短期益赛普与甲氨蝶呤环磷酰胺联合治疗类风湿关节炎的临床研究

目的 探讨短期使用重组人Ⅱ型肿瘤坏死因子受体一抗体融合蛋白(rhTNFR:Fc,益普赛)与甲氨蝶呤(MTX)、环磷酰胺(CTX)联合治疗类风湿关节炎(RA)的有效性和安全性.方法 对84例患者随机分为实验组和对照组,仅有56例患者完成了本实验.实验组给予益赛普皮下注射治疗3个月,每周2次,每次25 mg;同时给予MTX治疗,每周1次,每次7.5～15 mg;CTX每3周1次,每次200 mg,3个月后给予空白模拟益赛普,继续接受MTX和CTX维持治疗.对照组给予益赛普皮下注射治疗,剂量及方法同实验组,同时给予空白模拟MTX和CTX对照,疗程为1年,随时观察并记录治疗过程中的任何不良事件,在0、2、4、8、12、24、36、52周监测其血常规、红细胞沉降率(ESR)、肝功能、肾功能、类风湿因子(RF)、抗环瓜氨酸肽(CCP)抗体.结果 实验组和对照组在ACR20,ACR70,ESR及CRP实验室指标均较入组时有明显改善,但两组问差异无统计学意义(P>0.05).治疗12周实验组停用益赛普时,两组的上述指标均进一步改善.疗程满36周时,实验组较对照组的各项指标仍持续好转,相关抗体水平浓度较对照组差异有统计学意义(P<0.05),两组间的不良反应率差异无统计学意义.结论 短期益赛普与MTX、CTX联合治疗RA,可以减少益赛普的疗程,有效地缓解RA的症状和降低抗体水平,并不增加不良反应,具有较好的安全性.

The clinical efficacy and safety of short-term combination therapy with etanercept, methotrexate and cyclophosphamide for rheumatoid arthritis

Objective To study the efficiency and safety of short-term combination therapy with e-tanercept, methotrexate and eyclophosphamide in the patients with active rheumatoid arthritis. Methods Eighty-four patients with rheumatoid arthritis were included into this study. However, only fifty-six patients were treated with either twice-weekly subcutaneous etanercept, weekly oral MTX and CTX injection every three weeks or twice-weekly subcutaneous etanercept only. The American College of Rheumamatology (ACR) criteria for improvement was used for clinical efficacy assessment and the following laboratory papameters were analyzed:blood routine test, ESR, liver enzymes and renal function parameters, RF and anti-CCP antibody at baseline and the 2,4,8,12,24,36,52 weeks .At the same time ,all the adverse events were monitored throughout the study. Results The improvement of patients who received etanercept shortly, MTX and CTX periodically was as rapid as that of the patients who only received etanercept in ACR20, ACRYO, ESR and CRP (P>0.05). At the end of 36 weeks treatment, the level of anti-CCP antibody in the control group was higher than that of the test group. There was no significant difference between the two groups in adverse events (P<0.05). Conclusion The efficacy and safety of treatment with etanercept, methotrexate and cyclophosphamide in the patients with active rheumatoid arthritis is good.