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血清白蛋白与急性住院患者静脉血栓栓塞风险的反比关系:APEXX 试验分析。

Inverse relationship of serum albumin to the risk of venous thromboembolism among acutely ill hospitalized patients: Analysis from the APEX trial.

机构信息

Division of Cardiovascular Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts.

Baim Institute for Clinical Research, Boston, Massachusetts.

出版信息

Am J Hematol. 2019 Jan;94(1):21-28. doi: 10.1002/ajh.25296. Epub 2018 Oct 17.

DOI:10.1002/ajh.25296
PMID:30252149
Abstract

Hypoalbuminemia is a common finding and independent predictor for unfavorable prognosis. The prognostic value of albumin measurement for short-term VTE prediction in hospitalized patients remains unclear. In the APEX trial (ClinicalTrials.gov identifier: NCT01583218), medical inpatients were randomized to receive either extended-duration betrixaban or shorter-duration enoxaparin and followed for 77 days. Baseline albumin concentrations were obtained in 7266 subjects with evaluable VTE endpoints. The association of baseline albumin to VTE was assessed, with adjustment for patient characteristics, thromboprophylaxis, and biomarkers for fibrinolysis and inflammation (ie, D-dimer and C-reactive protein [CRP]). VTE risk refinement was evaluated by incorporation of albumin to well-validated risk assessment models. A stepwise increase in the risk of VTE (P < .0001) was observed with lower levels of albumin. Patients at the bottom albumin quartile (<35 g/L) had a two-fold greater odds for developing VTE compared with the top quartile (≥42 g/L) (OR = 2.119 [95% CI, 1.592-2.820]; adjusted OR = 2.079 [1.485-2.911]). The odds for VTE increased by 1.368 (95% CI, 1.240-1.509) times per SD decrement of albumin (5.24 g/L). Compared with the propensity score-matched pairs of patients with albumin ≥35 g/L, patients with albumin <35 g/L had a greater risk of VTE (OR = 1.623 [1.260-2.090]; adjusted OR = 1.658 [1.209-2.272]). Albumin measurement also refined VTE risk discrimination and reclassification after inclusion in the risk assessment models. In conclusion, acutely ill hospitalized patients with low serum albumin had an increased VTE risk through 77 days. VTE risk assessment models for medical inpatients should consider incorporation of baseline albumin measurement.

摘要

低白蛋白血症是一种常见的发现,也是预后不良的独立预测因素。白蛋白测量对住院患者短期 VTE 预测的预后价值尚不清楚。在 APEX 试验(ClinicalTrials.gov 标识符:NCT01583218)中,将住院患者随机分配至接受延长疗程贝曲西班或短疗程依诺肝素治疗,并随访 77 天。在可评估 VTE 终点的 7266 名受试者中获得了基线白蛋白浓度。评估了基线白蛋白与 VTE 的关系,并根据患者特征、血栓预防措施以及纤维蛋白溶解和炎症的生物标志物(即 D-二聚体和 C 反应蛋白 [CRP])进行了调整。通过将白蛋白纳入经过良好验证的风险评估模型来评估 VTE 风险的细化。随着白蛋白水平的降低,VTE 的风险呈逐步增加(P < .0001)。白蛋白最低四分位数(<35 g/L)的患者与白蛋白最高四分位数(≥42 g/L)相比,发生 VTE 的可能性高两倍(OR = 2.119 [95%CI,1.592-2.820];调整后的 OR = 2.079 [1.485-2.911])。VTE 的可能性每降低 1 个标准差(白蛋白减少 5.24 g/L),则增加 1.368 倍(95%CI,1.240-1.509)。与白蛋白≥35 g/L 的倾向评分匹配患者对相比,白蛋白<35 g/L 的患者发生 VTE 的风险更高(OR = 1.623 [1.260-2.090];调整后的 OR = 1.658 [1.209-2.272])。白蛋白测量还改善了纳入风险评估模型后的 VTE 风险区分度和重新分类。总之,血清白蛋白水平较低的急性住院患者在 77 天内 VTE 风险增加。住院患者的 VTE 风险评估模型应考虑纳入基线白蛋白测量。

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