Coutsoudis A, Adhikari M, Pillay K, Coovadia H M
Department of Paediatrics and Child Health, University of Natal, Durben.
S Afr Med J. 1996 Oct;86(10 Suppl):1337-9.
A randomised, double-blind placebo-controlled trial was designed to determine whether high-dose (25,000 IU) enteral vitamin A, to correct deficiency, would be absorbed and well tolerated in low-birth-weight (LBW) neonates. Thirty-five LBW infants (950-1700 g; gestational age 27-36 weeks) were allocated to receive either placebo or vitamin A (25,000 IU) via nasogastric tube on the first day of the study (between 36 and 60 hours after delivery). The dose was repeated on study days 4 and 8. Serum retinol concentrations were determined pre- and post-supplementation. Toxic effects of vitamin A were monitored by noting vomiting, drowsiness and irritability, and palpating for a bulging fontanelle. The mean serum retinol concentration was significantly higher following supplementation in the vitamin A-treated group than in the placebo group (45.77 +/- 17.07 micrograms/dl v. 12.88 +/- 6.48 micrograms/dl; P = 0.0001). Toxic effects were not detected in any of the infants. In conclusion, high-dose enteral vitamin A is well absorbed in LBW neonates and three doses of 25,000 IU given over a period of 8 days are not associated with any detectable toxic effects.
一项随机、双盲、安慰剂对照试验旨在确定高剂量(25,000国际单位)肠内维生素A用于纠正缺乏症时,在低出生体重(LBW)新生儿中是否能被吸收且耐受性良好。35名低出生体重婴儿(950 - 1700克;胎龄27 - 36周)在研究第一天(出生后36至60小时之间)通过鼻胃管被分配接受安慰剂或维生素A(25,000国际单位)。在研究第4天和第8天重复给药。在补充前后测定血清视黄醇浓度。通过记录呕吐、嗜睡和易激惹情况以及触摸囟门是否隆起监测维生素A的毒性作用。维生素A治疗组补充后平均血清视黄醇浓度显著高于安慰剂组(45.77±17.07微克/分升对12.88±6.48微克/分升;P = 0.0001)。在任何婴儿中均未检测到毒性作用。总之,高剂量肠内维生素A在低出生体重新生儿中吸收良好,在8天内给予三剂25,000国际单位与任何可检测到的毒性作用无关。