Department of Pediatrics, Washington University, St. Louis, MO, USA.
Collaborative Mass Spectrometry Innovation Center, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of California, San Diego, San Diego, CA, USA.
Glob Health Sci Pract. 2019 Jun 27;7(2):203-214. doi: 10.9745/GHSP-D-19-00004. Print 2019 Jun.
Only 20% of children with severe acute malnutrition (SAM) have access to ready-to-use therapeutic food (RUTF), and RUTF cost limits its accessibility.
This randomized, double-blind controlled study involved a clinical equivalence trial comparing the effectiveness of an alternative RUTF with standard RUTF in the home-based treatment of uncomplicated SAM and moderate malnutrition in Ghanaian children aged 6 to 59 months. The primary outcome was recovery, equivalence was defined as being within 5 percentage points of the control group, and an intention-to-treat analysis was used. Alternative RUTF was composed of whey protein, soybeans, peanuts, sorghum, milk, sugar, and vegetable oil. Standard RUTF included peanuts, milk, sugar, and vegetable oil. The cost of alternative RUTF ingredients was 14% less than standard RUTF. Untargeted metabolomics was used to characterize the bioactive metabolites in the RUTFs.
Of the 1,270 children treated for SAM or moderate malnutrition, 554 of 628 (88%) receiving alternative RUTF recovered (95% confidence interval [CI]=85% to 90%) and 516 of 642 (80%) receiving standard RUTF recovered (95% CI=77% to 83%). The difference in recovery was 7.7% (95% CI=3.7% to 11.7%). Among the 401 children with SAM, the recovery rate was 130 of 199 (65%) with alternative RUTF and 156 of 202 (77%) with standard RUTF (=.01). The default rate in SAM was 60 of 199 (30%) for alternative RUTF and 41 of 202 (20%) for standard RUTF (=.04). Children enrolled with SAM who received alternative RUTF had less daily weight gain than those fed standard RUTF (2.4 ± 2.4 g/kg vs. 2.9 ± 2.6 g/kg, respectively; <.05). Among children with moderate wasting, recovery rates were lower for alternative RUTF, 386 of 443 (87%), than standard RUTF, 397 of 426 (93%) (=.003). More isoflavone metabolites were found in alternative RUTF than in the standard.
The lower-cost alternative RUTF was less effective than standard RUTF in the treatment of severe and moderate malnutrition in Ghana.
仅有 20%的严重急性营养不良 (SAM) 患儿能够获得即食治疗食品 (RUTF)，而 RUTF 的成本限制了其可及性。
本项随机、双盲对照研究开展了一项临床等效性试验，比较了替代 RUTF 与标准 RUTF 在加纳 6 至 59 月龄、无需住院的 SAM 及中度营养不良患儿家庭治疗中的有效性。主要结局为恢复，等效性定义为与对照组相差 5 个百分点以内，采用意向治疗分析。替代 RUTF 由乳清蛋白、大豆、花生、高粱、牛奶、糖和植物油组成。标准 RUTF 包含花生、牛奶、糖和植物油。替代 RUTF 成分的成本比标准 RUTF 低 14%。采用非靶向代谢组学来描述 RUTF 中的生物活性代谢物。
在接受 SAM 或中度营养不良治疗的 1270 名儿童中，554 名接受替代 RUTF 治疗的儿童（628 名中的 88%）恢复（95%置信区间 [CI]：85%至 90%），516 名接受标准 RUTF 治疗的儿童（642 名中的 80%）恢复（95% CI：77%至 83%）。恢复率差异为 7.7%（95% CI：3.7%至 11.7%）。在 401 名 SAM 患儿中，接受替代 RUTF 治疗的 130 名患儿（199 名中的 65%）和接受标准 RUTF 治疗的 156 名患儿（202 名中的 77%）恢复（P=0.01）。SAM 患儿的默认率为替代 RUTF 组 60 名（199 名中的 30%），标准 RUTF 组 41 名（202 名中的 20%）（P=0.04）。接受替代 RUTF 治疗的 SAM 患儿的每日体重增加量少于接受标准 RUTF 治疗的患儿（分别为 2.4±2.4 g/kg 与 2.9±2.6 g/kg；P<0.05）。在中度消瘦的患儿中，替代 RUTF 的恢复率较低（443 名中的 386 名，87%），标准 RUTF 的恢复率较高（426 名中的 397 名，93%）（P=0.003）。替代 RUTF 中发现的异黄酮代谢物多于标准 RUTF。
在加纳，成本较低的替代 RUTF 治疗严重和中度营养不良的效果不如标准 RUTF。
