Department of Pediatrics, Washington University in St. Louis, St. Louis, MO 63110, USA.
N Engl J Med. 2013 Jan 31;368(5):425-35. doi: 10.1056/NEJMoa1202851.
Severe acute malnutrition contributes to 1 million deaths among children annually. Adding routine antibiotic agents to nutritional therapy may increase recovery rates and decrease mortality among children with severe acute malnutrition treated in the community.
In this randomized, double-blind, placebo-controlled trial, we randomly assigned Malawian children, 6 to 59 months of age, with severe acute malnutrition to receive amoxicillin, cefdinir, or placebo for 7 days in addition to ready-to-use therapeutic food for the outpatient treatment of uncomplicated severe acute malnutrition. The primary outcomes were the rate of nutritional recovery and the mortality rate.
A total of 2767 children with severe acute malnutrition were enrolled. In the amoxicillin, cefdinir, and placebo groups, 88.7%, 90.9%, and 85.1% of the children recovered, respectively (relative risk of treatment failure with placebo vs. amoxicillin, 1.32; 95% confidence interval [CI], 1.04 to 1.68; relative risk with placebo vs. cefdinir, 1.64; 95% CI, 1.27 to 2.11). The mortality rates for the three groups were 4.8%, 4.1%, and 7.4%, respectively (relative risk of death with placebo vs. amoxicillin, 1.55; 95% CI, 1.07 to 2.24; relative risk with placebo vs. cefdinir, 1.80; 95% CI, 1.22 to 2.64). Among children who recovered, the rate of weight gain was increased among those who received antibiotics. No interaction between type of severe acute malnutrition and intervention group was observed for either the rate of nutritional recovery or the mortality rate.
The addition of antibiotics to therapeutic regimens for uncomplicated severe acute malnutrition was associated with a significant improvement in recovery and mortality rates. (Funded by the Hickey Family Foundation and others; ClinicalTrials.gov number, NCT01000298.).
严重急性营养不良导致每年有 100 万儿童死亡。在社区中治疗严重急性营养不良的儿童中,常规添加抗生素可能会提高康复率并降低死亡率。
在这项随机、双盲、安慰剂对照试验中,我们将年龄在 6 至 59 个月之间患有严重急性营养不良的马拉维儿童随机分配,接受 7 天的阿莫西林、头孢地尼或安慰剂治疗,同时接受用于治疗简单严重急性营养不良的即用型治疗食品。主要结局是营养恢复率和死亡率。
共有 2767 名患有严重急性营养不良的儿童入组。在阿莫西林、头孢地尼和安慰剂组中,分别有 88.7%、90.9%和 85.1%的儿童康复(与安慰剂相比,阿莫西林治疗失败的相对风险为 1.32;95%置信区间[CI],1.04 至 1.68;与安慰剂相比,头孢地尼的相对风险为 1.64;95%CI,1.27 至 2.11)。三组的死亡率分别为 4.8%、4.1%和 7.4%(与安慰剂相比,阿莫西林死亡的相对风险为 1.55;95%CI,1.07 至 2.24;与安慰剂相比,头孢地尼的相对风险为 1.80;95%CI,1.22 至 2.64)。在康复的儿童中,接受抗生素治疗的儿童体重增加率增加。在营养恢复率或死亡率方面,未观察到严重急性营养不良类型与干预组之间的任何相互作用。
在治疗简单严重急性营养不良的方案中添加抗生素可显著提高康复率和死亡率。(由 Hickey 家族基金会等资助;ClinicalTrials.gov 编号,NCT01000298。)