我国药源性进行性多灶性白质脑病的风险认知分析

摘要/Abstract

摘要： 目的了解我国关于药源性进行性多灶性白质脑病（PML）的风险认知水平,为临床正确认识及合理防治药源性PML提供参考。方法对国内外文献数据库、世界卫生组织药品不良反应监测数据库以及我国药品不良反应监测数据库中关于PML及药源性PML的相关资料进行整理与分析。结果目前国外医务人员及监管部门已经非常重视药源性PML的诊断、报告以及风险控制。但在我国,无论是从文献的数量,还是药品不良反应报告的资料,均显示出对药源性PML的认知能力存在一定的不足。结论药源性PML的风险在我国持续存在,但我国药品不良反应监测系统在药源性PML的监测方面与国外相比仍存在一定差距。为更好提升我国药源性PML的监测及风险控制能力,需要包括药品生产企业、临床医生及药师以及监管部门在内的多个部门不断努力和沟通协调。

关键词: 药源性, 进行性多灶性白质脑病, 风险认知

Abstract: Objective To investigate the perception ability of risk on drug induced progressive multifocal leukoencephalopathy (PML) in China, and to provide support to treat and prevent PML reasonably. Methods The literatures in domestic and overseas bibliographic databases, the individual adverse drug reaction cases in Vigibase and China adverse drug reaction database were analyzed. Results Health professionals and Regulators in other countries have paid great attention on the diagnose, individual cases report and risk management of drug induced PML. But in our country, the perception of risk on drug induced PML is insufficient. Conclusion The risk of drug induced PML will exist for a long time, while the monitoring ability in our country lags behind other countries. In order to improve the monitoring and risk management ability on drug induced PML, several departments, such as manufactures, health professionals and regulators need to do more efforts and communication.

Key words: drug induced, progressive multifocal leukoencephalopathy, perception of risk

中图分类号:

R965

冯红云, 范燕, 吴桂芝, 董铎. 我国药源性进行性多灶性白质脑病的风险认知分析[J]. 中国药物警戒, 2016, 13(9): 557-562.

FENG Hong-yun, FAN Yan, WU Gui-zhi, DONG Duo. Analysis of the Perception of Risk on Drug-induced Progressive Multifocal Leukoencephalopathy[J]. Chinese Journal of Pharmacovigilance, 2016, 13(9): 557-562.

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