Kjolhede C L, Chew F J, Gadomski A M, Marroquin D P
Department of International Health, Johns Hopkins University, Baltimore, Maryland, USA.
J Pediatr. 1995 May;126(5 Pt 1):807-12. doi: 10.1016/s0022-3476(95)70416-7.
To test the efficacy of a high dose of vitamin A as adjuvant treatment for radiographically confirmed cases of acute lower respiratory tract infection (ALRI).
Randomized, double-masked, placebo-controlled clinical trial.
Two large urban hospitals in Guatemala City.
Sequential sample of 263 children aged 3 to 48 months, identified in the emergency departments and admitted to the hospital.
Vitamin A (100,000 IU for children less than 1 year of age, and 200,000 IU for older children) or placebo in addition to standard treatment for ALRI which included antibiotics, oxygen, bronchodilators, and intravenously administered solutions.
The children were assessed every 8 hours. There were neither statistically nor clinically significant differences by treatment group in the rate of normalization in respiratory rate, oxygen saturation, temperature, or clinical score. Duration of hospitalization was not different by treatment group. Adverse outcomes (mechanical ventilation, prolonged hospitalization, readmission or transfer, and death) were equally distributed between the two groups.
Treatment with high doses of vitamin A over and above standard care for infants and children with non-measles-related ALRI is not efficacious for the current episode. Additional trials among populations in which vitamin A deficiency is more prevalent and severe should be considered.
检验大剂量维生素A作为影像学确诊的急性下呼吸道感染（ALRI）辅助治疗的疗效。
随机、双盲、安慰剂对照临床试验。
危地马拉城的两家大型城市医院。
从急诊科筛选并收治入院的263名3至48个月大儿童的序贯样本。
除了对ALRI的标准治疗（包括抗生素、氧气、支气管扩张剂和静脉输液）外，给予维生素A（1岁以下儿童100,000国际单位，1岁以上儿童200,000国际单位）或安慰剂。
每8小时对儿童进行一次评估。治疗组在呼吸频率、血氧饱和度、体温或临床评分的恢复正常率方面，在统计学和临床上均无显著差异。治疗组的住院时间无差异。不良结局（机械通气、延长住院时间、再次入院或转院以及死亡）在两组中分布均匀。
对于非麻疹相关的ALRI婴幼儿，在标准治疗基础上加用大剂量维生素A对当前病程无效。应考虑在维生素A缺乏更为普遍和严重的人群中进行更多试验。
