Nutrition Services, University of Virginia Children's Hospital, Charlottesville, VA 22903, USA.
American Regent, Inc., Norristown, PA 19403, USA.
Nutrients. 2022 Apr 23;14(9):1770. doi: 10.3390/nu14091770.
Parenteral nutrition (PN) provides support for patients lacking sufficient intestinal absorption of nutrients. Historically, the need for trace element (TE) supplementation was poorly appreciated, and multi-TE products were not initially subjected to rigorous oversight by the United States Food and Drug Administration (FDA). Subsequently, the American Society for Parenteral and Enteral Nutrition (ASPEN) issued dosage recommendations for PN, which are updated periodically. The FDA has implemented review and approval processes to ensure access to safer and more effective TE products. The development of a multi-TE product meeting ASPEN recommendations and FDA requirements is the result of a partnership between the FDA, industry, and clinicians with expertise in PN. This article examines the rationale for the development of TRALEMENT (Trace Elements Injection 4*) and the FDA's rigorous requirements leading to its review and approval. This combination product contains copper, manganese, selenium, and zinc and is indicated for use in adults and pediatric patients weighing ≥10 kg. Comprehensive management of PN therapy requires consideration of many factors when prescribing, reviewing, preparing, and administering PN, as well as monitoring the nutritional status of patients receiving PN. Understanding patients' TE requirements and incorporating them into PN is an important part of contemporary PN therapy.
肠外营养（PN）为那些肠道无法充分吸收营养的患者提供支持。在历史上，人们对微量元素（TE）补充的需求认识不足，而且多 TE 产品最初并未受到美国食品和药物管理局（FDA）的严格监管。随后，美国肠外和肠内营养学会（ASPEN）发布了 PN 的剂量推荐，这些推荐会定期更新。FDA 已实施审查和批准程序，以确保能够获得更安全、更有效的 TE 产品。符合 ASPEN 建议和 FDA 要求的多 TE 产品的开发是 FDA、行业和具有 PN 专业知识的临床医生之间合作的结果。本文探讨了开发 TRALEMENT（Trace Elements Injection 4*）的基本原理，以及 FDA 为其审查和批准制定的严格要求。该组合产品包含铜、锰、硒和锌，适用于成人和体重≥10 公斤的儿科患者。全面管理 PN 治疗需要在开具、审查、准备和输注 PN 以及监测接受 PN 的患者的营养状况时考虑许多因素。了解患者的 TE 需求并将其纳入 PN 是当代 PN 治疗的重要组成部分。
