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固定剂量四因子凝血酶原复合物与基于体重给药用于颅内出血的紧急使用的回顾性比较:评估药物给药时间和成本

A retrospective comparison of the emergent use of fixed-dose four-factor prothrombin complex versus weight-based dosing for intracranial hemorrhage assessing medication delivery time and cost.

作者信息

Riha Gordon M, Englehart Michael S, Walton Karin Z, Saunders Megan E, Carter Benjamin T, Thompson Simon J

机构信息

Trauma & General Surgery, Billings Clinic Billings, MT, USA.

Pharmacy, Billings Clinic Billings, MT, USA.

出版信息

Int J Physiol Pathophysiol Pharmacol. 2023 Jun 15;15(3):98-104. eCollection 2023.

Abstract

OBJECTIVES

The goal of this study was to evaluate a low fixed-dose versus weight-based dosing strategy for four-factor prothrombin complex (4F-PCC) time to administration in intracranial hemorrhage (ICH) patients.

METHODS

A retrospective analysis was conducted at a single rural Tertiary referral center in patients ≥18 years old on warfarin with ICH who received 4F-PCC. Continuous variables were summarized using mean (±95% CI) and compared using two-tailed tests; values ≤0.05 were considered statistically significant.

RESULTS

A total of 46 ICH patients were reversed using 4F-PCC (Fixed, n = 27 and Weight, n = 19). Baseline characteristics were equivalent. Total units of 4F-PCC (mean dose units 2525.1 versus 1623.3) and dose per kg were significantly reduced in the fixed-dose group. Total time from order to delivery was significantly reduced with the fixed-dose strategy (mean time 43.0 versus 29.0 minutes). Hospital length of stay (LOS), intensive care unit LOS, and mortality were equivalent with a similar mechanism. International Normalized Ratio (INR) reversal success (≤1.5) and total INR change was comparable with no difference in adverse thromboses between groups.

CONCLUSIONS

A fixed-dosed strategy reduced time to 4F-PCC administration for warfarin reversal in ICH, as compared to a weight-based strategy; with no increase in LOS, mortality, or need for additional dosing. This also resulted in significant cost savings.

摘要

目的

本研究的目的是评估低固定剂量与基于体重的给药策略用于四因子凝血酶原复合物(4F-PCC)治疗颅内出血(ICH)患者时的给药时间。

方法

在一家农村三级转诊中心对年龄≥18岁、服用华法林且发生ICH并接受4F-PCC治疗的患者进行回顾性分析。连续变量采用均值(±95%CI)进行汇总,并使用双侧检验进行比较;P值≤0.05被认为具有统计学意义。

结果

共有46例ICH患者使用4F-PCC进行逆转治疗(固定剂量组,n = 27;基于体重剂量组,n = 19)。基线特征相当。固定剂量组的4F-PCC总单位数(平均剂量单位2525.1对1623.3)和每千克剂量显著降低。采用固定剂量策略时,从医嘱到给药的总时间显著缩短(平均时间43.0对29.0分钟)。住院时间(LOS)、重症监护病房住院时间和死亡率相当,机制相似。国际标准化比值(INR)逆转成功(≤1.5)以及INR总变化相当,两组之间不良血栓形成无差异。

结论

与基于体重的策略相比,固定剂量策略可缩短4F-PCC用于华法林逆转治疗ICH时的给药时间;且不增加住院时间、死亡率或额外给药需求。这也带来了显著的成本节约。

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