摘要
[目的]评价益赛普(rh TNFR:Fc重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白)联合甲氨蝶呤(MTX)治疗早期类风湿关节炎(RA)的有效性和安全性。[方法]将32例早期活动性RA患者(病程≤2年)随机分为两组,试验组22例在给予MTX每周7.5～15 mg治疗同时予以益赛普皮下注射治疗,每周2次,每次25 mg。对照组10例单用MTX每周7.5～15 mg治疗,疗程共为24周。在0、4、8、12、24周观察两组患者的休息痛、晨僵持续时间、关节肿胀压痛、健康评价(HAQ)、病人对疾病的评估、医生对病情的评估、红细胞沉降率(ESR)、C反应蛋白(CRP)、类风湿因子(RF),采用ACR20、ACR50、ACR70标准来评价疗效,并记录治疗过程中的任何不良事件。[结果]30例完成了试验。在第4、8、12、24周两组疗效比较差异均有统计学意义(P<0.05或P<0.01),在第24周末,试验组有77.27%(17/20)的患者达到ACR70标准,明显优于对照组。24周末两组的ESR、CRP及RF较0周时均有明显改善(P<0.05),但两组间比较无统计学差异(P>0.05)。试验组脱落2例,不良反应主要是感染,无严重不良反应。[结论]益赛普联用MTX的治疗方案对早期活动性RA疗效确切,治疗RA的短期疗效明显优于单用MTX,而不良反应以感染为多见。
[Objective] To evaluate the efficacy and safety of recombinant human tumor necosis factor-Fc fusion protein（rh TNFR：Fc）（etanercept） in combination with methotrexate（MTX） for the treatment of early rheumatoid arthritis（RA）.[Methods] A total of 32 patients with active early RA were randomly divided into the treatment group（n=22） and the control group（n=10）.The former was treated with rh TNFR：Fc（injected with 25mg subcutaneously,twice a week） along with oral MTX（7.5-15mg/w）;the latter was treated with MTX only.The whole course lasted 24 weeks and the curative effect was statistically evaluated by the United States Institute of Rheumatology（ACR） 20,ACR50 and ACR70 improvement criteria 4,8,12 and 24 weeks after treatment.Meanwhile,adverse events were recorded and evaluated.[Results] Thirty participants completed the trial and 2/3 of them were in the treatment group.At the 4th,8th,12th and 24th week,the ACR20,ACR50,ACR70 effective rates of the treatment group were respectively higher than those of the control group and the difference between the two groups was significant（P0.05 or P0.01）.Twenty four weeks after treatment,approximately 77.27%（17/20） patients in the treatment group and 2 patients in the treatment group developed infection,but no severe adverse effect was encountered. [Conclusion] Etanercept combined with methotrexate had accurate curative effect in the treatment of active early RA and its short-term clinical effect was superior to that of methotrexate used alone.Its most common adverse effect was infection.
出处
《上海预防医学》
CAS
2011年第10期499-502,共4页
Shanghai Journal of Preventive Medicine
关键词
关节炎
类风湿
甲氨蝶呤
益赛普
Arthritis
Rheumatoid
Methotrexade
rh TNFR：Fc
