英利西单抗治疗活动性类风湿关节炎临床观察

摘要

目的 观察英利西单抗治疗活动性类风湿关节炎(RA)的临床疗效和安全性.方法 30例活动性RA患者分为研究组和对照组,各15例.研究组在每周口服甲氨蝶呤(MTX)10～15 mg基础上联合应用英利西单抗,在第0、2、6周接受3 mg/kg的英利西单抗静脉滴注;对照组口服相同剂量的MTX,联合应用其他改善病情抗风湿药(DMARDs),如柳氮磺吡啶、来氟米特或羟氯喹.疗程均为12周.结果 治疗6周后,研究组和对照组的临床症状和实验室指标均有改善,美国风湿病学会(ACR)20有效率分别为40%(6/15)和20%(3/15),差异有统计学意义(P＜0.05);ACR50有效率分别为27%(4/15)和6%(1/15),差异有统计学意义(P＜0.05).治疗12周后各项指标进一步改善.研究组和对照组的ACR20有效率分别为60%(9/15)和33%(5/15),差异有统计学意义(P＜0.05);ACR50有效率分别为40%(6/15)和13%(2/15),差异有统计学意义(P＜0.05).治疗6周后,研究组和对照组的临床症状和实验室指标均有改善.结果 表明,研究组在治疗12周后休息痛、关节肿胀和关节压痛改善明显,红细胞沉降率、C反应蛋白和类风湿因子改善情况也明显优于对照组.研究组和对照组治疗前简明疾病活动评分分别为(5.8±2.5)和(5.9±2.2)分,差异无统计学意义(P＞0.05).治疗6周后2组分别为(2.4±1.6)和(4.7±1.9)分,差异有统计学意义(P＜0.05).治疗12周后2组分别为(1.8±1.1)和(4.2±1.8)分,差异有统计学意义(P＜0.05).研究组共有2例患者出现不良反应,1例注射局部出现皮疹或红斑,未见局部溃疡和坏死.上述不良反应均自行消失,未中断治疗.1例患者出现上呼吸道感染,对症处理后症状消失,亦未中断治疗.结论 英利西单抗是安全有效的治疗RA的药物,可以更早期达到诱导缓解病情的目的.%Objective To investigate the clinical efficacy and safety of the infliximab in the treatment of patients with active rheumatoid arthritis(RA). Methods Thirty cases of RA were retrospectively analyzed. In infliximab treatment group,15 patients were treated with infliximab 3mg/kg, week 0,2,6, combined with weekly oral methotrexate(MTX) 10-15 mg per week for 12 weeks. Fifteen patients receiving the same dosage MTX combined with Disease modifying antirheumatic drugs (DMARDs): salicylazosulfapyridine (SASP), leflunomide (LEF) or hydroxychloroquine(HCQ)for 12 weeks were observed as a control group. Results All patients completed treatment. As compared with the control group, the infliximab treatment group had a more rapid improvement in ACR20 and ACR50 in disease activity during the first 6 weeks(40% vs 20%, 27% vs 6%, P ＜0.05 respectively). At the end of 12 week, the infliximab treatment group also had significant improvement in ACR20 and ACR50 when compared with the control group(60% vs 33%, 40% vs 13%, P ＜0.05 respectively). Compared with the control group, the infliximab treatment group had a more significant decrease of the DAS28 score, and there was also significant difference between the infliximab group and the control group after 12 weeks (P ＜ 0.05). The most common adverse events of infliximab included injection site reaction and respiratory infection. Conclusion Infliximab is a safe and effective drug for RA patients.