甲氨蝶呤联合重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白治疗严重未分化脊柱关节病的短期疗效观察

Short research on the efficacy and safety of Methotrexate combined with the TNF-α receptor fusion protein etanercept in patients with severe undifferentiated spondyloarthropathy

目的探索甲氨蝶呤联合重组人Ⅱ型肿瘤坏死因子受体-抗体融合蛋白etanercept治疗严重未分化脊柱关节病的临床疗效和安全性。方法60例确诊为严重活动性未分化脊柱关节病的患者随机分为两组,30例作为对照组接受甲氨蝶呤(10mg,口服每周1次)联合柳氮磺吡啶(1.0,1日2次)治疗,30例接受甲氨蝶呤(10mg,口服每周1次)联合etanercept(25mg,皮下注射,每周2次)治疗。观察12周末患者的临床症状改善情况及药物不良反应。结果治疗12周末甲氨蝶呤联合etanercept治疗的患者较对照组在疼痛程度、外周关节肿胀数、BASDAI、BASFI以及CRP、ESR等临床指标上有明显改善,差异有统计学意义(P<0.05)。两组在达到BASDAI改善大于20%的患者数上差异无统计学意义(P>0.05);但etanercept组达到BASDAI改善大于50%及70%的患者数远远多于对照组(P<0.05)。etanercept组有1/3(10名)患者在停用etanercept后(平均4.2周)病情复发。两组总的药物不良反应发生率差异无统计学意义(P>0.05)。结论甲氨蝶呤联合etanercept治疗严重未分化脊柱关节病的短期疗效可能优于甲氨蝶呤联合柳氮磺吡啶治疗,且不良反应不增加,耐受性好。

[Objectives] To explore the efficacy and safety of combination therapy with Methotrexate （MTX） and the TNF-α receptor fusion protein etanercept in patients with severe undifferentiated spondyloarthropathy （uSpA）. [Methods] Sixty active and severe uSpA patients were randomly divided into two groups, with 30 patients receiving the combination （MTX 10 mg/week＋SSZ 1.0 bid） as control group, while 30 patients receiving MTX （10 mg/week） and etanercept （25 mg ihyp two times a＇week） for 12 weeks. The changes of disease activity variables and the occurrence of side effects were recorded at the end of 12 week. [Results] Etanereept group has more significant improvement in pain, swollen joint scores, BASDAI, BASFI, CRP and ESR than control group （P 〈0.05）. More Patients receiving MTX and etanercept achieved 50% and 70% BASDAI improvement than those receiving MTX and SSZ （P 〈 0.05）, while no significant difference in 20% BASDAI improvement between two groups （P 〉0.05）. After cessation of anti-TNF therapy, 10 out of 30 patients relapsed after an average of 4.2 weeks. There is no significant differences in side effects between two groups （P 〉0.05）. [Conclusion] The combination of MTX and etanercept had short term efficacy and was well-tolerated in patients with active and severe uSpA.