摘要
目的:评价长链脂肪乳(LCT)、中/长链脂肪乳(MCT/LCT)、鱼油脂肪乳(FO)及多种油脂肪乳(SMOF)等静脉注射用脂肪乳剂(IVLEs)的临床安全性。方法:检索2004年1月至2021年3月美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)数据库中IVLEs相关不良反应(ADRs)数据。分析总结病人临床特征,比较ADRs发生时间及预后。并采用系统器官分类(SOC)及标准MedDRA查询(SMQ)术语对ADRs分类。结果:本研究共纳入1 059例IVLEs相关ADRs报告,其中MCT/LCT 14例(1.32%),LCT 784例(74.03%),FO 38例(3.59%),SMOF 223例(21.06%);ADRs报告病人的平均年龄为49.5岁;62.66%的ADRs发生于IVLEs输注当天;在所有报告中,寒战、发热等全身性及给药部位反应(645,32.94%)是最常见的ADRs,其次是胃肠系统(236,12.05%)和呼吸系统症状(207,10.57%);排在前三位ADRs的SMQ分类分别为药物反应伴嗜酸粒细胞增多症和全身性症状(12.06%)、非特异性胃肠症状(11.21%)和速发过敏反应(8.39%)。结论:FAERS数据库中IVLEs相关ADRs以首用即发型为主,多为轻度的全身性及给药部位反应、胃肠系统和呼吸系统症状,但仍应警惕必需脂肪酸缺乏、心脏骤停、肾衰竭、低血糖、组织细胞增多症等说明书中未提及的ADRs。
Objective: To evaluate the clinical safety of intravenous lipid emulsions(IVLEs), including long chain triglycerides(LCT), medium and long chain triglycerides(MCT/LCT), fish oil triglycerides(FO), and multi-oil fat emulsion(SMOF). Methods: IVLEs related adverse drug reactions(ADRs) data were retrieved from the FDA adverse events reporting system(FAERS) database from January 2004 to March 2021. The clinical characteristics of the patients were summarized by descriptive analysis, and the time to onset and prognosis of ADRs were compared. System Organ Classes(SOC) and Standardized MedDRA Queries(SMQ) terms were used to classify ADRs. Results: A total of 1059IVLEs-related ADRs were reported, including 14 MCT/LCT cases(1.32%), 784 LCT cases(74.03%), 38 FO cases(3.59%), and 223 SMOF cases(21.06%). The mean age of patients reported for ADRs was 49.5 years. 62.66% of ADRs occurred on the day of IVLEs infusion. Systemic and administration site disorders, such as chills and pyrexia(645,32.94%), were the most common among all the reporting ADRs, followed by gastrointestinal disorders(236,12.05%) and respiratory disorders(207, 10.57%). The top three ADRs of SMQ were drug reaction with eosinophilia and systemic symptoms syndrome(12.06%), nonspecific gastrointestinal symptoms(11.21%), and anaphylactic reaction(8.39%).Conclusion: IVLEs related ADRs in the FAERS database mostly occurred at first use and were generally mild systemic and administration site disorders, gastrointestinal and respiratory disorders, but vigilance should be directed to essential fatty acid deficiency, cardiac arrest, renal failure, hypoglycemia, histiocytosis, and other ADRs not mentioned in the instructions.
作者
李晓琳
张凡
胡扬
李潇潇
赵彬
陈伟
梅丹
LI Xiao-lin;ZHANG Fan;HU Yang;LI Xiao-xiao;ZHAO Bin;CHEN Wei;MEI Dan(Department of Pharmacy,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100730,China;Department of Pharmacology,Institute of Materia Medica,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100050,China;Department of Pharmacy,Peking University Third Hospital,Beijing 100191,China;Department of Clinical Nutrition,Peking Union Medical College Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100730,China)
出处
《肠外与肠内营养》
CAS
CSCD
北大核心
2022年第4期193-200,共8页
Parenteral & Enteral Nutrition
