HA280免疫吸附治疗炎性肌病的近期疗效及安全性

The short-term efficacy and safety of HA280 immunoadsorption column in patients with idiopathic inflammatory myopathies

目的探讨HA280免疫吸附治疗炎性肌病的近期临床疗效和安全性。方法回顾性分析2015年1月至2018年3月在中南大学湘雅二医院风湿免疫科住院的72例炎性肌病患者的临床资料。其中22例接受了HA280免疫吸附治疗(免疫吸附组),50例为仅接受药物治疗的对照组。观察各组治疗前后患者的临床表现、自身抗体(ANA、肌炎特异性抗体及其他自身抗体)、炎症指标(ESR、CRP、铁蛋白)、免疫球蛋白、补体、心肌酶谱、肺部影像学的变化。计数资料比较采用χ^2检验,正态计量资料比较采用成组t检验;非正态计量资料比较采用秩和检验。结果HA280免疫吸附治疗后患者的症状和体征有明显改善,尤其是非特异性肌炎的临床好转率免疫吸附组(89%,16/18)高于对照组(58%,22/38),2组差异有统计学意义(χ^2=5.379,P<0.05)。免疫吸附组能更有效清除患者的ANA[对照组平均等级39.41,吸附组平均等级28.38,Z=-2.51,P=0.01];且能更显著地降低患者的ESR[对照组24(22)mm/1 h,免疫吸附组10(7)mm/1 h,Z=-3.0,P=0.003];肌酶[对照组717(1564)U/L,免疫吸附组126(432)U/L,Z=3.09,P<0.01]和IgG[对照组11(5)g/L,免疫吸附组9(2)g/L,Z=-4.8,P=0.001]、IgM[对照组0.9(0.4)g/L,免疫吸附组1.2(0.8)g/L,Z=-2.0,P=0.05]。随访3个月后复查患者肺部高分辨CT,影像学结果显示:与对照组相比,免疫免疫吸附组能更有效改善患者肺间质纤维化[对照组61%(27/44),免疫吸附组89%(17/19)],2组差异有统计学意义(χ^2=4.98,P<0.05)。所有患者在观察期间未发生严重不良反应。结论HA280免疫吸附治疗能够在短时间内有效清除炎性肌病患者的自身抗体,降低患者肌酶学、炎症指标、免疫球蛋白水平和改善部分患者的肺间质纤维化,且具有较好的安全性。HA280免疫吸附治疗为炎性肌病患者的治疗提供了新途径。

Objective To evaluate the short-term efficacy and safety of HA280 immunoadsorption(IA)column in idiopathic inflammatory myopathies(IIM).Methods The clinical data of 72 patients with IIM admitted to the Department of Rheumatology of Xiangya No.2 Hospital of Central South University from January 2015 to March 2018 were analyzed.Of these patients,22 patients were treated with HA280 immunoadsorption column for three times(the immunoadsorption group)and 50 patients were treated with drugs only(the control group).The changes of clinical symptoms and signs,autoimmune antibodies,myocardial enzyme spectrum,the inflammatory markers[erythrocyte sedimentation rate(ESR),C-reactive protein(CRP)and ferritin],immunoglobulin,complement,other biochemical indexes and pulmonary images of the patients were detected and analyzed before and after the treatment.And then the data were analyzed by Chi-square test,samples t testand Wilcoxon rank sum test.Results Compared with the control group,the symptoms and signs were obviously improved after treatment with HA280 immunoadsorption column.In particular,the clinical improvement rate of non-specific myositis(89%,16/18)was higher than that of the control group[(58%,22/38),χ^2=5.379,P<0.05].And the clearance of autoantibody(control group)was grade 39.41 in average,28.38 in average in the immunoadsorption group(Z=-2.51,P=0.01),myocardial enzyme spectrum[control 717(1564)U/L,immunoadsorption group 126(432)U/L,Z=3.09,P<0.01],the inflammatory markers such as ESR[the control group was 24(22)mm/1 h,the immunoadsorption group was 10(7)mm/1 h,Z=-3.0,P=0.003]and immunoglobulin G[the control group was 11(5)g/L,the immunoadsorption group was 9(2)g/L,Z=-4.8,P=0.001]and immunoglobulin M[the control group was 0.9(0.4)g/L,the immunoadsorption group was 1.2(0.8)g/L,Z=-2.0,P=0.05].Moreover,the lung CT scan showed that pulmonary lesions of the patients in the immunoadsorption group(89%,17/19)was much more improved than the control group[(61%,27/44),χ^2=4.98,P<0.05].No serious adverse reactions occurred.Conclusion HA280 immunoadsorption therapy can significantly clear the autoantibodies,decrease muscle enzymes,inflammatory markers and immunoglobulin,improve lung images of some patients in a short time.It has been shown that it is safein patients with IIM.HA280 immunoadsorption therapy could be an effective treatment for IIM.