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。
【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.
出处
《中国现代医学杂志》
CAS
CSCD
北大核心
2011年第14期1634-1636,1640,共4页
China Journal of Modern Medicine
关键词
类风湿关节炎
Ⅱ型肿瘤坏死因子受体
甲氨蝶呤
Arthritis rheumatoid
type Ⅱ receptors of tumor necrosis factor
Methotrexate Inhibitors
