Department of Haematology, Copenhagen University Hospital Roskilde , Koegevej 7-13, 4000 Roskilde , Denmark.
Platelets. 2012;23(6):423-9. doi: 10.3109/09537104.2011.634931. Epub 2011 Dec 20.
The objective of this study was to investigate the use of thrombopoietin-receptor agonists (TPO-ra) in patients with refractory primary immune thrombocytopenia (ITP) as well as off-label use of TPO-ra in Danish haematology departments. Hospital medical records from 32 of the 39 patients having received TPO-ra from 2009 to 1 May 2011 were available for data collection and included in the study. Of these patients, 15 received TPO-ra for refractory primary ITP, 7 for secondary ITP (chronic lymphatic leukaemia, systemic lupus erythematosus, Evans syndrome, human immunodeficiency virus and celiac disease) and 10 were treated for non-ITP (chemotherapy-induced, acute myeloid leukaemia, myelodysplastic syndrome, hereditary spherocytosis and suspected chemically induced thrombocytopenia). Initial response to TPO-ra defined as platelet counts >30 × 10(9)/l after 4 weeks of treatment was found in 59% of primary ITP patients, 57% of patients with secondary ITP and 40% of patients with non-ITP. There were four deaths in the cohort, three of which were related to pre-existing medical conditions. Otherwise adverse effects were in general mild. This Danish retrospective registration study has demonstrated that in the off-protocol setting, the use of TPO-ra is associated with response rates largely similar to those seen in previous protocol-monitored studies and no new adverse events were reported.
本研究旨在调查在丹麦血液科中,血小板生成素受体激动剂(TPO-ra)在难治性原发性免疫性血小板减少症(ITP)患者中的应用情况,以及 TPO-ra 的超适应证使用情况。我们收集了 2009 年至 2011 年 5 月 1 日期间接受 TPO-ra 治疗的 39 例患者中的 32 例的医院病历,这些患者均纳入了本研究。其中,15 例患者因难治性原发性 ITP 接受 TPO-ra 治疗,7 例患者因继发性 ITP(慢性淋巴细胞白血病、系统性红斑狼疮、Evans 综合征、人类免疫缺陷病毒和乳糜泻)接受 TPO-ra 治疗,10 例患者因非 ITP(化疗诱导、急性髓系白血病、骨髓增生异常综合征、遗传性球形红细胞增多症和疑似化学诱导性血小板减少症)接受 TPO-ra 治疗。我们将治疗 4 周后血小板计数>30×10(9)/l 定义为初始应答,结果发现,原发性 ITP 患者、继发性 ITP 患者和非 ITP 患者的初始应答率分别为 59%、57%和 40%。该队列中有 4 例死亡,其中 3 例与先前存在的医疗条件有关。其他不良反应通常较轻。本丹麦回顾性注册研究表明,在非方案治疗中,TPO-ra 的使用与之前方案监测研究中观察到的应答率相似,且未报告新的不良事件。