中国临床药学杂志2024，Vol.33Issue(12)：908-912,5.DOI:10.19577/j.1007-4406.2024.12.005
基于中国医院药物警戒系统研究脂肪乳类药物相关肝损害的人群特征及影响因素
Population characteristics and influencing factors of nutritional lipid emulsions-associated liver injury based on China hospital pharmacovigilance system
摘要
Abstract
AIM To evaluate the liver ingury of nutritional lipid emulsions in the real world.METHODS A retrospective study was conducted to analyze the population characteristics and clinical data of all patients who received nutritional lipid emulsions between August 1,2021 and January 1,2023 in the hospital using the China hospital pharmacovigilance system platform for liver ingury of nutritional lipid emulsions.A retrospective single cohort study was used to investigate the characteristic of the liver injury resulted from nutritional lipid emulsions.A nested case-control study was used to discuss the population characteristics and the influencing factors of liver injury associated with nutritional lipid emulsions.Specifically,the patients who received lipid emulsions and developed liver injury were regarded as the case group,while those who received lipid emulsions but without liver injury were matched as the control group in a ratio of 1:2 for exploration.RESULTS A total of 14 351 patients were incorporated in the study.Among them,349 patients developed liver injury after using nutritional lipid emulsions,with an incidence of 2.43％.The main characteristics of the population were mainly middle-aged and elderly patients,as well as those suffering from tumors,hematological diseases and digestive system diseases.The liver injury occurred more frequently within 2 to 8 days after medication use(76.22％).Among more than half of the patients after the occurrence of related liver injury,appropriate measures such as drug withdrawal and treatment with liver-protecting medications were not implemented(198 patients,accounting for 56.73％).There were no significant differences in gender,age,and population characteristics of pregnant and lactating women in the nested case-control study.The difference was statistically significant in patients with allergic history,liver and renal insufficiency.The incidence of liver injury was associated with the species of nutritional lipid emulsions.Among the single use of lipid emulsions,the incidence of liver injury related to long-chain lipid emulsions was the highest,reaching 50.82％.CONCLUSION In the real world,liver injury is a common adverse reaction to lipid emulsion drugs.When using lipid emulsion drugs,particular attention should be paid to monitoring liver function,especially for patients with special conditions such as a history of allergies,liver and renal insufficiency.It is necessary to make a reasonable selection of lipid emulsions to ensure the rationality and safety of clinical drug use.关键词
脂肪乳类药物/肝损害/中国医院药物警戒系统/巢式病例对照/真实世界研究Key words
nutritional lipid emulsion/liver ingury/Chinese hospital pharmacovigilance system/nested case-control/real-world study引用本文复制引用
孙倩,张帆,杨雪..基于中国医院药物警戒系统研究脂肪乳类药物相关肝损害的人群特征及影响因素[J].中国临床药学杂志,2024,33(12):908-912,5.基金项目
山东省药学会医院合理用药天际健康中青年科研学术活动项目(编号hlyy2021-08) （编号hlyy2021-08）
山东省药学会医院合理用药天际健康中青年科研学术活动项目(第二期)(编号hlyy2024-08) （第二期）
