Calkins Kara L, Dunn James C Y, Shew Stephen B, Reyen Laurie, Farmer Douglas G, Devaskar Sherin U, Venick Robert S
Department of Pediatrics, Division of Neonatology and Developmental Biology, Neonatal Research Center
Department of Surgery, Division of Pediatric Surgery.
JPEN J Parenter Enteral Nutr. 2014 Aug;38(6):682-92. doi: 10.1177/0148607113495416. Epub 2013 Jul 26.
Studies have suggested that when intravenous (IV) soybean oil (SO) is replaced with fish oil (FO), direct hyperbilirubinemia is more likely to resolve. The necessary duration of FO has not been established. This study seeks to determine if 24 weeks of FO is an effective and safe therapy for intestinal failure-associated liver disease (IFALD).
This is a clinical trial using patients with IFALD between the ages of 2 weeks and 18 years. SO was replaced with FO (1 g/kg/d) in 10 patients who were receiving most of their calories from parenteral nutrition (PN). Patients were compared with 20 historic controls receiving SO. SO for both groups was prescribed by the primary medical team at variable doses. The primary outcome was time to reversal of cholestasis. Secondary outcomes were death, transplant, and full enteral feeds. Safety measurements included growth, essential fatty acid deficiency, and laboratory markers to assess bleeding risk.
The Kaplan-Meier method estimated that 75% in the FO group would experience resolution of cholestasis by 17 weeks vs 6% in the SO group (P < .0001). When compared with the SO group, the FO group had decreased serum direct bilirubin concentrations at weeks 8 (P = .03) and 12, 16, 20, and 24 weeks (P < .0001). Although length z score at the end of the study increased in the FO group compared with baseline (P = .03), there were no significant differences in other outcomes.
A limited duration of FO appears to be safe and effective in reversing IFALD.
研究表明,当静脉注射大豆油(SO)被鱼油(FO)替代时,直接胆红素血症更有可能得到缓解。FO的必要疗程尚未确定。本研究旨在确定24周的FO治疗对肠衰竭相关肝病(IFALD)是否有效且安全。
这是一项针对2周龄至18岁IFALD患者的临床试验。10名主要通过肠外营养(PN)获取大部分热量的患者,其SO被替换为FO(1 g/kg/天)。将这些患者与20名接受SO的历史对照患者进行比较。两组的SO均由初级医疗团队以可变剂量开具。主要结局是胆汁淤积逆转的时间。次要结局是死亡、移植和完全肠内喂养。安全性测量包括生长、必需脂肪酸缺乏以及评估出血风险的实验室指标。
Kaplan-Meier方法估计,FO组75%的患者在17周时胆汁淤积会得到缓解,而SO组为6%(P <.0001)。与SO组相比,FO组在第8周(P =.03)以及第12、16、20和24周时血清直接胆红素浓度降低(P <.0001)。尽管与基线相比,FO组在研究结束时的身长z评分有所增加(P =.03),但在其他结局方面无显著差异。
有限疗程的FO在逆转IFALD方面似乎是安全有效的。