Bandim Health Project, INDEPTH Network, Apartado 861, Bissau, Guinea-Bissau.
Vaccine. 2013 Jun 28;31(31):3191-8. doi: 10.1016/j.vaccine.2013.04.072. Epub 2013 May 14.
WHO recommends vitamin A supplementation (VAS) at vaccination contacts after six months of age. The effect of this recommendation on mortality has not been evaluated.
We tested the effect of VAS at vaccination contacts on mortality in a randomised trial in Guinea-Bissau. In a subgroup within this trial we studied adverse reactions to VAS and whether VAS modified known adverse reactions to live and inactivated vaccines and general morbidity during the first month after supplementation overall and by sex. Children aged 6-17 months were randomised to VAS or placebo at the day of vaccination (day 0). We interviewed the caretaker, assessed the fontanel and measured temperature and local reaction at the injection site at home visits on day 1, 2, 3, 7, 14, 21, and 31. We defined systemic adverse reactions to inactivated and live vaccines as fever on day 1 and 2 and on 4-14 respectively. Clinical symptoms associated with increased intracranial pressure (ICP) on day 1 were considered possible adverse reactions to VAS.
In 1673 children VAS had no overall effect on clinical symptoms associated with increased ICP (Relative Risk(RR)=1.07 (95%CI: 0.85-1.35)). However, VAS was associated with such clinical symptoms in boys RR=1.38 (1.00-1.91)) but not in girls (p=0.03 for interaction between VAS and sex). VAS had no effect on fever after inactivated vaccines. VAS had no overall effect on fever after live vaccines (RR=0.86 (0.53-1.39)), but tended to reduce the prevalence of fever in boys (RR=0.58 (0.30-1.14)), but not in girls (RR=1.37 (0.66-2.84)) (p=0.09 for interaction between VAS and sex). VAS was associated with increased local reactions to measles vaccine in both sexes (RR=3.65 (1.20-11.12)).
Adverse reactions were rare, mild and transient and may not in their own right cause concern. However, VAS caused sex-differential adverse reactions and may have sex-differential effects on adverse reactions to vaccines.
世界卫生组织（WHO）建议在 6 个月龄后的疫苗接种接触时进行维生素 A 补充（VAS）。但该建议对死亡率的影响尚未得到评估。
我们在几内亚比绍进行的一项随机试验中，检验了在疫苗接种接触时进行 VAS 对死亡率的影响。在该试验的一个亚组中，我们研究了 VAS 的不良反应，以及 VAS 是否改变了活疫苗和灭活疫苗的已知不良反应以及补充后第一个月的总体和性别特异性一般发病率。6-17 月龄的儿童在接种日（第 0 天）随机分配至 VAS 组或安慰剂组。我们在家庭访视中于第 1、2、3、7、14、21 和 31 天询问看护人、评估囟门并测量体温和注射部位的局部反应。我们将活疫苗和灭活疫苗的全身不良反应定义为第 1 和 2 天以及第 4-14 天的发热。第 1 天与颅内压升高（ICP）相关的临床症状被认为是 VAS 的可能不良反应。
在 1673 名儿童中，VAS 对与 ICP 升高相关的临床症状总体上没有影响（相对风险[RR]=1.07（95%CI：0.85-1.35））。然而，VAS 与男孩的此类临床症状相关（RR=1.38（1.00-1.91）），但与女孩无关（VAS 与性别之间的交互作用 P=0.03）。VAS 对灭活疫苗后发热没有影响。VAS 对活疫苗后发热也没有总体影响（RR=0.86（0.53-1.39）），但有降低男孩发热流行率的趋势（RR=0.58（0.30-1.14）），但对女孩没有影响（RR=1.37（0.66-2.84））（VAS 与性别之间的交互作用 P=0.09）。VAS 与两性的麻疹疫苗局部反应增加有关（RR=3.65（1.20-11.12））。
不良反应罕见、轻微且短暂，本身可能不会引起关注。然而，VAS 引起了性别差异的不良反应，并且可能对疫苗的不良反应有性别差异的影响。
