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真性红细胞增多症患者的血细胞比容水平与血栓事件:一项退伍军人健康管理局数据分析。

Hematocrit levels and thrombotic events in patients with polycythemia vera: an analysis of Veterans Health Administration data.

机构信息

Incyte Corporation, 1801 Augustine Cut-Off, Wilmington, DE, 19803, USA.

STATinMED Research, 5360 Legacy Dr Ste 120, Plano, TX, 75024, USA.

出版信息

Ann Hematol. 2019 Nov;98(11):2533-2539. doi: 10.1007/s00277-019-03793-w. Epub 2019 Sep 24.

Abstract

Patients with polycythemia vera (PV) have a high incidence of thrombotic events (TEs), contributing to a greater mortality risk than the general population. The relationship between hematocrit (HCT) levels and TE occurrence among patients with PV from the Veterans Health Administration (VHA) was evaluated to replicate findings of the CYTO-PV trial with a real-world patient population. This retrospective study used VHA medical record and claims data from the first claim with a PV diagnosis (index) until death, disenrollment, or end of study, collected between October 1, 2005, and September 30, 2012. Patients were aged ≥ 18 years at index, had ≥ 2 claims for PV (ICD-9-CM code, 238.4) ≥ 30 days apart during the identification period, continuous health plan enrollment from 12 months pre-index until end of study, and ≥ 3 HCT measurements per year during follow-up. This analysis focused on patients with no pre-index TE, and with all HCT values either < 45% or ≥ 45% during the follow-up period. The difference in TE risk between HCT groups was assessed using unadjusted Cox regression models based on time to first TE. Patients (N = 213) were mean (SD) age 68.9 (11.5) years, 98.6% male, and 61.5% white. TE rates for patients with HCT values < 45% versus ≥ 45% were 40.3% and 54.2%, respectively. Among patients with ≥ 1 HCT before TE, TE risk hazard ratio was 1.61 (95% CI, 1.03-2.51; P = 0.036). This analysis of the VHA population further supports effective monitoring and control of HCT levels < 45% to reduce TE risk in patients with PV.

摘要

患者患有真性红细胞增多症 (PV),血栓事件 (TE) 的发生率较高,其死亡率风险高于一般人群。为了在真实患者人群中复制 CYTO-PV 试验的发现,评估退伍军人健康管理局 (VHA) 中真性红细胞增多症患者的血细胞比容 (HCT) 水平与 TE 发生之间的关系。这项回顾性研究使用了 VHA 病历和索赔数据,从首次诊断为 PV(索引)的首次索赔开始,直到死亡、退出或研究结束,时间为 2005 年 10 月 1 日至 2012 年 9 月 30 日。患者在索引时年龄≥18 岁,在确定期间至少有 2 次间隔≥30 天的真性红细胞增多症(ICD-9-CM 代码,238.4)诊断索赔,在索引前 12 个月至研究结束期间连续参加健康计划,并且在随访期间每年至少有 3 次 HCT 测量。本分析主要针对无索引前 TE 的患者,且在随访期间所有 HCT 值要么 <45%,要么≥45%。根据首次 TE 发生时间,使用未调整的 Cox 回归模型评估 HCT 组之间的 TE 风险差异。患者(N=213)的平均(SD)年龄为 68.9(11.5)岁,98.6%为男性,61.5%为白人。HCT 值<45%与≥45%的患者 TE 发生率分别为 40.3%和 54.2%。在 TE 发生前至少有 1 次 HCT 值的患者中,TE 风险的危险比为 1.61(95%CI,1.03-2.51;P=0.036)。本项对 VHA 人群的分析进一步支持有效监测和控制 HCT 水平<45%,以降低 PV 患者的 TE 风险。

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