West K P, Khatry S K, LeClerq S C, Adhikari R, See L, Katz J, Shrestha S R, Pradhan E K, Pokhrel R P, Sommer A
School of Medicine, Johns Hopkins University, Baltimore, MD.
Bull World Health Organ. 1992;70(6):733-9.
A randomized, double-masked trial was carried out in rural Nepal to investigate the incidence and severity of acute side-effects among neonates ( < 1 month of age) and infants aged 1-6 months who received a large, oral dose of vitamin A (15,000 retinol equivalents (RE) (50,000 IU) and 30,000 RE (100,000 IU), respectively) or placebo (75 RE (250 IU) and 150 RE (500 IU), respectively) in oil. Infants (vitamin A group, n = 1461; controls, n = 1379) were assessed for vomiting, loose stools, fever, and irritability during the 24 hours before and after dosing. Fontanelles were palpated 24 hours after dosing. Neonates exhibited no excess risk of adverse side-effects after receiving 15,000 RE. Compared with controls the older infants who ingested 30,000 RE had a 1.6% excess rate of vomiting (95% confidence interval (CI): 0.2-3.0%) and a 0.5% excess rate (95% CI: -0.1 to 1.1%) in the occurrence of bulging fontanelles. There were no other significant differences in the older infants. The controlled, periodic distribution of a single 15,000 RE dose of vitamin A therefore confers no apparent acute risk to young infants; a 30,000 RE dose is associated with a minimum risk of transient, acute side-effects.
在尼泊尔农村地区进行了一项随机双盲试验，以调查接受大剂量口服维生素A（分别为15,000视黄醇当量（RE）（50,000国际单位）和30,000 RE（100,000国际单位））或安慰剂（分别为75 RE（250国际单位）和150 RE（500国际单位））的1个月龄以下新生儿和1至6个月龄婴儿急性副作用的发生率和严重程度。在给药前后24小时内评估婴儿（维生素A组，n = 1461；对照组，n = 1379）的呕吐、腹泻、发热和易激惹情况。给药24小时后触诊囟门。接受15,000 RE的新生儿未出现不良反应的额外风险。与对照组相比，摄入30,000 RE的较大婴儿呕吐发生率高出1.6%（95%置信区间（CI）：0.2 - 3.0%），囟门隆起发生率高出0.5%（95% CI： - 0.1至1.1%）。较大婴儿没有其他显著差异。因此，单次15,000 RE剂量的维生素A定期控制性分发对幼儿没有明显的急性风险；30,000 RE剂量与短暂急性副作用的最低风险相关。
