摘要
目的评价英利昔单抗与甲氨蝶呤(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。方法本研究为随机、双盲、平行对照的临床试验。49例接受过至少3个月稳定剂量MTX治疗的活动性RA患者随机分为试验组(24例)和对照组(25例)。两组受试者在第0、2、6、14周分别接受3mg/kg的英利昔单抗或安慰剂静脉滴注,同时每周按固定剂量继续服MTX。并于试验的第0、2、6、14、18周随访,评价疗效和不良反应。以美国风湿病学会(ACR)疗效评价指标ACR20为主要疗效指标,ACR50、ACR70、晨僵时间、关节肿胀数、关节肿胀指数、关节压痛数、关节压痛指数；次要疗效指标为疼痛目视模拟测量表(VAS)评分、疲乏VAS评分、疾病总体状况的医生评价VAS评分、疾病总体状况的病人评价VAS评分、健康评价问卷(HAQ)评分。结果治疗后第2周时,英利昔单抗联合MTX组ACR20有效率为62．5%,对照组仅为8．0%(P=0．002)；晨僵时间、关节压痛数、关节压痛指数、关节肿胀数、关节肿胀指数、疼痛VAS、疲乏VAS、医生总体评价VAS、病人总体评价VAS、HAQ和血沉等较对照组也均有显著的改善(P＜0．05或P＜0．01)。第18周时,英利昔单抗联合MTX组ACR20有效率为79．2%,对照组只有48．0%(P=0．024)。两组之间不良事件发生率差异无统计学意义。结论英利昔单抗联合MTX治疗RA的疗效明显优于单用MTX的疗效,能迅速改善与RA有关的各项症状、体征和实验室炎性活动指标,具有良好的安全性。
Objective To evaluate the efficacy and safety of infliximab plus methotrexate （MTX） com- bination therapy in patients with rheumatoid arthritis （RA）. Methods This was a randomized, double blind, controlled clinical trial, 49 patients with active RA were randomised to placebo （n=25） or infliximab （n=24） at weeks 0, 2, 6 and 14 on a background of a stable close of MTX. Patients were assessed at weeks 0, 2, 6, 14 and 18. The primary endpoint was proportion of ACR20 responders. The secondary endpoints were the proportion of ACR50 and ACR70 responders. The change from baseline in duration of morning stiffness, tender joint count/index, swollen joint count/index, pain, fatigue, patient＇s global assessment, physician＇s global assessment, ESR and CRP were also evaluated. Re, suits At week 2, the ACR20 was achieved in 62.5% of patients receiving infliximab plus MTX, compared with 8% of patients receiving placebo plus MTX （P=0.0002） . The results for other secondary efficacy endpoints showed that infliximab could provide substantial benefits to patients with RA by improving clinical signs and symptoms and quality of life. At week 18, the ACR20 improvement was achieved in 79.2% of patients receiving infliximab plus MTX, compared with 48% of patients receiving placebo plus MTX （P=-0.024）. There was no significant difference between the two groups in adverse effects. Conclusion A regimen of infliximab plus MTX has demonstrated consistent evidence of more effective than MTX alone and is well tolerated in the treatment of active RA.
出处
《中华风湿病学杂志》
CAS
CSCD
2006年第9期522-526,共5页
Chinese Journal of Rheumatology
基金
国家自然科学基金(30571726)
