Centre for Diarrhoeal Diseasesand Nutrition Research, All IndiaInstitute of Medical Sciences, New Delhi, India.
Lancet. 2012 Jun 2;379(9831):2072-8. doi: 10.1016/S0140-6736(12)60477-2.
Serious bacterial infections are a major cause of death in early infancy in developing countries. Inexpensive and accessible interventions that can add to the effect of standard antibiotic treatment could reduce infant mortality. We measured the effect of zinc as an adjunct to antibiotics in infants with probable serious bacterial infection.
In this randomised, double-blind, placebo-controlled trial, we enrolled infants aged 7-120 days with probable serious bacterial infection at three hospitals in New Delhi, India, between July 6, 2005, and Dec 3, 2008. With computer-generated sequences, we randomly assigned infants in permuted blocks of six, stratified by whether patients were underweight or had diarrhoea at enrolment, to receive either 10 mg of zinc or placebo orally every day in addition to standard antibiotic treatment. The primary outcome was treatment failure, which was defined as a need to change antibiotics within 7 days of randomisation, or a need for intensive care, or death at any time within 21 days. Participants and investigators were masked to treatment allocation. All analyses were done by intention-to-treat. This trial is registered with ClinicalTrials.gov, number NCT00347386.
352 infants were randomly assigned to receive zinc and 348 to placebo. 332 given zinc and 323 given placebo could be assessed for treatment failure. Significantly fewer treatment failures occurred in the zinc group (34 [10%]) than in the placebo group (55 [17%]; relative risk reduction 40%, 95% CI 10-60, p=0·0113; absolute risk reduction 6·8%, 1·5-12·0, p=0·0111). Treatment of 15 (95% CI eight to 67) infants with zinc would prevent one treatment failure. Ten infants receiving zinc died compared with 17 given placebo (relative risk 0·57, 0·27-1·23, p=0·15).
Zinc could be given as adjunct treatment to reduce the risk of treatment failure in infants aged 7-120 days with probable serious bacterial infection.
Department of Biotechnology, Government of India; the European Commission; the Meltzer Foundation; and the Research Council of Norway.
严重细菌感染是发展中国家婴儿早期死亡的主要原因。一些廉价且易于获得的干预措施，如果能增强标准抗生素治疗的效果，就可能降低婴儿死亡率。我们评估了补锌作为严重细菌感染婴儿辅助治疗的效果。
这是一项在印度新德里的 3 家医院进行的、随机、双盲、安慰剂对照试验。2005 年 7 月 6 日至 2008 年 12 月 3 日，我们纳入了年龄在 7-120 天的疑似严重细菌感染婴儿。根据计算机生成的序列，采用区组随机化（区组大小为 6）、按患儿是否消瘦或入组时是否腹泻分层，将患儿随机分为补锌组或安慰剂组，两组患儿均每日接受标准抗生素治疗和 10mg 锌口服治疗。主要转归为治疗失败，定义为随机分组后 7 天内需要更换抗生素、需要重症监护或 21 天内任何时候死亡。患儿及其家属、研究者均对治疗分组不知情。所有分析均基于意向治疗原则。该试验已在 ClinicalTrials.gov 注册，编号为 NCT00347386。
352 名患儿被随机分配至补锌组，348 名患儿被分配至安慰剂组。332 名接受锌治疗的患儿和 323 名接受安慰剂的患儿可评估治疗失败情况。补锌组治疗失败（34 例，10%）的患儿少于安慰剂组（55 例，17%）（相对风险降低 40%，95%CI 10-60，p=0.0113；绝对风险降低 6.8%，1.5-12.0，p=0.0111）。治疗 15 名（95%CI 8-67）患儿即可预防 1 例治疗失败。10 名接受锌治疗的患儿死亡，而接受安慰剂的患儿有 17 名死亡（相对风险 0.57，0.27-1.23，p=0.15）。
锌可作为辅助治疗用于严重细菌感染婴儿，以降低其治疗失败风险。
印度生物技术部、欧盟委员会、Meltzer 基金会、挪威研究理事会。
