Department of Pharmacy, Lucile Packard Children's Hospital at Stanford, 725 Welch Road, Palo Alto, CA 94304, USA.
Nutrients. 2012 Nov 2;4(11):1566-74. doi: 10.3390/nu4111566.
Aluminum (Al) is a contaminant in all parenteral nutrition (PN) solution component products. Manufacturers currently label these products with the maximum Al content at the time of expiry. We recently published data to establish the actual measured concentration of Al in PN solution products prior to being compounded in the clinical setting [1]. The investigation assessed quantitative Al content of all available products used in the formulation of PN solutions. The objective of this study was to assess the Al exposure in neonatal patients using the least contaminated PN solutions and determine if it is possible to meet the FDA “safe limit” of less than 5 μg/kg/day of Al. The measured concentrations from our previous study were analyzed and the least contaminated products were identified. These concentrations were entered into our PN software and the least possible Al exposure was determined. A significant decrease (41%–44%) in the Al exposure in neonatal patients can be achieved using the least contaminated products, but the FDA “safe limit” of less than 5 μg/kg/day of Al was not met. However, minimizing the Al exposure may decrease the likelihood of developing Al toxicity from PN.
铝（Al）是所有肠外营养（PN）溶液成分产品的污染物。制造商目前在产品过期时用最大 Al 含量对这些产品进行贴标。我们最近发布了数据，以确定在临床配制前 PN 溶液产品中的实际测量的 Al 浓度[1]。该调查评估了 PN 溶液配方中使用的所有可用产品的定量 Al 含量。本研究的目的是使用污染最少的 PN 溶液评估新生儿患者的 Al 暴露情况，并确定是否有可能达到 FDA 的“安全限量”，即每天每公斤体重少于 5 μg 的 Al。对我们之前研究中的测量浓度进行了分析，并确定了污染最少的产品。将这些浓度输入我们的 PN 软件，确定了最小的 Al 暴露量。使用污染最少的产品可使新生儿患者的 Al 暴露量显著降低（41%-44%），但未能达到 FDA 每天每公斤体重少于 5 μg 的 Al“安全限量”。然而，最大程度地减少 Al 暴露可能会降低 PN 引起的 Al 毒性的可能性。
