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目的采用磁共振成像(MRI)评价临床活动性类风湿关节炎(RA)患者对注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白联合甲氨蝶呤的疗效。方法收集2008年10月至2010年4月北京协和医院、北京大学第一医院及白求恩国际和平医院收治的28例临床高度活动[28处关节疾病活动度评估(DAS28)≥5.1]的RA患者,所有患者均接受了为期52周的注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白25 mg每周2次皮下注射联合甲氨蝶呤治疗。过程中定期评价临床疾病活动度。在试验基线期及进行至24周及52周时应用改良Sharp评分(vd HSS)评价双手X线平片;应用RAMRIS评分方法评价患者基线期及第52周时双手及腕关节MRI改变,包括滑膜炎、骨水肿及骨侵蚀3项指标。根据基线期MRI骨侵蚀评分除以病程(年)获得粗略基线骨侵蚀年进展速率,并与试验52周期间骨侵蚀改变进行比较。结果试验进行至52周时,基于28关节的平均肿胀关节数、压痛关节数及DAS28-ESR出现显著下降(P<0.001)。分别有24例及23例患者的RAMRIS滑膜炎及骨水肿评分得到改善;所有患者的MRI下骨侵蚀均出现了进展。进一步分析显示,MRI骨侵蚀与时间加权疾病活动度间存在弱相关(rs=0.39,P=0.046)。经过治疗,全部6例短病程RA的MRI骨侵蚀年进展速率从基线时的70.72±28.38降至8.00±4.15(P=0.004);而26例长病程患者中仅有8例出现骨侵蚀速率下降。结论注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白联合甲氨蝶呤治疗能够改善大多数RA患者MRI下滑膜炎及骨水肿的作用,治疗病程小于2年的患者能够更为有效地减慢骨侵蚀的进展速度。
Objective To evaluate the efficacy of recombinant human type Ⅱ tumor necrosis factor receptor-antibody fusion protein combined with methotrexate in patients with clinical active rheumatoid arthritis (RA) by using magnetic resonance imaging (MRI). Methods A total of 28 patients with RA at the Peking Union Medical College Hospital, Peking University First Hospital and Norman Bethune International Peace Hospital were enrolled in the study. Among them, 28 RA patients with joint disease activity assessment (DAS28) ≥5.1 were recruited from October 2008 to April 2010, All patients received a combination of subcutaneous injection of methotrexate 25 mg twice weekly for methotrexate and recombinant human type 2 TNF receptor-antibody fusion protein for 52 weeks. Regular evaluation of clinical disease activity in the process. Two-handed X-ray plain films were evaluated at baseline and up to week 24 and week 52 using a modified Sharp score (vd HSS). RAMRIS score was used to assess MRI changes of hands and wrists at baseline and week 52, including sliding Meningitis, bone edema and bone erosion three indicators. Baseline MRI bone erosion scores divided by duration of disease (year) obtained rough baseline rate of bone erosion rate of progress, and with the 52-week trial of bone erosion changes were compared. Results At 52 weeks, the average number of swollen joints, joint at tenderness, and DAS28-ESR was significantly decreased at 28 weeks (P <0.001). RAMRIS synovitis and bone edema scores were improved in 24 and 23 patients, respectively; and all patients underwent MRI progression of bone erosion. Further analysis showed a weak correlation between MRI bone erosion and time-weighted disease activity (rs = 0.39, P = 0.046). After treatment, the rate of annual progression of MRI bone erosion in all 6 patients with short course RA decreased from 70.72 ± 28.38 at baseline to 8.00 ± 4.15 (P = 0.004), whereas only 8 of 26 patients with long courses had decreased rates of bone erosion . CONCLUSION: Injection of recombinant human Tumor Necrosis Factor Receptor-Antibody Fusion Protein (MHC Ⅱ) combined with methotrexate can improve the synovitis and edema in most RA patients. The treatment of patients with disease duration less than 2 years can be more effective Slow down the rate of bone erosion progress.