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与用二甲基亚砜冷冻保存的造血干细胞相关的不良反应的历史回顾与未来展望

Historical perspectives and the future of adverse reactions associated with haemopoietic stem cells cryopreserved with dimethyl sulfoxide.

作者信息

Cox Michael A, Kastrup Jens, Hrubiško Mikulas

机构信息

Danish Medicines Agency, Axel Heides Gade 1, 2300, Copenhagen S, Denmark.

出版信息

Cell Tissue Bank. 2012 Jun;13(2):203-15. doi: 10.1007/s10561-011-9248-2. Epub 2011 Mar 11.

Abstract

A retrospective review of the published literature identified several hundred adverse reactions (e.g. nausea, chills, cardiac arrhythmias, neurological symptoms and respiratory arrest) associated with the transplantation of stem cells cryopreserved with dimethyl sulfoxide. The occurrences of these are generally accepted as commonplace, as the majority of reactions are transient, whilst a few patients may require clinical treatment. This exploratory study is a collation of the historical data and the expectations for the notification of serious adverse reactions. Outline information is presented on the development of related European Directives, some technical aspects of dimethyl sulfoxide and the sequential stages of preservation and administration.

摘要

对已发表文献的回顾性研究发现,数百例不良反应(如恶心、寒战、心律失常、神经症状和呼吸骤停)与用二甲基亚砜冷冻保存的干细胞移植有关。这些不良反应的发生通常被认为是常见的,因为大多数反应是短暂的,而少数患者可能需要临床治疗。这项探索性研究是对历史数据以及严重不良反应通报预期的整理。文中概述了相关欧洲指令的发展、二甲基亚砜的一些技术方面以及保存和给药的连续阶段。

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