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

Short-term clinical observation of moderate to severe active rheumatoid arthritis treated with tocilizumab combined with disease modifying antirheumatic drugs

目的:研究托珠单抗联合改善病情抗风湿药(DMARDs)治疗中重度活动性类风湿关节炎(RA) 12周临床疗效及不良反应。方法:20例中重度活动的RA患者分别在0周、4周、8周接受托珠单抗8 mg/kg治疗,同时予以DMARDs治疗,在4周、8周、12周观察疗效及不良反应。观察指标为血沉、C反应蛋白(CRP)、类风湿因子(RF)、血红蛋白、血小板、疾病活动度评分(DAS28)、肝功能、肾功能、患者对疾病总体评价和医生对疾病总体评价及美国风湿病学会疗效评价指标(ACR20、ACR50)。结果:与治疗前相比,20例RA患者在4周、8周、12周时血沉、CRP、RF、血小板均明显下降,差异均有统计学意义(P<0. 01); DAS28在治疗4周时明显改善,在治疗8周时进一步改善,差异均有统计学意义(P <0. 01);而血红蛋白在4周时明显上升,到12周时进一步上升,差异均有统计学差异(P <0. 01);患者和医生总体评价评分持续性下降,差异有统计学意义(P <0. 01);在8周和12周时达到ACR20者达90%、95%,达到ACR50者达80%、90%; 20例患者中有1例出现上呼吸道感染,但无严重感染、肝肾损害及过敏反应发生。结论:托珠单抗联合DMARDs治疗RA短期之内即改善患者的症状体征及炎症指标,且无明显不良反应发生。

AIM:To study the clinical efficacy and adverse reactions of tocilizumab combined with disease modifying antirheumatic drugs(DMARDs)in the treatment of moderate-to-severe active rheumatoid arthritis(RA)for 12 weeks.METHODS:Twenty patients with moderate-to-severe active RA were treated with 8 mg/kg of tocilizumab at 0,4th,and 8th week and treated with DMARDs.The effects and adverse reactions were observed at 4th week,8th week and 12th week.The observed indicators were erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),rheumatoid factor(RF),hemoglobin,platelet,DAS28,hepatic function,renal function,ACR20,ACR50,overall evaluation of the patient and physician to disease.RESULTS:Compared with baseline,ESR,CRP,RF and platelet counts in 20 RA patients were significantly decreased at 4th week,8th week,and 12th week,and the difference was statistically significant(P<0.01);DAS28 was significantly improved at 4th week of treatment,and further improved at 8th week of treatment,the difference was statistically significant(P<0.01);and hemoglobin increased significantly at 4th weeks,and further increased at 12th week,the difference was statistically significant(P<0.01).The overall evaluation scores of the patients and doctors decreased continuously,the difference was statistically significant(P<0.01);At 8th week and 12th week,ACR20 reached 90%,95%,and ACR50 reached 80%,90%;1 of 20 patients appeared upper respiratory tract infection,there were no liver,kidney and hypersensitivity reactions.CONCLUSION:Tocilizumab combined with DMARDs in the treatment of RA within a short period of time improve the patient's symptoms,signs and inflammation indicators with no significant adverse reactions occurred.