Journal Article ANCA関連血管炎に対するアフェレシス療法 : 抗好中球細胞質抗体関連血管炎に対する血漿交換療法と国際共同臨床試験PEXIVAS(<特集>血管炎症候群とアフェレシス)
Apheresis Therapy for ANCA-associated Vasculitis : Plasma Exchange and Glucocorticoids in Anti-neutrophil Cytoplasm Antibody Associated Vasculitis:A Randomized Controlled Trial (PEXIVAS)

猪原, 登志子  ,  藤元, 昭一  ,  鈴木, 和男  ,  遠藤, 知美  ,  武曾, 惠理  ,  PEXIVAS-JPグループ  ,  Toshiko, Ito-Ihara  ,  Shouichi, Fujimoto  ,  Kazuo, Suzuki  ,  Tomomi, Endo  ,  Eri, Muso  ,  PEXIVAS-JP Group  ,  京都大学医学部附属病院臨床研究総合センター早期臨床試験部  ,  宮崎大学医学部医学科血液・血管先端医療学講座  ,  帝京大学アジア国際感染症制御研究所:帝京大学大学院医学研究科国際感染症・危機管理学:帝京大学医学部附属病院安全管理部  ,  公益財団法人田附興風会医学研究所北野病院腎・泌尿器センター,腎臓内科  ,  公益財団法人田附興風会医学研究所北野病院腎・泌尿器センター,腎臓内科  ,  Department of Clinical Innovative Medicine, Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital  ,  Department of Hemovascular Medicine and Artificial Organs, Faculty of Medicine, University of Miyazaki  ,  The Institute of Asia International Infectious Disease Control, Teikyo University:Department of Health Protection, Graduate School of Medicine, Teikyo University:Safety Control Department, Teikyo University Hospital  ,  Division of Nephrology and Dialysis, Center for Nephrology and Dialysis, Kitano Hospital, The Tazuke Kofukai Medical Research Institute  ,  Division of Nephrology and Dialysis, Center for Nephrology and Dialysis, Kitano Hospital, The Tazuke Kofukai Medical Research Institute

Anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV) results in high rates of morbidity and mortality due to uncontrolled disease and treatment toxicity. Randomized trials and a meta-analysis suggest adjunctive plasma exchange may improve disease control, while observational evidence suggests that current oral glucocorticoid doses are associated with severe infections in patients with AAV. A randomized study of both plasma exchange and glucocorticoids is required to evaluate plasma exchange and oral glucocorticoid dosing in patients with AAV. PEXIVAS is a two by two factorial design randomized trial evaluating adjunctive plasma exchange and two oral glucocorticoid regimens in severe AAV. Seven hundred patients are being randomized at centers across Europe, North America, Japan and Australia to receive plasma exchange or no plasma exchange, and to receive standard or reduced oral glucocorticoid dosing. All patients receive immunosuppression with either cyclophosphamide or rituximab. The primary outcome is the time to the composite of all-cause mortality and end-stage renal disease. PEXIVAS is the largest trial in AAV undertaken to date and will inform the future standard of care for patients with severe AAV. Trial Registrations : EudraCT 2009-013220-24, ISRCTN07757949, NCT00987389, UMIN000009523.

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