中华风湿病学杂志
中華風濕病學雜誌
중화풍습병학잡지
CHINESE JOURNAL OF RHEUMATOLOGY
2011年
10期
671-676
,共6页
陈晓翔%戴青%吴华香%赵东宝%李兴福%胡绍先%杨南萍%陶怡%徐建华%黄安斌%姜林娣%鲍春德
陳曉翔%戴青%吳華香%趙東寶%李興福%鬍紹先%楊南萍%陶怡%徐建華%黃安斌%薑林娣%鮑春德
진효상%대청%오화향%조동보%리흥복%호소선%양남평%도이%서건화%황안빈%강림제%포춘덕
关节炎,类风湿%甲氨蝶呤%重组人肿瘤坏死因子受体Ⅱ-Fc融合蛋白
關節炎,類風濕%甲氨蝶呤%重組人腫瘤壞死因子受體Ⅱ-Fc融閤蛋白
관절염,류풍습%갑안접령%중조인종류배사인자수체Ⅱ-Fc융합단백
Arthritis,rheumatoid%Methotrexate%TNFRⅡ-Fc
目的 评价重组人肿瘤坏死因子受体Ⅱ-Fc融合蛋白(TNFRⅡ-Fc,商品名:安佰诺)治疗中重度活动性类风湿关节炎(RA)的临床和影像学疗效.方法 396例RA患者随机分为联合用药组、TNFRⅡ-Fc组和甲氨蝶呤组,疗程均为24周,单因素方差分析美国风湿病学会(ACR)-N、ACR20、ACR50、ACR70、疾病活动指数(DAS )28和治疗前后双手的X线Sharp评分(SHS)等疗效和安全性指标.结果 治疗24周后,ACR-N的年改善率联合组为(12.79±9.24)％,TNFRⅡ-Fc组为(9.56±11.16)％,甲氨蝶呤组为(5.08±11.10)％,联合用药组优于TNFRⅡ-Fc组和甲氨蝶呤组(P＜0.05),TNFRⅡ-Fc组优于甲氨蝶呤组(P＜0.05).ACR20的达标率联合组(80.4％)优于TNFR Ⅱ -Fc组(71.1％)和甲氨蝶呤组(56.7％),差异有统计学意义(P＜0.05或P＜0.01).治疗24周后,联合组ACR50和ACR70的达标率分别为53.6％和27.7％,TNFRⅡ-Fc组为41.2％和15.8％,甲氨蝶呤组为30.8％和7.7％,联合组ACR50达标率优于甲氨蝶呤组(P＜0.01),联合组ACR70达标率优于TNFRⅡ-Fc组和甲氨蝶呤组(P＜0.05或P＜0.01).联合组的DAS28-红细胞沉降率(ESR)改善优于TNFRⅡ-Fc组和甲氨蝶呤组,差异有统计学意义(P＜0.05).双手SHS评分治疗前后差值联合组(-1.7±11.2)较甲氨蝶呤组(2.1±11.5)显著下降(P=0.03).联合组不良反应发生率(40.9％)高于甲氨蝶呤组(28.8％),差异有统计学意义(P＜0.05).结论 本研究显示TNFRⅡ-Fc联合甲氨蝶呤较单独使用TNFRⅡ-Fc或甲氨蝶呤能更有效控制RA的活动性和影像学进展.
目的 評價重組人腫瘤壞死因子受體Ⅱ-Fc融閤蛋白(TNFRⅡ-Fc,商品名:安佰諾)治療中重度活動性類風濕關節炎(RA)的臨床和影像學療效.方法 396例RA患者隨機分為聯閤用藥組、TNFRⅡ-Fc組和甲氨蝶呤組,療程均為24週,單因素方差分析美國風濕病學會(ACR)-N、ACR20、ACR50、ACR70、疾病活動指數(DAS )28和治療前後雙手的X線Sharp評分(SHS)等療效和安全性指標.結果 治療24週後,ACR-N的年改善率聯閤組為(12.79±9.24)％,TNFRⅡ-Fc組為(9.56±11.16)％,甲氨蝶呤組為(5.08±11.10)％,聯閤用藥組優于TNFRⅡ-Fc組和甲氨蝶呤組(P＜0.05),TNFRⅡ-Fc組優于甲氨蝶呤組(P＜0.05).ACR20的達標率聯閤組(80.4％)優于TNFR Ⅱ -Fc組(71.1％)和甲氨蝶呤組(56.7％),差異有統計學意義(P＜0.05或P＜0.01).治療24週後,聯閤組ACR50和ACR70的達標率分彆為53.6％和27.7％,TNFRⅡ-Fc組為41.2％和15.8％,甲氨蝶呤組為30.8％和7.7％,聯閤組ACR50達標率優于甲氨蝶呤組(P＜0.01),聯閤組ACR70達標率優于TNFRⅡ-Fc組和甲氨蝶呤組(P＜0.05或P＜0.01).聯閤組的DAS28-紅細胞沉降率(ESR)改善優于TNFRⅡ-Fc組和甲氨蝶呤組,差異有統計學意義(P＜0.05).雙手SHS評分治療前後差值聯閤組(-1.7±11.2)較甲氨蝶呤組(2.1±11.5)顯著下降(P=0.03).聯閤組不良反應髮生率(40.9％)高于甲氨蝶呤組(28.8％),差異有統計學意義(P＜0.05).結論 本研究顯示TNFRⅡ-Fc聯閤甲氨蝶呤較單獨使用TNFRⅡ-Fc或甲氨蝶呤能更有效控製RA的活動性和影像學進展.
목적 평개중조인종류배사인자수체Ⅱ-Fc융합단백(TNFRⅡ-Fc,상품명:안백낙)치료중중도활동성류풍습관절염(RA)적림상화영상학료효.방법 396례RA환자수궤분위연합용약조、TNFRⅡ-Fc조화갑안접령조,료정균위24주,단인소방차분석미국풍습병학회(ACR)-N、ACR20、ACR50、ACR70、질병활동지수(DAS )28화치료전후쌍수적X선Sharp평분(SHS)등료효화안전성지표.결과 치료24주후,ACR-N적년개선솔연합조위(12.79±9.24)％,TNFRⅡ-Fc조위(9.56±11.16)％,갑안접령조위(5.08±11.10)％,연합용약조우우TNFRⅡ-Fc조화갑안접령조(P＜0.05),TNFRⅡ-Fc조우우갑안접령조(P＜0.05).ACR20적체표솔연합조(80.4％)우우TNFR Ⅱ -Fc조(71.1％)화갑안접령조(56.7％),차이유통계학의의(P＜0.05혹P＜0.01).치료24주후,연합조ACR50화ACR70적체표솔분별위53.6％화27.7％,TNFRⅡ-Fc조위41.2％화15.8％,갑안접령조위30.8％화7.7％,연합조ACR50체표솔우우갑안접령조(P＜0.01),연합조ACR70체표솔우우TNFRⅡ-Fc조화갑안접령조(P＜0.05혹P＜0.01).연합조적DAS28-홍세포침강솔(ESR)개선우우TNFRⅡ-Fc조화갑안접령조,차이유통계학의의(P＜0.05).쌍수SHS평분치료전후차치연합조(-1.7±11.2)교갑안접령조(2.1±11.5)현저하강(P=0.03).연합조불량반응발생솔(40.9％)고우갑안접령조(28.8％),차이유통계학의의(P＜0.05).결론 본연구현시TNFRⅡ-Fc연합갑안접령교단독사용TNFRⅡ-Fc혹갑안접령능경유효공제RA적활동성화영상학진전.
Objective To evaluate the clinical and radiological efficacy of TNFR Ⅱ -Fc combined with methotrexate ( MTX ) in treatment of patients with moderate and severe rheumatoid arthritis.Methods Three hundred and ninty-six RA patients were randomized into the combined treatment group,the TNFR Ⅱ -Fc only group and MTX only group.All patients were treated for 24 weeks.ACR-N,ACR20,ACR50,ACR70,DAS28-ESR and Sharp score of both hands were measured for efficacy,and the side-effects were analyzed by one-way ANOVA.Results After 24-week therapy,the ACR-N of the combined treatment group [( 12.79±9.24)％-year] was significantly improved than that of the TNFR Ⅱ-Fc only group [(9.56±11.16)％-year,P＜0.05] and that of the MTX only group [(5.08±11.10)％-year,P＜0.05],and the TNFR Ⅱ-Fc group was significantly improved than that of the MTX group (P＜0.05).The ACR20 response rate of the combined group (80.4％) was significantly higher than that of the TNFR Ⅱ -Fc group (71.1％,P＜0.05) and the MTX group (56.7％,P＜0.01 ).The ACRS0 response rate of the combined group (53.6％) was significantly higher than that of the MTX group (30.8％,P＜0.01 ).The ACR70 response rate of the combined group was 27.7％,which was significantly different from that of the TNFR Ⅱ -Fc group (15.8％) and MTX group (7.7％,P＜0.05or P＜0.01 ).DAS28-ESR in the combination group was significantly reduced than those of the TNFR Ⅱ -Fc group and MTX group,and the DAS28-ESR of the TNFR Ⅱ -Fc group was significantly reduced than MTX group.The average total Sharp score of both hands,which demonstrated the radiographic changes,was significantly reduced in the combination group than the MTX group (P=0.03).The total adverse events in the combined group (40.9％) was significantly high than that of the MTX group (28.8％,P＜0.05).Conclusion TNFR Ⅱ -Fc combined with MTX can effectively control the activity of RA and radiological progress.
