JPEN. Journal of parenteral and enteral nutrition · 2025
Variations in adverse events associated with different infusion modalities of parenteral nutrition: A pharmacovigilance study.
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Jing Zhou, Zhengli Jiang, Ying Su, Shiyu Man, Jingjing Ma, Mujuan Pang, Hongyan Xu, Yan Hu
Аннотация
BACKGROUND: Parenteral nutrition can be administered through various infusion modalities. However, limited research has examined the differences in adverse reactions associated with these modalities.
METHODS: Data from the Food and Drug Administration adverse event reporting system database were analyzed using disproportionality analysis to identify and compare adverse event signals across different infusion modalities.
RESULTS: A total of 1642 adverse event reports related to parenteral nutrition were included: 356 in the all-in-one group, 85 in the two-in-one group, 1086 in the fat emulsion group, and 115 in the amino acid supplementation group. Across all reports, 4159 preferred terms were identified, distributed as follows: 858 in the all-in-one group, 152 in the two-in-one group, 2975 in the fat emulsion group, and 174 in the amino acid supplementation group, with these events spanning 20 system organ classes. In the all-in-one group, the top three preferred terms were lymphangitis, increased blood magnesium, and incorrect drug administration rate. In the two-in-one group, the leading preferred terms were fungemia, extravasation, and disease complications. In the fat emulsion group, the most significant preferred terms included fat overload syndrome, fatty acid deficiency, and parenteral nutrition-associated liver disease. In the amino acid supplementation group, key preferred terms were impaired glucose tolerance, hyperglycemia, and elevated hepatic enzymes.
CONCLUSION: This study identified significant variations in the adverse events associated with different parenteral nutrition infusion modalities. These findings underscore the need for tailored interventions to ensure the safe and effective use of parenteral nutrition, thereby optimizing therapeutic outcomes in clinical practice.
METHODS: Data from the Food and Drug Administration adverse event reporting system database were analyzed using disproportionality analysis to identify and compare adverse event signals across different infusion modalities.
RESULTS: A total of 1642 adverse event reports related to parenteral nutrition were included: 356 in the all-in-one group, 85 in the two-in-one group, 1086 in the fat emulsion group, and 115 in the amino acid supplementation group. Across all reports, 4159 preferred terms were identified, distributed as follows: 858 in the all-in-one group, 152 in the two-in-one group, 2975 in the fat emulsion group, and 174 in the amino acid supplementation group, with these events spanning 20 system organ classes. In the all-in-one group, the top three preferred terms were lymphangitis, increased blood magnesium, and incorrect drug administration rate. In the two-in-one group, the leading preferred terms were fungemia, extravasation, and disease complications. In the fat emulsion group, the most significant preferred terms included fat overload syndrome, fatty acid deficiency, and parenteral nutrition-associated liver disease. In the amino acid supplementation group, key preferred terms were impaired glucose tolerance, hyperglycemia, and elevated hepatic enzymes.
CONCLUSION: This study identified significant variations in the adverse events associated with different parenteral nutrition infusion modalities. These findings underscore the need for tailored interventions to ensure the safe and effective use of parenteral nutrition, thereby optimizing therapeutic outcomes in clinical practice.