罗普司亭临床合理应用专家共识(2024年版)

Expert consensus on the clinical application of romiplostim(2024 version)

罗普司亭是全球首个获批用于治疗既往对皮质类固醇、免疫球蛋白和脾切除术反应不佳的原发性免疫性血小板减少症(ITP),免疫抑制治疗效果不佳的再生障碍性贫血(AA)以及急性放射综合征(ARS)造血综合征的新一代拟肽类、长效血小板生成素受体激动剂,且在多项临床研究中显示出对于肿瘤治疗所致血小板减少症(CTIT)有较好的疗效及安全性。作为我国首个罗普司亭生物类似药,罗普司亭N01在成年人慢性ITP临床试验中亦显示出良好的疗效,为我国成年慢性ITP患者提供了新的治疗手段。为进一步指导临床合理、有效、安全应用罗普司亭,中国临床肿瘤学会(CSCO)淋巴瘤专家委员会和白血病专家委员会组织相关专家结合临床研究数据、国内外权威指南和临床实践,制定了罗普司亭临床合理应用专家共识,以供临床参考。

Romiplostim,a novel peptidomimetic,long-acting thrombopoietin receptor agonists,was the first globally approved for the treatment of primary immune thrombocytopenia(ITP)with an insufficient response to corticosteroids,immunoglobulins or splenectomy,aplastic anemia(AA)that has respond insufficiently to immunosuppressive therapy and hematopoietic syndrome of acute radiation syndrome(ARS).Several clinical studies have demonstrated that the romiplostim shows good therapeutic efficacy and safety in the treatment of cancer therapy induced thrombocytopenia(CTIT).As the first romiplostim biomimic in China,romiplostim N01 has also shown excellent efficacy in clinical trials of adult chronic ITP,providing a new treatment option for Chinese adult patients with chronic ITP.To further guide the rational,effective and safe application of romiplostim,Lymphoma Expert Committee of Chinese Society of Clinical Oncology(CSCO)and the Leukemia Expert Committee of CSCO organized experts to formulate this expert consensus on the clinical application of romiplostim for clinical reference by collecting and analyzing the published data from clinical studies,authoritative guidelines nationwide and abroad and routine practices.