.09)、(30.31±9.32)分,两组差异无统计学意义(P>0.05);治疗结束时联合用药组的PASI评分显著低于单药组[(5.31±2.35)分vs(7.10±2.94)分],差异有统计学意义(P<0.05)。治疗12周,两组达到PASI 75的比例分别为66.7%和46.7%;24周分别为80.0%和66.7%,联合用药组疗效优于单药组。联合用药组AE发生率为60%,单药组为33.3%。但AE均为轻中度,治疗期间无严重感染及肿瘤的发生。结论益赛普联合MTX疗效优于单用益赛普,不良反应轻,安全性好。Objective To evaluate the efficacy and safety of etanercept combined with methotrexate（ MTX） in treatment of moderate to severe plaque psoriasis. Methods Thirty patients with moderate to severe plaque psoriasis were divided into two groups： 15 patients in combination group were treated by etanercept with MTX,and 15 patients in monotherapy group were treated by etanercept alone.Patients of both group used drugs for 24 weeks. The PASI scores were documented and PASI 50,PASI75 and PASI 90 proportions were calculate at week 0,2,6,12,18 and 24. The physician＇s global assessment（ PGA）,patient＇s global assessment（ Pt GA） and dermatology life quality index（ DLQI）were evaluated at the same time points. The blood routine, liver and kidney function, blood sedimentation and C-reactive protein were measured at week 0,2,6,12,18,24. Adverse events including infection,tumor,headache,abnormal liver function were recorded. Results The PASI scores of combination group and monotherapy group at week 0 were 28. 97 ± 7. 09 and 30. 31 ± 9. 32,respectively（ P〉0. 05）. The PASI score of combination group at week 24 was significantly lower than that of monotherapy group（ 5. 31 ± 2. 35 vs 7. 10 ± 2. 94,P 0. 05）. The PASI 75 of the two groups were 66. 7% and 46. 7% at week 12,80. 0% and 66. 7% at week 24,indicating that the efficacy of the combination group was better than the monotherapy group. The incidence of adverse events in combination group and in monotherapy group was 60% and 33. 3%,respectively; however,all adverse events were mild to moderate,no severe infections and tumor occurred during the period of treatment.Conclusion Etanercept combined with methotrexate had better efficacy and good safety with slightly increased adverse reactions in treatment of patients with moderate to severe plaque psoriasis.

关 键 词：银屑病 斑块 益赛普 甲氨蝶呤 

分 类 号：R758.63[医药卫生—皮肤病学与性病学]