【摘要】 目的观察注射用重组人II型肿瘤坏死因子受体:抗体融合蛋白(依那西普,etanercept,rhTNF:Fc)治疗活动性类风湿关节炎(RA)的临床疗效和安全性。方法 50例活动性RA患者分为治疗组和对照组,治疗组25例,对照组25例。治疗组在每周口服甲氨蝶呤(MTX)10～15 mg基础上联合应用依那西普,每周皮下注射2次,每次25 mg;对照组口服相同剂量的MTX,联合应用其他改变病情药(DMARDs),如柳氮磺胺吡啶、来氟米特或羟氯喹。疗程均为12周。疗效采用美国风湿病学会(ACR)标准评定。结果治疗6周后,治疗组和对照组的临床症状和实验室指标均有改善,ACR 20%改善标准(ACR20)有效率分别为44%和16%(P<0.01),ACR 50%改善标准(ACR50)有效率为20%和4%(P<0.01)。治疗12周后各项指标进一步改善,治疗组和对照组的ACR20有效率分别为64%和36%(P<0.01),ACR50有效率为48%和12%(P<0.01)。进一步比较两组治疗前后简明疾病活动评分(DAS28)的变化,发现治疗组患者DAS28下降更明显。治疗后两组DAS28差异有显著性(P<0.05)。治疗组最常见的不良反应主要是注射部位反应和上呼吸道感染。结论依那西普是安全有效的治疗RA的药物,常常可以更早期的达到诱导缓解病情的目的。更多还原

【Abstract】 【Objective】 To investigate the clinical efficacy and safety of the tumonecrosis factor-α(TNF-α) inhibitor Etanercept in the treatment of patients with active rheumatoid arthritis(RA).【Methods】 We retrospectively analyzed 50 cases of RA.In Etanercept treatment group,25 patients were treated with Etanercept 25 mg twice a week combined with weekly oral methotrexate(MTX) 10~15 mg per week for 12 weeks.25 patients receiving the same dosage MTX combined with Disease modifying antirheumatic drugs(DMARDs): salicylazosulfapyridine(SASP),leflunomide(LEF) or hydroxychloroquine(HCQ) for 12 weeks were observed as a control group.Clinical assessments used the American College of Rheumatology criteria(ACR).【Results】 All patients complete treatment.As compared with the control group the Etanercept treatment group had a more rapid improvement in ACR20 and ACR50 in disease activity during the first 6 weeks(44% vs 16% 20% vs 4%,P <0.01 respectively),At the end of 12 week treatment the Etanercept treatment group also had significant improvement in ACR20 and ACR50 when compared with the control group(64% vs 36% 48% vs 12%,P <0.01 respectively) Compared with the control group,the Etanercept treatment group had a more obviously decrease of the DAS28 score,and there was also significant difference between the Etanercept group and the control group after 12 weeks(P <0.05).The most common adverse events of Etanercept included injection site reaction and upper respiratory infection in our study.【Conclusion】 Etanercept is a safe and effective drug for RA patients and relieves symptoms more quickly.更多还原