Walker Mindi, Makropoulos Dorie, Achuthanandam Ram, Bugelski Peter J
Centocor R&D, Toxicology and Investigational Pharmacology, R-4-2, Radnor, PA 19087, USA.
Curr Opin Drug Discov Devel. 2010 Jan;13(1):124-35.
Infusion reactions and cytokine release syndrome (CRS) are an emerging issue in drug development and are of particular importance with the development of new therapeutic proteins. Increasing concerns regarding patient safety require a better understanding of the mechanism involved and the development of novel methods for preventing and predicting such reactions and CRS. This review discusses developments during the past few years in understanding the mechanisms that cause infusion reactions and CRS, advances in approaches to prevent CRS, the reason why preclinical animal models are unreliable predictors of CRS, and new developments in the design and analysis of in vitro screening systems for the prediction of CRS.
输注反应和细胞因子释放综合征（CRS）是药物研发中一个新出现的问题，在新型治疗性蛋白质的研发中尤为重要。对患者安全的日益关注要求更好地理解其中涉及的机制，并开发预防和预测此类反应及CRS的新方法。本文综述了过去几年在理解引起输注反应和CRS的机制方面的进展、预防CRS方法的进步、临床前动物模型作为CRS不可靠预测指标的原因，以及用于预测CRS的体外筛选系统的设计和分析方面的新进展。
