Preventing the Progression of Intestinal Failure-Associated Liver Disease in Infants Using a Composite Lipid Emulsion: A Pilot Randomized Controlled Trial of SMOFlipid
Preventing the Progression of Intestinal Failure-Associated Liver Disease in Infants Using a Composite Lipid Emulsion: A Pilot Randomized Controlled Trial of SMOFlipid
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DOI：
10.1177/0148607115626921
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发表时间：
2017-07-01
影响因子：
3.4
通讯作者：
Wales, Paul W.
中科院分区：
文献类型：
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作者：
Diamond, Ivan R.;Grant, Robert C.;Wales, Paul W.
背景资料：研究SMOFlipid是否可预防肠外营养（PN）依赖型早期IFALD婴儿（结合胆红素17-50 μ mol/L，1-3 mg/dL）肠衰竭相关肝病（IFALD）的进展。研究设计：比较SMOFlipid与Intralidid的初步多中心盲法随机对照试验。患者接受试验脂质长达12周，除非他们更早达到完全肠内耐受。主要临床结局为血清结合胆红素。结果：24名婴儿（平均年龄，6周）参加了试验（13名Intramidid和11名SMOFlipid）。在试验入组时，两组患者均通过PN获得90%的热量。试验的平均持续时间为8周，根据治疗没有差异（P = .99）。在试验结束时，接受SMOFlipid治疗的患者的结合胆红素低于接受Intralidid治疗的患者（平均差异，-59 μ mol/L; P = .03）。在整个观察期内，接受SMOFlipid治疗的患者血清结合胆红素降低至0 μ mol/L的可能性也高于Intralidid组（风险比，10.6; 95%; P = 0.03）。两组间达到完全肠内耐受的时间无统计学差异（风险比，1.3; P = .59）。两组之间的安全性结局无显著差异。结论：与Intralidid相比，SMOFlipid可降低肠衰竭儿童发生进展性IFALD的风险。本试验在clinicaltrials.gov上注册为NCT 00793195。
Background: To examine whether SMOFlipid prevents progression of intestinal failure-associated liver disease (IFALD) in parenteral nutrition (PN)-dependent infants with early IFALD (conjugated bilirubin 17-50 mu mol/L, 1-3 mg/dL). Study Design: Pilot multicenter blinded randomized controlled trial comparing SMOFlipid with Intralipid. Patients received the trial lipid for up to 12 weeks, unless they achieved full enteral tolerance sooner. The primary clinical outcome was the serum conjugated bilirubin. Results: Twenty-four infants (mean age, 6 weeks) participated in the trial (13 Intralipid and 11 SMOFlipid). At the time of trial enrollment, patients in both groups were receiving 90% of their calories by PN. Mean duration on trial was 8 weeks and did not differ according to treatment (P = .99). At trial conclusion, patients who received SMOFlipid had a lower conjugated bilirubin than those who received Intralipid (mean difference, -59 mu mol/L; P = .03). Patients receiving SMOFlipid were also more likely to have a decrease in serum conjugated bilirubin to 0 mu mol/L than those in the Intralipid group over the entire observation period (hazard ratio, 10.6; 95%; P = .03). The time to achievement of full enteral tolerance did not differ statistically (hazard ratio, 1.3; P = .59) between the groups. There was no significant difference in safety outcomes between the groups. Conclusions: Compared with Intralipid, SMOFlipid reduces the risk of progressive IFALD in children with intestinal failure. This trial was registered at clinicaltrials.gov as NCT00793195.