依那西普联合来氟米特治疗脊柱关节病的疗效观察

The efficacy and safety of etanercept and leflunomide on patients with spondyloarthropathy

目的观察依那西普联合来氟米特在治疗脊柱关节病(SpA)中的疗效及安全性。方法 21例SpA患者接受依那西普50 mg/周+来氟米特20 mg/d联合治疗,所有入组病人每10 d记录一次疼痛目视模拟测试表(VAS),患者及医生对患者健康状况的总体评估,检测强直性脊柱炎活动指数(BASDAI)和功能指数(BASFI)、C-反应蛋白(CRP)、血沉及血尿常规、肝肾功能及安全性指标。结果 21例入组病人在疼痛目视模拟测试表(VAS),患者及医生对患者健康状况的总体评估,BASDAI、BASFI、C-反应蛋白、血沉,显示出显著改善。安全性方面,注射部位反应6/21(其中1例出现局部结节红斑,直径超过50mm),头痛2/21,上呼吸道感染3/21例,腔隙性脑梗死1/21(因怀疑可能与应用依那西普有关,该例病人在应用1周后退出观察),血液系统改变中有6/21例,出现淋巴细胞的轻度升高,肝功轻度异常4/21例,所有患者均未出现肾功方面的不良反应。结论依那西普联合来氟米特在脊柱关节病治疗中,10周时症状迅速得到控制,无严重的不良反应,并且是安全的。

Objective To evaluate the efficacy and safety of Etanercept and leflunomide for the patients with spondyloarthropathy（SpA）.Methods Twenty-one patients with SpA received etanercept 50 mg once a week for a therapeutic course,combined with leflunomide 20 mg once a day.Visual Analogue Score（VAS）,Clinical Health Assessment,Bath Ankylosing Spondylitis Disease Activity Index（BASDAI）,Bath Ankylosing Spondylitis Functional Index（BASFI）,C-reactive protein（CRP）,erythrocyte sedimentation rate（ESR）,blood routine,urine routine,liver function,renal function and other safety indexes were examined every ten days.Results The BASDAI,BASFI,VAS,Clinical Health Assessment,CRP,ESR of the twenty-one patients were significantly ameliorated within 10 weeks.Six patients had injection site reactions,one of them has a local nodal erythema which size is more than 50 millimetre in diameter.Other adverse reactions happened in the twenty-one patients during the observation,including the headache（2/21）,upper respiratory tract infection（3/21）,lacuna infarction（1/21）（this patient quit after the first week）,moderately elevated lymphocytes（6/21） and liver dysfunction（4/21）.All the patients did not appear kidney merit adverse reactions.Conclusion The treatment with etanercept combined with leflunomide has obvious therapeutic effect on SpA with less serious adverse reactions in 10 weeks.