摘要
目的比较单独应用注射用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(益赛普)或该药联合甲氨蝶呤、来氟米特治疗类风湿性关节炎的疗效及安全性。方法将30例符合入选标准的类风湿性关节炎患者随机分为试验组与对照组,试验组予以益赛普联合甲氨蝶呤、来氟米特治疗12周后,停用益赛普,甲氨蝶呤、来氟米特继续维持;对照组始终单用益赛普。在2、4、8、12、36、52周评价疗效,记录治疗过程中的不良事件。结果两组疗效及不良反应发生率并无明显差异(P>0.05),两组均未发生严重不良反应。结论短期益赛普续以甲氨蝶呤、来氟米特联合治疗类风湿性关节炎,与单用益赛普疗效相当,可减少益赛普用量,但长期疗效及安全性还需观察。
Objective To evaluate the efficacy and safety of etanereept（Ecep） combined with Methotrexate （MTX） and Leflunomide（LEF） for treatment of Rheumatoid arthritis （RA）. Methods 30 RA patients meet the inclusive criterion were randomly assigned to receive either Eeep ＋ MTX ＋ LEF for 12 weeks following by MTX ＋ LEF maintenance（ test group, n = 18 ） or just Ecep （ control group, n = 12）. Efficacy rates were account at 2,4,8,12,24,36 and 52 weeks for both groups. Adverse events were registered. Results There was no significant difference of the efficacy rate and the rates of adverse events between the two groups （ P 〉 0.05 ）. No serious adverse events were noted during the trial. Conclusion Short - term Eeep following by MTX ＋ LEF maintenance may gets the same outcome as Ecep monotherapy in patients with RA. So, it can save the dose of Eeep. Research about long - term treat shoud be performed yet.
出处
《中国医学创新》
CAS
2010年第26期7-9,共3页
Medical Innovation of China
基金
广东省东莞市科技局资助项目(NO200910515000447)
