与腹腔营养辅助疗法相关的不良事件:一个药监测研究
Zhou Jing1, Xu Hongyan2, Ma Jingjing3
1Department of Pharmacy, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China.
JPEN. Journal of parenteral and enteral nutrition
|October 24, 2024
概括
腹腔营养 (PN) 对于营养支持至关重要,但相关的不良事件 (AE) 报告不足. 这项研究分析了FAERS数据,确定肝胆道疾病和PNALD等特定疾病是PN相关的显著AE.
科学领域:
- 临床营养学 临床营养学
- 药物监督 药物监督 药物监督
- 数据挖掘 数据挖掘
背景情况:
- 亲肠道营养 (PN) 对于营养支持至关重要.
- 关于PN相关不良事件 (AE) 的现实数据有限.
- 需要对FDA不良事件报告系统 (FAERS) 的分析来确定PNAE.
研究的目的:
- 使用FAERS数据库分析与亲肠道营养 (PN) 相关的AE信号.
- 在大型数据集中识别与PN治疗相关的常见和罕见副作用.
- 通过使用多个不成比例算法来评估PN及其AE之间的关联.
主要方法:
- 从FAERS (2004年第一季度 - 2024年第一季度) 提取的数据.
- 标准化药物名称和副作用.
- 使用四种算法进行不成比例分析,以评估与PN相关的AE.
主要成果:
- 分析了48,890,925份报告,确定了1642份与PN相关的AE报告.
- 肝胆道疾病是所有算法中最重要的器官系统类 (SOC).
- 确定了99个具有显著不成比例的首选术语 (PT),包括脂肪过载综合征,脂肪酸缺乏,亲肠营养相关性肝病 (PNALD) 和感染.
结论:
- 从FAERS数据中确定了与PN治疗相关的常见和罕见的副作用.
- 强调了患者和医疗保健提供者对PNAE的警的重要性.
- 强调需要了解PN风险,并实施减轻AE的实际程序.
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