摘要
目的评价infliximab与甲氨蝶呤(MTX)联合使用与单独使用MTX在治疗类风湿关节炎(RA)中的疗效与安全性。方法随机、双肓、平行、多中心试验。患者在入组前至少MTX治疗3个月,且MTX剂量稳定在7．5～20 mg/周,病情未得到满意控制。受试者在第0、2、6、14周分别接受3 mg/kg的infliximab或安慰剂静脉滴注,同时每周按同定剂量服MTX。受试者分别在试验的第0、2、6、14、18周随访．评价疗效和不良反应。疗效以美国风湿病学会(ACR)疗效评价指标为指标。其中以ACR20为主要疗效指标,ACR50、ACR70、关节肿胀数、关节肿胀评分、关节触痛数、晨僵持续时间、疼痛视觉模拟评分(VAS)及疲乏VAS评分、C反应蛋白(CRP)、血沉(ESR)、健康状况问卷(HAQ)为次要疗效指标。结果本研究试验组87例、对照组86例。试验第2周时,infliximab+MTX组ACR20改善者占52．9％,对照组只有14．0％(P=0．0003)；且关节肿胀数、关节触痛数、晨僵时间、疼痛VAS的评分、CRP、ESR等指标明显改善,有统计学意义(P＜0．05)。第18周,infliximab+MTX组ACR20改善者75．9％,对照组只有48．8％(P= 0．0003)：ACR50改善者43．7％、对照组25．6％(P=0．01 1)。与单用MTX对照组相比,其不良事件发生率差异无统计学意义(P=0．215),多数不良事件无需停药,试验组有1例结核感染者。结论Infliximab+ MTX治疗RA的疗效明显优于单用MTX的疗效,能迅速改善RA的各项症状、体征和实验室炎性活动指标。
Objective To evaluate the efficacy and safety of infliximab plus methotrexate combination therpy in Chinese with rheumatoid arthritis patients. Methods This was a double-blind placebo-controlled phase m clinical trial, 173 patients who had active rheumatoid arthritis were randomised to placebo （n=86） or infliximab （n=87） group on a background of a stable dosage of methotrexate. Patients were assessed at weeks 0, 2, 6, 14 and 18. Results At week 2, the American College of Rheumatology （20） response criteria, which represent a 20% improvement from baseline, the same results with swollen joint count, tender joint count, duration of morning stiffness, VAS score, CRP, ESR were achieved in 52.9% of patients, compared with 14.0% of patients receiving placebo plus metbotrexate. A 20% improvement was achieved in 75.9% of infliximab plus methotrexate at week 18, compared with 48.8% of patients on placebo plus methotrexate （P=0.0003）. A 50% improvement was achieved in 43.7% of infliximab plus methotrexate at week 18, compared with 25.6% of patients on placebo plus methotrexate （P=0.011）. Infliximab was well-tolerated; withdrawals for adverse events as well as the occurrence of serious adverse events or serious infections were similar to those in the placebo group. There was only one case of tuberculosis in the treatment group. Conclusion Treatment with infliximab plus methotrexate is more effective than methotrexate alone in patients with active rheumatoid arthritis. It has rapid onset of effect and the efficacy is persistent.
出处
《中华风湿病学杂志》
CAS
CSCD
2006年第11期658-663,共6页
Chinese Journal of Rheumatology
