风湿

甲氨蝶呤用于ANCA相关性血管炎维持缓解有效安全

作者:Maritati F,et al 翻译:北医三院柴静 来源:中国风湿病公众论坛 日期:2019-09-04
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         甲氨蝶呤用于ANCA相关性血管炎维持缓解有效安全

        摘要:目的:抗中性粒胞浆抗体(ANCA)相关性血管炎(AAV)的治疗包括诱导缓解和维持缓解。甲氨蝶呤是广泛应用的免疫抑制剂,但是其应用于AAV维持的研究非常少。该试验研究甲氨蝶呤作为AAV维持治疗的有效性和安全性。

        方法:在该单中心、开放性、随机试验中比较甲氨蝶呤和环磷酰胺AAV的维持治疗。纳入肉芽肿性多血管炎(GPA),显微镜下多血管炎(MPA)和嗜酸性肉芽肿性多血管炎(EGPA)患者,后者合并预后不佳因素和/或外周神经病变。使用环磷酰胺诱导缓解。维持缓解阶段,患者随机分配接受甲氨蝶呤或继续环磷酰胺治疗12个月;治疗后,继续随访12个月。首要终点为复发,次要终点包括肾脏结局和治疗相关的毒性。

        结果:纳入的94例患者中,23例在诱导缓解阶段退出或未达到缓解;剩下的71例随机分配到环磷酰胺组(n=33)或甲氨蝶呤组(n=38)。两组随机后12和24个月复发频率无差异(P=1.00和1.00)。无复发生存也是相当的(时序检验p=0.99)。分别分析GPA+MPA和EGPA时,两组治疗复发无差异。在12和24个月估算的肾小球滤过率无差异;仅在环磷酰胺组(P=0.0007)蛋白尿明显下降(从诊断到24个月)。在不良事件发生频率方面无明显差。

        结论:甲氨蝶呤用于AAV维持缓解是有效且安全的。

        附原文:AbstractOBJECTIVES:The treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV) is based on remission-induction and remission-maintenance. Methotrexate is a widely used immunosuppressant but only a few studies explored its role for maintenance in AAV. This trial investigated the efficacy and safety of methotrexate as maintenance therapy for AAV.

        METHODS:In this single-centre, open-label, randomised trial we compared methotrexate and cyclophosphamide for maintenance in AAV. We enrolled patients with granulomatosis with polyangiitis (GPA), microscopic polyangiitis (MPA) and eosinophilic granulomatosis with polyangiitis (EGPA), the latter with poor-prognosis factors and/or peripheral neuropathy. Remission was induced with cyclophosphamide. At remission, the

        patients were randomised to receive methotrexate or to continue with cyclophosphamide for 12 months; after treatment, they were followed for another 12 months. The primary end-point was relapse; secondary end-points included renal outcomes and treatment-related toxicity.

        RESULTS:

        Of the 94 enrolled patients, 23 were excluded during remission-induction or did not achieve remission; the remaining 71 were randomised to cyclophosphamide (n = 33) or methotrexate (n = 38). Relapse frequencies at months 12 and 24 after randomisation were not different between the two groups (p = 1.00 and 1.00). Relapse-free survival was also comparable (log-rank test p = 0.99). No differences in relapses were detected between the two treatments when GPA+MPA and EGPA were analysed separately. There were no differences in eGFR at months 12 and 24; proteinuria declined significantly (from diagnosis to month 24) only in the cyclophosphamide group (p = 0.0007). No significant differences in adverse event frequencies were observed.

        CONCLUSIONS:MTX may be effective and safe for remission-maintenance in AAV.

        引自:Maritati F, Alberici F, Oliva E,et al. Methotrexate versus cyclophosphamide for remission maintenance in ANCA-associated vasculitis: A randomised trial. PLoS One. 2017 Oct 10;12(10):e0185880.

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