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A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition
Published on: September 20, 2019
Phytosterol content in lipid components used in patients receiving parenteral nutrition
David Berlana1, Belén Montañes2, Consuelo Pellicer3
1Servicio de Farmacia, Hospital Universitari Vall d'Hebron, Barcelona, España.
Objective:
To quantify the phytosterol content of lipid emulsions (LE) used for parenteral nutrition (PN) and of lipid-based medications administered to PN patients, and to compare the phytosterol load across different formulations.
Methods:
Observational, cross-sectional, multicenter study. Over a 6-month period (September 2021-February 2022), 13 hospitals collected samples from different batches of multi-chamber PN bags, LE vials, and lipid-containing medications used in patients receiving PN. Phytosterols were analyzed by gas chromatography with flame ionization detection. A descriptive and comparative analysis was carried out between products and emulsion groups (pure soybean oil, and mixtures containing medium-chain triglycerides, olive oil, or fish oil).
Results:
Phytosterol content was determined in 76 samples: 62 multi-chamber bags, 12 LE vials, and 2 propofol vials. Multi-chamber bags containing omega-3-enriched emulsions had a significantly lower phytosterol load than those without omega-3 (808.8; standard deviation [SD] 109.8 vs 1,210.4; SD 262.6 μg/g lipid; p < 0.01). Bags with 100% soybean oil lipids showed the highest phytosterol content (1,879.3; SD 111.2 vs 944.9; SD 195.6 μg/g lipid; p < 0.01). An additional phytosterol contribution was observed from lipid-based drugs such as propofol (109.4; SD 6.2 μg/mL).
Conclusions:
Phytosterol content in PN varies substantially according to the lipid emulsion used. Formulations that include fish oil and reduce the proportion of soybean oil deliver a lower phytosterol load, which may be advantageous in patients at risk of PN-associated liver dysfunction. These findings provide an objective basis for product selection and for future studies exploring the relationship between phytosterol exposure and PN-related hepatotoxicity.
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