Pereira-da-Silva Luís, Nóbrega Sara, Rosa Maria Luísa, Alves Marta, Pita Ana, Virella Daniel, Papoila Ana Luísa, Serelha Micaela, Cordeiro-Ferreira Gonçalo, Koletzko Berthold
Neonatal Intensive Care Unit, Woman, Infant and Adolescent Department, Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central, Lisbon, Portugal.
Neonatal Intensive Care Unit, Woman, Infant and Adolescent Department, Hospital Dona Estefânia, Centro Hospitalar de Lisboa Central, Lisbon, Portugal.
Clin Nutr ESPEN. 2017 Dec;22:7-12. doi: 10.1016/j.clnesp.2017.08.007. Epub 2017 Aug 26.
Cholestasis is a common complication in infants receiving prolonged parenteral nutrition (PN). We studied the effects of two intravenous lipid emulsions composed with either 30% soybean oil, 30% medium-chain triglycerides (MCT), 25% olive oil, and 15% fish oil (SMOF) or with 50% MCT and 50% soybean oil n-6 (MCT/SOY) on the incidence of cholestasis in surgical term and near-term neonates.
A single-center, double-blinded, randomized controlled trial compared the incidence of cholestasis using either SMOF or MCT/SOY in neonates born at gestational age ≥34 weeks undergoing major surgery. The primary outcome was the incidence of conjugated serum bilirubin >1 mg/dL. Other liver enzymes were assessed as secondary outcomes. A post-hoc analysis assessed serum triglycerides levels. Odds ratios were estimated by mixed-effects regression models.
Enrollment was prematurely interrupted because the MCT/SOY became unavailable, thus 49 infants (SMOF 22, MCT/SOY 27) completed the study. The exposure (time on PN, cumulative dose of lipids) was similar in both groups. Similar cumulative incidence rates were found for elevated conjugated bilirubinemia and other liver enzymes. Hypertriglyceridemia >250 mg/dL (12/49) was more frequent in MCT/SOY (37.0%, 95% CI 21.53-55.77) than in SMOF (9.1%, 95% CI 2.53-27.81, p = 0.024). Triglyceridemia at the first assessment (median 8 postnatal days) was significantly higher with MCT/SOY than with SMOF (181 vs. 134 mg/dL, p = 0.006). Over the whole study period, mean triglyceride concentration was 36.5 mg/dL higher with MCT/SOY compared with SMOF (p = 0.013).
Both emulsions had similar effects on the incidence of cholestasis and markers of liver integrity, but MCT/SOY induced higher serum triglyceride concentrations.
ClinicalTrials.gov, NCT02633384.
胆汁淤积是接受长期肠外营养（PN）的婴儿常见的并发症。我们研究了两种静脉脂质乳剂，一种由30%大豆油、30%中链甘油三酯（MCT）、25%橄榄油和15%鱼油（SMOF）组成，另一种由50%MCT和50%大豆油n-6（MCT/SOY）组成，对足月儿和近足月儿外科手术新生儿胆汁淤积发生率的影响。
一项单中心、双盲、随机对照试验比较了在胎龄≥34周接受大手术的新生儿中使用SMOF或MCT/SOY时胆汁淤积的发生率。主要结局是结合胆红素血清水平>1mg/dL的发生率。其他肝酶作为次要结局进行评估。事后分析评估血清甘油三酯水平。通过混合效应回归模型估计比值比。
由于MCT/SOY无法获得，研究提前中断，因此49名婴儿（SMOF组22名，MCT/SOY组27名）完成了研究。两组的暴露情况（PN使用时间、脂质累积剂量）相似。结合胆红素血症升高和其他肝酶的累积发生率相似。MCT/SOY组（37.0%，95%CI 21.53 - 55.77）中甘油三酯血症>250mg/dL（12/49）的发生率高于SMOF组（9.1%，95%CI 2.53 - 27.81，p = 0.024）。首次评估（出生后中位数8天）时，MCT/SOY组的甘油三酯血症显著高于SMOF组（181 vs. 134mg/dL，p = 0.006）。在整个研究期间，MCT/SOY组的平均甘油三酯浓度比SMOF组高36.5mg/dL（p = 0.013）。
两种乳剂对胆汁淤积发生率和肝脏完整性标志物的影响相似，但MCT/SOY会导致更高的血清甘油三酯浓度。
ClinicalTrials.gov，NCT02633384。
