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安全性研究

The safety profiles of short-term etanercept combined with methotrexade and cyclophosphamide for treatment of rheumatoid arthritis

目的探讨短期使用重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白(rhTNFR:Fc,益塞普)与甲氨蝶呤﹙MTX﹚、环磷酰胺(CTX)联合治疗类风湿关节炎(RA)的安全性。方法将84例患者随机分为实验组和对照组,其中74例患者完成了本研究,实验组给予益赛普皮下注射治疗3个月,每周2次,每次25mg;同时给予MTX治疗,每周1次,每次7.5￣15mg;CTX每3周1次,每次200mg;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MTX和CTX治疗,剂量同实验组,同时给予益赛普空白模拟对照,两组疗程均为1年。随时观察并记录治疗过程中的任何不良事件,在第0、2、4、8、12、24、36、52周监测其血常规、红细胞沉降率、肝肾功能。结果整个试验过程中未发生严重不良事件,治疗组和对照组不良事件发生率比较,差异无统计学意义(P>0.05)。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,并不增加不良反应,具有较好的安全性。

Objective To study the safety profiles of short-term etanercept combined with methotrexade and cyclophosphamide for treatment of rheumatoid arthritis. Methods Eighty-four patients with rheumatoid arthritis were randomized into the study group or control group. The study group received initially 3-month treatment with 25 mg subcutaneous etanereept twice a week, added with 7.5-15 mg oral MTX （once a week） and 200 mg intravenous CTX once in 3 weeks, then switched to dummy etanercept while sustained on MTX and CTX at the end of 3 months. The control group received dummy etanercept and concomitant MTX and CTX as described above. The whole duration of intervention lasted 1 year in the both groups. Any adverse event throughout the study was recorded. Clinical assessments with blood routine, ESR, liver and renal function were performed at the baseline and at 2. 4, 8, 12, 24, 36 and 52 weeks. Results Seventy-four patients fulfilled the study protocol. No serious adverse events were noted during the trial, and the rates of adverse events were not significantly different between the two groups （P〉0.05）. Conclusion Short-term etanercept in combination with MTX and CTX in the patients with active rheumaloid arthritis may be useful to avoid prolonged use of etanereept, aud was not shown to associated with increased risk of adverse events