Department of Pharmacy, Sengkang Health, Singapore.
Department of Pharmacy, Singapore General Hospital, Singapore.
Thromb Res. 2017 Jul;155:53-57. doi: 10.1016/j.thromres.2017.05.007. Epub 2017 May 6.
Patients with moderate thrombocytopenia and comorbidities requiring anticoagulation are currently sub-optimally treated because of bleeding concerns. Guidance on anticoagulating such patients is currently lacking because of limited data on safety and efficacy of anticoagulation in such patients.
This retrospective study compared the incidence of bleeding and thrombosis in a cohort of warfarinized patients with sustained platelet counts below 100×10/L against a cohort with normal platelet counts (>140×10/L). Primary outcomes of safety and efficacy were determined by incidence rate ratios (IRR) of bleeding and thrombotic events. International normalized ratio (INR) and platelet counts during adverse events in thrombocytopenic arm were secondary outcomes.
137 thrombocytopenic patients (104,985 patient-exposure days) were compared against 939 normal patients (715,193 patient-exposure days). IRR of minor, major bleeding and thrombosis among thrombocytopenic patients were 3.03 (95% CI: 1.57-5.60), 1.48 (95% CI: 0.44-3.98), and 0.807 (95% CI: 0.09-3.43) respectively. Median INR and platelet count readings during minor and major bleeds were 3.60 (IQR: 2.70-4.12) and 3.12 (IQR: 2.82-4.22), and 99×10/L (IQR: 77.0-147.0×10/L) and 115×10/L (IQR: 107.5-169.5×10/L) respectively.
Warfarinized thrombocytopenic patients are at higher risk of minor bleeding complications with a higher tendency for major bleeding but derive similar benefits against thrombotic events compared to normal patients. Bleeding events are associated with higher INRs. A narrow INR target with an upper limit below 2.5 together with closer anticoagulation monitoring may improve safety of patients.
由于出血问题,目前患有中度血小板减少症和需要抗凝治疗的合并症的患者的治疗效果并不理想。由于此类患者抗凝治疗的安全性和有效性数据有限,因此目前缺乏此类患者的抗凝治疗指南。
本回顾性研究比较了华法林化血小板计数持续低于 100×10/L 的患者队列与血小板计数正常 (>140×10/L) 的患者队列之间的出血和血栓形成发生率。安全性和疗效的主要结果通过出血和血栓形成事件的发生率比(IRR)来确定。血小板减少组中不良事件期间的国际标准化比值(INR)和血小板计数为次要结果。
将 137 例血小板减少症患者(104,985 患者暴露天数)与 939 例正常患者(715,193 患者暴露天数)进行比较。血小板减少症患者的轻微、严重出血和血栓形成的 IRR 分别为 3.03(95%CI:1.57-5.60)、1.48(95%CI:0.44-3.98)和 0.807(95%CI:0.09-3.43)。轻微和严重出血期间的中位数 INR 和血小板计数分别为 3.60(IQR:2.70-4.12)和 3.12(IQR:2.82-4.22),99×10/L(IQR:77.0-147.0×10/L)和 115×10/L(IQR:107.5-169.5×10/L)。
与正常患者相比,华法林化血小板减少症患者发生轻微出血并发症的风险更高,发生大出血的倾向更高,但在预防血栓形成方面获益相似。出血事件与更高的 INR 相关。将 INR 目标设定在 2.5 以下的较窄范围,并加强抗凝监测,可能会提高患者的安全性。