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分析意大利多个急诊科记录的致命药物不良事件(MEREAFaPS 研究)。

Analysis of fatal adverse drug events recorded in several Italian emergency departments (the MEREAFaPS study).

机构信息

Department of Medicine, ASST Vimercate, Via Santi Cosma e Damiano 10, 20871, Vimercate, MB, Italy.

Department of Neurosciences, Psychology, Drug Research and Child Health, Section of Pharmacology and Toxicology, University of Florence, Florence, Italy.

出版信息

Intern Emerg Med. 2021 Apr;16(3):741-748. doi: 10.1007/s11739-020-02521-x. Epub 2021 Jan 4.

DOI:10.1007/s11739-020-02521-x
PMID:33392971
Abstract

Fatal Adverse Events (FADEs) are a major public health problem, and some FADEs could be preventable. The aim of the present study is to describe the frequency, the drugs involved and the preventability in the FADEs collected through the MEREAFaPS Study between 2012 and 2018. All cases including the outcome "death" have been examined. We excluded cases with vaccine-related ADEs, overdose or suicide, and ADEs occurred during the hospitalisation. Two trained assessors evaluated all cases fulfilling the inclusion criteria. ADEs' preventability was evaluated applying the Schumock and Thornton algorithm. During the study period, we observed 429 cases of death, 92 of which were excluded. The remaining 337 cases involved 187 women and 150 men, with a mean age of 79 and of 77 years, respectively. For each report, the suspected drugs and concomitant ones were 1.26 and 4.20, respectively. Anticoagulants and antiplatelet agents account for more than 40% of FADE cases and the most frequent reactions are haemorrhages (37.5%). The 25% of the FADEs were preventable. This study confirms that FADEs are still a relevant clinical occurrence, and are often caused by widely used old drugs associated with adverse events. The death of one in four patients was preventable. Further efforts should be done to improve the appropriateness of the therapy, especially in older patients who are treated with anticoagulants.

摘要

严重不良事件(FADEs)是一个主要的公共卫生问题,其中一些 FADEs 是可以预防的。本研究的目的是描述 2012 年至 2018 年期间通过 MEREAFaPS 研究收集的 FADEs 的频率、涉及的药物和可预防程度。所有包含“死亡”结果的病例都进行了检查。我们排除了与疫苗相关的 ADEs、过量或自杀以及住院期间发生的 ADEs 的病例。两名经过培训的评估员评估了所有符合纳入标准的病例。应用 Schumock 和 Thornton 算法评估 ADEs 的可预防程度。在研究期间,我们观察到 429 例死亡病例,其中 92 例被排除。其余 337 例涉及 187 名女性和 150 名男性,平均年龄分别为 79 岁和 77 岁。对于每例报告,可疑药物和伴随药物分别为 1.26 和 4.20。抗凝剂和抗血小板药物占 FADE 病例的 40%以上,最常见的反应是出血(37.5%)。25%的 FADEs 是可以预防的。本研究证实,FADEs 仍然是一个重要的临床事件,并且经常由广泛使用的与不良反应相关的旧药物引起。四分之一患者的死亡是可以预防的。应进一步努力提高治疗的适当性,特别是在接受抗凝治疗的老年患者中。

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