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活动性类风湿关节炎的疗效和安全性的开放多中心临床研究  

ReABLE study on the efficacy and long-term safety of recombinant human tumor necrosis factor-α receptor ⅡIgG Fc fusion protein with methotrexate in active rheumatoid arthritis

作　　者：吴庆军[1] 张卓莉[2] 李振彬[3] 徐东[1] 李光韬[2] 耿丽芬[3] 李梦涛[1] 王昱[2] 朱建君[3] 郝燕捷[2] 惠乃玲[3] 杨静[3] 崔晓青[3] 张晓刚[3] 赵岩[1] 

机构地区：[1]中国医学科学院北京协和医院风湿免疫科,100032 [2]北京大学第一医院风湿免疫科 [3]中国人民解放军白求恩国际和平医院风湿免疫科

出　　处：《中华风湿病学杂志》2011年第9期600-603,共4页Chinese Journal of Rheumatology

摘　　要：目的评估重组人Ⅱ型肿瘤坏死因子受体一抗体融合蛋白（rhTNRF：Fc）联合甲氨蝶呤治疗活动性类风湿关节炎（RA）52周的临床疗效、放射学改变和安全性。方法30例中重度活动性RA患者应用rhTNRF：Fc（25mg皮下注射，每周2次）联合甲氨蝶呤（每周15mg口服）治疗。应用美国风湿病学会（ACR）20、50、70疗效标准和28个关节的疾病活动度评分（DAS28）评估临床疗效，应用改良的sharD评分标准评价放射学疗效。计数资料应用x2检验或Fisher精确检验，计量资料采用配对t检验。结果治疗52周时达到ACR20、50、70标准的有效率分别为90％、87％和67％。DAS28由6．4±0．6降至3．4±1．1（R0．01），23％患者达到疾病缓解，17％达到低度活动状态。健康状况问卷由1．18±0．56降至0．25±0．34（P〈0．01）。基线期和52周时，双手和双腕X线片关节间隙狭窄（8±10与8±11）和关节侵蚀（10±15与10±15）的改良Sharp评分差异无统计学意义；73％患者无放射学进展。未见严重不良反应，无新发结核菌感染和恶性肿瘤。结论rhTNRF：Fc联合甲氨蝶呤治疗RA52周能够显著减低疾病活动度、改善关节功能以及延缓放射学进展，达到临床缓解和阻止放射学进展的治疗目标；且耐受性良好。Objective To evaluate the clinical and radiographic efficacy and safety of the combination of recombinant human tumor necrosis factor-α receptor Ⅱ IgG Fc fusion protein （rhTNFR：Fc） and methotrexate （MTX） in patients with rheumatoid arthritis （RA）. Methods Thirty patients with highly active RA were treated with rhTNFR：Fc （25 mg subcutaneously twice weekly） and oral MTX （up to 15 rag weekly）. Clinical efficacy was assessed using ACR response criteria and the disease activity score in 28 joints （DAS28）. Radiographs of the hands and wrists were assessed with the modified Sharp score. Chi-square test, Fisher is exact test and paired t-test were performed. Results At week 52, ACR20, ACR50 and ACR70 responses were achieved by 90%, 87% and 67% respectively. At week 52, mean DAS28 was 3.4±1.1 compared to 6.4± 0.6 at base-line （P〈0.01）, with 23% patients achieving clinical remission and 17% patients in low diseaseactivity. Similarly, the HAQ was improved significantly, declining from 1.18±0.56 at base-line to 0.25±0.34 at week 52 （P〈0.01）. No radiographic progression was found in 22 cases. Adverse events were mild in general. Conclusion Treatment with rhTNFR：Fc plus MTX has shown good efficacy throughout 52 study period in reducing disease activity, improving function, and retarding radiographic progression. Combination therapy for 52 weeks can achieve disease remission and no radiographic progression, which are the two goals of therapy for RA.

关 键 词：关节炎 类风湿 重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白 治疗 

分 类 号：R593.22[医药卫生—内科学]