医院环境中抗维生素 K 药物过量的流行情况和处理。

Prevalence and management of antivitamin K overdose in a hospital setting.

机构信息

Vascular medicine department, Groupe Hospitalier Paris Saint-Joseph, Paris, France.

Medical Information Department, Groupe Hospitalier Paris Saint-Joseph, Paris, France.

出版信息

J Med Vasc. 2021 Jul;46(4):175-181. doi: 10.1016/j.jdmv.2021.05.008. Epub 2021 Jun 8.

DOI:10.1016/j.jdmv.2021.05.008

PMID:34238512

Abstract

INTRODUCTION

Vitamin K antagonist (VKA) related adverse events are the first cause for iatrogenic events in France, particularly due to the narrow therapeutic margin. The risk of bleeding increases significantly when the INR level is ≥5. The main objective of this study was to assess the prevalence of VKA overdose in a hospital setting (at D2 of hospital entry) and to evaluate physicians' adherence to clinical practice guidelines for the management of VKA overdose according to French National Authority for Health recommendations.

METHODS

This single-center retrospective observational study consisted in querying the computerized database of a Parisian hospital on 21275INR determinations (3995 patients, 6813 hospital stays) performed between 2013 and 2018.

RESULTS

An INR level ≥5 was noted during 350 (6%) of the hospital stays, in 331 patients (of whom 57% were women). The mean age of the patient population with an INR≥5 was 81.1 years. Infection, heart failure and renal failure were the most frequent acute medical conditions for hospital admission. Twenty-three patients (7%) had a bleeding complication, 11 of which were major bleeding complications. Older age was associated with the severity of bleeding complications. Fifteen in-hospital deaths (4%) were reported, not related to bleeding events. The management of VKA overdose did not comply with the recommendations in 43% of cases, in particular for the highest INRs (50% of noncompliance for an INR>6.4). Non-compliance with recommendations for VKA overdose was related to: the delay until the INR was checked (44% of cases); the indication for prescribing vitamin K (34% of cases); the dose or route of administration of vitamin K therapy (19% of cases); and the interruption or not of VKA therapy (12% of cases).

CONCLUSION

The management of VKA overdose in a hospital setting remains non-compliant with the recommendations in almost half of the cases, mainly due to the delayed INR control and inappropriate management of vitamin K therapy. Computerized alert system would be helpful for personalized patient management and improved pharmacovigilance to prevent iatrogenic VKA events.

摘要

引言

在法国，维生素 K 拮抗剂（VKA）相关的不良事件是医源性事件的首要原因，尤其是由于治疗窗较窄。当 INR 水平≥5 时，出血风险显著增加。本研究的主要目的是评估医院环境中 VKA 过量的发生率（入院第 2 天），并根据法国国家卫生管理局的建议评估医生对 VKA 过量管理的临床实践指南的遵循情况。

方法

这是一项单中心回顾性观察性研究，对 2013 年至 2018 年间在巴黎一家医院进行的 21275 次 INR 测定（3995 名患者，6813 次住院）的计算机数据库进行了查询。

结果

在 350 次（6%）住院期间观察到 INR≥5，涉及 331 名患者（其中 57%为女性）。INR≥5 的患者人群的平均年龄为 81.1 岁。感染、心力衰竭和肾衰竭是住院的最常见急性医疗状况。23 名患者（7%）发生出血并发症，其中 11 名发生严重出血并发症。年龄较大与出血并发症的严重程度相关。报告了 15 例院内死亡（4%），与出血事件无关。在 43%的情况下，VKA 过量的处理不符合建议，特别是对于 INR 较高的情况（50%的非依从性发生在 INR>6.4 时）。不符合 VKA 过量处理建议的原因包括：INR 检查的延迟（44%的病例）；维生素 K 用药的指示（34%的病例）；维生素 K 治疗的剂量或途径（19%的病例）；以及 VKA 治疗的中断或不中断（12%的病例）。