Thrombotic risk in patients with primary immune thrombocytopenia is only mildly increased and explained by personal and treatment-related risk factors
Thrombotic risk in patients with primary immune thrombocytopenia is only mildly increased and explained by personal and treatment-related risk factors
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DOI：
10.1111/jth.12636
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发表时间：
2014-08-01
影响因子：
10.4
通讯作者：
Rodeghiero, F.
中科院分区：
文献类型：
--
作者：
Ruggeri, M.;Tosetto, A.;Rodeghiero, F.
背景资料：基于使用管理数据库的人群研究，已报告原发性免疫性血小板减少症（ITP）和使用血小板生成素（TPO）受体激动剂时血栓形成风险增加。目的：评价原发性ITP患者静脉和动脉血栓形成的发生率是否高于具有临床意义的临界值（3%和6.4%）。患者/方法：我们在一个大型队列中进行了一项回顾性多中心研究，该队列中的患者需要至少一种ITP治疗，这些患者来自意大利主要的治疗ITP的三级中心。共分析了986例患者。结果如下：在3888患者年随访期间，发生了43起首次血栓形成事件：28起动脉血栓形成事件和15起静脉血栓形成事件，导致5年时动脉血栓形成的累积发生率为3.2%（95% CI，2.0-5.0），静脉血栓形成的累积发生率为1.4%（95% CI，0.8-2.5）。总血栓、静脉血栓和动脉血栓的100患者-年化发生率分别为1.14（95% CI，0.84-1.54）、0.39（95% CI，0.23-0.65）和0.71（95% CI，0.49-1.04）。与非脾切除患者相比，在136例患者（13.7%）中进行的脾切除术增加了血栓形成风险（HR = 3.5，95% CI）。年龄> 60岁，诊断时血栓形成的两个以上危险因素和类固醇使用与血栓形成风险增加独立相关。结论：在这项研究中，我们证明了ITP患者静脉和动脉血栓形成的5年累积发生率远低于预定阈值。静脉和动脉血栓栓塞不是ITP常见的并发症，除非在特殊情况下，如脾切除术和老年患者。
Background: An increased risk of thrombosis has been reported in primary immune thrombocytopenia (ITP) and with the use of thrombopoietin (TPO) receptor agonists, on the basis of population studies using administrative databases. Objectives: To evaluate if the incidence of venous and arterial thrombosis in patients with primary ITP is higher than a clinically significant cut-off set at of 3% and 6.4%. Patients/Methods: We undertook a retrospective multicenter investigation in a large cohort of patients requiring at least one treatment for ITP, enrolled from the major tertiary Italian centers treating ITP. A total of 986 patients were analyzed. Results: During a 3888 patient-year follow-up, 43 first thrombotic events occurred: 28 arterial and 15 venous, resulting in a cumulative incidence of 3.2% for arterial (95% CI, 2.0-5.0) and 1.4% (95% CI, 0.8-2.5) for venous thrombosis at 5 years. The annualized rates for 100 patient-years were 1.14 (95% CI, 0.84-1.54), 0.39 (95% CI, 0.23-0.65) and 0.71 (95% CI, 0.49-1.04) for total, venous and arterial thrombosis. Splenectomy, performed in 136 patients (13.7%), increased thrombotic risk (HR = 3.5, 95% CI) compared with non-splenectomized patients. Age > 60 years, more than two risk factors for thrombosis at diagnosis and steroid use were independently associated with an increased risk of thrombosis. Conclusions: In this study, we demonstrate that the 5-year cumulative incidence of venous and arterial thrombosis in ITP is well below the predefined thresholds. Venous and arterial thromboembolism are not frequent complications in ITP, except in particular settings, such as in splenectomized and elderly patients.