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对骨代谢的影响  

An open-label, multicentric clinical trial to evaluate the efficacy and impact on bone metabolism of recombinant human tumor necrosis factor-α receptor Ⅱ IgG Fc fusion protein with methotrexate in active rheumatoid arthritis：24-week clinical and radiographic results from ReABLE study

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[3] 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学院北京协和医院风湿免疫科,100730 [2]北京大学第一医院风湿免疫科 [3]中国人民解放军自求恩国际和平医院风湿免疫科

出　　处：《中华医学杂志》2010年第35期2481-2485,共5页National Medical Journal of China

摘　　要：目的 评估重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白（商品名益赛普）联合甲氨蝶呤治疗活动性类风湿关节炎（RA）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患者应用益赛普（25 mg皮下注射,每周2次）联合甲氨蝶呤（15 mg口服每周）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Sharp评分标准评价关节腔狭窄和关节侵蚀.结果 治疗24周时达到ACR20、50、70标准的有效率分别为90%、76.67%和46.67% DAS28由基线的6.41±0.61降至3.65±1.26（P＜0.01）,36.67%的RA患者达到疾病缓解或低度活动状态 欧洲抗风湿病联盟（EULAR）中等应答率和优良应答率分别为60%和36.67% 健康状况问卷评估逐渐减低,由基线的1.12降至0.36（P＜0.01） 90%患者双手腕X线片无放射学进展.不良反应与以往报道相似.结论 益赛普联合甲氨蝶呤治疗RA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,且耐受性良好 值得进行大样本的随机对照研究.Objective To evaluate the efficacy, radiographic changes 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 30 RA patients were treated with rhTNFR： Fc （25 mg subcutaneously twice weekly） and oral MTX （up to 15 mg weekly） in an openlabel manner. Clinical response was assessed by American College of Rheumatology （ACR） criteria and Disease Activity Score in 28 joints （DAS28）. Radiographs of hands and wrist were assessed by the modified Sharp score. Results At Week 24, ACR20, ACR50 and ACR70 responses were achieved by 90%,76. 67% and 46. 67% respectively. At Week 24, the mean DAS28 was 3.65 ± 1.26 versus 6. 41 ±0. 61 at baseline （ P 〈 0. 001 ）. And 20% patients achieved remission and 16. 67% patients had a low disease activity. At week 24, EULAR good and moderate responses were attained by 36. 67% and 60%respectively. Similarly, Health Assessment Questionnaire （HAQ） improved significantly, declining from 1.12 at baseline to 0. 36 at week 24 （P 〈0. 001 ）. No radiographic progression （ based on change of total Sharp score） was found in 27 cases. Adverse events were mild. Conclusion rhTNFR： Fc in combination with MTX shows an excellent efficacy of reduced disease activity, improved function and slowed radiographic progression through 24 weeks. A combination therapy for 24 weeks can lead to disease remission and an inhibition of radiographic progression. Further study is warranted.

关 键 词：类风湿关节炎 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]