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Improved residual fat malabsorption and growth in children with cystic fibrosis treated with a novel oral structured lipid supplement: A randomized controlled trial.

新型口服结构脂质补充剂治疗囊性纤维化儿童改善残余脂肪吸收不良和生长: 一项随机对照试验。

  • 影响因子:3.02
  • DOI:10.1371/journal.pone.0232685
  • 作者列表:"Stallings VA","Tindall AM","Mascarenhas MR","Maqbool A","Schall JI
  • 发表时间:2020-05-08
Abstract

BACKGROUND:In the primary analysis of a 12-month double-blind randomized active placebo-controlled trial, treatment of children with cystic fibrosis (CF) and pancreatic insufficiency (PI) with a readily absorbable structured lipid (Encala™, Envara Health, Wayne, PA) was safe, well-tolerated and improved dietary fat absorption (stool coefficient of fat absorption [CFA]), growth, and plasma fatty acids (FA). OBJECTIVE:To determine if the Encala™ treatment effect varied by severity of baseline fat malabsorption. METHODS:Subjects (n = 66, 10.5±3.0 yrs, 39% female) with baseline CFA who completed a three-month treatment with Encala™ or a calorie and macronutrient-matched placebo were included in this subgroup analysis. Subjects were categorized by median baseline CFA: low CFA (<88%) and high CFA (≥88%). At baseline and 3-month evaluations, CFA (72-hour stool, weighed food record) and height (HAZ), weight (WAZ) and BMI (BMIZ) Z-scores were calculated. Fasting plasma fatty acid (FA) concentrations were also measured. RESULTS:Subjects in the low CFA subgroup had significantly improved CFA (+7.5±7.2%, mean 86.3±6.7, p = 0.002), and reduced stool fat loss (-5.7±7.2 g/24 hours) following three months of EncalaTM treatment. These subjects also had increased plasma linoleic acid (+20%), α-linolenic acid (+56%), and total FA (+20%) (p≤0.005 for all) concentrations and improvements in HAZ (0.06±0.08), WAZ (0.17±0.16), and BMIZ (0.20±0.25) (p≤0.002 for all). CFA and FA were unchanged with placebo in the low CFA group, with some WAZ increases (0.14±0.24, p = 0.02). High CFA subjects (both placebo and Encala™ groups) had improvements in WAZ and some FA. CONCLUSIONS:Subjects with CF, PI and more severe fat malabsorption experienced greater improvements in CFA, FA and growth after three months of Encala™ treatment. Encala™ was safe, well-tolerated and efficacious in patients with CF and PI with residual fat malabsorption and improved dietary energy absorption, weight gain and FA status in this at-risk group.

摘要

背景: 在一项为期12个月的双盲随机活性安慰剂对照试验的主要分析中,囊性纤维化 (CF) 和胰腺功能不全 (PI) 儿童用易吸收结构脂质 (encla) 治疗™,Envara Health,Wayne,PA) 是安全的,耐受性良好,改善了膳食脂肪吸收 (粪便脂肪吸收系数 [CFA]),生长和血浆脂肪酸 (FA)。 目的: 确定Encala™治疗效果因基线脂肪吸收不良的严重程度而异。 方法: 基线CFA的受试者 (n = 66,10.5 ± 3.0岁,39% 为女性) 完成了encla三个月治疗™或热量和常量营养素匹配的安慰剂被包括在这个亚组分析中。根据中位基线CFA对受试者进行分类: 低CFA (<88%) 和高CFA (≥ 88%)。在基线和3个月评估时,计算CFA (72小时粪便,称重食物记录) 和身高 (HAZ) 、体重 (WAZ) 和BMI (BMIZ) Z-评分。还测量了空腹血浆脂肪酸 (FA) 浓度。 结果: 低CFA亚组的受试者在EncalaTM治疗三个月后,CFA显著改善 (+ 7.5 ± 7.2%,平均值86.3 ± 6.7,p = 0.002),粪便脂肪减少 (-5.7 ± 7.2g/24小时)。这些受试者的血浆亚油酸 (+ 20%),α-亚麻酸 (+ 56%) 和总FA (+ 20%) (p ≤ 0.005) 浓度也有所增加,HAZ (0.06 ± 0.08),WAZ (0.17 ± 0.16) 和BMIZ (0.20 ± 0.25) 也有所改善 (全部p ≤ 0.002)。在低CFA组中,安慰剂组的CFA和FA无变化,一些WAZ增加 (0.14 ± 0.24,p = 0.02)。高CFA受试者 (安慰剂和恩卡拉™组) 在WAZ和一些FA方面有改善。 结论: 患有CF,PI和更严重的脂肪吸收不良的受试者在encla三个月后,CFA,FA和生长有更大的改善™治疗。恩卡拉™在该风险组中,CF和PI患者的残余脂肪吸收不良和改善的饮食能量吸收,体重增加和FA状态是安全的,良好的耐受性和有效的。

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新生儿/早产方向

新生儿指的是胎儿娩出母体并自脐带结扎起,至出生后满28天这一段时间的婴儿;早产儿是指胎龄在37足周以前出生的活产婴儿称为早产儿或未成熟儿。

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