托珠单抗治疗活动性难治性类风湿关节炎的疗效及不良反应
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摘要
目的评价托珠单抗注射液治疗活动性难治性类风湿关节炎(refractory rheumatoid arthritis,RRA)的临床疗效及安全性。方法选取2014年6月至2016年6月于重庆三峡中心医院血液风湿免疫科门诊就诊的69例活动性RRA患者。所有患者均接受托珠单抗静脉注射治疗,可同时与氨甲蝶呤(methotrexate,MTX)或其他抗风湿药物(disease-modifying antirheumatic drugs,DMARDs)联用。观察治疗前及治疗后第4、8、12周时的红细胞沉降率(erythrocytesedimentationrate,ESR)、C-反应蛋白(C-reactive protein,CRP)、肿胀关节数、压痛关节数、休息痛、晨僵时间、28个关节的疾病活动度评分(disease activity score of 28 joints,DAS28)、临床疾病活动指数(clinical disease activity index,CDAI)、简化疾病活动指数(simpli?ed disease activity index,SDAI)评分,并记录不良反应发生情况。结果治疗后ESR、CRP、肿胀关节数、压痛关节数、休息痛、晨僵时间较治疗前均有不同程度改善,差异有显著性(P<0.05);对治疗前、治疗后第4、8、12周SDAI、CDAI、DAS28评分进行比较,发现治疗后第4周即有显著改善,差异有显著性(P<0.05)。本组患者均能坚持完成治疗及疗效评价,未出现严重的不良反应。结论托珠单抗能明显缓解活动性RRA患者的临床症状和体征,减轻疾病活动度,且安全性较高。
Objective To evaluate the ef?cacy and safety of tocilizumab in the treatment of active refractory rheumatoid arthritis(RRA).Method From June 2014 to June 2016, 69 patients with active RRA who were admitted to the Department of Rheumatology and Immunology in our hospital received intravenous injection of tocilizumab. They were also treated with methotrexate(MTX) or other antirheumatic drugs(disease-modifying antirheumatic drugs, DMARDs). The patients were followed up for treatment at 4, 8, and 12 weeks after treatment. The indicators included erythrocyte sedimentation rate(ESR), C-reactive protein(CRP), number of swollen joints, number of tender joints, rest pain, morning stiffness time, disease activity score of 28 joints(DAS28), clinical disease activity index(CDAI),simplified disease activity index(SDAI) score and record the occurrence of adverse reactions. Result After treatment, the number of ESR, CRP, swollen joints, number of tender joints, rest pain and morning stiffness were improved to different degrees before treatment.The difference was statistically significant(P<0.05). SDAI, CDAI and DAS28 scores before treatment. Compared with the 4 th, 8 th and 12 th week after treatment, it was found that there was a signi?cant improvement at the 4 th week after treatment, and the difference was statistically signi?cant(P<0.05). The patients enrolled in this study were able to adhere to the completion of treatment and ef?cacy evaluation. Serious adverse reactions occurred. Conclusion Tocilizumab can signi?cantly alleviate the clinical symptoms and signs of active RRA patients, reduce disease activity, and have higher safety.
Objective To evaluate the ef?cacy and safety of tocilizumab in the treatment of active refractory rheumatoid arthritis(RRA).Method From June 2014 to June 2016, 69 patients with active RRA who were admitted to the Department of Rheumatology and Immunology in our hospital received intravenous injection of tocilizumab. They were also treated with methotrexate(MTX) or other antirheumatic drugs(disease-modifying antirheumatic drugs, DMARDs). The patients were followed up for treatment at 4, 8, and 12 weeks after treatment. The indicators included erythrocyte sedimentation rate(ESR), C-reactive protein(CRP), number of swollen joints, number of tender joints, rest pain, morning stiffness time, disease activity score of 28 joints(DAS28), clinical disease activity index(CDAI),simplified disease activity index(SDAI) score and record the occurrence of adverse reactions. Result After treatment, the number of ESR, CRP, swollen joints, number of tender joints, rest pain and morning stiffness were improved to different degrees before treatment.The difference was statistically significant(P<0.05). SDAI, CDAI and DAS28 scores before treatment. Compared with the 4 th, 8 th and 12 th week after treatment, it was found that there was a signi?cant improvement at the 4 th week after treatment, and the difference was statistically signi?cant(P<0.05). The patients enrolled in this study were able to adhere to the completion of treatment and ef?cacy evaluation. Serious adverse reactions occurred. Conclusion Tocilizumab can signi?cantly alleviate the clinical symptoms and signs of active RRA patients, reduce disease activity, and have higher safety.
引文
[1]Strangfeld A,Richter A,Siegmund B,et al.Risk for lower intestinal perforations in patients with rheumatoid arthritis treated with tocilizumab in comparison to treatment with other biologic or conventional synthetic DMARDs[J].Ann Rheum Dis,2017,76(3):504-510.
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[3]陈兰芳,强孚勇,徐亮.托珠单抗联合改善病情抗风湿药治疗中重度类风湿关节炎短期临床观察[J].中国临床药理学与治疗学,2018,23(12):1386-1391.
[4]陈乐锋,马剑达,韦秀宁,等.托珠单抗联合治疗对难治性类风湿关节炎患者病情活动及心理状态的疗效观察[J].中华风湿病学杂志,2015,19(2):115-118.
[5]Diaz-Torne C,Ortiz MDA,Moya P,et al.The combination of IL-6 and its soluble receptor is associated with the response of rheumatoid arthritis patients to tocilizumab[J].Semin Arthritis Rheum,2018,47(6):757-764.
[6]施卫民.托珠单抗对难治性类风湿关节炎患者血清TL1A、IL-17的影响[J].现代实用医学,2018,30(12):1619-1621.
[7]吴会霞,任洁,朱丽花,等.托珠单抗与依那西普治疗类风湿关节炎疗效观察[J].暨南大学学报(自然科学与医学版),2016,37(4):358-362.
[8]张敏,谭震,马艳,等.托珠单抗联合cDMARDs治疗难治性类风湿关节炎的疗效及安全性评估[J].中华疾病控制杂志,2018,22(2):211-214.
[9]孙芳芳,叶霜.托珠单抗联合甲氨蝶呤治疗难治性类风湿关节炎的疗效观察[J].上海交通大学学报(医学版),2016,36(11):1640-1642,1647.
[10]尚可,皮慧,王友莲,等.托珠单抗注射液治疗32例难治性活动性类风湿关节炎的临床观察[J].中华风湿病学杂志,2015,19(7):451-454.
[11]张雅媛,钱小青,樊志丹,等.托珠单抗治疗难治性全身型幼年特发性关节炎25例回顾性分析[J].中华风湿病学杂志,2017,21(4):241-246.
[12]张海宁,尹园,柳玉梅,等.托珠单抗对心衰大鼠辅助性T细胞17介导的心肌炎症反应的影响[J].中国现代医学杂志,2015,25(35):7-12.
[13]李晓燕,张惠琴,李辉,等.英夫利西单克隆抗体治疗类风湿关节炎患者血脂水平的变化[J].中国医刊,2017,52(12):42-44.
[14]Burmester GR,Rigby WF,Vollenhoven RF,et al.Tocilizumab combination therapy or monotherapy or methotrexate monotherapy in methotrexate-naive patients with early rheumatoid arthritis:2-year clinical and radiographic results from the randomised,placebo-controlled FUNCTION trial[J].Ann Rheum Dis,2017,76(7):1279-1284.
[15]黄煜鹏,刘钢.托珠单抗治疗难治性类风湿关节炎的疗效与安全性[J].华西医学,2017,32(7):988-992.
[16]温丽英,朱由瑾,冯冬梅.类风湿因子、C反应蛋白、抗链O在银屑病关节炎中的检测及意义[J].中国临床医生杂志,2015,43(6):56-57.
[2]Scott LJ.Tocilizumab:a review in rheumatoid arthritis[J].Drugs,2017,77(17):1865-1879.
[3]陈兰芳,强孚勇,徐亮.托珠单抗联合改善病情抗风湿药治疗中重度类风湿关节炎短期临床观察[J].中国临床药理学与治疗学,2018,23(12):1386-1391.
[4]陈乐锋,马剑达,韦秀宁,等.托珠单抗联合治疗对难治性类风湿关节炎患者病情活动及心理状态的疗效观察[J].中华风湿病学杂志,2015,19(2):115-118.
[5]Diaz-Torne C,Ortiz MDA,Moya P,et al.The combination of IL-6 and its soluble receptor is associated with the response of rheumatoid arthritis patients to tocilizumab[J].Semin Arthritis Rheum,2018,47(6):757-764.
[6]施卫民.托珠单抗对难治性类风湿关节炎患者血清TL1A、IL-17的影响[J].现代实用医学,2018,30(12):1619-1621.
[7]吴会霞,任洁,朱丽花,等.托珠单抗与依那西普治疗类风湿关节炎疗效观察[J].暨南大学学报(自然科学与医学版),2016,37(4):358-362.
[8]张敏,谭震,马艳,等.托珠单抗联合cDMARDs治疗难治性类风湿关节炎的疗效及安全性评估[J].中华疾病控制杂志,2018,22(2):211-214.
[9]孙芳芳,叶霜.托珠单抗联合甲氨蝶呤治疗难治性类风湿关节炎的疗效观察[J].上海交通大学学报(医学版),2016,36(11):1640-1642,1647.
[10]尚可,皮慧,王友莲,等.托珠单抗注射液治疗32例难治性活动性类风湿关节炎的临床观察[J].中华风湿病学杂志,2015,19(7):451-454.
[11]张雅媛,钱小青,樊志丹,等.托珠单抗治疗难治性全身型幼年特发性关节炎25例回顾性分析[J].中华风湿病学杂志,2017,21(4):241-246.
[12]张海宁,尹园,柳玉梅,等.托珠单抗对心衰大鼠辅助性T细胞17介导的心肌炎症反应的影响[J].中国现代医学杂志,2015,25(35):7-12.
[13]李晓燕,张惠琴,李辉,等.英夫利西单克隆抗体治疗类风湿关节炎患者血脂水平的变化[J].中国医刊,2017,52(12):42-44.
[14]Burmester GR,Rigby WF,Vollenhoven RF,et al.Tocilizumab combination therapy or monotherapy or methotrexate monotherapy in methotrexate-naive patients with early rheumatoid arthritis:2-year clinical and radiographic results from the randomised,placebo-controlled FUNCTION trial[J].Ann Rheum Dis,2017,76(7):1279-1284.
[15]黄煜鹏,刘钢.托珠单抗治疗难治性类风湿关节炎的疗效与安全性[J].华西医学,2017,32(7):988-992.
[16]温丽英,朱由瑾,冯冬梅.类风湿因子、C反应蛋白、抗链O在银屑病关节炎中的检测及意义[J].中国临床医生杂志,2015,43(6):56-57.