Bhandari Nita, Mohan Sanjana Brahmawar, Bose Anuradha, Iyengar Sharad D, Taneja Sunita, Mazumder Sarmila, Pricilla Ruby Angeline, Iyengar Kirti, Sachdev Harshpal Singh, Mohan Venkata Raghava, Suhalka Virendra, Yoshida Sachiyo, Martines Jose, Bahl Rajiv
Centre for Health Research and Development, Society for Applied Studies, New Delhi, India.
Christian Medical College, Vellore, Tamil Nadu, India.
BMJ Glob Health. 2016 Dec 30;1(4):e000144. doi: 10.1136/bmjgh-2016-000144. eCollection 2016.
To assess the efficacy of ready-to-use therapeutic food (RUTF), centrally produced RUTF (RUTF-C) or locally prepared RUTF (RUTF-L) for home-based management of uncomplicated severe acute malnutrition (SAM) compared with micronutrient-enriched (augmented) energy-dense home-prepared foods (A-HPF, the comparison group).
In an individually randomised multicentre trial, we enrolled 906 children aged 6-59 months with uncomplicated SAM. The children enrolled were randomised to receive RUTF-C, RUTF-L or A-HPF. We provided foods, counselling and feeding support until recovery or 16 weeks, whichever was earlier and measured outcomes weekly (treatment phase). We subsequently facilitated access to government nutrition services and measured outcomes once 16 weeks later (sustenance phase). The primary outcome was recovery during treatment phase (weight-for-height ≥-2 SD and absence of oedema of feet).
Recovery rates with RUTF-L, RUTF-C and A-HPF were 56.9%, 47.5% and 42.8%, respectively. The adjusted OR was 1.71 (95% CI 1.20 to 2.43; p=0.003) for RUTF-L and 1.28 (95% CI 0.90 to 1.82; p=0.164) for RUTF-C compared with A-HPF. Weight gain in the RUTF-L group was higher than in the A-HPF group (adjusted difference 0.90 g/kg/day, 95% CI 0.30 to 1.50; p=0.003). Time to recovery was shorter in both RUTF groups. Morbidity was high and similar across groups. At the end of the study, the proportion of children with weight-for-height Z-score (WHZ) >-2 was similar (adjusted OR 1.12, 95% CI 0.74 to 1.95; p=0.464), higher for moderate malnutrition (WHZ<-2 and ≥-3; adjusted OR 1.46, 95% CI 1.02 to 2.08; p=0.039), and lower for those with SAM (adjusted OR 0.58, 95% CI 0.40 to 0.85; p=0.005) in the RUTF-L when compared with the A-HPF group.
This first randomised trial comparing options for home management of uncomplicated SAM confirms that RUTF-L is more efficacious than A-HPF at home. Recovery rates were lower than in African studies, despite longer treatment and greater support for feeding.
NCT01705769; Pre-results.
评估即食治疗性食品（RUTF）、中央生产的RUTF（RUTF-C）或本地制备的RUTF（RUTF-L）用于家庭管理单纯性重度急性营养不良（SAM）的疗效，并与富含微量营养素（强化）的高能量家庭自制食品（A-HPF，对照组）进行比较。
在一项个体随机多中心试验中，我们纳入了906名年龄在6至59个月的单纯性SAM儿童。纳入的儿童被随机分配接受RUTF-C、RUTF-L或A-HPF。我们提供食物、咨询和喂养支持，直至康复或16周，以先到者为准，并每周测量结果（治疗阶段）。随后，我们协助儿童获得政府营养服务，并在16周后测量一次结果（维持阶段）。主要结局是治疗阶段的康复情况（身高别体重≥-2标准差且足部无水肿）。
RUTF-L、RUTF-C和A-HPF的康复率分别为56.9%、47.5%和42.8%。与A-HPF相比，RUTF-L的校正比值比为1.71（95%置信区间1.20至2.43；p=0.003），RUTF-C的校正比值比为1.28（95%置信区间0.90至1.82；p=0.164）。RUTF-L组的体重增加高于A-HPF组（校正差异0.90g/kg/天；95%置信区间0.30至1.50；p=0.003）。两个RUTF组的康复时间均较短。发病率较高且各组相似。在研究结束时，身高别体重Z评分（WHZ）>-2的儿童比例相似（校正比值比1.12；95%置信区间0.74至1.95；p=0.464），中度营养不良儿童（WHZ<-2且≥-3）的比例较高（校正比值比1.46；95%置信区间1.02至2.08；p=0.039），与A-HPF组相比，RUTF-L组中SAM儿童的比例较低（校正比值比0.58；95%置信区间0.40至0.85；p=0.005）。
这项比较单纯性SAM家庭管理方案的首次随机试验证实，RUTF-L在家中比A-HPF更有效。尽管治疗时间更长且喂养支持更多，但康复率低于非洲的研究。
NCT01705769；预结果。
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