依那西普治疗中国接受甲氨蝶呤治疗的活动性类风湿关节炎患者随机双盲多中心对照研究
의나서보치료중국접수갑안접령치료적활동성류풍습관절염환자수궤쌍맹다중심대조연구
A multi-center,double-blind,randomized,placebo-controlled study on the efficacy and safety of etanercept and methotrexate in the treatment of active rheumatoid arthritis
  • 万方数据
    中华风湿病学杂志 중화풍습병학잡지
    CHINESE JOURNAL OF RHEUMATOLOGY
    2010年 7期 450-455 ,共6页

    陈盛%陈顺乐%黄烽%黄建林%栗占国%吴东海%朱平%潘云峰%陈适%马丽%冷南%杨尊明

    진성%진순악%황봉%황건림%률점국%오동해%주평%반운봉%진괄%마려%랭남%양존명

    关节炎,类风湿%治疗结果%安全性%依那西普 關節炎,類風濕%治療結果%安全性%依那西普
    관절염,류풍습%치료결과%안전성%의나서보
    Arthritis,rheumatoid%Treatment outcome%Safety%Etanercept
    目的 研究依那西普每周1次皮下注射50 mg对接受甲氨蝶呤(MTX)治疗的中国活动性类风湿关节炎(RA)患者的疗效及安全性.方法 本研究由2部分组成:12周双盲治疗阶段和12周安全性开放研究阶段.双盲期间的随机通过临床操作随机化(CORE)系统完成.在双盲阶段,RA患者被随机分配到依那西普50mg治疗组或安慰剂组,每周1次皮下注射给药,同时坚持一定剂量MTX给药.完成双盲治疗的RA患者在开放治疗中均接受每周1次依那西普50 mg和MTX给药.以美国风湿病学会(ACR)疗效评价指标ACR 20为主要终点疗效指标.次要终点疗效指标包括医生和患者总体评价、晨僵持续时间、疼痛目视模拟测试表(VAS)、健康评估问卷(HAQ)、C反应蛋白(CRP)值、疼痛和肿胀关节数.并且比较2组的安全性结果.采用Fisher精确概率法对主要终点疗效指标第12周ACR 20应答情况及其他次要终点疗效指标进行分析.使用协方差方法分析连续终点相对于基线的变化.结果 双盲治疗期间修正的意向性治疗人群(Mitt)共有156例患者,其中依那西普+MTX组77例.安慰剂+MTX组79例,149例患者完成双盲阶段的治疗.治疗4周时,依那西普+MTX组ACR 20有效率为39%(30/77),安慰剂+MTX组为16%(13/79),差异有统计学意义(P<0.01);12周时,依那西普+MTX组ACR 20有效率为62%(48/77),安慰剂+MTX组为23%(18/79),差异有统计学意义(P<0.01).其他疗效指标包括医生和患者总体评价、晨僵持续时间、疼痛VAS、HAQ、CRP、触痛关节数、肿胀关节数等均从第4周开始,在依那西普+MTX组明显优于安慰剂+MTX组(P<0.01).总的不良反应发生率在2组间差异无统计学意义.结论 与安慰剂治疗活动性RA相比.依那西普治疗活动性RA起效迅速、疗效显著.依那西普50 mg+MTX每周1次给药治疗中国成年活动性RA患者24周,耐受性良好.
    목적 연구의나서보매주1차피하주사50 mg대접수갑안접령(MTX)치료적중국활동성류풍습관절염(RA)환자적료효급안전성.방법 본연구유2부분조성:12주쌍맹치료계단화12주안전성개방연구계단.쌍맹기간적수궤통과림상조작수궤화(CORE)계통완성.재쌍맹계단,RA환자피수궤분배도의나서보50mg치료조혹안위제조,매주1차피하주사급약,동시견지일정제량MTX급약.완성쌍맹치료적RA환자재개방치료중균접수매주1차의나서보50 mg화MTX급약.이미국풍습병학회(ACR)료효평개지표ACR 20위주요종점료효지표.차요종점료효지표포괄의생화환자총체평개、신강지속시간、동통목시모의측시표(VAS)、건강평고문권(HAQ)、C반응단백(CRP)치、동통화종창관절수.병차비교2조적안전성결과.채용Fisher정학개솔법대주요종점료효지표제12주ACR 20응답정황급기타차요종점료효지표진행분석.사용협방차방법분석련속종점상대우기선적변화.결과 쌍맹치료기간수정적의향성치료인군(Mitt)공유156례환자,기중의나서보+MTX조77례.안위제+MTX조79례,149례환자완성쌍맹계단적치료.치료4주시,의나서보+MTX조ACR 20유효솔위39%(30/77),안위제+MTX조위16%(13/79),차이유통계학의의(P<0.01);12주시,의나서보+MTX조ACR 20유효솔위62%(48/77),안위제+MTX조위23%(18/79),차이유통계학의의(P<0.01).기타료효지표포괄의생화환자총체평개、신강지속시간、동통VAS、HAQ、CRP、촉통관절수、종창관절수등균종제4주개시,재의나서보+MTX조명현우우안위제+MTX조(P<0.01).총적불량반응발생솔재2조간차이무통계학의의.결론 여안위제치료활동성RA상비.의나서보치료활동성RA기효신속、료효현저.의나서보50 mg+MTX매주1차급약치료중국성년활동성RA환자24주,내수성량호.
    Objective To compare the efficacy and safety of etanercept injection 50 mg once weekly combined with methotrexate (MTX) therapy for patients with active rheumatoid arthritis.Methods This study consists of 2 parts：a 12-week double-blind treatment period (part A) followed by a 12-week open-label safety study period (part B).The randomization of treatments in double-blind treatment period was completed through the clinical operations randomization environment (CORE) system.During part A,the subjects were randomly assigned to the etanercept 50 mg or placebo group. The dosage regimen for etanercept was 50 mg administered subcutaneously once weekly while MTX was administered orally.All subjects who completed part A received 50 mg etanercept once weekly and MTX1 during the open-label treatment.The primary endpoint was ACR 20 response at week 12.Secondary endpoint variables included physician／patient global assessments of disease activities,duration of morning stiffness,pain visual analog scale (VAS),health assessment questi onnaire (HAQ),CRP level and tender and swollen joint counts .The results of safety between the two groups were compared.The primary endpoint and other secondary binary endpoints were analyzed using the Fisher’s exact test.For continuous endpoints.the change from baseline was analyzed with analysis of covariance. Results One hundred and fifty six subjects satisfied modified intent-to-treat (mITT) population were enrolled during part A,of which 77 subjects were in the etanercept+MTX group,and 79 subjects were in the placebo+MTX group respectively.A total of 149 subjects completed part A.As early as week 4.the ACR 20 response achieved 39％ (30,77) in the etanercept group,which was significantly higher than that of the placebo group [16％(13／79),P<0.001].At week 12,the ACR 20 respouse achieved 62％(48,77)in the etanercept group and 23％(18／79) in the placebo group (P<0.01).From week 4,other study endpoints including physician global assessment,patient global assessment,duration of morning stiffness,pain VAS,HAQ,CRP level,tender joint counts,swollen joint counts were also compared.The results showed that all above efficacy endpoints in the etanercept+MTX group were better than those of the placebo+MTX group(P<0.01).But there Was no significant difference in the total adverse eriects between the two groups.Conclusion Etanercept 50 mg once weekly + MTX treatment for 24 weeks is well tolerated.During the first 12-week treatment period,the etanercept group has shown a rapid efficacy onset and a significantly better therapeutic effect compared to that of the placebo group.
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