Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota, USA.
College of Pharmacy, Sookmyung Women's University, Seoul, Republic of Korea.
Basic Clin Pharmacol Toxicol. 2019 Feb;124(2):154-162. doi: 10.1111/bcpt.13116. Epub 2018 Sep 25.
In this study, clinical manifestations of adverse events and frequently used medications in patients receiving parenteral nutrition (PN) in Korea were evaluated using Korea Adverse Event Reporting System (KAERS) database records between 2011 and 2015. Amino acids, fat emulsions, carbohydrates, combinations and solutions for PN were identified as causative agents. Adverse events classified as "certain", "probable" and "possible" based on the WHO-Uppsala Monitoring Centre criteria were analysed. In total, 6439 adverse events from 4260 patients were included for analysis. Mean patient age was 54.4 ± 18.1 years and the mean number of adverse events per patient was 1.5 ± 1.1. Frequent adverse events were gastrointestinal (2159 events, 33.5%), skin/appendage (1344 events, 20.9%), general (846 events, 13.1%) and central/peripheral nervous system (716 events, 11.1%) disorders. Common clinical symptoms were nausea (1248 events, 19.4%), vomiting (558, 8.7%), pruritus (456 events, 7.1%), rash (386 events, 6.0%) and dizziness (329 events, 5.1%). The frequently reported concomitant agents were tramadol (n = 475, 3.1%), fentanyl (n = 405, 2.7%), paracetamol (n = 329, 2.2%), ketorolac (n = 322, 2.1%) and metoclopramide (n = 289 cases, 1.9%). The frequent adverse events remained consistent after accounting for concurrent medications. Our findings from a nationwide reporting system database found that gastrointestinal disorders (nausea and vomiting) were the leading adverse events, requiring further studies on their prevalence, mechanisms and therapeutic options.
本研究利用 2011 年至 2015 年韩国药品不良反应监测系统（KAERS）数据库记录，评估了韩国接受肠外营养（PN）患者的不良反应临床表现和常用药物。将氨基酸、脂肪乳剂、碳水化合物、PN 组合和溶液作为致病因素。根据世界卫生组织-乌普萨拉监测中心标准，将分类为“肯定”、“可能”和“很可能”的不良反应进行了分析。共纳入 4260 例患者的 6439 例不良反应进行分析。患者平均年龄为 54.4±18.1 岁，平均每名患者发生不良反应 1.5±1.1 次。常见的不良反应为胃肠道（2159 例，33.5%）、皮肤/附属器（1344 例，20.9%）、一般（846 例，13.1%）和中枢/周围神经系统（716 例，11.1%）疾病。常见的临床症状有恶心（1248 例，19.4%）、呕吐（558 例，8.7%）、瘙痒（456 例，7.1%）、皮疹（386 例，6.0%）和头晕（329 例，5.1%）。常报告的伴随药物有曲马多（n=475，3.1%）、芬太尼（n=405，2.7%）、对乙酰氨基酚（n=329，2.2%）、酮咯酸（n=322，2.1%）和甲氧氯普胺（n=289 例，1.9%）。在考虑伴随药物后，仍报告了常见的不良反应。本研究从全国报告系统数据库中发现，胃肠道疾病（恶心和呕吐）是主要的不良反应，需要进一步研究其流行率、机制和治疗选择。
