CAJ | 학술논문

目的观察重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(rhTNFR:Fc,商品名益赛普)对类风湿关节炎(RA)患者IgM-类风湿因子(RF),IgG-RF,IgA-RF的影响,探讨rhTNFR:Fc治疗RA的免疫学机制.方法选择华中科技大学同济医学院附属协和医院及武汉市中心医院2007-2008年110例RA患者,采用随机数字表法随机分为rhTNFR:Fc组和甲氨蝶呤组.rhTNFR:Fc组55例,每周2次皮下注射rhTNFR:Fc(25 mg/次),24周.甲氨蝶呤组55例,每周1次口服甲氨蝶呤片,7.5mg/次起,8周内逐步加到15 mg/次,24周.观察药物对IgM-RF、IgG-RF、IgA-RF的影响,临床疗效评价采用28个关节疾病活动度(DAS28)疗效评定标准.组内治疗前后的差异采用配对t检验分析,组间治疗前后的差异采用两样本t检验分析.结果 ①2组患者病情均明显改善,rhTNFR:Fc的IgM-RF降低时间早于甲氨蝶呤组(P＜0.05).②rhTNFR:Fc组血清IgM-RF (29±16) U/ml明显降低(P＜0.05),IgG-RF (145±20) U/ml和IgA-RF(153±34)U/ml明显升高(P＜0.05).③甲氨蝶呤组IgM-RF (44±14) U/ml,IgG-RF (62±14) U/ml和IgA-RF (66±19) U/ml均明显降低(P＜0.05).④对临床指标的分析表明rhTNFR:Fc治疗RA疗效确切.结论 rhTNFR:Fc与甲氨蝶呤均能有效缓解RA的病情.rhTNFR:Fc能显著降低RA患者血清中IgM-RF的水平,而对IgG-RF,IgA-RF水平有升高作用,可能与其治疗RA的免疫学机制有关.
목적 관찰중조인Ⅱ형종류배사인자수체-항체융합단백(rhTNFR:Fc,상품명익새보)대류풍습관절염(RA)환자IgM-류풍습인자(RF),IgG-RF,IgA-RF적영향,탐토rhTNFR:Fc치료RA적면역학궤제.방법 선택화중과기대학동제의학원부속협화의원급무한시중심의원2007-2008년110례RA환자,채용수궤수자표법수궤분위rhTNFR:Fc조화갑안접령조.rhTNFR:Fc조55례,매주2차피하주사rhTNFR:Fc(25 mg/차),24주.갑안접령조55례,매주1차구복갑안접령편,7.5mg/차기,8주내축보가도15 mg/차,24주.관찰약물대IgM-RF、IgG-RF、IgA-RF적영향,림상료효평개채용28개관절질병활동도(DAS28)료효평정표준.조내치료전후적차이채용배대t검험분석,조간치료전후적차이채용량양본t검험분석.결과 ①2조환자병정균명현개선,rhTNFR:Fc적IgM-RF강저시간조우갑안접령조(P＜0.05).②rhTNFR:Fc조혈청IgM-RF (29±16) U/ml명현강저(P＜0.05),IgG-RF (145±20) U/ml화IgA-RF(153±34)U/ml명현승고(P＜0.05).③갑안접령조IgM-RF (44±14) U/ml,IgG-RF (62±14) U/ml화IgA-RF (66±19) U/ml균명현강저(P＜0.05).④대림상지표적분석표명rhTNFR:Fc치료RA료효학절.결론 rhTNFR:Fc여갑안접령균능유효완해RA적병정.rhTNFR:Fc능현저강저RA환자혈청중IgM-RF적수평,이대IgG-RF,IgA-RF수평유승고작용,가능여기치료RA적면역학궤제유관.
Objective To observe the effect of recombinant human tumor necrosis factor receptor Fc fusion Protein (rhTNFR:Fc) treatment on IgM-RF,IgG-RF,IgA-RF of patients with rheumatoid arthritis.Methods A randomized,active-comparator controlled,parallel group study were conducted.110 patients were enrolled and were randomly divided to the treatment group,in which patients were treated with twice weekly subcutaneous injection of rhTNFR:Fc (25 mg) (rhTNFR:Fc treatment group,n=55),and the MTX froup,in which MTX (the mean dosage was 15 mg/week) (MTX group,n=55) for 24 weeks.Blood routine,IgM-RF,IgG-RF,IgA-RF,and disease activity score 28 (DAS28) were monitored.Student's t-test was used for statistical analysis.Results The level of IgM-RF decreased significantly in the rhTNFR:Fc treatment group 24 week(29±16) U/ml later.However,the level of IgG-RF(145±20) U/ml,IgA-RF(153±34) U/ml increased significantly in the rhTNFR:Fc group,and the level of IgG-RF (62±14) U/ml,IgA-RF (66-±19) U/ml decreased significantly in the MTX group.Conclusion Although rhTNFR:Fc,is effective in treating the clinical symptoms of RA,it seems to affect RF producing-B cells either directly or indirectly.