Nutrition and Clinical Services Division, International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.
GlaxoSmithKline R&D, Gunnels Wood Road, Stevenage, Hertfordshire, UK.
J Glob Health. 2020 Jun;10(1):010414. doi: 10.7189/jogh.10.010414.
Topical emollient therapy can improve neonatal health and growth and potentially provides an additional avenue for augmenting the provision of nutrition to children with severe acute malnutrition (SAM). We hypothesised that topical treatment of hospitalised children with SAM using sunflower seed oil (SSO), in addition to standard-of-care for SAM, would improve skin barrier function and weight gain, reduce risk of infection, and accelerate clinical recovery.
We conducted a randomised, two-arm, controlled, unblinded clinical trial in 212 subjects aged 2 to 24 months who were admitted for care of SAM at the 'Dhaka Hospital' of icddr,b during January 2016 to November 2017. Enrollment was age-stratified into 2 to <6 months and 6 to 24 months age groups in a 1:2 ratio. All children received SAM standard-of-care, and the SSO group was also treated with 3 g of SSO per kg body weight three times daily for 10 days. Primary outcome was rate of weight gain over the 10-day study period. Secondary endpoints included rate of nosocomial infection, time to recovery from acute illness, skin condition score, rate of transepidermal water loss (TEWL) and C-reactive protein (CRP) level.
Rate of weight gain was higher in the SSO than the control group (adjusted mean difference, AMD = 0.90 g/kg/d, 95% confidence interval (CI) = -1.22 to 3.03 in the younger age stratum), but did not reach statistical significance. Nosocomial infection rate was significantly lower in the SSO group in the older age stratum (adjusted odds ratio (OR) = 0.41, 95% CI = 0.19 to 0.85; = 0.017), but was comparable in the younger age stratum and overall. Skin condition score improved (AMD = -14.88, 95% CI = -24.12 to -5.65, = 0.002) and TEWL was reduced overall (AMD = -2.59, 95% CI = -3.86 to -1.31, < 0.001) in the SSO group. Reduction in CRP level was significantly greater in the SSO group (median: -0.28) than the control group (median 0.00) ( = 0.019) in the younger age stratum.
Topical therapy with SSO was beneficial for children with SAM when applied as adjunctive therapy. A community-based trial with a longer intervention period is recommended to validate these results.
ClinicalTrials.gov: NCT02616289.
局部保湿疗法可改善新生儿健康和生长状况，还有可能为严重急性营养不良（SAM）儿童提供额外的营养途径。我们假设，在标准的 SAM 治疗之外，用葵花籽油（SSO）对住院 SAM 儿童进行局部治疗，将改善皮肤屏障功能和体重增加，降低感染风险，并加速临床康复。
我们在 2016 年 1 月至 2017 年 11 月期间，在 icddr,b 的达卡医院对年龄在 2 至 24 个月的 212 名 SAM 住院儿童进行了一项随机、两臂、对照、非盲临床试验。按年龄分层，分为 2 至<6 个月和 6 至 24 个月两个年龄组，比例为 1:2。所有儿童均接受 SAM 标准治疗，SSO 组还接受了每日 3 克 SSO/kg 体重，连续 10 天。主要结局为 10 天研究期间的体重增加率。次要终点包括院内感染率、急性疾病恢复时间、皮肤状况评分、经表皮水分流失（TEWL）和 C 反应蛋白（CRP）水平。
与对照组相比，SSO 组体重增加率更高（调整平均差异，AMD=0.90g/kg/d，95%置信区间（CI）=-1.22 至 3.03，年龄较小组），但无统计学意义。SSO 组在年龄较大组的院内感染率显著降低（调整后的优势比（OR）=0.41，95%CI=0.19 至 0.85；=0.017），但在年龄较小组和总体上无差异。SSO 组皮肤状况评分改善（AMD=-14.88，95%CI=-24.12 至-5.65，=0.002），TEWL 总体降低（AMD=-2.59，95%CI=-3.86 至-1.31，<0.001）。年龄较小组 SSO 组 CRP 水平降低幅度显著大于对照组（中位数：-0.28 比 0.00）（=0.019）。
局部使用 SSO 对 SAM 儿童有益，可以作为辅助治疗。建议进行一项以社区为基础、干预时间更长的试验来验证这些结果。
ClinicalTrials.gov：NCT02616289。
