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已批准的多发性硬化症治疗方法的安全性监测要求:概述

Requirement for safety monitoring for approved multiple sclerosis therapies: an overview.

作者信息

Rommer P S, Zettl U K, Kieseier B, Hartung H-P, Menge T, Frohman E, Greenberg B M, Hemmer B, Stüve O

机构信息

Department of Neurology, Medical University of Vienna, Vienna, Austria.

出版信息

Clin Exp Immunol. 2014 Mar;175(3):397-407. doi: 10.1111/cei.12206.

Abstract

During the last two decades, treatment options for patients with multiple sclerosis (MS) have broadened tremendously. All agents that are currently approved for clinical use have potential side effects, and a careful risk-benefit evaluation is part of a decision algorithm to identify the optimal treatment choice for an individual patient. Whereas glatiramer acetate and interferon beta preparations have been used in MS for decades and have a proven safety record, more recently approved drugs appear to be more effective, but potential risks might be more severe. The potential complications of some novel therapies might not even have been identified to their full extent. This review is aimed at the clinical neurologist in that it offers insights into potential adverse events of each of the approved MS therapeutics: interferon beta, glatiramer acetate, mitoxantrone, natalizumab, fingolimod and teriflunomide, as well as recently approved therapeutics such as dimethyl fumarate and alemtuzumab. It also provides recommendations for monitoring the different drugs during therapy in order to avoid common side effects.

摘要

在过去二十年中,多发性硬化症(MS)患者的治疗选择有了极大的拓展。目前所有获批用于临床的药物都有潜在副作用,而仔细的风险效益评估是确定个体患者最佳治疗选择的决策算法的一部分。醋酸格拉替雷和β-干扰素制剂已在MS治疗中使用了数十年,且有经证实的安全记录,而最近获批的药物似乎更有效,但潜在风险可能更严重。一些新型疗法的潜在并发症甚至可能尚未被完全识别。本综述面向临床神经科医生,旨在深入探讨每种获批的MS治疗药物(β-干扰素、醋酸格拉替雷、米托蒽醌、那他珠单抗、芬戈莫德和特立氟胺)以及最近获批的疗法(如富马酸二甲酯和阿仑单抗)的潜在不良事件。它还提供了在治疗期间监测不同药物以避免常见副作用的建议。

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