英夫利西单抗治疗类风湿关节炎的疗效与安全性
영부리서단항치료류풍습관절염적료효여안전성
Efficacy and safety of infliximab in patients with rheumatoid arthritis
  • 万方数据
    中华医学杂志 중화의학잡지
    National Medical Journal of China
    2009年 27期 1876-1880 ,共5页

    张文%史群%吴东海%鲍春德%杨南萍%栗占国%朱平%张晓%黄慈波%何东仪%叶志中%陶怡%方勇飞%古洁若%吴华香%孙凌云%杨岫岩%黄烽%徐沪济%赵东宝%张缪佳%郑毅%艾脉兴%陆军%张奉春

    장문%사군%오동해%포춘덕%양남평%률점국%주평%장효%황자파%하동의%협지중%도이%방용비%고길약%오화향%손릉운%양수암%황봉%서호제%조동보%장무가%정의%애맥흥%륙군%장봉춘

    肿瘤坏死因子抑制剂%甲氨蝶呤%类风湿关节炎 腫瘤壞死因子抑製劑%甲氨蝶呤%類風濕關節炎
    종류배사인자억제제%갑안접령%류풍습관절염
    TNF inhibitor:Methotrexate:Rheumatoid arthritis
    目的 比较英夫利西单抗(IFX)与甲氨蝶呤(MTX)合用治疗中度、重度类风湿关节炎(RA)的疗效和安全性,为临床选择合适的患者和治疗时机提供依据.方法 本研究为开放、多中心、前瞻性临床研究.234例接受稳定剂量MTX治疗至少4周的RA受试者参加本试验,其中中度RA患者104例,重度RA患者130例.受试者分别在观察的第0、2、6、14和22周接受3mg/kg IFX的静脉滴注,并完成临床病情评估,不良事件及实验室检查等.在第26周时受试者完成最后一次评估.结果 治疗第26周时,RA患者达到美国风湿病学会疗效评价标准(ACR)20、ACRS0和ACR70的比率分别为69.8%、52.4%和29.5%,3种评价指标在中度RA组与重度RA组的差异无统计学意义(P>0.05);而达到ACR90的患者比率为7.21%,中度RA组与重度RA组的差异有统计学意义(P<0.05).中度和重度RA组患者治疗前后触痛关节数、肿胀关节数、疼痛的视觉模拟(VAS)评分、受试者疾病总体状况VAS评分、研究者评估疾病总体状况VAS评分等指标差异均有统计学意义(均P<0.05).结论 IFX+MTX治疗中、重度RA患者有较好的疗效和安全性,能够迅速改善各项症状、体征和实验室炎性活动指标,尤其对于中度RA患者能更加有效地降低疾病活动性和抑制关节组织损害进展.
    목적 비교영부리서단항(IFX)여갑안접령(MTX)합용치료중도、중도류풍습관절염(RA)적료효화안전성,위림상선택합괄적환자화치료시궤제공의거.방법 본연구위개방、다중심、전첨성림상연구.234례접수은정제량MTX치료지소4주적RA수시자삼가본시험,기중중도RA환자104례,중도RA환자130례.수시자분별재관찰적제0、2、6、14화22주접수3mg/kg IFX적정맥적주,병완성림상병정평고,불량사건급실험실검사등.재제26주시수시자완성최후일차평고.결과 치료제26주시,RA환자체도미국풍습병학회료효평개표준(ACR)20、ACRS0화ACR70적비솔분별위69.8%、52.4%화29.5%,3충평개지표재중도RA조여중도RA조적차이무통계학의의(P>0.05);이체도ACR90적환자비솔위7.21%,중도RA조여중도RA조적차이유통계학의의(P<0.05).중도화중도RA조환자치료전후촉통관절수、종창관절수、동통적시각모의(VAS)평분、수시자질병총체상황VAS평분、연구자평고질병총체상황VAS평분등지표차이균유통계학의의(균P<0.05).결론 IFX+MTX치료중、중도RA환자유교호적료효화안전성,능구신속개선각항증상、체정화실험실염성활동지표,우기대우중도RA환자능경가유효지강저질병활동성화억제관절조직손해진전.
    Objective To investigate the efficacy and safety of Infliximab(IFX) plus methotrexate (MTX) combination therapy in patients with rheumatoid arthritis (RA). Methods Prospectively observe refractory RA patients who were treated with combination therapy of MTX and IFX. IFX was infused at the dosage of 3 mg/kg, in week O, 2, 6, and then every 8 weeks. During treatment, clinical variables, disease activity and adverse effects were eva]uated.Results After treatment,69.8%,52.4%,29.5%and 7.2%RA patients achieyed ACR20.ACR50,ACR70 and ACR90 respectively.111ere Were significant statistical differences in the changes of swollen;oint counts,tender joint counts,VAS scale,patient's global assessment.and physician'8 global assessment before and after therapy.Conclusion Infliximab plus MTX achieved significant efficacy and safety in refractory RA patients.
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