Center for Drug Safety, University of Maryland School of Pharmacy, Baltimore, Maryland, 220 Arch Street 12 Floor, Baltimore, Maryland, USA. 21201.
Haematologica. 2012 Jan;97(1):15-20. doi: 10.3324/haematol.2011.051755. Epub 2011 Nov 18.
There are limited reports of thrombosis among myelodysplastic syndrome patients exposed to erythropoiesis stimulating agents. It is not clear whether erythropoiesis stimulating agents are associated with an increased risk of thrombosis in myelodysplastic syndromes, as they are among patients with solid tumors.
The association between use of erythropoiesis stimulating agent and transient thrombosis risk in patients with myelodysplastic syndromes was assessed in a case-crossover study nested within a cohort of incident myelodysplastic syndrome patients. Using the US Surveillance, Epidemiology, and End Results Medicare-linked database, cases with an incident diagnosis of deep vein thrombosis were identified. Using conditional logistical regression, the odds of exposure to erythropoiesis stimulating agents in the 12 weeks prior to the incident deep vein thrombosis (hazard period) was compared to the exposure odds in a prior 12-week comparison period.
Within the cohort of eligibles with myelodysplastic syndromes (n = 5,673) there were 212 incident cases of deep vein thrombosis events. Mean age was 76.2 (standard deviation = ± 8.6) years. Use of erythropoiesis stimulating agents was not associated with deep vein thrombosis in the crude nor the adjusted models (OR = 1.21, 95% CI: 0.60, 2.43). Central venous catheter placement (OR = 6.47, 95% CI: 2.37, 17.62) and red blood cell transfusion (OR = 4.60, 95% CI: 2.29, 9.23) were associated with deep vein thrombosis.
Despite the link between use of erythropoiesis stimulating agents and thrombosis among patients with solid tumors, this study provides evidence that their safety profile may be different among patients with myelodysplastic syndromes.
接受促红细胞生成素刺激剂治疗的骨髓增生异常综合征患者发生血栓的报道有限。目前尚不清楚促红细胞生成素刺激剂是否会增加骨髓增生异常综合征患者发生血栓的风险,因为它们与实体瘤患者有关。
在一项嵌套于骨髓增生异常综合征患者队列中的病例交叉研究中,评估了促红细胞生成素刺激剂的使用与骨髓增生异常综合征患者短暂性血栓风险之间的关联。使用美国监测、流行病学和最终结果医疗保险相关数据库,确定了深静脉血栓形成的新发诊断病例。使用条件逻辑回归,比较了在深静脉血栓形成的危险期间(发病前 12 周)暴露于促红细胞生成素刺激剂的几率与之前 12 周比较期的暴露几率。
在符合条件的骨髓增生异常综合征队列(n = 5673)中,有 212 例深静脉血栓形成事件。平均年龄为 76.2 岁(标准差 = ± 8.6)。在未调整和调整模型中,使用促红细胞生成素刺激剂与深静脉血栓形成均无关(OR = 1.21,95% CI:0.60,2.43)。中央静脉导管放置(OR = 6.47,95% CI:2.37,17.62)和红细胞输注(OR = 4.60,95% CI:2.29,9.23)与深静脉血栓形成有关。
尽管促红细胞生成素刺激剂的使用与实体瘤患者的血栓形成之间存在联系,但本研究提供的证据表明,其安全性特征可能在骨髓增生异常综合征患者中有所不同。