Medical Research Council Unit The Gambia, Fajara, Gambia.
Department of Paediatrics: Child and Youth Health, University of Auckland, Auckland, New Zealand.
J Glob Health. 2018 Jun;8(1):010418. doi: 10.7189/jogh.08.010418.
The benefit of zinc as an adjunct therapy for severe pneumonia is not established. We assessed the benefit of adjunct zinc therapy for severe pneumonia in children and determined whether the study children were zinc deficient.
This was a randomized, parallel group, double-blind, placebo-controlled trial with an allocation ratio of 1:1 conducted in children with severe pneumonia to evaluate the efficacy of daily zinc as an adjunct treatment in preventing 'treatment failure' (presence of any sign of severe pneumonia) on day-5 and day-10 and in reducing the time to resolution of signs of severe pneumonia. Six hundred and four children 2-59 months of age presenting with severe pneumonia at six urban and rural health care facilities in The Gambia were individually randomised to receive placebo (n = 301) or zinc (n = 303) for seven days. To determine if the study children were zinc deficient, supplementation was continued in a randomly selected subgroup of 121 children from each arm for six months post-enrolment, and height-gain, nutritional status, plasma zinc concentrations, and immune competence were compared.
Percentage of treatment failure were similar in placebo and zinc arms both on day 5 (14.0% vs 14.1%) and day 10 (5.2% vs 5.9%). The time to recovery from lower chest wall indrawing and sternal retraction was longer in the placebo compared to zinc arm (24.4 vs 23.0 hours; = 0.011 and 18.7 vs 11.0 hours; = 0.006 respectively). The time to resolution for all respiratory symptoms of severity was not significantly different between placebo and zinc arms (42.3 vs 30.9 hours respectively; = 0.242). In the six months follow-up sub-group, there was no significant difference in height gain, height-for-age and weight-for-height Z-scores, mid upper arm circumference, plasma zinc concentrations, and anergy at six months post-enrolment.
In this population, zinc given as an adjunct treatment for severe pneumonia showed no benefit in treatment failure rates, or clinically important benefit in time to recovery from respiratory symptoms and showed marginal benefit in rapidity of resolution of some signs of severity. This finding does not support routine use of zinc as an adjunct treatment in severe pneumonia in generally zinc replete children.
ISRCTN33548493.
锌作为重症肺炎辅助治疗的益处尚未确定。我们评估了重症肺炎患儿补锌辅助治疗的益处，并确定研究患儿是否缺锌。
这是一项在 6 家城市和农村医疗机构的重症肺炎患儿中进行的随机、平行组、双盲、安慰剂对照试验，分配比例为 1:1，旨在评估每日补锌作为辅助治疗在预防第 5 天和第 10 天“治疗失败”（出现任何重症肺炎体征）方面的疗效，并评估其在降低重症肺炎体征消退时间方面的作用。604 名 2-59 月龄的重症肺炎患儿分别接受安慰剂（n=301）或锌（n=303）治疗 7 天。为确定研究患儿是否缺锌，在每个治疗组中随机选择 121 名患儿继续补锌 6 个月，并比较身高增长、营养状况、血浆锌浓度和免疫功能。
安慰剂组和锌组第 5 天（14.0% vs 14.1%）和第 10 天（5.2% vs 5.9%）的治疗失败率相似。安慰剂组较锌组的肋间隙凹陷和胸骨后凹陷恢复时间更长（24.4 小时 vs 23.0 小时； = 0.011 和 18.7 小时 vs 11.0 小时； = 0.006）。安慰剂组和锌组所有严重呼吸症状的缓解时间无显著差异（分别为 42.3 小时和 30.9 小时； = 0.242）。在 6 个月随访亚组中，锌组和安慰剂组在 6 个月时的身高增长、身高年龄 Z 评分、体重身高 Z 评分、上臂中部周长、血浆锌浓度和无反应性均无显著差异。
在本研究人群中，补锌作为重症肺炎的辅助治疗，在治疗失败率方面没有获益，在缓解呼吸症状的时间方面没有临床显著获益，在一些严重症状的快速缓解方面有一定获益。这一发现不支持在一般锌充足的儿童中常规使用锌作为重症肺炎的辅助治疗。
ISRCTN33548493。
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