重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗强直性脊柱炎的多中心随机双盲对照临床研究  

Efficacy and safety of a novel recombinant human tumor necrosis factor-α receptor Ⅱ ： Fc fusion protein in Chinese patients with active ankylosing spondylitis： results of a randomized, double-blind,multicenter trial

作　　者：李佳[1] 陈晓翔[1] 姜林娣[2] 赵东宝[3] 吴华香[4] 陶怡[5] 徐建华[6] 李兴福[7] 杨南萍[8] 胡绍先[9] 黄安斌[10] 鲍春德[1] 

机构地区：[1]上海交通大学医学院附属仁济医院风湿科, 200001 [2]复旦大学附属中山医院风湿免疫科 [3]第二军医大学长海医院风湿免疫科 [4]浙江大学医学院附属第二医院风湿科 [5]广州医学院第二附属医院风湿科 [6]安徽医科大学第一附属医院风湿免疫科 [7]山东大学齐鲁医院风湿科 [8]四川大学华西医院风湿免疫科 [9]华中科技大学同济医学院附属同济医院风湿免疫科 [10]华中科技大学同济医学院附属协和医院风湿免疫科

出　　处：《中华风湿病学杂志》2015年第11期750-755,共6页Chinese Journal of Rheumatology

摘　　要：目的 评估一种新型重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白（rhTN FR： Fc,商品名：安佰诺）治疗活动性AS的短期疗效与安全性.方法 纳入180例活动性AS患者,随机接受新型及已上市的2种rhTNFR：Fc,每周2次,25 mg治疗12周.主要疗效指标为12周达到ASAS20的受试者比例,次要疗效指标为不同时点达到ASAS20、ASAS40、BASDAI50、ASAS5/6应答的受试者比例,以及强直性脊柱炎病情活动度评分（ASDAS）、BASDAI、晨僵时间、Bath AS测量指数（BASMI）、BASFI、胸廓扩张度、肿胀关节数、疼痛关节数、总背痛、夜间痛、疾病活动性的受试者整体评价、ESR、CRP、强直性脊柱炎健康评价问卷（HAQ-S）等单项指标.所有受试者均进行安全性评价.统计学处理采用t检验和x2检验.结果 用药12周后试验组ASAS20为88％（89例）;对照组ASAS20为88％（90例）（x2=0.001,P=0.978）.次要疗效指标2组间差异亦无统计学意义.2组不良事件和不良反应发生率差异均无统计学意义.结论 2种重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白对活动性AS均具有显著疗效和良好的安全性.Objective To evaluate the efficacy and safety of tumor necrosis factor-α receptor Ⅱ ： Fc fusion protein （TNFR Ⅱ ： Fc）, a new recombinant human TNFR Ⅱ ： Fc fusion protein in Chinese patients with active ankylosing spondylitis （AS）.Methods 180 patients with active AS were treated 1：1 with two kinds of recom-binant human TNFRI Ⅱ ： Fc fusion proteins for 12 weeks.The primary efficacy endpoint was the percentage of patients meeting the Assessment in Spondylo-arthritis International Society response criteria （ASAS20） at week 12.The secondary endpoints included ASAS40, BASDAI50, ASAS5/6, Ankylosing Spondylitis Disease Activity Score （ASDAS）, Bath Ankylosing Spond-ylitis Disease Activity Index （BASDAI）, Morning stiffness, Bath Ankylosing Spondylitis Metrology Index （BASMI）, Bath Ankylosing Spondylitis Functional Index （BASFI）, Chest expansion.Swollen joint count, Tender joint count, Patient Global Assessment of disease activity, Erythrocyte Sedimentation Rate （ESR）, C-reactive protein （CRP） and the Health Assessment Questionnaire modified for the spondyloarthro-pathies （HAQ-S） total score.All patients were evaluated for safety.T test and x2 test were used for statistical analysis.Results After 12 weeks of treatment, ASAS20 achieved 88% in the experimental group （n=89）, and 88% in the control group （n=90）, the difference was not statistically significant （x2=0.001, P〉0.05）.The secondary endpoints were not significantly different between the two groups.The number of adverse events was not different between the two groups.Common adverse drug reactions included elevated liver enzymes, upper respiratory tract infection and injection site reactions.Conclusion The two kinds of Etanercepts appears to be fast-acting, effective and well tolerated in Chinese patients with active AS.

关 键 词：脊柱炎 强直性 双盲法 随机对照试验 重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白 

分 类 号：R593.23[医药卫生—内科学]