Vitamin A to prevent bronchopulmonary dysplasia in very-low-birth-weight infants: Has the dose been too low?

Vitamin A to prevent bronchopulmonary dysplasia in very-low-birth-weight infants: Has the dose been too low?
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DOI:
10.1016/s0378-3782(97)01869-0
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发表时间:
1997-07-24
影响因子:
2.5
通讯作者:
Verter, J
Verter, J
中科院分区:
医学4区
文献类型:
--
作者:
Kennedy, KA;Stoll, BJ;Verter, J

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目的:补充维生素A对预防支气管肺发育不良的效果不一致。这些报告的荟萃分析显示,与维生素A补充相关的死亡或支气管肺发育不良的相对风险为0.69-1.02。有效的剂量方案或血清视黄醇浓度尚未确定在以前的报告。这项初步研究的目的是确定一种维生素A方案,使血清视黄醇浓度达到25-55 μ g/dl。研究设计:在这项三阶段研究中,入组了91名婴儿(平均出生体重799-864 g)。维生素A每周给药3次,持续4周,平均日剂量为986-2143 IU/天。进行体格检查,每周采集血清视黄醇样本,以评估毒性的临床体征。结果如下:大部分血清视黄醇浓度保持< 25 μ g/dl,直到每周三次肌内注射5000 IU/剂维生素A。没有临床毒性体征与维生素A的较高剂量和较高血清浓度相关。结论:需要进行一项5000 IU/剂每周三次的维生素A补充剂的大型临床试验(比三项已发表的临床试验中使用的剂量高25-114%),以评估维生素A补充剂是否安全地降低极低出生体重儿支气管肺发育不良的风险。(C)1997 Elsevier Science爱尔兰有限公司
Objective: Inconsistent effects of vitamin A supplementation on prevention of bronchopulmonary dysplasia have been reported. Meta-analysis of these reports resulted in a relative risk of 0.69-1.02 for death or bronchopulmonary dysplasia associated with vitamin A supplementation. Effective dosage regimens or serum retinol concentrations have not been determined in previous reports. The purpose of this pilot study was to define a vitamin A regimen that produces serum retinol concentrations of 25-55 mu g/dl. Study design: In this three-phase study, 91 infants (mean birth weight 799-864 g) were enrolled. Vitamin A was administered three times/week for 4 weeks at an average daily dose of 986-2143 IU/day. Physical examinations were performed and serum retinol specimens were collected weekly to assess clinical signs of toxicity. Results: The majority of serum retinol concentrations remained < 25 mu g/dl until an intramuscular vitamin A dose of 5000 IU/dose three times/week was used. No clinical signs of toxicity were associated with the higher dosage and higher serum concentrations of vitamin A. Conclusion: A large clinical trial of vitamin A supplementation with 5000 IU/dose three times/week (25-114% more than the dose used in the three published clinical trials) is needed to assess whether vitamin A supplementation safely reduces the risk of bronchopulmonary dysplasia in very-low-birth-weight infants. (C) 1997 Elsevier Science Ireland Ltd.