摘要
目的比较英夫利西单抗（IFX）与甲氨蝶呤（MTX）合用治疗中度、重度类风湿关节炎（RA）的疗效和安全性，为临床选择合适的患者和治疗时机提供依据。方法本研究为开放、多中心、前瞻陛临床研究。234例接受稳定剂量MTX治疗至少4周的RA受试者参加本试验，其中中度RA患者104例，重度RA患者130例。受试者分别在观察的第0、2、6、14和22周接受3mg／kg IFX的静脉滴注，并完成临床病情评估，不良事件及实验室检查等。在第26周时受试者完成最后一次评估。结果治疗第26周时，RA患者达到美国风湿病学会疗效评价标准（ACR）20、ACRS0和ACR70的比率分别为69．8％、52．4％和29．5％，3种评价指标在中度RA组与重度RA组的差异无统计学意义（P〉0．05）；而达到ACR90的患者比率为7．21％，中度RA组与重度RA组的差异有统计学意义（P〈0．05）。中度和重度RA组患者治疗前后触痛关节数、肿胀关节数、疼痛的视觉模拟（VAS）评分、受试者疾病总体状况VAS评分、研究者评估疾病总体状况VAS评分等指标差异均有统计学意义（均P〈0．05）。结论IFX＋MTX治疗中、重度RA患者有较好的疗效和安全性，能够迅速改善各项症状、体征和实验室炎性活动指标，尤其对于中度RA患者能更加有效地降低疾病活动性和抑制关节组织损害进展。
Objective To investigate the efficacy and safety of Infliximab（IFX） plus methotrexate （MTX） combination therapy in patients with rheumatoid arthritis （RA）. Methods Prospectively observe refractory RA patients who were treated with combination therapy of MTX and IFX. IFX was infused at the dosage of 3 mg/kg, in week 0, 2, 6, and then every 8 weeks. During treatment, clinical variables, disease activity and adverse effects were evaluated. Results After treatment, 69. 8% , 52. 4%, 29. 5% and 7.2% RA patients achieved ACR20, ACRS0, ACRT0 and ACR90 respectively. There were significant statistical differences in the changes of swollen joint counts, tender joint counts, VAS scale, patient＇s global assessment, and physician＇s global assessment before and after therapy. Conclusion Infliximab plus MTX achieved significant efficacy and safety in refractory RA patients.
出处
《中华医学杂志》
CAS
CSCD
北大核心
2009年第27期1876-1880,共5页
National Medical Journal of China
