药源性进行性多灶性白质脑病的风险因素及相关药品风险管理实践  

Research of the Risk Factors and Practice of Drug Risk Management on Drug-induced Progressive Multifocal Leukoencephalopathy

作　　者：冯红云[1] 范燕[1] 吴桂芝[1] 董铎[1] 

机构地区：[1]国家食品药品监督管理总局药品评价中心,北京100045

出　　处：《中国药物警戒》2016年第8期472-475,488,共5页Chinese Journal of Pharmacovigilance

摘　　要：目的深入了解药源性进行性多灶性白质脑病的病因及风险因素,实现对风险药物及药源性疾病的有效控制。方法对进行性多灶性白质脑病的病原学基础、发病机制、药物相关性的风险因素、以及相应的风险管理实践进行了分析和梳理。结果 JC病毒感染是发生药源性进行性多灶性白质脑病的病原学基础,免疫功能受损患者是易感人群,长期及多种免疫抑制剂或免疫调节剂使用可增加药源性进行性多灶性白质脑病的风险。结论合理的风险控制措施可有效控制不同风险级别药品进行性多灶性白质脑病的发生风险。我国相关病例报告较少,仍需要加强监测,提高风险控制能力。Objective To investigate the etiology and risk factors, to control effectively the risk of the drug-induced progressive multifocal leukoencephalopathy （PML）. Methods The etiology and pathogenesis of PML, the risk factors of drug-induced PML, and the practice of risk management were analyzed. Results The JC virus infection is etiology base of drug-induced PML, the patients who are immtmosuppressed or have malfunction of the immune system are at higher risk of developing PML. Immunosuppressive medications used for long time or combination with immunomodulators could increase the risk of drug- induced PML. Conclusion The reasonable risk managements could control effectively the risk of drug-induced PML. The individual serious case report of drug-induced PML is few now, so we should enhance the abilities of monitoring and drug risk management on drug-induced PML.

关 键 词：药源性 进行性多灶性白质脑病 药品风险管理 

分 类 号：R994.11[医药卫生—毒理学]