与肠外营养支持疗法相关的不良事件:一项药物警戒研究。

IF 3.2 3区 医学 Q2 NUTRITION & DIETETICS
Zhou Jing, Xu Hongyan, Ma Jingjing, Pang Mujuan, Man Shiyu, Su Ying, Hu Yan
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引用次数: 0

摘要

背景:肠外营养(PN)在营养支持治疗中起着至关重要的作用,但在实际应用中相关不良事件(AEs)的数据却很少。为此,我们分析了美国食品药品管理局不良事件报告系统(FAERS)数据库中与肠外营养治疗相关的不良事件信号:我们从 FAERS 数据库中提取了 2004 年第一季度(Q1)至 2024 年第一季度的数据。药物名称和 AE 均已标准化。然后,我们使用四种不同的算法进行了比例失调分析,以评估 PN 与其相关 AEs 之间的关联:我们从 FAERS 数据库中共收集了 48,890,925 份报告,其中 1642 份涉及 PN 相关的 AE。经过分类,我们确定了 21 个系统器官类别(SOC),肝胆疾病是所有四种算法中唯一重要的 SOC。在首选术语(PT)层面,我们发现有 99 个 PT 在所有四种算法中都显示出显著的不相称性。脂肪超负荷综合征、脂肪酸缺乏症、肠外营养相关肝病(PNALD)、马拉色菌感染和盘菌感染是最突出的 PT。此外,一些潜在的新AE信号包括神经、心脏、免疫、精神、血液、肾脏、泌尿和眼部疾病:我们的研究发现了 FAERS 数据库中报告的几种常见和罕见的 PN 相关 AE。患者和医疗服务提供者应对这些 AE 保持警惕。了解 PN 治疗的风险并制定切实可行的程序有助于减少 AEs。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Adverse events associated with parenteral nutrition support therapy: A pharmacovigilance study.

Background: Parenteral nutrition (PN) plays a crucial role in nutrition support therapy, yet data on related adverse events (AEs) in practical settings are scarce. To address this, we analyzed AE signals associated with PN treatment from the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database.

Methods: We extracted data from the FAERS database, covering the period from the first quarter (Q1) of 2004 to Q1 of 2024. Drug names and AEs were standardized. We then conducted disproportionality analyses using four different algorithms to evaluate the association between PN and its associated AEs.

Results: We collected a total of 48,890,925 reports from the FAERS database, of which 1642 involved PN-related AEs. After categorization, we identified 21 system organ classes (SOCs), and hepatobiliary disorders were the only significant SOC across all four algorithms. At the preferred term (PT) level, we identified 99 PTs that showed significant disproportionality in all four algorithms. Fat overload syndrome, fatty acid deficiency, parenteral nutrition-associated liver disease (PNALD), Malassezia infection, and Pantoea agglomerans infection were the most prominent PTs. In addition, several potential new AE signals included nervous, cardiac, immune, psychiatric, blood, renal, urinary, and eye disorders.

Conclusion: Our study identified several common and rare PN-related AEs reported in the FAERS database. Patients and healthcare providers should remain vigilant about these AEs. Understanding the risks of PN therapy and establishing practical procedures can help reduce AEs.

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来源期刊
CiteScore
7.80
自引率
8.80%
发文量
161
审稿时长
6-12 weeks
期刊介绍: The Journal of Parenteral and Enteral Nutrition (JPEN) is the premier scientific journal of nutrition and metabolic support. It publishes original peer-reviewed studies that define the cutting edge of basic and clinical research in the field. It explores the science of optimizing the care of patients receiving enteral or IV therapies. Also included: reviews, techniques, brief reports, case reports, and abstracts.
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