托珠单抗治疗难治性类风湿关节炎患者的效果  

Efficacy of Tocilizumab treating refractory rheumatoid arthritis

作　　者：戴莉萍[1,2] 何伟珍[1,2] 孔卫红[1,2] 尹志华[1,2] 叶志中[1,2] 

机构地区：[1]广东医学院附属福田医院香蜜湖风湿病分院 [2]广东医学院风湿病研究所,广东深圳518040

出　　处：《中国医药导报》2014年第22期60-62,69,共4页China Medical Herald

基　　金：广东省科技计划项目(编号2010B031600027)

摘　　要：目的：评价托珠单抗治疗难治性类风湿性关节炎的效果及安全性。方法选择2013年8月-2014年2月于广东医学院附属福田医院香蜜湖风湿病分院诊治的难治性类风湿关节炎患者57例,按2颐1的比例分为两组,实验组38例,对照组19例。试验组给予托珠单抗联合甲氨蝶呤,每4周静脉滴注1次托珠单抗8 mg/kg,联合甲氨蝶呤10 mg每周口服；对照组同等剂量的甲氨蝶呤,治疗12周。试验组及对照组均在治疗后第1、12周评价疗效。疗效评价采用美国风湿病学会（ACR）疗效评价指标ACR 20、ACR 50。结果试验组及对照组治疗后第1周达到ACR 20为80.6豫,ACR 50为77.8豫,分别均高于对照组的36.9豫和15.8豫,试验组优于对照组,差异有高度统计学意义（〈0.01）。同样,治疗12周后,试验组ACR 20为92.1豫,ACR 50为86.1豫,明显高于对照组的57.9豫和31.6豫,试验组优于对照组,差异有高度统计学意义（〈0.01）。试验组患者临床症状,红细胞沉降率、C反应蛋白的改善优于对照组,差异有高度统计学意义（〈0.01）。实验组出现不良反应5例,对照组出现不良反应3例,症状较轻,对症治疗好转。结论托珠单抗联合甲氨蝶呤治疗难治性类风湿关节炎效果显著,明显优于单纯甲氨蝶呤治疗,且起效快,疗效较持久,安全性好。Objective To evaluate the efficacy and safety of Tocilizumab for treating refractory rheumatoid arthritis （RA）. Methods From August 2013 to February 2014, Xiangmihu Rheumatology Branch of the Affiliated Futian Hospital of Guangdong Medical College, the 57 patients with refractory rheumatoid arthritis were devided into two groups. The test group （38 cases） were treated with combinated treatment of Tocilizumab 8 mg/kg infusion every 4 weeks and MTX, 10 mg/week; the control group （19 cases） along with the same dose of MTX, for 12 weeks. Activity and efficacy evalua-tion indexes were compared between the two groups after treatment. The primary analysis evaluated by the proportion of patients with American College of Rheumatology （ACR） 20, ACR50. Results After 1 week, the proportion of patients with ACR20, ACR50 in test group were significantly higher than that in control group （80.6% vs 36.9%, 77.8% vs 15.8%）, the differences were statistically significant （〈0.01）. After 12 weeks, the proportion of patients with ACR20, ACR50 in test group were significantly higher than that in control group （92.1% vs 57.9%, 86.1% vs 31.6%）, the dif-ferences were statistically significant （P〈 0.01）. And, the major clinical manifests of the text group were alleviate and the indexes of disease activity were downward, the differences were statistically significant （P〈 0.01）. Adverse event （AE） occurred were 5 cases in and the test group and 3 cases in the control group, most of the AE were mild. Conclu-sion The study shows that tocilizumab is safe and effective in treatment of refractory RA patients.

关 键 词：托珠单抗 类风湿关节炎 难治性 疗效 

分 类 号：R593.22[医药卫生—内科学]