依那西普治疗强直性脊柱炎的临床研究

目的 评价肿瘤坏死因子抑制剂依那西普治疗强直性脊柱炎(AS)的临床疗效和安全性,并检测其治疗前后AS患者血清基质金属蛋白酶(MMP)-3浓度的变化,为AS疗效判断寻找新的指标.方法 应用依那两普治疗48例AS患者,25 mg/次,每周2次,疗程12周,记录治疗前后患者的症状、体征、AS疾病活动指数(BASDAI)、AS的功能指数(BASH)、红细胞沉降率(ESR)及C-反应蛋白(CRP)等实验室指标及不良反应;应用ELISA检测治疗前后MMP-3浓度.结果 依那西普治疗后患者的脊柱痛与夜间痛程度、晨僵时间均改善,指地距、BASDAI、BASH均下降,与治疗前比较均有统计学差异(P＜0.05).AS组血清MMP-3水平与正常对照之间差异无显著性.依那西普治疗12周后患者的MMP-3水平显著下降(P＜0.05),CRP和ESR也较治疗前显著下降.进一步的相关分析显示,治疗后MMP-3降低水平与ESR、CRP的下降值亦呈正相关关系(r分别为0.397和0.474,P＜0.05).最常见的不良反应主要是注射部位反应和上呼吸道感染.结论 依那两普对AS有显著的临床疗效,无严重不良反应.能够显著降低AS外周血清中MMP-3水平:MMP-3可作为评价依那西普治疗AS疗效的一个有用的客观指标.

Clinical study of etanercept for treating ankylosing spondylitis

OBJECTIVE: To evaluate the efficacy and safety of etanercept, a tumor necrosis factor (TNF)-alpha inhibitor, in the treatment of ankylosing spondylitis (AS), and investigate its effect on serum levels of matrix metalloproteinase-3 (MMP-3). METHODS:Forty-eight patients with AS received etanercept 25 mg twice a week for a treatment course of 12 weeks. The patients' symptoms, signs, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) levels and side effects were observed before and after the treatment. The serum levels of MMP-3 was determined using enzyme-linked immunosorbent assay (ELISA).RESULTS: All the patients completed the treatment. The degree of spinal pain and pain at night, the duration of morning stiffness, the finger-to-floor distance, BASDAI and BASFI were significantly improved after the treatment (P<0.05). Etanercept treatment resulted in a significant reduction in serum MMP-3 level in the AS patients to 31.22-/+10.26 ng/ml as compared with the level before treatment (46.17-/+25.74 ng/ml, P<0.05). The reduction of serum MMP-3 was positively correlated to decrement of ESR and CRP (r=0.397 and 0.474, respectively, P<0.05). The most common adverse events of etanercept included injection site reaction and upper respiratory infection.CONCLUSION: Etanercept treatment has obvious therapeutic effects on AS without serious adverse effects. MMP-3 may be a potentially useful indicator to assess the effect of anti-TNF-alpha treatment in AS patients.