Department of Pharmacy, Novant Health Forsyth Medical Center, Winston-Salem, NC.
Department of Pharmacy, Brenner Children's Hospital, Winston-Salem, NC.
Am J Health Syst Pharm. 2021 Jan 22;78(3):210-215. doi: 10.1093/ajhp/zxaa377.
Results of a study comparing the safety and efficacy outcomes with use of a soybean oil-based injectable lipid emulsion (SO-ILE) vs a 4-oil alternative product in a neonatal population are presented.
In an institutional review board-approved, multicenter retrospective review, the medical records of 328 patients who were born at a gestational age of ≤34 weeks, had a birth weight of 500 to 2,000 g, were admitted to one of 2 neonatal intensive care units (NICUs) within a large health system, and received at least 7 days of a parenteral nutrition containing either lipid emulsion product were reviewed: 151 (46%) had received SO-ILE and 177 (54%) had received SMOFlipid (Fresenius Kabi). The primary outcome of the study was a composite of development of cholestasis and development of hypertriglyceridemia. Secondary outcomes included total duration of cholestasis treatment with ursodiol and change in body weight from initiation to completion of lipid emulsion treatment.
The primary outcome of development of cholestasis or hypertriglyceridemia occurred in 14.6% of patients in the SO-ILE group and 18.1% of patients in the SMOFlipid group (P = 0.393). There were no statistically significant differences between the groups in total days of ursodiol treatment or average body weight change during the course of lipid emulsion treatment.
In preterm neonates weighing 500 to 2,000 g, use of SMOFlipid did not significantly reduce the incidence of cholestasis or hypertriglyceridemia relative to the incidence with use of SO-ILE. Further research to validate these results is needed.
本研究旨在比较大豆油基注射用脂肪乳(SO-ILE)与其他 4 种油替代产品在新生儿中的安全性和疗效结果。
在一项机构审查委员会批准的多中心回顾性研究中,回顾了在一个大型医疗系统内的 2 个新生儿重症监护病房(NICU)之一出生胎龄≤34 周、出生体重为 500 至 2000g、接受至少 7 天含脂肪乳剂的肠外营养的 328 例患者的病历:151 例(46%)接受了 SO-ILE,177 例(54%)接受了 SMOFlipid(费森尤斯卡比)。研究的主要结局是胆汁淤积和高甘油三酯血症的综合发展。次要结局包括熊去氧胆酸治疗胆汁淤积的总持续时间和从开始到完成脂肪乳剂治疗时体重的变化。
SO-ILE 组中发生胆汁淤积或高甘油三酯血症的主要结局发生率为 14.6%,SMOFlipid 组为 18.1%(P=0.393)。两组在熊去氧胆酸治疗的总天数或脂肪乳剂治疗过程中的平均体重变化方面无统计学差异。
在体重为 500 至 2000g 的早产儿中,与使用 SO-ILE 相比,使用 SMOFlipid 并不能显著降低胆汁淤积或高甘油三酯血症的发生率。需要进一步的研究来验证这些结果。