药物性低镁血症的检测和预警:FDA不良事件报告系统的药物警戒研究。

IF 1 4区 医学 Q4 BIOCHEMISTRY & MOLECULAR BIOLOGY
Yanghai Xiao, Jianjiang Fang, Yixia Zhou, Ting Zhou
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引用次数: 0

摘要

低镁血症是一种常见的疾病,由于症状严重程度不同,经常被忽视。在医院环境中,药物不良反应和低镁血症之间的联系并不总是很清楚,一些药物标签忽略了这一风险,从而加剧了潜在的危险。我们通过挖掘FDA不良事件报告系统(FAERS)中涵盖2004年第一季度至2023年第四季度的数据进行了横断面研究。我们使用《药物调节活动医学词典》对低镁血症病例进行识别,根据药物名称确定引起低镁血症的信号药物,并采用描述性和歧化分析方法进行信号检测。从17,381,220例不良事件报告中,确定了11,228例涉及低镁血症的个体安全报告(isr)。奥美拉唑报告最多,1556例(20.75%),其次是泮托拉唑、帕尼单抗、西妥昔单抗和埃索美拉唑。歧化分析显示,奈西单抗是信号最强的药物,其次是卷曲霉素、帕尼单抗、泮托拉唑和奥美拉唑。在歧化分析的前50种药物中,31种信号药物的标签没有提及低镁血症的风险。我们对与特定联合治疗相关的药物发出警告,这些药物会引起导致低镁血症的不良反应。此外,为了更深入地研究药物与低镁血症之间的关系,需要在这一领域依赖更可信的研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Detection and warning of drug-induced hypomagnesemia: a pharmacovigilance study of the FDA Adverse Event Reporting System.

Hypomagnesemia, a common condition, frequently goes unnoticed due to varying symptom severity. In the hospital setting, the link between adverse drug reactions and hypomagnesemia is not always clear, and some drug labels omit this risk, compounding the potential danger. We conducted a cross-sectional study by mining data from the FDA Adverse Event Reporting System (FAERS) covering Q1 2004 to Q4 2023. Using the Medical Dictionary for Regulatory Activities, we identified cases of hypomagnesemia, determined the signal drugs causing hypomagnesemia based on the drug name, and employed descriptive and disproportionality analysis methods for signal detection. From 17,381,220 adverse event reports, 11,228 individual safety reports (ISRs) involving hypomagnesemia were identified. Omeprazole led with 1,556 reports (20.75%), followed by pantoprazole, panitumumab, cetuximab, and esomeprazole. Disproportionality analysis revealed necitumumab as the drug with the strongest signal, followed by capreomycin, panitumumab, pantoprazole, and omeprazole. Among the top 50 drugs from the disproportionality analysis, 31 signal drugs had labels that did not mention the risk of hypomagnesemia. We issue warnings regarding drugs associated with specific combination therapies that cause adverse reactions leading to hypomagnesemia. Furthermore, to delve deeper into the relationship between drugs and hypomagnesemia, reliance on more credible research in this field is required.

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来源期刊
Magnesium research
Magnesium research 医学-内分泌学与代谢
CiteScore
3.50
自引率
9.40%
发文量
6
审稿时长
>12 weeks
期刊介绍: Magnesium Research, the official journal of the international Society for the Development of Research on Magnesium (SDRM), has been the benchmark journal on the use of magnesium in biomedicine for more than 30 years. This quarterly publication provides regular updates on multinational and multidisciplinary research into magnesium, bringing together original experimental and clinical articles, correspondence, Letters to the Editor, comments on latest news, general features, summaries of relevant articles from other journals, and reports and statements from national and international conferences and symposiums. Indexed in the leading medical databases, Magnesium Research is an essential journal for specialists and general practitioners, for basic and clinical researchers, for practising doctors and academics.
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