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影响静脉铁-碳水化合物纳米药物安全性和疗效的因素:从生产到临床实践。

Factors influencing safety and efficacy of intravenous iron-carbohydrate nanomedicines: From production to clinical practice.

机构信息

Laboratory for Particles-Biology interactions, Department of materials meet life, Swiss Federal Laboratories for Materials Science and Technology (Empa), St. Gallen, Switzerland.

Institute of Pharmaceutical Sciences of Western Switzerland (ISPSO), University of Geneva, Geneva, Switzerland.

出版信息

Nanomedicine. 2020 Jun;26:102178. doi: 10.1016/j.nano.2020.102178. Epub 2020 Mar 5.

Abstract

Iron deficiency is an important subclinical disease affecting over one billion people worldwide. A growing body of clinical records supports the use of intravenous iron-carbohydrate complexes for patients where iron replenishment is necessary and oral iron supplements are either ineffective or cannot be tolerated by the gastrointestinal tract. A critical characteristic of iron-carbohydrate drugs is the complexity of their core-shell structure, which has led to differences in the efficacy and safety of various iron formulations. This review describes parameters influencing the safety and effectiveness of iron-carbohydrate complexes during production, storage, handling, and clinical application. We summarized the physicochemical and biological assessments of commercially available iron carbohydrate nanomedicines to provide an overview of publicly available data. Further, we reviewed studies that described how subtle differences in the manufacturing process of iron-carbohydrate complexes can impact on the physicochemical, biological, and clinical outcomes of original product versus their intended copies or so-called iron "similar" products.

摘要

缺铁是一种影响全球超过 10 亿人的重要亚临床疾病。越来越多的临床记录支持使用静脉内铁-碳水化合物复合物来补充铁,对于那些需要补充铁且口服铁补充剂无效或胃肠道无法耐受的患者。铁-碳水化合物药物的一个关键特征是其核壳结构的复杂性,这导致了各种铁配方的疗效和安全性存在差异。本综述描述了在生产、储存、处理和临床应用过程中影响铁-碳水化合物复合物安全性和有效性的参数。我们总结了市售铁碳水化合物纳米药物的理化和生物学评估,以提供公开数据的概述。此外,我们还回顾了描述铁-碳水化合物复合物制造过程中的细微差异如何影响原始产品与其预期副本或所谓的铁“类似”产品的理化、生物学和临床结果的研究。

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